Last data update: May 20, 2024. (Total: 46824 publications since 2009)
Records 1-30 (of 227 Records) |
Query Trace: Kit B[original query] |
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Continuous quality evaluation of the Asanté rapid test for recent infection for robust kit lot quality verification
Zheng A , Detorio M , Dobbs T , Shanmugam V , Tan X , Vuong J , Domaoal RA , Lee K , Williams L , Jackson K , Parekh B , Yufenyuy EL . PLOS Glob Public Health 2024 4 (5) e0003195 The Sedia Biosciences Asanté rapid test for recent infection (RTRI) can identify HIV infections and characterize HIV-1 as recent or long-term infection via the positive verification (V) line and long-term line (LT) line, respectively. Tracking with Recency Assays to Control the Epidemic (TRACE) program uses RTRI assays. Successful implementation of TRACE requires high-quality test performance. The goal of this study is to evaluate the additional quality practices established for new kit lots prior to field use. Asanté lot quality control data from the manufacturer is reviewed by the Centers for Disease Control and Prevention International Laboratory Branch (CDC-ILB) in the Division of Global HIV and TB using. If a lot passes manufacturer quality control and CDC-ILB review, test kits are sent to CDC-ILB for further evaluation. Evaluation by CDC includes inter-rater reliability and linear regressions comparing the V and LT lines against reference data as well as V and LT line data between testers. A Bland-Altman analysis was conducted to assess bias and systematic error. Overall, CDC-ILB passed 29 (91%) out of 32 Sedia Biosciences Asanté kit lots that initially passed manufacturing quality control from July 2017 to May 2020. Regression analyses demonstrate that test kits are performing as expected with consistent R2≥0.92 for both V and LT lines. On average, inter-rater reliability kappa was 0.9, indicating a strong level of agreement. Bland-Altman analyses demonstrate high agreement with little to no systematic error and bias. Ongoing evaluation of new RTRI kit lots is important to ensure high quality test performance. Rejecting 9% of kit lots highlight the importance of continuing to work with manufacturers to ensure consistent kit production and quality assurance (QA) activities. Investing in effective QA measures, conducting both pre- and post-market performance data reviews, could help improve RTRI accuracy and outcomes in similar testing programs. |
Detection of anatoxins in human urine by liquid chromatography triple quadrupole mass spectrometry and ELISA
Cunningham BR , Lagon SR , Bragg WA , Hill D , Hamelin EI . Toxins (Basel) 2024 16 (3) Harmful cyanobacterial blooms are becoming more common and persistent around the world. When in bloom, various cyanobacterial strains can produce anatoxins in high concentrations, which, unlike other cyanobacterial toxins, may be present in clear water. Potential human and animal exposures to anatoxins occur mainly through unintentional ingestion of contaminated algal mats and water. To address this public health threat, we developed and validated an LC-MS/MS method to detect anatoxins in human urine to confirm exposures. Pooled urine was fortified with anatoxin-a and dihydroanatoxin at concentrations from 10.0 to 500 ng/mL to create calibrators and quality control samples. Samples were diluted with isotopically labeled anatoxin and solvent prior to LC-MS/MS analysis. This method can accurately quantitate anatoxin-a with inter- and intraday accuracies ranging from 98.5 to 103% and relative standard deviations < 15%, which is within analytical guidelines for mass spectrometry methods. Additionally, this method qualitatively detects a common degradation product of anatoxin, dihydroanatoxin, above 10 ng/mL. We also evaluated a commercial anatoxin-a ELISA kit for potential diagnostic use; however, numerous false positives were detected from unexposed individual human urine samples. In conclusion, we have developed a method to detect anatoxins precisely and accurately in urine samples, addressing a public health area of concern, which can be applied to future exposure events. |
Predictors of severity and prolonged hospital stay of viral acute respiratory infections (ARI) among children under five years in Burkina Faso, 2016-2019
Ilboudo AK , Cissé A , Milucky J , Tialla D , Mirza SA , Diallo AO , Bicaba BW , Charlemagne KJ , Diagbouga PS , Owusu D , Waller JL , Talla-Nzussouo N , Charles MD , Whitney CG , Tarnagda Z . BMC Infect Dis 2024 24 (1) 331 BACKGROUND: Viruses are the leading etiology of acute respiratory infections (ARI) in children. However, there is limited knowledge on drivers of severe acute respiratory infection (SARI) cases involving viruses. We aimed to identify factors associated with severity and prolonged hospitalization of viral SARI among children < 5 years in Burkina Faso. METHODS: Data were collected from four SARI sentinel surveillance sites during October 2016 through April 2019. A SARI case was a child < 5 years with an acute respiratory infection with history of fever or measured fever ≥ 38 °C and cough with onset within the last ten days, requiring hospitalization. Very severe ARI cases required intensive care or had at least one danger sign. Oropharyngeal/nasopharyngeal specimens were collected and analyzed by multiplex real-time reverse-transcription polymerase chain reaction (rRT-PCR) using FTD-33 Kit. For this analysis, we included only SARI cases with rRT-PCR positive test results for at least one respiratory virus. We used simple and multilevel logistic regression models to assess factors associated with very severe viral ARI and viral SARI with prolonged hospitalization. RESULTS: Overall, 1159 viral SARI cases were included in the analysis after excluding exclusively bacterial SARI cases (n = 273)very severe viral ARI cases were common among children living in urban areas (AdjOR = 1.3; 95% CI: 1.1-1.6), those < 3 months old (AdjOR = 1.5; 95% CI: 1.1-2.3), and those coinfected with Klebsiella pneumoniae (AdjOR = 1.9; 95% CI: 1.2-2.2). Malnutrition (AdjOR = 2.2; 95% CI: 1.1-4.2), hospitalization during the rainy season (AdjOR = 1.71; 95% CI: 1.2-2.5), and infection with human CoronavirusOC43 (AdjOR = 3; 95% CI: 1.2-8) were significantly associated with prolonged length of hospital stay (> 7 days). CONCLUSION: Younger age, malnutrition, codetection of Klebsiella pneumoniae, and illness during the rainy season were associated with very severe cases and prolonged hospitalization of SARI involving viruses in children under five years. These findings emphasize the need for preventive actions targeting these factors in young children. |
Examination of SARS-CoV-2 serological test results from multiple commercial and laboratory platforms with an in-house serum panel
Lester SN , Stumpf M , Freeman BD , Mills L , Schiffer J , Semenova V , Jia T , Desai R , Browning P , Alston B , Ategbole M , Bolcen S , Chen A , David E , Manitis P , Tatum H , Qin Y , Zellner B , Drobeniuc J , Tejada-Strop A , Chatterjee P , Shrivastava-Ranjan P , Jenks MH , McMullan LK , Flint M , Spiropoulou CF , Niemeyer GP , Werner BJ , Bean CJ , Johnson JA , Hoffmaster AR , Satheshkumar PS , Schuh AJ , Owen SM , Thornburg NJ . Access Microbiol 2024 6 (2) Severe acute respiratory syndrome (SARS) coronavirus 2 (SARS-CoV-2) is a novel human coronavirus that was identified in 2019. SARS-CoV-2 infection results in an acute, severe respiratory disease called coronavirus disease 2019 (COVID-19). The emergence and rapid spread of SARS-CoV-2 has led to a global public health crisis, which continues to affect populations across the globe. Real time reverse transcription polymerase chain reaction (rRT-PCR) is the reference standard test for COVID-19 diagnosis. Serological tests are valuable tools for serosurveillance programs and establishing correlates of protection from disease. This study evaluated the performance of one in-house enzyme linked immunosorbent assay (ELISA) utilizing the pre-fusion stabilized ectodomain of SARS-CoV-2 spike (S), two commercially available chemiluminescence assays Ortho VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and Abbott SARS-CoV-2 IgG assay and one commercially available Surrogate Virus Neutralization Test (sVNT), GenScript USA Inc., cPass SARS-CoV-2 Neutralization Antibody Detection Kit for the detection of SARS-CoV-2 specific antibodies. Using a panel of rRT-PCR confirmed COVID-19 patients' sera and a negative control group as a reference standard, all three immunoassays demonstrated high comparable positivity rates and low discordant rates. All three immunoassays were highly sensitive with estimated sensitivities ranging from 95.4-96.6 %. ROC curve analysis indicated that all three immunoassays had high diagnostic accuracies with area under the curve (AUC) values ranging from 0.9698 to 0.9807. High positive correlation was demonstrated among the conventional microneutralization test (MNT) titers and the sVNT inhibition percent values. Our study indicates that independent evaluations are necessary to optimize the overall utility and the interpretation of the results of serological tests. Overall, we demonstrate that all serological tests evaluated in this study are suitable for the detection of SARS-CoV-2 antibodies. |
Validation of improved automated nucleic acid extraction methods for direct detection of polioviruses for global polio eradication
Miles SJ , Harrington C , Sun H , Deas A , Oberste MS , Nix WA , Vega E , Gerloff N . J Virol Methods 2024 326 114914 Polioviruses (PV), the main causative agent of acute flaccid paralysis (AFP), are positive-sense single-stranded RNA viruses of the family Picornaviridae. As we approach polio eradication, accurate and timely detection of poliovirus in stool from AFP cases becomes vital to success for the eradication efforts. Direct detection of PV from clinical diagnostic samples using nucleic acid (NA) extraction and real-time reverse transcriptase polymerase chain reaction (rRT-PCR) instead of the current standard method of virus isolation in culture, eliminates the long turn-around time to diagnosis and the need for high viral titer amplification in laboratories. An essential component of direct detection of PV from AFP surveillance samples is the efficient extraction of NA. Potential supply chain issues and lack of vendor presence in certain areas of the world necessitates the validation of multiple NA extraction methods. Using retrospective PV-positive surveillance samples (n=104), two extraction kits were compared to the previously validated Zymo Research Quick-RNA™ Viral Kit. The Roche High Pure Viral RNA Kit, a column-based manual extraction method, and the MagMaX™ Pathogen RNA/DNA kit used in the automated Kingfisher Flex system were both non-inferior to the Zymo kit, with similar rates of PV detection in pivotal rRT-PCR assays, such as pan-poliovirus (PanPV), poliovirus serotype 2 (PV2), and wild poliovirus serotype 1 (WPV1). These important assays allow the identification and differentiation of PV genotypes and serotypes and are fundamental to the GPLN program. Validation of two additional kits provides feasible alternatives to the current piloted method of NA extraction for poliovirus rRT-PCR assays. |
Assessment of open data kit mobile technology adoption to enhance reporting of supportive supervision conducted for oral poliovirus vaccine supplementary immunization activities in Nigeria, March 2017-February 2020
Bammeke P , Erbeto T , Aregay A , Kamran Z , Adamu US , Damisa E , Usifoh N , Nsubuga P , Waziri N , Bolu O , Dagoe E , Shuaib F . Pan Afr Med J 2023 45 5 INTRODUCTION: in Nigeria, supportive supervision of Supplementary Immunization Activities (SIA) is a quality improvement strategy for providing support to vaccination teams administering the poliovirus vaccines to children under 5 years of age. Supervision activities were initially reported in paper forms. This had significant limitations, which led to Open Data Kit (ODK) technology being adopted in March 2017. A review was conducted to assess the impact of ODK for supervision reporting in place of paper forms. METHODS: issues with paper-based reporting and the benefits of ODK were recounted. We determined the average utilization of ODK per polio SIA rounds and assessed the supervision coverage over time based on the proportion of local government areas with ODK geolocation data per round. RESULTS: a total of 17 problematic issues were identified with paper-based reporting, and ODK addressed all the issues. Open Data Kit-based supervision reports increased from 3,125 in March 2017 to 51,060 in February 2020. Average ODK submissions for national rounds increased from 84 in March 2017 to 459 in February 2020 and for sub-national rounds increased from 533 in July 2017 to 1,596 in October 2019. Supportive supervision coverage improved from 42.5% in March 2017 to 97% in February 2020. CONCLUSION: the use of digital technologies in public health has comparative advantages over paper forms, and the adoption of ODK for supervision reporting during polio SIAs in Nigeria experienced the advantages. The visibility and coverage of supportive supervision improved, consequentially contributing to the improved quality of polio SIAs. |
Factors affecting maternal participation in the genetic component of the National Birth Defects Prevention Study-United States, 1997-2007.
Glidewell J , Reefhuis J , Rasmussen SA , Woomert A , Hobbs C , Romitti PA , Crider KS . Genet Med 2014 16 (4) 329-37 PURPOSE: As epidemiological studies expand to examine gene-environment interaction effects, it is important to identify factors associated with participation in genetic studies. The National Birth Defects Prevention Study is a multisite case-control study designed to investigate environmental and genetic risk factors for major birth defects. The National Birth Defects Prevention Study includes maternal telephone interviews and mailed buccal cell self-collection kits. Because subjects can participate in the interview, independent of buccal cell collection, detailed analysis of factors associated with participation in buccal cell collection was possible. METHODS: Multivariable logistic regression models were used to identify the factors associated with participation in the genetic component of the study. RESULTS: Buccal cell participation rates varied by race/ethnicity (non-Hispanic whites, 66.9%; Hispanics, 60.4%; and non-Hispanic blacks, 47.3%) and study site (50.2-74.2%). Additional monetary incentive following return of buccal cell kit and shorter interval between infant's estimated date of delivery and interview were associated with increased participation across all racial/ethnic groups. Higher education and delivering an infant with a birth defect were associated with increased participation among non-Hispanic whites and Hispanics. CONCLUSION: Factors associated with participation varied by race/ethnicity. Improved understanding of factors associated with participation may facilitate strategies to increase participation, thereby improving generalizability of study findings. |
Evaluation of DNA extraction from granulocytes discarded in the separation medium after isolation of peripheral blood mononuclear cells and plasma from whole blood.
Murray JR , Rajeevan MS . BMC Res Notes 2013 6 440 BACKGROUND: Whole blood is generally processed for plasma and peripheral blood mononuclear cells (PBMCs) from granulocytes/erythrocytes using gradient centrifugation of blood with Histopaue-Ficoll. After separation of plasma and PBMCs, the residual erythrocytes/granulocytes, a rich source of DNA, is often discarded along with the separation medium. In order to isolate DNA from the granulocytes, current methods require the removal of the separation medium and subsequent purification of granulocytes. This report provides a method for extracting DNA using the PAXgene Blood DNA kit from granulocytes without purifying them from the separation medium. FINDINGS: Based on 719 erythrocyte/granulocyte samples stored frozen for approximately 10 years in Ficoll-Hypaque separation medium, the mean yield of DNA was 395 μg (median = 281 μg; range = 1.36 to 2077.2 μg), with mean A260/A280 ratio of 1.84 (median = 1.84; range = 1.17 to 2.23). The quality of isolated DNA was sufficient for use as a template for restriction enzyme digestion, real-time PCR, pyrosequencing, and gel based variable number tandem repeats (VNTR) genotyping. CONCLUSIONS: By demonstrating the extraction of substantial amounts of high quality granulocytes DNA without purifying them from the separation medium, this method offers laboratories and biobanks a flexible and cost-effective approach to obtain plasma, PBMCs, and large amounts of DNA from a single blood collection for a variety of molecular genetics/epidemiologic studies. |
Prevalence and characterization of gastroenteritis viruses among hospitalized children during a pilot rotavirus vaccine introduction in Vietnam
Mai CTN , Ly LTK , Doan YH , Oka T , Mai LTP , Quyet NT , Mai TNP , Thiem VD , Anh LT , Van Sanh L , Hien ND , Anh DD , Parashar UD , Tate JE , Van Trang N . Viruses 2023 15 (11) Rotavirus (RV), norovirus (NoV), sapovirus (SaV), and human astrovirus (HAstV) are the most common viral causes of gastroenteritis in children worldwide. From 2016 to 2021, we conducted a cross-sectional descriptive study to determine the prevalence of these viruses in hospitalized children under five years old in Nam Dinh and Thua Thien Hue provinces in Vietnam during the pilot introduction of the RV vaccine, Rotavin-M1 (POLYVAC, Hanoi, Vietnam). We randomly selected 2317/6718 (34%) acute diarrheal samples from children <5 years of age enrolled at seven sentinel hospitals from December 2016 to May 2021; this period included one year surveillance pre-vaccination from December 2016 to November 2017. An ELISA kit (Premier Rotaclone(®), Meridian Bioscience, Inc., Cincinnati, OH, USA) was used to detect RV, and two multiplex real-time RT-PCR assays were used for the detection of NoV, SaV and HAstV. The prevalence of RV (single infection) was reduced from 41.6% to 22.7% (p < 0.0001) between pre- and post-vaccination periods, while the single NoV infection prevalence more than doubled from 8.8% to 21.8% (p < 0.0001). The SaV and HAstV prevalences slightly increased from 1.9% to 3.4% (p = 0.03) and 2.1% to 3.3% (p = 0.09), respectively, during the same period. Viral co-infections decreased from 7.2% to 6.0% (p = 0.24), mainly due to a reduction in RV infection. Among the genotypeable samples, NoV GII.4, SaV GI.1, and HAstV-1 were the dominant types, representing 57.3%, 32.1%, and 55.0% among the individual viral groups, respectively. As the prevalence of RV decreases following the national RV vaccine introduction in Vietnam, other viral pathogens account for a larger proportion of the remaining diarrhea burden and require continuing close monitoring. |
Shigellosis outbreak among persons experiencing homelessness - San Diego County, California, October-December 2021
Ohlsen EC , Angel K , Maroufi A , Kao A , Victorio MJ , Cua LS , Kimura A , Vanden Esschert K , Logan N , McMichael TM , Beatty ME , Shah S . Epidemiol Infect 2023 1-23 During October 2021, the County of San Diego Health and Human Services Agency identified | 18 five cases of shigellosis among persons experiencing homelessness (PEH). We conducted an | 19 outbreak investigation and developed interventions to respond to shigellosis outbreaks among | 20 PEH. Confirmed cases occurred among PEH with stool-cultured Shigella sonnei; probable cases | 21 were among PEH with Shigella-positive culture-independent diagnostic testing. Patients were | 22 interviewed to determine infectious sources and risk factors. Fifty-three patients were identified | 23 (47 confirmed, six probable); 34 (64%) were hospitalized. None died. No point source was | 24 identified. Patients reported inadequate access to clean water and sanitation facilities, including | 25 public restrooms closed because of the COVID-19 pandemic. After implementing interventions, | 26 including handwashing stations, more frequent public restroom cleaning, sanitation kit | 27 distribution, and isolation housing for ill persons, S. sonnei cases decreased to preoutbreak | 28 frequencies. Improving public sanitation access was associated with decreased cases and should | 29 be considered to prevent outbreaks among PEH |
Equipping educators to empower students with a tracking education kit
Curtiss C . J Environ Health 2023 86 (1) 34-36 Recent findings reveal serious recruitment needs within the environmental health workforce. In addition, the public health landscape continues to evolve, with technological improvements in data collection, analysis, visualization, and dissemination. New environmental public health professionals must be equipped with the most current and best resources to help them succeed in their jobs. | | The Environmental Public Health Tracking Program (Tracking Program) within the Centers for Disease Control and Prevention aims to connect environmental and health information into one place, making it accessible to anyone and easy to share. Tools are only effective, however, when they are known and used. Student education on how to use the Tracking Program tools is a step toward empowering and readying the future workforce. This month’s column highlights a new Tracking Education Kit for educators—a collection of instructor lessons featuring PowerPoint slides, an assignment bank, a questions bank, an assignment bank navigator, and an instructor guide. |
COVID-19 testing of United States-bound agricultural workers in Mexico
Teleaga J , White ZA , Cervantes J , Assael R , Barrera G , Toney S , Marano N , Rodriguez Lainz A , Assael C , Ortega A , Chappelle CG , Bustamante N , Moser K , Posey DL . J Immigr Minor Health 2023 25 (6) 1295-1301 The COVID-19 pandemic presents global health, welfare, and economic concerns. The agricultural workforce has experienced adverse effects, placing the U.S. food supply at risk. Agricultural workers temporarily travel to the United States on H-2A visas to supplement the agricultural workforce. Approximately 300,000 agricultural workers enter the United States with H-2A visas each year; over 90.0% are from Mexico. During February-May 2021, a COVID-19 testing pilot was performed with Clínica Médica Internacional (CMI), a clinic that performs medical examinations for US-bound immigrants, to determine the SARS-CoV-2 infection status of H-2A agricultural workers in Mexico before entry to the US. The CerTest VIASURE Real Time PCR Detection Kit was used. Participants' demographic information, test results, and testing turnaround times were collected. Workers who tested positive for SARS-CoV-2 completed isolation before US entry. During the pilot, 1195 H-2A workers were tested; 15 (1.3%) tested positive. Average reporting time was 31 h after specimen collection. This pilot demonstrated there is interest from H-2A employers and agents in testing the H-2A community before US entry. Testing for SARS-CoV-2 can yield public health benefit, is feasible, and does not delay entry of temporary agricultural workers to the US. |
Executive summary: A compendium of strategies to prevent healthcare-associated infections in acute-care hospitals: 2022 updates
Yokoe DS , Advani SD , Anderson DJ , Babcock HM , Bell M , Berenholtz SM , Bryant KA , Buetti N , Calderwood MS , Calfee DP , Dubberke ER , Ellingson KD , Fishman NO , Gerding DN , Glowicz J , Hayden MK , Kaye KS , Klompas M , Kociolek LK , Landon E , Larson EL , Malani AN , Marschall J , Meddings J , Mermel LA , Patel PK , Perl TM , Popovich KJ , Schaffzin JK , Septimus E , Trivedi KK , Weinstein RA , Maragakis LL . Infect Control Hosp Epidemiol 2023 44 (10) 1-15 Strategies to prevent catheter-associated urinary tract infections (CAUTIs) | Essential practices | Infrastructure and resources | 1 Perform a CAUTI risk assessment and implement an organization-wide program to identify and remove catheters that are no longer necessary using 1 or | more methods documented to be effective. (Quality of evidence: MODERATE) | 2 Provide appropriate infrastructure for preventing CAUTI. (Quality of evidence: LOW) | 3 Provide and implement evidence-based protocols to address multiple steps of the urinary catheter life cycle: catheter appropriateness (step 0), insertion | technique (step 1), maintenance care (step 2), and prompt removal (step 3) when no longer appropriate. (Quality of evidence: LOW) | 4 Ensure that only trained healthcare personnel (HCP) insert urinary catheters and that competency is assessed regularly. (Quality of evidence: LOW) | 5 Ensure that supplies necessary for aseptic technique for catheter insertion are available and conveniently located. (Quality of evidence: LOW) | 6 Implement a system for documenting the following in the patient record: physician order for catheter placement, indications for catheter insertion, date | and time of catheter insertion, name of individual who inserted catheter, nursing documentation of placement, daily presence of a catheter and | maintenance care tasks, and date and time of catheter removal. Record criteria for removal and justification for continued use. (Quality of evidence: | LOW) | 7 Ensure that sufficiently trained HCP and technology resources are available to support surveillance for catheter use and outcomes. (Quality of evidence: | LOW) | 8 Perform surveillance for CAUTI if indicated based on facility risk assessment or regulatory requirements. (Quality of evidence: LOW) | 9 Standardize urine culturing by adapting an institutional protocol for appropriate indications for urine cultures in patients with and without indwelling | catheters. Consider incorporating these indications into the electronic medical record, and review indications for ordering urine cultures in the CAUTI | risk assessment. (Quality of evidence: LOW) | Education and training | 1 Educate HCP involved in the insertion, care, and maintenance of urinary catheters about CAUTI prevention, including alternatives to indwelling | catheters, and procedures for catheter insertion, management, and removal. (Quality of evidence: LOW) | 2 Assess healthcare professional competency in catheter use, catheter care, and maintenance. (Quality of evidence: LOW) | 3 Educate HCP about the importance of urine-culture stewardship and provide indications for urine cultures. (Quality of evidence: LOW) | 4 Provide training on appropriate collection of urine. Specimens should be collected and should arrive at the microbiology laboratory as soon as possible, | preferably within an hour. If delay in transport to the laboratory is expected, samples should be refrigerated (no more than 24 hours) or collected in | preservative urine transport tubes. (Quality of evidence: LOW) | 5 Train clinicians to consider other methods for bladder management, such as intermittent catheterization or external male or female collection devices, | when appropriate, before placing an indwelling urethral catheter. (Quality of evidence: LOW) | 6 Share data in a timely fashion and report to appropriate stakeholders. (Quality of evidence: LOW) | Insertion of indwelling catheters | 1 Insert urinary catheters only when necessary for patient care and leave in place only as long as indications remain. (Quality of evidence: MODERATE) | 2 Consider other methods for bladder management such as intermittent catheterization, or external male or female collection devices, when appropriate. | (Quality of evidence: LOW) | 3 Use appropriate technique for catheter insertion. (Quality of evidence: MODERATE). | 4 Consider working in pairs to help perform patient positioning and monitor for potential contamination during placement. (Quality of evidence: LOW) | 5 Practice hand hygiene (based on CDC or WHO guidelines) immediately before insertion of the catheter and before and after any manipulation of the | catheter site or apparatus. (Quality of evidence: LOW) | 6 Insert catheters following aseptic technique and using sterile equipment. (Quality of evidence: LOW) | 7 Use sterile gloves, drape, and sponges, a sterile antiseptic solution for cleaning the urethral meatus, and a sterile single-use packet of lubricant jelly for | insertion. (Quality of evidence: LOW) | 8 Use a catheter with the smallest feasible diameter consistent with proper drainage to minimize urethral trauma but consider other catheter types and | sizes when warranted for patients with anticipated difficult catheterization to reduce the likelihood that a patient will experience multiple, sometimes | traumatic, catheterization attempts. (Quality of evidence: LOW) | Management of indwelling catheters | 1 Properly secure indwelling catheters after insertion to prevent movement and urethral traction. (Quality of evidence: LOW) | 2 Maintain a sterile, continuously closed drainage system. (Quality of evidence: LOW) | 3 Replace the catheter and the collecting system using aseptic technique when breaks in aseptic technique, disconnection, or leakage occur. (Quality of | evidence: LOW) | 4 For examination of fresh urine, collect a small sample by aspirating urine from the needleless sampling port with a sterile syringe/cannula adaptor after | cleansing the port with disinfectant. (Quality of evidence: LOW) | (Continued) | 2 Deborah S. Yokoe et al | https://doi.org/10.1017/ice.2023.138 Published online by Cambridge University Press | Strategies to prevent central-line–associated bloodstream infections (CLABSIs) | (Continued ) | 5 Facilitate timely transport of urine samples to laboratory. If timely transport is not feasible, consider refrigerating urine samples or using samplecollection cups with preservatives. Obtain larger volumes of urine for special analyses (eg, 24-hour urine) aseptically from the drainage bag. (Quality of | evidence: LOW) | 6 Maintain unobstructed urine flow. (Quality of evidence: LOW) | 7 Employ routine hygiene. Cleaning the meatal area with antiseptic solutions is an unresolved issue, though emerging literature supports chlorhexidine | use prior to catheter insertion. Alcohol-based products should be avoided given concerns about the alcohol causing drying of the mucosal tissues. | (Quality of evidence: LOW) | Additional approaches | 1 Develop a protocol for standardizing diagnosis and management of postoperative urinary retention, including nurse-directed use of intermittent | catheterization and use of bladder scanners when appropriate as alternatives to indwelling urethral catheterization. (Quality of evidence: MODERATE) | 2 Establish a system for analyzing and reporting data on catheter use and adverse events from catheter use. (Quality of evidence: LOW) | 3 Establish a system for defining, analyzing, and reporting data on non–catheter-associated UTIs, particularly UTIs associated with the use of devices | being used as alternatives to indwelling urethral catheters. (Quality of evidence: LOW) | Essential practices | Before insertion | 1 Provide easy access to an evidence-based list of indications for CVC use to minimize unnecessary CVC placement. (Quality of evidence: LOW) | 2 Require education and competency assessment of healthcare personnel (HCP) involved in insertion, care and maintenance of CVCs about CLABSI | prevention. (Quality of evidence: MODERATE) | 3 Bathe ICU patients aged >2 months with a chlorhexidine preparation on a daily basis. (Quality of evidence: HIGH) | At insertion | 1 In ICU and non-ICU settings, a facility should have a process in place, such as a checklist, to ensure adherence to infection prevention practices at the | time of CVC insertion. (Quality of evidence: MODERATE) | 2 Perform hand hygiene prior to catheter insertion or manipulation. (Quality of evidence: MODERATE) | 3 The subclavian site is preferred to reduce infectious complications when the catheter is placed in the ICU setting. (Quality of evidence: HIGH) | 4 Use an all-inclusive catheter cart or kit. (Quality of evidence: MODERATE) | 5 Use ultrasound guidance for catheter insertion. (Quality of evidence: HIGH) | 6 Use maximum sterile barrier precautions during CVC insertion. (Quality of evidence: MODERATE) | After insertion | 1 Ensure appropriate nurse-to-patient ratio and limit use of float nurses in ICUs. (Quality of evidence: HIGH) | 2 Use chlorhexidine-containing dressings for CVCs in patients aged >2 months. (Quality of evidence: HIGH) | 3 For nontunneled CVCs in adults and children, change transparent dressings and perform site care with a chlorhexidine-based antiseptic at least every 7 | days or immediately if the dressing is soiled, loose, or damp. Change gauze dressings every 2 days or earlier if the dressing is soiled, loose, or damp. | (Quality of evidence: MODERATE) | 4 Disinfect catheter hubs, needleless connectors, and injection ports before accessing the catheter. (Quality of evidence: MODERATE) | 5 Remove nonessential catheters. (Quality of evidence: MODERATE) | 6 Routine replacement of administration sets not used for blood, blood products, or lipid formulations can be performed at intervals up to 7 days. | (Quality of evidence: HIGH) | 7 Perform surveillance for CLABSI in ICU and non-ICU settings. (Quality of evidence: HIGH) | Additional approaches | 1 Use antiseptic or antimicrobial-impregnated CVCs. (Quality of evidence: HIGH in adult patients; MODERATE in pediatric patients) | 2 Use antimicrobial lock therapy for long-term CVCs. (Quality of evidence: HIGH) | 3 Use recombinant tissue plasminogen activating factor (rt-PA) once weekly after hemodialysis in patients undergoing hemodialysis through a CVC. | (Quality of evidence: HIGH) | 4 Utilize infusion or vascular access teams for reducing CLABSI rates. (Quality of evidence: LOW) | 5 Use antimicrobial ointments for hemodialysis catheter-insertion sites. (Quality of evidence: HIGH) | 6 Use an antiseptic-containing hub, connector cap, or port protector to cover connectors. (Quality of evidence: MODERATE) | Infection Control & Hospital Epidemiology 3 | https://doi.org/10.1017/ice.2023.138 Published online by Cambridge University Press | Strategies to prevent Clostridioides difficile infections (CDIs) | Strategies to prevent methicillin-resistant Staphylococcus aureus (MRSA) transmission and infection | Essential practices | 1 Encourage appropriate use of antimicrobials through implementation of an antimicrobial stewardship program. (Quality of evidence: MODERATE) | 2 Implement diagnostic stewardship practices for ensuring appropriate use and interpretation of C. difficile testing. (Quality of evidence: LOW) | 3 Use contact precautions for infected patients, single-patient room preferred. (Quality of evidence: LOW for hand hygiene; MODERATE for gloves; LOW | for gowns; LOW for single-patient room) | 4 Adequately clean and disinfect equipment and the environment of patients with CDI. (Quality of evidence: LOW for equipment; LOW for environment) | 5 Assess the adequacy of room cleaning. (Quality of evidence: LOW) | 6 Implement a laboratory-based alert system to provide immediate notification to infection preventionists and clinical personnel about newly diagnosed | patients with CDI. (Quality of evidence: LOW) | 7 Conduct CDI surveillance and analyze and report CDI data. (Quality of evidence: LOW) | 8 Educate healthcare personnel (HCP), environmental service personnel, and hospital administration about CDI. (Quality of evidence: LOW) | 9 Educate patients and their families about CDI as appropriate. (Quality of evidence: LOW) | 10 Measure compliance with CDC or WHO hand hygiene and contact precaution recommendations. (Quality of evidence: LOW) | Additional approaches | 1 Intensify the assessment of compliance with process measures. (Quality of evidence: LOW) | 2 Perform hand hygiene with soap and water as the preferred method following care of or interacting with the healthcare environment of a patient with | CDI. (Quality of evidence: LOW) | 3 Place patients with diarrhea on contact precautions while C. difficile testing is pending. (Quality of evidence: LOW) | 4 Prolong the duration of contact precautions after the patient becomes asymptomatic until hospital discharge. (Quality of evidence: LOW) | 5 Use an EPA-approved sporicidal disinfectant, such as diluted (1:10) sodium hypochlorite, for environmental cleaning and disinfection. Implement a | system to coordinate with environmental services if it is determined that sodium hypochlorite is needed for environmental disinfection. (Quality of | evidence: LOW) | Essential practices | 1 Implement an MRSA monitoring program. (Quality of evidence: LOW) | 2 Conduct an MRSA risk assessment. (Quality of evidence: LOW) | 3 Promote compliance with CDC or World Health Organization (WHO) hand hygiene recommendations. (Quality of evidence: MODERATE) | 4 Use contact precautions for MRSA-colonized and MRSA-infected patients. A facility that chooses or has already chosen to modify the use of contact | precautions for some or all of these patients should conduct an MRSA-specific risk assessment to evaluate the facility for transmission risks and to | assess the effectiveness of other MRSA risk mitigation strategies (eg, hand hygiene, cleaning and disinfection of the environment, single occupancy | patient rooms) and should establish a process for ongoing monitoring, oversight, and risk assessment. (Quality of evidence: MODERATE) | 5 Ensure cleaning and disinfection of equipment and the environment. (Quality of evidence: MODERATE) | 6 Implement a laboratory-based alert system that notifies healthcare personnel (HCP) of new MRSA-colonized or MRSA-infected patients in a timely | manner. (Quality of evidence: LOW) | 7 Implement an alert system that identifies readmitted or transferred MRSA-colonized or MRSA-infected patients. (Quality of evidence: LOW) | 8 Provide MRSA data and outcome measures to key stakeholders, including senior leadership, physicians, nursing staff, and others. (Quality of evidence: | LOW) | 9 Educate healthcare personnel about MRSA. (Quality of evidence: LOW) | 10 Educate patients and families about MRSA. (Quality of evidence: LOW) | 11 Implement an antimicrobial stewardship program. (Quality of evidence: LOW) | Additional approaches | Active surveillance testing (AST) | 1 Implement an MRSA AST program for select patient populations as part of a multifaceted strategy to control and prevent MRSA. (Quality of evidence: | MODERATE) Note: specific populations may have different evidence ratings. | 2 Active surveillance for MRSA in conjunction with decolonization can be performed in targeted populations prior to surgery to prevent postsurgical | MRSA infection. (Quality of evidence: MODERATE) | (Continued) | 4 Deborah S. Yokoe et al | https://doi.org/10.1017/ice.2023.138 Published online by Cambridge University Press | Strategies to prevent surgical-site infections (SSIs) | (Continued ) | 3 Active surveillance with contact precautions is inferior to universal decolonization for reduction of MRSA clinical isolates in adult ICUs. (Quality of | evidence: HIGH) | 4 Hospital-wide active surveillance for MRSA can be used in conjunction with contact precautions to reduce the incidence of MRSA infection. (Quality of | evidence: MODERATE) | 5 Active surveillance can be performed in the setting of an MRSA outbreak or evidence of ongoing transmission of MRSA within a unit as part of a | multifaceted strategy to halt transmission. (Quality of evidence: MODERATE) | Screen healthcare personnel for MRSA infection or colonization | 1 Screen HCP for MRSA infection or colonization if they are epidemiologically linked to a cluster of MRSA infections. (Quality of evidence: LOW) | MRSA decolonization therapy | 1 Use universal decolonization (ie, daily CHG bathing plus 5 days of nasal decolonization) for all patients in adult ICUs to reduce endemic MRSA clinical | cultures. (Quality of evidence: HIGH) | 2 Perform preoperative nares screening with targeted use of CHG and nasal decolonization in MRSA carriers to reduce MRSA SSI from surgical | procedures involving implantation of hardware. (Quality of evidence: MODERATE) | 3 Screen for MRSA and provide targeted decolonization with CHG bathing and nasal decolonization to MRSA carriers in surgical units to reduce | postoperative MRSA inpatient infections. (Quality of evidence: MODERATE) | 4 Provide CHG bathing plus nasal decolonization to known MRSA carriers outside the ICU with medical devices, specifically central lines, midline | catheters, and lumbar drains to reduce MRSA clinical cultures. (Quality of evidence: MODERATE) | 5 Consider postdischarge decolonization of MRSA carriers to reduce postdischarge MRSA infections and readmissions. (Quality of evidence: HIGH) | 6 Neonatal ICUs should consider targeted or universal decolonization during times of above-average MRSA infection rates or targeted decolonization for | patients at high risk of MRSA infection (eg, low birth weight, indwelling devices, or prior to high-risk surgeries). (Quality of evidence: MODERATE) | 7 Burn units should consider targeted or universal decolonization during times of above-average MRSA infection rates. (Quality of evidence: MODERATE) | 8 Consider targeted or universal decolonization of hemodialysis patients. (Quality of evidence: MODERATE) | 9 Decolonization should be strongly considered as part of a multimodal approach to control MRSA outbreaks. (Quality of evidence: MODERATE) | Universal use of gowns and gloves | 1 Use gowns and gloves when providing care to or entering the room of any adult ICU patient, regardless of MRSA colonization status. (Quality of | evidence: MODERATE) | Essential practices | 1 Administer antimicrobial prophylaxis according to evidence-based standards and guidelines. (Quality of evidence: HIGH) | 2 Use a combination of parenteral and oral antimicrobial prophylaxis prior to elective colorectal surgery to reduce the risk of SSI. (Quality of evidence: | HIGH) | 3 Decolonize surgical patients with an anti-staphylococcal agent in the preoperative setting for orthopedic and cardiothoracic procedures. (Quality of | evidence: HIGH) | Decolonize surgical patients in other procedures at high risk of staphylococcal SSI, such as those involving prosthetic material. (Quality of evidence: | LOW) | 4 Use antiseptic-containing preoperative vaginal preparation agents for patients undergoing cesarean delivery or hysterectomy. (Quality of evidence: | MODERATE) | 5 Do not remove hair at the operative site unless the presence of hair will interfere with the surgical procedure. (Quality of evidence: MODERATE) | 6 Use alcohol-containing preoperative skin preparatory agents in combination with an antiseptic. (Quality of evidence: HIGH) | 7 For procedures not requiring hypothermia, maintain normothermia (temperature >35.5 °C) during the perioperative period. (Quality of evidence: HIGH). | 8 Use impervious plastic wound protectors for gastrointestinal and biliary tract surgery. (Quality of evidence: HIGH) | 9 Perform intraoperative antiseptic wound lavage. (Quality of evidence: MODERATE) | 10 Control blood glucose level during the immediate postoperative period for all patients. (Quality of evidence: HIGH) | 11 Use a checklist and/or bundle to ensure compliance with best practices to improve surgical patient safety. (Quality of evidence: HIGH) | 12 Perform surveillance for SSI. (Quality of evidence: MODERATE) | 13 Increase the efficiency of surveillance by utilizing automated data. (Quality of evidence: MODERATE) | 14 Provide ongoing SSI rate feedback to surgical and perioperative personnel and leadership. (Quality of evidence: MODERATE) | 15 Measure and provide feedback to healthcare personnel (HCP) regarding rates of compliance with process measures. (Quality of evidence: LOW) | (Continued) | Infection Control & Hospital Epidemiology 5 | https://doi.org/10.1017/ice.2023.138 Published online by Cambridge University Press | Strategies to prevent ventilator-associated pneumonia (VAP) and ventilator-associated events (VAEs) | Adult patients | (Continued ) | 16 Educate surgeons and perioperative personnel about SSI prevention measures. (Quality of evidence: LOW) | 17 Educate patients and their families about SSI prevention as appropriate. (Quality of evidence: LOW) | 18 Implement policies and practices to reduce the risk of SSI for patients that align with applicable evidence-based standards, rules and regulations, and | medical device manufacturer instructions for use. (Quality of evidence: MODERATE) | 19 Observe and review operating room personnel and the environment of care in the operating room and in central sterile reprocessing. (Quality of | evidence: LOW) | Additional approaches | 1 Perform an SSI risk assessment. (Quality of evidence: LOW) | 2 Consider use of negative-pressure dressings in patients who may benefit. (Quality of evidence: MODERATE) | 3 Observe and review practices in the preoperative clinic, post-anesthesia care unit, surgical intensive care unit, and/or surgical ward. (Quality of | evidence: MODERATE) | 4 Use antiseptic-impregnated sutures as a strategy to prevent SSI. (Quality of evidence: MODERATE) | Essential practices | Interventions with little risk of harm and that are associated with decreases in duration of mechanical ventilation, length of stay, mortality, antibiotic utilization, | and/or costs | Avoid intubation and prevent reintubation if possible. | 1 Use high flow nasal oxygen or non-invasive positive pressure ventilation (NIPPV) as appropriate, whenever safe and feasible. (Quality of evidence: HIGH) | Minimize sedation. | 1 Minimize sedation of ventilated patients whenever possible. (Quality of evidence: HIGH) | 2 Preferentially use multimodal strategies and medications other than benzodiazepines to manage agitation. (Quality of evidence: HIGH) | 3 Utilize a protocol to minimize sedation. (Quality of evidence: HIGH) | 4 Implement a ventilator liberation protocol. (Quality of evidence: HIGH) | Maintain and improve physical conditioning. | 1 Provide early exercise and mobilization. (Quality of evidence: MODERATE) | Elevate the head of the bed to 30°–45°. (Quality of evidence: LOW) | Provide oral care with toothbrushing but without chlorhexidine. (Quality of evidence: MODERATE) | Provide early enteral rather than parenteral nutrition. (Quality of evidence: HIGH) | Maintain ventilator circuits. | 1 Change the ventilator circuit only if visibly soiled or malfunctioning (or per manufacturers’ instructions) (Quality of evidence: HIGH). | Additional approaches | May decrease duration of mechanical ventilation, length of stay, and/or mortality in some populations but not in others, and they may confer some risk of harm | in some populations. | 1 Consider using selective decontamination of the oropharynx and digestive tract to decrease microbial burden in ICUs with low prevalence of antibiotic | resistant organisms. Antimicrobial decontamination is not recommended in countries, regions, or ICUs with high prevalence of antibiotic-resistant | organisms. (Quality of evidence: HIGH) | Additional approaches | May lower VAP rates, but current data are insufficient to determine their impact on duration of mechanical ventilation, length of stay, and mortality. | 1 Consider using endotracheal tubes with subglottic secretion drainage ports to minimize pooling of secretions above the endotracheal cuff in patients | likely to require >48–72 hours of intubation. (Quality of evidence: MODERATE) | 2 Consider early tracheostomy. (Quality of evidence: MODERATE) | 3 Consider postpyloric feeding tube placement in patients with gastric feeding intolerance at high risk for aspiration. (Quality of evidence: MODERATE) | 6 Deborah S. Yokoe et al | https://doi.org/10.1017/ice.2023.138 Published online by Cambridge University Press | Preterm neonatal patients | Pediatric patients | Essential practices | Confer minimal risk of harm and may lower VAP and/or PedVAE rates. | Avoid intubation. (Quality of evidence: HIGH) | Minimize duration of mechanical ventilation. (Quality of evidence: HIGH) | 1 Manage patients without sedation whenever possible. (Quality of evidence: LOW) | 2 Use caffeine therapy for apnea of prematurity within 72 hours after birth to facilitate extubation. (Quality of evidence: HIGH) | 3 Assess readiness to extubate daily. (Quality of evidence: LOW) | 4 Take steps to minimize unplanned extubation and reintubation. (Quality of evidence: LOW) | 5 Provide regular oral care with sterile water (extrapolated from practice in infants and children, no data in preterm neonates). (Quality of evidence: | LOW) | 6 Change the ventilator circuit only if visibly soiled or malfunctioning or according to the manufacturer’s instructions for use (extrapolated from studies in | adults and children, no data in preterm neonates). (Quality of evidence: LOW) | Additional approaches | Minimal risks of harm, but impact on VAP and VAE rates is unknown. | 1 Lateral recumbent positioning. (Quality of evidence: LOW) | 2 Reverse Trendelenberg positioning. (Quality of evidence: LOW) | 3 Closed or in-line suctioning. (Quality of evidence: LOW) | 4 Oral care with maternal colostrum. (Quality of evidence: MODERATE) | Essential practices | Confer minimal risk of harm and some data suggest that they may lower VAP rates, PedVAE rates, and/or duration of mechanical ventilation. | Avoid intubation. | 1 Use noninvasive positive pressure ventilation (NIPPV) or high-flow oxygen by nasal cannula whenever safe and feasible. (Quality of evidence: | MODERATE) | Minimize duration of mechanical ventilation. | 1 Assess readiness to extubate daily using spontaneous breathing trials in patients without contraindications. (Quality of evidence: MODERATE) | 2 Take steps to minimize unplanned extubations and reintubations. (Quality of evidence: LOW) | 3 Avoid fluid overload. (Quality of evidence: MODERATE) | Provide regular oral care (ie, toothbrushing or gauze if no teeth). (Quality of evidence: LOW) | Elevate the head of the bed unless medically contraindicated. (Quality of evidence: LOW) | Maintain ventilator circuits. | 1 Change ventilator circuits only when visibly soiled or malfunctioning (or per manufacturer’s instructions). (Quality of evidence: MODERATE) | 2 Remove condensate from the ventilator circuit frequently and avoid draining the condensate toward the patient. (Quality of evidence: LOW) | Endotracheal tube selection and management | 1 Use cuffed endotracheal tubes. (Quality of evidence: LOW) | 2 Maintain cuff pressure and volume at the minimal occlusive settings to prevent clinically significant air leaks around the endotracheal tube, typically | 20-25cm H2O. This “minimal leak” approach is associated with lower rates of post-extubation stridor. (Quality of evidence: LOW) | 3 Suction oral secretions before each position change. (Quality of evidence: LOW) | Additional approaches | Minimal risks of harm and some evidence of benefit in adult patients but data in pediatric populations are limited. | 1 Minimize sedation. (Quality of evidence: MODERATE) | 2 Use endotracheal tubes with subglottic secretion drainage ports for patients ≥10 years of age. (Quality of evidence: LOW) | 3 Consider early tracheostomy. (Quality of evidence: LOW) | Infection Control & Hospital Epidemiology 7 | https://doi.org/10.1017/ice.2023.138 Published online by Cambridge University Press | Strategies to prevent nonventilator hospital-acquired pneumonia (NV-HAP) | Strategies to prevent healthcare-associated infections through hand hygiene | Essential practices | Promote the maintenance of healthy hand skin and nails. (Quality of evidence: HIGH) | 1 Promote the preferential use of alcohol-based hand sanitizer (ABHS) in most clinical situations. (Quality of evidence: HIGH) | 2 Perform hand hygiene as indicated by CDC or the WHO Five Moments. (Quality of evidence: HIGH) | 3 Include fingernail care in facility-specific policies related to hand hygiene. (Quality of evidence: HIGH) | a) Healthcare personnel (HCP) should maintain short, natural fingernails. | b) Nails should not extend past the fingertip. | c) HCP who provide direct or indirect care in high-risk areas | (eg, ICU or perioperative) should not wear artificial fingernail extenders. | d) Prohibitions against fingernail polish (standard or gel shellac) are at the discretion of the infection prevention program, except among scrubbed | individuals who interact with the sterile field during surgical procedures; these individuals should not wear fingernail polish or gel shellac. | 4 Engage all HCP in primary prevention of occupational irritant and allergic contact dermatitis. (Quality of evidence: HIGH) | 5 Provide cotton glove liners for HCP with hand irritation and educate these HCP on their use. (Quality of evidence: MODERATE) | Select appropriate products. | 1 For routine hand hygiene, choose liquid, gel, or foam ABHS with at least 60% alcohol. (Quality of evidence: HIGH) | 2 Involve HCP in selection of products. (Quality of evidence: HIGH) | 3 Obtain and consider manufacturers’ product-specific data if seeking ABHS with ingredients that may enhance efficacy against organisms anticipated to | be less susceptible to biocides. (Quality of evidence: MODERATE) | 4 Confirm that the volume of ABHS dispensed is consistent with the volume shown to be efficacious. (Quality of evidence: HIGH) | 5 Educate HCP about an appropriate volume of ABHS and the time required to obtain effectiveness. (Quality of evidence: HIGH) | 6 Provide facility-approved hand moisturizer that is compatible with antiseptics and gloves. (Quality of evidence: HIGH) | 7 For surgical antisepsis, use an FDA-approved surgical hand scrub or waterless surgical hand rub. (Quality of evidence: HIGH) | Ensure the accessibility of hand hygiene supplies. (Quality of evidence: HIGH) | 1 Ensure ABHS dispensers are unambiguous, visible, and accessible within the workflow of HCP. (Quality of evidence: HIGH) | 2 In private rooms, consider 2 ABHS dispensers the minimum threshold for adequate numbers of dispensers: 1 dispenser in the hallway, and 1 in the | patient room. (Quality of evidence: HIGH) | 3 In semiprivate rooms, suites, bays, and other multipatient bed configurations, consider 1 dispenser per 2 beds the minimum threshold for adequate | numbers of dispensers. Place ABHS dispensers in the workflow of HCP. (Quality of evidence: LOW) | 4 Ensure that the placement of hand hygiene supplies (eg, individual pocket-sized dispensers, bed mounted ABHS dispenser, single use pump bottles) is | easily accessible for HCP in all areas where patients receive care. (Quality of evidence: HIGH) | 5 Evaluate for the risk of intentional consumption. Utilize dispensers that mitigate this risk, such as wall-mounted dispensers that allow limited numbers | of activations within short periods (eg, 5 seconds). (Quality of evidence: LOW) | 6 Have surgical hand rub and scrub available in perioperative areas. (Quality of evidence: HIGH) | 7 Consider providing ABHS hand rubs or handwash with FDA-approved antiseptics for use in procedural areas and prior to high-risk bedside procedures | (eg, central-line insertion). (Quality of evidence: LOW) | (Continued) | Practices supported by interventional studies suggesting lower | NV-HAP rates | 1 Provide regular oral care. | 2 Diagnose and manage dysphagia. | 3 Provide early mobilization. | 4 Implement multimodal interventions to prevent viral infections. | 5 Use prevention bundles. | 8 Deborah S. Yokoe et al | https://doi.org/10.1017/ice.2023.138 Published online by Cambridge University Press | Implementing strategies to prevent healthcare-associated infections | Standard approach to implementation | Examples of implementation frameworks | (Continued ) | Ensure appropriate glove use to reduce hand and environmental contamination. (Quality of Evidence: HIGH) | 1 Use gloves for all contact with the patient and environment as indicated by standard and contact precautions during the care of individuals with | organisms confirmed to be less susceptible to biocides (e.g., C. difficile or norovirus) | 2 Educate HCP about the potential for self-contamination and environmental contamination when gloves are worn. (Quality of evidence: HIGH) | 3 Educate and confirm the ability of HCP to doff gloves in a manner that avoids contamination. (Quality of evidence: HIGH) | Take steps to reduce environmental contamination associated with sinks and sink drains. (Quality of evidence: HIGH) | Monitor adherence to hand hygiene. (Quality of evidence: HIGH) | Provide timely and meaningful feedback to enhance a culture of safety. (Quality of evidence: MODERATE) | Additional approaches during outbreaks | 1 Consider educating HCP using a structured approach (eg, WHO Steps) for handwashing or hand sanitizing. Evaluate HCP adherence to technique. | (Quality of evidence: LOW) | 2 For waterborne pathogens of premise plumbing, consider disinfection of sink drains using an EPA-registered disinfectant with claims against biofilms. | Consult with state or local public health for assistance in determining appropriate protocols for use and other actions needed to ensure safe supply. | (Quality of evidence: LOW) | 3 For C. difficile and norovirus, in addition to contact precautions, encourage hand washing with soap and water after the care of patients with known or | suspected infections. (Quality of evidence: LOW) | 1 Assess determinants of change and | classify as follows: | • Facilitators: promote practice or | change, or | • Barriers: hinder practice or change | Individual level: healthcare personnel, leaders, patients, and visitors’ preferences, needs, attitudes, and | knowledge. | Facility level: team composition, communication, culture, capacity, policies, resources. | Partners: degree of support and buy-in. | 2 Choose measures Measurement methods must be appropriate for the question(s) they seek to answer and adhere to the | methods’ data collection and analysis rules: | • Outcome measure: ultimate goal (eg, HAI reduction). | • Process measure: action reliability (eg, bundle adherence). | • Balancing measure: undesired outcome of change (eg, staff absences due to required vaccine side effects). | 3 Select framework(s) See below and “Implementing Strategies to Prevent Infections in Acute Care Settings” (Table 3) | 32 | Framework Published Experience Resources | 4Es Settings | • Healthcare facilities | • Large-scale projects including multiple | sites | Infection prevention and control | • HAI prevention (including mortality | reduction and cost savings) | • 4Es Framework11 | • HAI reduction12–14 | • Mortality reduction15 | • Cost savings16 | Behavior Change Wheel Settings | • Community-based practice | • Healthcare facilities | Healthy behaviors | • Smoking cessation | • Obesity prevention | • Increased physical activity | Infection prevention and control | • Hand hygiene adherence | • Antibiotic prescribing17 | • Behavior Change Wheel: A Guide to Designing Interventions18 | • Stand More at Work (SMArT Work)19 | (Continued) | Infection Control & Hospital Epidemiology 9 | https://doi.org/10.1017/ice.2023.138 Published online by Cambridge University Press | Acknowledgments. The Compendium Partners thank the authors for their | dedication to this work, including maintaining adherence to the rigorous | process for the development of the Compendium: 2022 Updates, involving but | not limited to screening of thousands of articles; achieving multilevel consensus; | and consideration of, response to, and incorporation of many organizations’ | feedback and comments. We acknowledge these efforts especially because they | occurred as the authors handled the demands of the COVID-19 pandemic. The | authors thank Valerie Deloney, MBA, for her organizational expertise in the | development of this manuscript and Janet Waters, MLS, BSN, RN, for her | expertise in developing the strategies used for the literature searches that | informed this manuscript. The authors thank the many individuals and | organizations who gave their time and expertise to review and provide | (Continued ) | Comprehensive Unit-based | Safety Program (CUSP) | Settings | • Intensive care units | • Ambulatory centers | Improvements | • Antibiotic prescribing | • CLABSI prevention | • CAUTI prevention | • CUSP Implementation Toolkit20 | • AHA/HRET: Eliminating CAUTI (Stop CAUTI)21 | • AHRQ Toolkit to Improve Safety in Ambulatory Surgery Centers22 | European Mixed Methods Settings | • European institutions of varied | healthcare systems and cultures | Improvements: | • CLABSI prevention | • Hand hygiene | • PROHIBIT: Description and Materials23 | Getting to Outcomes (GTO)® Settings | • Community programs and services | Improvements | • Sexual health promotion | • Dual-disorder treatment program in | veterans | • Community emergency preparedness | • RAND Guide for Emergency Preparedness24 (illustrated overview of GTO® methodology) | Model for Improvement Settings | • Healthcare (inpatient, perioperative, | ambulatory) | • Public health | Interventions | • PPE use | • HAI prevention | • Public health process evaluation | • Institute for Healthcare Improvement25 | • The Improvement Guide26 | • Deming’s System of Profound Knowledge27 | Reach, Effectiveness, Adoption, | Implementation, Maintenance | (RE-AIM) | Settings | • Healthcare | • Public health | • Community programs | • Sexual health | Evaluations | • Antimicrobial stewardship in the ICU | • Clinical practice guidelines for STIs | • Promotion of vaccination | • Implementation of contact tracing | • RE-AIM.org28 | • Understanding and applying the RE-AIM framework: Clarifications and | resources29 | Replicating Effective Practices | (REP) | Settings | • Healthcare | • Public health | • HIV prevention | Interventions that have produced | positive results are reframed for local | relevance | CDC Compendium of HIV Prevention Interventions with Evidence of | Effectiveness30 (see Section C, Intervention Checklist) | Theoretical Domains Settings | • Healthcare (inpatient, perioperative, | ambulatory) | • Community (individual and communitybased behaviors) | Health maintenance | • Diabetes management in primary care | • Pregnancy weight management | HCP practice | • ICU blood transfusion | • Selective GI tract decontamination | • Preoperative testing | • Spine imaging | • Hand hygiene |
Mask use in public places in Maputo City, Mozambique: Cross-sectional survey
Balate D , Afai G , Sallé F , Simone T , Baltazar CS , Zulliger R , Rossetto É V . PLoS One 2023 18 (8) e0288957 INTRODUCTION: The use of face masks is one of the preventive measures that Mozambique adopted in order to limit the spread of COVID-19. A study carried out from May 25 to June 6, 2020 found that although many wore masks, incorrect use was observed in 27.5% of the population observed. This data collection aimed to measure the degree of mask use compliance during a more protracted, higher second wave of transmission. METHODOLOGY: A cross-sectional study was conducted in the City of Maputo from 19 to 28 October 2020 through direct observation of mask use of all individuals present in markets, supermarkets and bus terminals. The data were collected using mobile phones with the Open Data Kit Collect (ODK) data collection program. Sociodemographic characteristics, mask use, and type of mask used were documented. Factors associated with incorrect mask use were evaluated considering sex, age, observation period and location. RESULTS: A total of 49,404 individuals were observed, of whom 24,977(50.6%) were male, 46,484 (94.1%) were adults and 17,549 (35.5%) were observed in the markets. An observed 41,786 (84.6%) wore a mask, of whom 33,851 (81.0%) used it correctly. Not covering the mouth and nose was common; observed in 4,649 (58.5%) of those using incorrectly. Of different types of masks, fabric masks were most often used incorrectly 7,225 (21.4%). The factors associated with incorrect mask use were female gender (OR = 1.2 [1.1-1.3], p <0.001), observation in peri-urban versus urban areas (OR = 1.9 [1.8-2.1], p <0.001) and observation during the afternoon (OR = 1.5 [1.5-1.6], p <0. 001). CONCLUSION: A high proportion of observed individuals wore a mask in the context of prevention of COVID-19, however some non-use and incorrect use persists. Intensified public awareness of the correct use of the mask is recommended, especially in peri-urban areas and at the end of the day. |
Comparison of Illumina MiSeq and the Ion Torrent PGM and S5 platforms for whole-genome sequencing of picornaviruses and caliciviruses (preprint)
Marine RL , Magana LC , Castro CJ , Zhao K , Montmayeur AM , Schmidt A , Diez-Valcarce M , Fan Ng TF , Vinje J , Burns CC , Allan Nix W , Rota PA , Oberste MS . bioRxiv 2019 705632 Next-generation sequencing is a powerful tool for virological surveillance. While Illumina® and Ion Torrent® sequencing platforms are used extensively for generating viral RNA genome sequences, there is limited data comparing different platforms. We evaluated the Illumina MiSeq, Ion Torrent PGM and Ion Torrent S5 platforms using a panel of sixteen specimens containing picornaviruses and human caliciviruses (noroviruses and sapoviruses). The specimens were processed, using combinations of three library preparation and five sequencing kits, to assess the quality and completeness of assembled viral genomes, and an estimation of cost per sample to generate the data was calculated. The choice of library preparation kit and sequencing platform was found to impact the breadth of genome coverage and accuracy of consensus viral genomes. The Ion Torrent S5 outperformed the older Ion Torrent PGM platform in data quality and cost, and generated the highest proportion of reads for enterovirus D68 samples. However, indels at homopolymer regions impacted the accuracy of consensus genome sequences. For lower throughput sequencing runs (i.e., Ion Torrent 510 or Illumina MiSeq Nano V2), the cost per sample was lower on the MiSeq platform, whereas with higher throughput runs (Ion Torrent 530 or Illumina MiSeq V2) the cost per sample was comparable. These findings suggest that the Ion Torrent S5 and Illumina MiSeq platforms are both viable options for genomic sequencing of RNA viruses, each with specific advantages and tradeoffs. |
Detection and discrimination of influenza B Victoria lineage deletion variant viruses by real-time RT-PCR (preprint)
Shu B , Kirby MK , Warnes C , Sessions WM , Davis WG , Liu J , Wilson MM , Wentworth DE , Barnes JR . bioRxiv 2019 818617 Influenza B viruses have two genetically and antigenically distinct lineages, B/Victoria/2/1987-like (VIC) and B/Yamagata/16/1988-like (YAM) viruses, that emerged in the 1980s and co-circulate annually during the influenza season. During the 2016-2017 influenza season, influenza B/VIC lineage variant viruses emerged with two (K162N163) or three (K162N163D164) amino acid (AA) deletions in the hemagglutinin protein. Hemagglutination inhibition assays demonstrate that these deletion variant influenza B/VIC viruses are antigenically distinct from each other and from the progenitor B/VIC virus that lacks the deletion. Therefore, there are currently four antigenically distinct HA proteins expressed by influenza B co-circulating: B/YAM, B/VIC V1A (no deletion), B/VIC V1A.1 (two-AA deletion), and B/VIC V1A.2 and V1A.3 (three-AA deletion). The prevalence of these viruses differs across geographic regions, making it critical to have a sensitive, rapid diagnostic assay(s) that detect and distinguish these Influenza B variant viruses during surveillance. Here, we present a real time RT-PCR assay that targets the influenza B/VIC deletion region in the HA gene and detects and distinguishes the influenza B/VIC V1A, B/VIC V1A.1, B/VIC V1A.2 and B/VIC V1A.3 variant viruses, with no cross-reactivity. This assay can be run as a multiplex reaction, allowing for increased testing efficiency and reduced cost. Coupling this assay with the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel Influenza B Lineage Genotyping Kit results in rapid detection and characterization of circulating influenza B viruses. Having accurate and detailed surveillance information on these distinct Influenza B variant viruses will provide insight into the prevalence and geographic distribution and could aid in vaccine recommendations. |
Performance Characteristics of Six Immunoglobulin M (IgM) ELISA Assays Used for Laboratory Confirmation of Measles (preprint)
Sowers SB , Anthony K , Mercader S , Colley H , Crooke SN , Rota PA , Latner DR , Hickman CJ . medRxiv 2022 04 Laboratory confirmation of infection is an essential component of measles surveillance. Detection of measles specific IgM in serum by enzyme linked immunosorbent assay (ELISA) is the most used method for confirming measles infection. ELISA formats vary as does the sensitivity and specificity of each assay. Specimens collected within 3 days of rash onset can yield a false negative result, which can delay confirmation of measles cases. Interfering substances can yield a false positive result, leading to unnecessary public health interventions. The IgM capture assay developed at the Centers for Disease Control (CDC) was compared against 5 commercially available ELISA kits for the ability to detect measles virus-specific IgM in a panel of 90 well-characterized specimens. Serum samples were tested in triplicate using each commercial kit as recommended by the manufacturer. Using the CDC measles IgM capture assay as the reference test; sensitivity and specificity for the commercial kits ranged from 50 to 83% and 86.9 to 98%, respectively. Discrepant results were observed for samples tested with all five commercial kits and ranged from 13.8 to 28.8% of the specimens tested. False positive results occurred in 2.0 to 13.1% of sera while negative results were observed in 16.7 to 50% of sera that were positive by the CDC measles IgM capture assay. Evaluation and interpretation of measles IgM serologic results can be complex, particularly in measles elimination settings. The performance characteristics of a measles IgM assay should be carefully considered when selecting an assay to achieve high quality measles surveillance. Copyright The copyright holder for this preprint is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CC0 license. |
Selective whole genome amplification as a tool to enrich specimens with low Treponema pallidum genomic DNA copies for whole genome sequencing (preprint)
Thurlow CM , Joseph SJ , Ganova-Raeva L , Katz SS , Pereira L , Chen C , Debra A , Vilfort K , Workowski K , Cohen SE , Reno H , Sun Y , Burroughs M , Sheth M , Chi KH , Danavall D , Philip SS , Cao W , Kersh EN , Pillay A . bioRxiv 2021 10 Downstream next generation sequencing (NGS) of the syphilis spirochete Treponema pallidum subspecies pallidum (T. pallidum) is hindered by low bacterial loads and the overwhelming presence of background metagenomic DNA in clinical specimens. In this study, we investigated selective whole genome amplification (SWGA) utilizing multiple displacement amplification (MDA) in conjunction with custom oligonucleotides with an increased specificity for the T. pallidum genome, and the capture and removal of CpG-methylated host DNA using the NEBNext Microbiome DNA Enrichment Kit followed by MDA with the REPLI-g Single Cell Kit as enrichment methods to improve the yields of T. pallidum DNA in isolates and lesion specimens from syphilis patients. Sequencing was performed using the Illumina MiSeq v2 500 cycle or NovaSeq 6000 SP platform. These two enrichment methods led to 93-98% genome coverage at 5 reads/site in 5 clinical specimens from the United States and rabbit propagated isolates, containing >14 T. pallidum genomic copies/ul of sample for SWGA and >129 genomic copies/ul for CpG methylation capture with MDA. Variant analysis using sequencing data derived from SWGA-enriched specimens, showed that all 5 clinical strains had the A2058G mutation associated with azithromycin resistance. SWGA is a robust method that allows direct whole genome sequencing (WGS) of specimens containing very low numbers of T. pallidum, which have been challenging until now. Copyright The copyright holder for this preprint is the author/funder, who has granted bioRxiv a license to display the preprint in perpetuity. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CC0 license. |
Factors associated with mobile app-based ordering of HIV self-test kits among men who have sex with men in Atlanta, Detroit and New York City: an exploratory secondary analysis of a randomized control trial
Mancuso N , Mansergh G , Stephenson R , Horvath KJ , Hirshfield S , Bauermeister JA , Chiasson MA , Downing MJ Jr , Sullivan PS . J Int AIDS Soc 2023 26 (5) e26100 INTRODUCTION: The United States Centers for Disease Control and Prevention currently recommends HIV screening at least annually among sexually active gay, bisexual and other men who have sex with men (MSM), but only half report being tested in the past year in the United States. As HIV self-test kits are becoming more available around the United States via web and app-based interventions, it is important to understand who is willing and able to order them. This analysis sought to better understand predictors of free HIV self-test kit utilization among MSM in M-cubed, an HIV prevention mobile app intervention trial in Atlanta, Detroit and New York City. METHODS: We conducted an exploratory secondary analysis of self-report and in-app data collected from the intervention arm of the M-Cubed study from 24 January 2018 to 31 October 2019. Behavioural, demographic and other potential predictors of HIV self-test ordering were identified from Social Cognitive Theoretical underpinnings of the app, and from the literature. Significant predictor variables in bivariate analyses were considered for inclusion in the empiric multivariable model. Demographic variables chosen a priori were then added to a final model estimating adjusted prevalence ratios (aPR). RESULTS: Over half of the 417 intervention participants ordered an HIV self-test kit during the study. In bivariate analyses, ordering a kit was associated with HIV testing history, plans to get tested and reported likelihood of getting tested. In the final model, participants were more likely to order a kit if they reported plans to get tested in the next 3 months (aPR = 1.58, 95% CI: 1.18-2.11) or had not tested for HIV in the past 3 months (aPR = 1.38, 95% CI: 1.13-1.70). There was no difference in HIV self-test kit ordering by income, race/ethnicity or age. CONCLUSIONS: HIV testing is an important tool in ending the HIV epidemic and must be accessible and frequent for key populations. This study demonstrates the effectiveness of HIV self-test kits in reaching populations with suboptimal testing rates and shows that self-testing may supplement community-based and clinical testing while helping overcome some of the structural barriers that limit access to annual HIV prevention services for MSM. |
A pilot PT scheme for external assessment of laboratory performance in testing synthetic opioid compounds in urine, plasma, and whole blood
Hart ED , Bynum ND , Evans A , Swanson KD , Blake TA . Forensic Sci Int 2023 347 111679 A proficiency testing (PT) scheme was prepared for laboratories engaged in bioanalytical testing for synthetic opioid compounds in urine, plasma, and whole blood. Samples were prepared using compounds included in the Opioid Certified Reference Material Kit (Opioid CRM Kit) developed by the U.S. Centers for Disease Control and Prevention. Laboratories received samples during a 2-year project with each year consisting of two PT events 6 months apart. In the first year (pilot test), participants included 10 public health laboratories throughout the United States. In the second year, the group of laboratories expanded to include clinical and forensic drug testing laboratories, and 12 additional participating labs joined the program. In Year 1, overall detection percentages for the compounds present in the PT samples were 95.5% in Event 1% and 97.2% in Event 2. There were 31 apparent false positives reported in Event 1 and four apparent false positives reported in Event 2. Carryover or contamination in laboratory analytical systems were found to be the most significant causes of the false positive results, and none of the laboratories that reported false positives in Event 1 did so in Event 2. In Year 2, overall detection percentages for the compounds present in the PT samples were 89.5% in Event 3% and 94.8% in Event 4. There was one apparent false positive reported in Event 3 and three apparent false positives reported in Event 4. Improvements in drug detection between the two PT events in each year demonstrated the benefit of PT schemes in identifying and addressing potential deficiencies in laboratory systems. |
Diagnostic yield of genetic screening in a diverse, community-ascertained cohort.
Rao Nandana D, Kaganovsky Jailanie, Malouf Emily A, Coe Sandy, Huey Jennifer, Tsinajinne Darwin, Hassan Sajida, King Kristine M, Fullerton Stephanie M, Chen Annie T, Shirts Brian H. Genome medicine 2023 15(1) 26 . Genome medicine 2023 15(1) 26 Rao Nandana D, Kaganovsky Jailanie, Malouf Emily A, Coe Sandy, Huey Jennifer, Tsinajinne Darwin, Hassan Sajida, King Kristine M, Fullerton Stephanie M, Chen Annie T, Shirts Brian H. Genome medicine 2023 15(1) 26 |
Etiologies of influenza-like illness and severe acute respiratory infections in Tanzania, 2017-2019
Kelly ME , Gharpure R , Shivji S , Matonya M , Moshi S , Mwafulango A , Mwalongo V , Mghamba J , Simba A , Balajee SA , Gatei W , Mponela M , Saguti G , Whistler T , Moremi N , Mmbaga V . PLOS Glob Public Health 2023 3 (2) e0000906 In 2016, Tanzania expanded sentinel surveillance for influenza-like illness (ILI) and severe acute respiratory infection (SARI) to include testing for non-influenza respiratory viruses (NIRVs) and additional respiratory pathogens at 9 sentinel sites. During 2017-2019, respiratory specimens from 2730 cases underwent expanded testing: 2475 specimens (90.7%) were tested using a U.S. Centers for Disease Control and Prevention (CDC)-developed assay covering 7 NIRVs (respiratory syncytial virus [RSV], rhinovirus, adenovirus, human metapneumovirus, parainfluenza virus 1, 2, and 3) and influenza A and B viruses. Additionally, 255 specimens (9.3%) were tested using the Fast-Track Diagnostics Respiratory Pathogens 33 (FTD-33) kit which covered the mentioned viruses and additional viral, bacterial, and fungal pathogens. Influenza viruses were identified in 7.5% of all specimens; however, use of the CDC assay and FTD-33 kit increased the number of specimens with a pathogen identified to 61.8% and 91.5%, respectively. Among the 9 common viruses between the CDC assay and FTD-33 kit, the most identified pathogens were RSV (22.9%), rhinovirus (21.8%), and adenovirus (14.0%); multi-pathogen co-detections were common. Odds of hospitalization (SARI vs. ILI) varied by sex, age, geographic zone, year of diagnosis, and pathogen identified; hospitalized illnesses were most common among children under the age of 5 years. The greatest number of specimens were submitted for testing during December-April, coinciding with rainy seasons in Tanzania, and several viral pathogens demonstrated seasonal variation (RSV, human metapneumovirus, influenza A and B, and parainfluenza viruses). This study demonstrates that expanding an existing influenza platform to include additional respiratory pathogens can provide valuable insight into the etiology, incidence, severity, and geographic/temporal patterns of respiratory illness. Continued respiratory surveillance in Tanzania, and globally, can provide valuable data, particularly in the context of emerging respiratory pathogens such as SARS-CoV-2, and guide public health interventions to reduce the burden of respiratory illnesses. |
Implementing mailed colorectal cancer fecal screening tests in real-world primary care settings: Promising implementation practices and opportunities for improvement
Hohl SD , Maxwell AE , Sharma KP , Sun J , Vu TT , DeGroff A , Escoffery C , Schlueter D , Hannon PA . Prev Sci 2023 1-12 Colorectal cancer (CRC) screening reduces morbidity and mortality, but screening rates in the USA remain suboptimal. The Colorectal Cancer Control Program (CRCCP) was established in 2009 to increase screening among groups disproportionately affected. The CRCCP utilizes implementation science to support health system change as a strategy to reduce disparities in CRC screening by directing resources to primary care clinics to implement evidence-based interventions (EBIs) proven to increase CRC screening. As COVID-19 continues to impede in-person healthcare visits and compel the unpredictable redirection of clinic priorities, understanding clinics' adoption and implementation of EBIs into routine care is crucial. Mailed fecal testing is an evidence-based screening approach that offers an alternative to in-person screening tests and represents a promising approach to reduce CRC screening disparities. However, little is known about how mailed fecal testing is implemented in real-world settings. In this retrospective, cross-sectional analysis, we assessed practices around mailed fecal testing implementation in 185 clinics across 62 US health systems. We sought to (1) determine whether clinics that do and do not implement mailed fecal testing differ with respect to characteristics (e.g., type, location, and proportion of uninsured patients) and (2) identify implementation practices among clinics that offer mailed fecal testing. Our findings revealed that over half (58%) of clinics implemented mailed fecal testing. These clinics were more likely to have a CRC screening policy than clinics that did not implement mailed fecal testing (p = 0.007) and to serve a larger patient population (p = 0.004), but less likely to have a large proportion of uninsured patients (p = 0.01). Clinics that implemented mailed fecal testing offered it in combination with EBIs, including patient reminders (92%), provider reminders (94%), and other activities to reduce structural barriers (95%). However, fewer clinics reported having the leadership support (58%) or funding stability (29%) to sustain mailed fecal testing. Mailed fecal testing was widely implemented alongside other EBIs in primary care clinics participating in the CRCCP, but multiple opportunities for enhancing its implementation exist. These include increasing the proportion of community health centers/federally qualified health centers offering mailed screening; increasing the proportion that provide pre-paid return mail supplies with the screening kit; increasing the proportion of clinics monitoring both screening kit distribution and return; ensuring patients with abnormal tests can obtain colonoscopy; and increasing sustainability planning and support. |
Diagnostic accuracy of the Panbio COVID-19 antigen rapid test device for SARS-CoV-2 detection in Kenya, 2021: A field evaluation
Irungu JK , Munyua P , Ochieng C , Juma B , Amoth P , Kuria F , Kiiru J , Makayotto L , Abade A , Bulterys M , Hunsperger E , Emukule GO , Onyango C , Samandari T , Barr BAT , Akelo V , Weyenga H , Munywoki PK , Bigogo G , Otieno NA , Kisivuli JA , Ochieng E , Nyaga R , Hull N , Herman-Roloff A , Aman R . PLoS One 2023 18 (1) e0277657 BACKGROUND: Accurate and timely diagnosis is essential in limiting the spread of SARS-CoV-2 infection. The reference standard, rRT-PCR, requires specialized laboratories, costly reagents, and a long turnaround time. Antigen RDTs provide a feasible alternative to rRT-PCR since they are quick, relatively inexpensive, and do not require a laboratory. The WHO requires that Ag RDTs have a sensitivity ≥80% and specificity ≥97%. METHODS: This evaluation was conducted at 11 health facilities in Kenya between March and July 2021. We enrolled persons of any age with respiratory symptoms and asymptomatic contacts of confirmed COVID-19 cases. We collected demographic and clinical information and two nasopharyngeal specimens from each participant for Ag RDT testing and rRT-PCR. We calculated the diagnostic performance of the Panbio™ Ag RDT against the US Centers for Disease Control and Prevention's (CDC) rRT-PCR test. RESULTS: We evaluated the Ag RDT in 2,245 individuals where 551 (24.5%, 95% CI: 22.8-26.3%) tested positive by rRT-PCR. Overall sensitivity of the Ag RDT was 46.6% (95% CI: 42.4-50.9%), specificity 98.5% (95% CI: 97.8-99.0%), PPV 90.8% (95% CI: 86.8-93.9%) and NPV 85.0% (95% CI: 83.4-86.6%). Among symptomatic individuals, sensitivity was 60.6% (95% CI: 54.3-66.7%) and specificity was 98.1% (95% CI: 96.7-99.0%). Among asymptomatic individuals, sensitivity was 34.7% (95% CI 29.3-40.4%) and specificity was 98.7% (95% CI: 97.8-99.3%). In persons with onset of symptoms <5 days (594/876, 67.8%), sensitivity was 67.1% (95% CI: 59.2-74.3%), and 53.3% (95% CI: 40.0-66.3%) among those with onset of symptoms >7 days (157/876, 17.9%). The highest sensitivity was 87.0% (95% CI: 80.9-91.8%) in symptomatic individuals with cycle threshold (Ct) values ≤30. CONCLUSION: The overall sensitivity and NPV of the Panbio™ Ag RDT were much lower than expected. The specificity of the Ag RDT was high and satisfactory; therefore, a positive result may not require confirmation by rRT-PCR. The kit may be useful as a rapid screening tool only for symptomatic patients in high-risk settings with limited access to rRT-PCR. A negative result should be interpreted based on clinical and epidemiological information and may require retesting by rRT-PCR. |
Performance characteristics of six immunoglobulin m enzyme-linked immunosorbent assays used for laboratory confirmation of measles
Sowers SB , Anthony K , Mercader S , Colley H , Crooke SN , Rota PA , Latner DR , Hickman CJ . J Clin Microbiol 2022 60 (12) e0122722 Laboratory confirmation of infection is an essential component of measles surveillance. Detection of measles-specific IgM in serum by enzyme-linked immunosorbent assay (ELISA) is the most common method used to confirm measles infection. ELISA formats vary, as does the sensitivity and specificity of each assay. Specimens collected within 3 days of rash onset can yield a false-negative result, which can delay confirmation of measles cases. Interfering substances can yield a false-positive result, leading to unnecessary public health interventions. The IgM capture assay developed at the Centers for Disease Control (CDC) was compared against five commercially available ELISA kits for the ability to detect measles virus-specific IgM in a panel of 90 well-characterized specimens. Serum samples were tested in triplicate using each commercial kit as recommended by the manufacturer. Using the CDC measles IgM capture assay as the reference test; the sensitivity and specificity for each commercial kit ranged from 50 to 83% and 86.9 to 98%, respectively. Discrepant results were observed for samples tested with all five commercial kits and ranged from 13.8 to 28.8% of the specimens tested. False-positive results occurred in 2.0 to 13.1% of sera, while negative results were observed in 16.7 to 50% of sera that were positive by the CDC measles IgM capture assay. Evaluation and interpretation of measles IgM serologic results can be complex, particularly in measles elimination settings. The performance characteristics of a measles IgM assay should be carefully considered when selecting an assay to achieve high-quality measles surveillance. |
Characterizing emergency supply kit possession in the United States during the COVID-19 pandemic - 2020-2021.
Schnall AH , Kieszak S , Hanchey A , Heiman H , Bayleyegn T , Daniel J , Stauber C . Disaster Med Public Health Prep 2022 17 1-29 BACKGROUND: In the immediate aftermath of a disaster, household members may experience lack of support services and isolation from one another. To address this, a common recommendation is to promote preparedness through the preparation of an emergency supply kit (ESK). The goal was to characterize ESK possession on a national level to help the Centers for Disease Control and Prevention (CDC) guide next steps to better prepare for and respond to disasters and emergencies at the community level. METHODS: The authors analyzed data collected through Porter Novelli's ConsumerStyles surveys in Fall 2020 (n=3,625) and Spring 2021 (n=6,455). RESULTS: ESK ownership is lacking. Overall, while most respondents believed that an ESK would help their chance of survival, only a third have one. Age, gender, education level, and region of the country were significant predictors of kit ownership in a multivariate model. In addition, there was a significant association between level of preparedness and ESK ownership. CONCLUSIONS: These data are an essential starting point in characterizing ESK ownership and can be used to help tailor public messaging, inform work with partners to increase ESK ownership, and guide future research. |
Laboratory evaluation of RealStar Yellow Fever Virus RT-PCR kit 1.0 for potential use in the global yellow fever laboratory network
Basile AJ , Niedrig M , Lambert AJ , Meurant R , Brault AC , Domingo C , Goodman CH , Johnson BW , Mossel EC , Mulders MN , Velez JO , Hughes HR . PLoS Negl Trop Dis 2022 16 (9) e0010770 BACKGROUND: Early detection of human yellow fever (YF) infection in YF-endemic regions is critical to timely outbreak mitigation. African National Laboratories chiefly rely on serological assays that require confirmation at Regional Reference Laboratories, thus delaying results, which themselves are not always definitive often due to antibody cross-reactivity. A positive molecular test result is confirmatory for YF; therefore, a standardized YF molecular assay would facilitate immediate confirmation at National Laboratories. The WHO-coordinated global Eliminate Yellow Fever Epidemics Laboratory Technical Working Group sought to independently evaluate the quality and performance of commercial YF molecular assays relevant to use in countries with endemic YF, in the absence of stringent premarket assessments. This report details a limited laboratory WHO-coordinated evaluation of the altona Diagnostics RealStar Yellow Fever Virus RT-PCR kit 1.0. METHODOLOGY AND PRINCIPAL FINDINGS: Specific objectives were to assess the assay's ability to detect YF virus strains in human serum from YF-endemic regions, determine the potential for interference and cross-reactions, verify the performance claims as stated by the manufacturer, and assess usability. RNA extracted from normal human serum spiked with YF virus showed the assay to be precise with minimal lot-to-lot variation. The 95% limit of detection calculated was approximately 1,245 RNA copies/ml [95% confidence interval 497 to 1,640 copies/ml]. Positive results were obtained with spatially and temporally diverse YF strains. The assay was specific for YF virus, was not subject to endogenous or exogenous interferents, and was clinically sensitive and specific. A review of operational characteristics revealed that a positivity cutoff was not defined in the instructions for use, but otherwise the assay was user-friendly. CONCLUSIONS AND SIGNIFICANCE: The RealStar Yellow Fever Virus RT-PCR kit 1.0 has performance characteristics consistent with the manufacturer's claims and is suitable for use in YF-endemic regions. Its use is expected to decrease YF outbreak detection times and be instrumental in saving lives. |
Mobile tablets for real-time data collection for hospital-based birth defects surveillance in Kampala, Uganda: Lessons learned
Kalibbala D , Kakande A , Serunjogi R , Williamson D , Mumpe-Mwanja D , Namale-Matovu J , Valencia D , Nalwoga B , Namirembe C , Seyionga J , Nanfuka M , Nakimuli S , Achom MO , Mwambi K , Musoke P , Barlow-Mosha L . PLoS Glob Public Health 2022 2 (6) Sustainable birth defects surveillance systems provide countries with estimates of the prevalence of birth defects to guide prevention, care activities, and evaluate interventions. We used free and open-source software (Open Data Kit) to implement an electronic system to collect data for a hospital-based birth defects surveillance system at four major hospitals in Kampala, Uganda. We describe the establishment, successes, challenges, and lessons learned from using mobile tablets to capture data and photographs. After intensive training, surveillance midwives collected data using Android tablets with inbuilt logic checks; another surveillance midwife checked the quality of the data in real-time before data were securely uploaded onto a local server. Paper forms were used when needed as a backup for the electronic system. We experienced several challenges implementing the surveillance system, including forgotten passwords, unstable network, reduced tablet speed and freezing, loss of touch-screen sensitivity, decreased battery strength, and repetitive extensive retraining. We addressed these challenges by backing up and removing all photos from the tablet, uninstalling irrelevant applications to the study to increase storage space and speed, and monitoring and updating the system based mainly on feedback from the midwives. From August 2015 to December 2018, surveillance midwives documented information on 110,752 births at the participating hospitals. Of these, 110,573 (99.8%) were directly entered into the electronic data system and 179 (0.2%) were captured on paper forms. The use of mobile tablets for real-time data collection was successful in a hospital-based birth defects surveillance system in a resource-limited setting. Extensive training and follow-up can overcome challenges and are key to preparing staff for a successful data collection system. |
Sequencing of Enteric Bacteria: Library Preparation Procedure Matters for Accurate Identification and Characterization.
Poates A , Truong J , Lindsey R , Griswold T , Williams-Newkirk AJ , Carleton H , Trees E . Foodborne Pathog Dis 2022 19 (8) 569-578 Enzymatic library preparation kits are increasingly used for bacterial whole genome sequencing. While they offer a rapid workflow, the transposases used in the kits are recognized to be somewhat biased. The aim of this study was to optimize and validate a protocol for the Illumina DNA Prep kit (formerly Nextera DNA Flex) for sequencing enteric pathogens and compare its performance against the Nextera XT kit. One hundred forty-three strains of Campylobacter, Escherichia, Listeria, Salmonella, Shigella, and Vibrio were prepared with both methods and sequenced on the Illumina MiSeq using 300 and/or 500 cycle chemistries. Sequences were compared using core genome multilocus sequence typing (cgMLST), 7-gene multilocus sequence typing (MLST), and detection of markers encoding serotype, virulence, and antimicrobial resistance. Sequences for one Escherichia strain were downsampled to determine the minimum coverage required for the analyses. While organism-specific differences were observed, the Prep libraries generated longer average read lengths and less fragmented assemblies compared to the XT libraries. In downstream analysis, the most notable difference between the kits was observed for Escherichia, particularly for the 300 cycle sequences. The O group was not predicted in 32% and 4% of XT sequences when using blast and kmer algorithms, respectively, while the O group was predicted from all Prep sequences regardless of the algorithm. In addition, the ehxA gene was not detected in 6% of XT sequences and 34% were missing one or more of the type III secretion systems and/or plasmid-associated genes, which were detected in the Prep sequences. The coverage downsampling revealed that acceptable assembly quality and allele detection was achieved at 30 × coverage with the Prep libraries, whereas 40-50 × coverage was required for the XT libraries. The better performance of the Prep libraries was attributed to more even coverage, particularly in genome regions low in GC content. |
Remote health interventions: Effectiveness, cost, and cost-effectiveness considerations
Williams AM , Gift TL . Sex Transm Dis 2022 49 S15-S17 With declining public health funding and increasing sexually transmitted infection (STI) rates,1 STI clinics must find ways to serve patients more efficiently. As remote health interventions become an integral part of sexual health services, it is critical that researchers assess the effectiveness, cost, and cost-effectiveness of these interventions. Remote health broadly encompasses medical services that do not involve in-person clinic visits. This includes not only services such as telehealth via phone or video calls, but also low-tech services that are performed away from brick-and-mortar health clinics. Examples of remote health services for STIs include expedited partner therapy (EPT),2 mailed specimen collection kits (e.g., I Want the Kit),3 field-delivered treatment, and postexposure prophylaxis hotlines, among others. |
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