Last data update: May 06, 2024. (Total: 46732 publications since 2009)
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Investigating the current harmonization status of tumor markers using global external quality assessment programs: A feasibility study
van Rossum HH . Clin Chem 2024 BACKGROUND: The harmonization status of most tumor markers (TMs) is unknown. We report a feasibility study performed to determine whether external quality assessment (EQA) programs can be used to obtain insights into the current harmonization status of the tumor markers α-fetoprotein (AFP), prostate specific antigen (PSA), carcinoembryonic antigen (CEA), cancer antigen (CA)125, CA15-3 and CA19-9. METHODS: EQA sample results provided by 6 EQA providers (INSTAND [Germany], Korean Association of External Quality Assessment Service [KEQAS, South Korea], National Center for Clinical Laboratories [NCCL, China], United Kingdom National External Quality Assessment Service [UK NEQAS, United Kingdom], Stichting Kwaliteitsbewaking Medische Laboratoriumdiagnostiek [SKML, the Netherlands], and the Royal College of Pathologists of Australasia Quality Assurance Programs [RCPAQAP, Australia]) between 2020 and 2021 were used. The consensus means, calculated from the measurement procedures present in all EQA programs (Abbott Alinity, Beckman Coulter DxI, Roche Cobas, and Siemens Atellica), was used as reference values. Per measurement procedure, the relative difference between consensus mean for each EQA sample and the mean of all patient-pool-based EQA samples were calculated and compared to minimum, desirable, and optimal allowable bias criteria based on biological variation. RESULTS: Between 19040 (CA15-3) and 25398 (PSA) individual results and 56 (PSA) to 76 (AFP) unique EQA samples were included in the final analysis. The mean differences with the consensus mean of patient-pool-based EQA samples for all measurement procedures were within the optimum bias criterion for AFP, the desirable bias for PSA, and the minimum bias criterion for CEA. However, CEA results <8 µg/L exceeded the minimum bias criterion. For CA125, CA15-3, and CA19-9, the harmonization status was outside the minimum bias criterion, with systematic differences identified. CONCLUSIONS: This study provides relevant information about the current harmonization status of 6 tumor markers. A pilot harmonization investigation for CEA, CA125, CA15-3, and CA19-9 would be desirable. |
A randomized trial of quadruple-fortified salt for anemia and birth defects prevention in southern India: Protocol design and methods
Finkelstein JL , Guetterman HM , Fothergill A , Johnson CB , Qi YP , Jabbar S , Zhang M , Pfeiffer CM , Rose CE , Yeung LF , Williams JL , Krisher JT , Ruth C , Roy Choudhury D , Venkatramanan S , Haas JD , Kuriyan R , Mehta S , Bonam W , Crider KS . Curr Dev Nutr 2023 7 (3) 100052 Background: Women of reproductive age are at an increased risk of anemia and micronutrient deficiencies. Evidence supports the role of periconceptional nutrition in the development of neural tube defects (NTDs) and other pregnancy complications. Vitamin B12 deficiency is a risk factor for NTDs and may modify folate biomarkers that predict NTD risk at the population level. There is an interest in mandatory fortification with vitamin B12 and folic acid for anemia and birth defect prevention. However, there are limited population-representative data needed to inform policy and guidelines. Objectives: This randomized trial will be conducted to evaluate the efficacy of quadruple-fortified salt (QFS; iron, iodine, folic acid, vitamin B12) in 1,000 households in Southern India. Methods: Women 18 to 49 y who are not pregnant or lactating and reside within the catchment area of our community-based research site in Southern India will be screened and invited to participate in the trial. After informed consent, women and their households will be randomized to receive one of the following 4 interventions: 1) double-fortified salt (DFS; iron, iodine), 2) DFS + folic acid (iron, iodine, folic acid), 3) DFS + vitamin B12 (iron, iodine, vitamin B12), or 4) DFS + folic acid and vitamin B12 (QFS; iron, iodine, folic acid, vitamin B12) for 12 mo. Structured interviews will be conducted by trained nurse enumerators to collect sociodemographic, anthropometric, dietary, health, and reproductive history data. Biological samples will be collected at baseline, midpoint, and endpoint. Whole blood will be analyzed for hemoglobin using Coulter Counter. Total vitamin B12 will be measured by chemiluminescence; red blood cell folate and serum folate will be evaluated using the World Health Organization-recommended microbiologic assay. Conclusions: The results of this randomized trial will help to evaluate the efficacy of QFS to prevent anemia and micronutrient deficiencies. Clinical trial registration numbers: NCT03853304 and Clinical Trial Registry of India REF/2019/03/024479. Registration number: NCT03853304 and REF/2019/03/024479. © 2023 The Author(s) |
Comparison of anemia screening methods using paired venous samples in women of reproductive age in Southern India
Fothergill A , Crider KS , Johnson CB , Raj MP , Guetterman HM , Bose B , Rose CE , Qi YP , Williams JL , Kuriyan R , Bonam W , Finkelstein JL . J Nutr 2022 152 (12) 2978-2992 BACKGROUND: Anemia is an important public health problem, and accurate estimates may inform policy and programs. Although hemoglobin assessment of venous blood via automated hematology analyzers (AHA) is recommended, most population-based surveys are based on analysis of capillary blood via portable hemoglobinometers to estimate anemia prevalence. OBJECTIVE: To evaluate screening methods for hemoglobin and anemia assessment using paired venous samples. DESIGN: Participants were women of reproductive age (15-40y) who were not pregnant or lactating. Paired venous whole blood samples (n = 896) were analyzed for hemoglobin (Hb) via portable hemoglobinometer (HemoCue 301) and Coulter Counter AHA. Anemia and severe anemia were defined as Hb <12.0 and <8.0 g/dL, respectively. Bland-Altman methods were used to assess level of agreement for Hb results (mean difference, standard deviation of differences, limits of agreement). Diagnostic accuracy parameters (sensitivity, specificity, positive predictive value, negative predictive value, accuracy) were calculated to evaluate HemoCue performance compared to the AHA reference, overall and by sociodemographic, nutritional, and metabolic characteristics. RESULTS: The estimated anemia prevalence was significantly lower via HemoCue vs. AHA (36.3% vs. 41.6%; p-value <0.0001). The HemoCue had 84.4% accuracy for anemia screening and 98.8% for severe anemia, compared to the AHA reference. The HemoCue had 74.8% sensitivity and 91.2% specificity, compared to AHA. HemoCue sensitivity was higher in WRA with iron deficiency (SF<15.0 g/L 81.6% vs. SF 15.0 g/L: 41.3%), and lower in WRA with metabolic risk factors, including overweight (BMI25.0 kg/m2; 63.9% vs. 78.8%), or elevated CRP (CRP>1.0 mg/L: 67.2% vs. 1.0 mg/L: 82.9%), trunk fat (TF>35%: 62.7% vs. 35%: 80.1), or whole-body fat (WBF >35%: 63.9% vs. 35%: 80.3%). CONCLUSION: Findings suggest that women with anemia may be incorrectly identified as not anemic via portable hemoglobinometer, and the anemia prevalence may be underestimated at the population level. Registration number: NCT04048330. |
The 2021 WHO catalogue of Mycobacterium tuberculosis complex mutations associated with drug resistance: a genotypic analysis
Walker TM , Fowler PW , Knaggs J , Hunt M , Peto TE , Walker AS , Crook DW , Walker TM , Miotto P , Cirillo DM , Kser CU , Knaggs J , Iqbal Z , Hunt M , Chindelevitch L , Farhat MR , Comas I , Comas I , Posey J , Omar SV , Peto TE , Walker AS , Crook DW , Suresh A , Uplekar S , Laurent S , Colman RE , Rodwell TC , Nathanson CM , Zignol M , Ismail N , Rodwell TC , Walker AS , Steyn AJC , Lalvani A , Baulard A , Christoffels A , Mendoza-Ticona A , Trovato A , Skrahina A , Lachapelle AS , Brankin A , Piatek A , GibertoniCruz A , Koch A , Cabibbe AM , Spitaleri A , Brandao AP , Chaiprasert A , Suresh A , Barbova A , VanRie A , Ghodousi A , Bainomugisa A , Mandal A , Roohi A , Javid B , Zhu B , Letcher B , Rodrigues C , Nimmo C , Nathanson CM , Duncan C , Coulter C , Utpatel C , Liu C , Grazian C , Kong C , Kser CU , Wilson DJ , Cirillo DM , Matias D , Jorgensen D , Zimenkov D , Chetty D , Moore DA , Clifton DA , Crook DW , vanSoolingen D , Liu D , Kohlerschmidt D , Barreira D , Ngcamu D , SantosLazaro ED , Kelly E , Borroni E , Roycroft E , Andre E , Bttger EC , Robinson E , Menardo F , Mendes FF , Jamieson FB , Coll F , Gao GF , Kasule GW , Rossolini GM , Rodger G , Smith EG , Meintjes G , Thwaites G , Hoffmann H , Albert H , Cox H , Laurenson IF , Comas I , Arandjelovic I , Barilar I , Robledo J , Millard J , Johnston J , Posey J , Andrews JR , Knaggs J , Gardy J , Guthrie J , Taylor J , Werngren J , Metcalfe J , Coronel J , Shea J , Carter J , Pinhata JM , Kus JV , Todt K , Holt K , Nilgiriwala KS , Ghisi KT , Malone KM , Faksri K , Musser KA , Joseph L , Rigouts L , Chindelevitch L , Jarrett L , Grandjean L , Ferrazoli L , Rodrigues M , Farhat M , Schito M , Fitzgibbon MM , Loemb MM , Wijkander M , Ballif M , Rabodoarivelo MS , Mihalic M , Wilcox M , Hunt M , Zignol M , Merker M , Egger M , O'Donnell M , Caws M , Wu MH , Whitfield MG , Inouye M , Mansj M , DangThi MH , Joloba M , Kamal SM , Okozi N , Ismail N , Mistry N , Hoang NN , Rakotosamimanana N , Paton NI , Rancoita PMV , Miotto P , Lapierre P , Hall PJ , Tang P , Claxton P , Wintringer P , Keller PM , Thai PVK , Fowler PW , Supply P , Srilohasin P , Suriyaphol P , Rathod P , Kambli P , Groenheit R , Colman RE , Ong RTH , Warren RM , Wilkinson RJ , Diel R , Oliveira RS , Khot R , Jou R , Tahseen S , Laurent S , Gharbia S , Kouchaki S , Shah S , Plesnik S , Earle SG , Dunstan S , Hoosdally SJ , Mitarai S , Gagneux S , Omar SV , Yao SY , GrandjeanLapierre S , Battaglia S , Niemann S , Pandey S , Uplekar S , Halse TA , Cohen T , Cortes T , Prammananan T , Kohl TA , Thuong NTT , Teo TY , Peto TEA , Rodwell TC , William T , Walker TM , Rogers TR , Surve U , Mathys V , Furi V , Cook V , Vijay S , Escuyer V , Dreyer V , Sintchenko V , Saphonn V , Solano W , Lin WH , vanGemert W , He W , Yang Y , Zhao Y , Qin Y , Xiao YX , Hasan Z , Iqbal Z , Puyen ZM , CryPticConsortium theSeq , Treat Consortium . Lancet Microbe 2022 3 (4) e265-e273 Background: Molecular diagnostics are considered the most promising route to achievement of rapid, universal drug susceptibility testing for Mycobacterium tuberculosis complex (MTBC). We aimed to generate a WHO-endorsed catalogue of mutations to serve as a global standard for interpreting molecular information for drug resistance prediction. Methods: In this systematic analysis, we used a candidate gene approach to identify mutations associated with resistance or consistent with susceptibility for 13 WHO-endorsed antituberculosis drugs. We collected existing worldwide MTBC whole-genome sequencing data and phenotypic data from academic groups and consortia, reference laboratories, public health organisations, and published literature. We categorised phenotypes as follows: methods and critical concentrations currently endorsed by WHO (category 1); critical concentrations previously endorsed by WHO for those methods (category 2); methods or critical concentrations not currently endorsed by WHO (category 3). For each mutation, we used a contingency table of binary phenotypes and presence or absence of the mutation to compute positive predictive value, and we used Fisher's exact tests to generate odds ratios and Benjamini-Hochberg corrected p values. Mutations were graded as associated with resistance if present in at least five isolates, if the odds ratio was more than 1 with a statistically significant corrected p value, and if the lower bound of the 95% CI on the positive predictive value for phenotypic resistance was greater than 25%. A series of expert rules were applied for final confidence grading of each mutation. Findings: We analysed 41 137 MTBC isolates with phenotypic and whole-genome sequencing data from 45 countries. 38 215 MTBC isolates passed quality control steps and were included in the final analysis. 15 667 associations were computed for 13 211 unique mutations linked to one or more drugs. 1149 (73%) of 15 667 mutations were classified as associated with phenotypic resistance and 107 (07%) were deemed consistent with susceptibility. For rifampicin, isoniazid, ethambutol, fluoroquinolones, and streptomycin, the mutations' pooled sensitivity was more than 80%. Specificity was over 95% for all drugs except ethionamide (914%), moxifloxacin (916%) and ethambutol (933%). Only two resistance mutations were identified for bedaquiline, delamanid, clofazimine, and linezolid as prevalence of phenotypic resistance was low for these drugs. Interpretation: We present the first WHO-endorsed catalogue of molecular targets for MTBC drug susceptibility testing, which is intended to provide a global standard for resistance interpretation. The existence of this catalogue should encourage the implementation of molecular diagnostics by national tuberculosis programmes. Funding: Unitaid, Wellcome Trust, UK Medical Research Council, and Bill and Melinda Gates Foundation. 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license |
Anemia and Vitamin B-12 and Folate Status in Women of Reproductive Age in Southern India: Estimating Population-Based Risk of Neural Tube Defects
Finkelstein JL , Fothergill A , Johnson CB , Guetterman HM , Bose B , Jabbar S , Zhang M , Pfeiffer CM , Qi YP , Rose CE , Williams JL , Bonam W , Crider KS . Curr Dev Nutr 2021 5 (5) nzab069 BACKGROUND: Women of reproductive age (WRA) are a high-risk population for anemia and micronutrient deficiencies. However, there are few representative population-level data from India, which could help inform evidence-based recommendations and policy. OBJECTIVE: To conduct a population-based biomarker survey of anemia and vitamin B-12 and folate status in WRA as part of a periconceptional surveillance program in southern India. METHODS: Participants were WRA (15-40 y) who were not pregnant or lactating. Whole blood (n = 979) was analyzed for hemoglobin via a Coulter counter (Coulter HMX). Plasma, serum, and RBCs were processed and stored at -80°C or less until batch analysis. Vitamin B-12 concentrations were measured via chemiluminescence; RBC and serum folate concentrations were evaluated via microbiological assay. Anemia and severe anemia were defined as hemoglobin <12.0 g/dL and <8.0 g/dL, respectively. Vitamin B-12 deficiency and insufficiency were defined as total vitamin B-12 <148 pmol/L and <221 pmol/L, respectively. Folate deficiency and insufficiency were defined as RBC folate <305 nmol/L and <748 nmol/L. A previously developed Bayesian model was used to predict neural tube defect (NTD) prevalence per 10,000 births. RESULTS: A total of 41.5% of WRA had anemia and 3.0% had severe anemia. A total of 48.3% of WRA had vitamin B-12 deficiency and 74.3% had vitamin B-12 insufficiency. The prevalence of RBC folate deficiency was 7.6%, and 79.3% of WRA had RBC folate <748 nmol/L, the threshold for optimal NTD prevention. Predicted NTD prevalence per 10,000 births based on RBC folate concentrations was 20.6 (95% uncertainty interval: 16.5-25.5). CONCLUSIONS: The substantial burden of anemia, vitamin B-12 deficiency, and RBC folate insufficiency in WRA in this setting suggests an opportunity for anemia and birth defects prevention. Findings will directly inform the development of a randomized trial for anemia and birth defects prevention in southern India.This study was registered at clinicaltrials.gov as NCT04048330. |
Dioxin-like compound exposures and DNA methylation in the Anniston Community Health Survey Phase II.
Pittman GS , Wang X , Campbell MR , Coulter SJ , Olson JR , Pavuk M , Birnbaum LS , Bell DA . Sci Total Environ 2020 742 140424 The Anniston Community Health Survey (ACHS-I) was initially conducted from 2005 to 2007 to assess polychlorinated biphenyl (PCB) exposures in Anniston, Alabama residents. In 2014, a follow-up study (ACHS-II) was conducted to measure the same PCBs as in ACHS-I and additional compounds e.g., polychlorinated dibenzo-p-dioxins (PCDDs), polychlorinated dibenzofurans (PCDFs), and dioxin-like non-ortho (cPCBs) substituted PCBs. In this epigenome-wide association study (EWAS), we examined the associations between PCDD, PCDF, and PCB exposures and DNA methylation. Whole blood DNA methylation was measured using Illumina EPIC arrays (n=292). We modeled lipid-adjusted toxic equivalencies (TEQs) for: SigmaDioxins (sum of 28 PCDDs, PCDFs, cPCBs, and mPCBs), PCDDs, PCDFs, cPCBs, and mPCBs using robust multivariable linear regression adjusting for age, race, sex, smoking, bisulfite conversion batch, and estimated percentages of six blood cell types. Among all exposures we identified 10 genome-wide (Bonferroni p</=6.74E-08) and 116 FDR (p</=5.00E-02) significant associations representing 10 and 113 unique CpGs, respectively. Of the 10 genome-wide associations, seven (70%) occurred in the PCDDs and four (40%) of these associations had an absolute differential methylation >/=1.00%, based on the methylation difference between the highest and lowest exposure quartiles. Most of the associations (six, 60%) represented hypomethylation changes. Of the 10 unique CpGs, eight (80%) were in genes shown to be associated with dioxins and/or PCBs based on data from the 2019 Comparative Toxicogenomics Database. In this study, we have identified a set of CpGs in blood DNA that may be particularly susceptible to dioxin, furan, and dioxin-like PCB exposures. |
Using an online modified-delphi approach to engage patients and caregivers in determining the patient-centeredness of Duchenne muscular dystrophy care considerations
Khodyakov D , Grant S , Denger B , Kinnett K , Martin A , Booth M , Armstrong C , Dao E , Chen C , Coulter I , Peay H , Hazlewood G , Street N . Med Decis Making 2019 39 (8) 1019-1031 Purpose. To determine the patient-centeredness of endocrine and bone health Duchenne muscular dystrophy (DMD) care considerations using the RAND/PPMD Patient-Centeredness Method (RPM), which is a novel, online, modified-Delphi approach to engaging patients and caregivers in clinical guideline development. Methods. We solicited input on the patient-centeredness of care considerations from 28 individuals with DMD and 94 caregivers, randomly assigned to 1 of 2 mixed panels. During a 3-round online modified-Delphi process, participants rated the importance and acceptability of 19 DMD care considerations (round 1), reviewed and discussed the initial results (round 2), and revised their original ratings (round 3). Patient-centeredness was operationalized as importance and acceptability of recommendations. We considered a care consideration to be patient-centered if both panels deemed it important and acceptable. Results. Ninety-five panelists (78%) participated in this study. Of these, 88 (93%) participated in round 1, 74 (78%) in round 2, and 56 (59%) in round 3. Panelists deemed 12 care considerations to be patient-centered: 3 weight management, 3 bone health, 4 vertical growth, and 2 puberty recommendations. Seven care considerations did not meet patient-centeredness criteria. Common reasons were lack of evidence specific to DMD and concerns about insurance coverage, access to treatment, and patient safety. Conclusions. Using the RPM, Duchenne families considered most care considerations to be patient-centered. Besides being clinically appropriate, these considerations are likely to be consistent with the preferences, needs, and values of Duchenne families. While all relevant care considerations should be discussed during patient-provider encounters, those that did not meet patient-centeredness criteria in particular should be carefully considered as part of joint decision making between Duchenne families and their providers. Study Registration: HSRProj 20163126. |
Polychlorinated biphenyl exposure and DNA methylation in the Anniston Community Health Survey.
Pittman GS , Wang X , Campbell MR , Coulter SJ , Olson JR , Pavuk M , Birnbaum LS , Bell DA . Epigenetics 2019 15 (4) 1-21 Anniston, Alabama was home to a major polychlorinated biphenyl (PCB) production facility from 1929 until 1971. The Anniston Community Health Survey I and II (ACHS-I 2005-2007, ACHS-II 2013-2014) were conducted to explore the effects of PCB exposures. In this report we examined associations between PCB exposure and DNA methylation in whole blood using EPIC arrays (ACHS-I, n = 518; ACHS-II, n = 299). For both cohorts, 35 PCBs were measured in serum. We modelled methylation versus PCB wet-weight concentrations for: the sum of 35 PCBs, mono-ortho substituted PCBs, di-ortho substituted PCBs, tri/tetra-ortho substituted PCBs, oestrogenic PCBs, and antiestrogenic PCBs. Using robust multivariable linear regression, we adjusted for age, race, sex, smoking, total lipids, and six blood cell-type percentages. We carried out a two-stage analysis; discovery in ACHS-I followed by replication in ACHS-II. In ACHS-I, we identified 28 associations (17 unique CpGs) at p </= 6.70E-08 and 369 associations (286 unique CpGs) at FDR p </= 5.00E-02. A large proportion of the genes have been observed to interact with PCBs or dioxins in model studies. Among the 28 genome-wide significant CpG/PCB associations, 14 displayed replicated directional effects in ACHS-II; however, only one in ACHS-II was statistically significant at p </= 1.70E-04. While we identified many novel CpGs significantly associated with PCB exposures in ACHS-I, the differential methylation was modest and the effect was attenuated seven years later in ACHS-II, suggesting a lack of persistence of the associations between PCB exposures and altered DNA methylation in blood cells. |
Accuracy of capillary hemoglobin measurements for the detection of anemia among U.S. low-income toddlers and pregnant women
Boghani S , Mei Z , Perry GS , Brittenham GM , Cogswell ME . Nutrients 2017 9 (3) The aim of this study is to evaluate the accuracy of capillary hemoglobin (Hb) measurements in detecting anemia among low-income toddlers (aged 12-35 months) and pregnant women. In analyses of data among toddlers from Kansas City (n = 402) and St. Louis, Missouri (n = 236), and pregnant women at <20 weeks gestation from Cleveland, Ohio (n = 397), we compared subjects' anemia status based on capillary Hb concentrations in finger puncture samples as measured by the HemoCue system with their anemia status based on venous Hb concentrations as measured by the HemoCue and Coulter Counter. The sensitivity of capillary blood analyses in identifying cases of anemia was 32.8% (95% Confidence Intervals (CI): 21.0%-46.3%), among Kansas City toddlers, 59.7% (95% CI: 45.8%-72.4%) among St. Louis toddlers, and 66.7% (95% CI: 46.0%-83.5%) among pregnant women in Cleveland; the corresponding specificities were 97.7%, 86.6%, and 96.7%, respectively. The correlation between HemoCue and Coulter Counter measurements of venous Hb (0.9) was higher than that between HemoCue measurements of capillary and venous blood (0.8). The results show that Hb measurements of capillary blood with HemoCue were not optimal for determining the anemia status of toddlers and pregnant women. |
Bolstering community cooperation in Ebola resurgence protocols: Combining field blood draw and point-of-care diagnosis
Fallah MP , Skrip LA , Raftery P , Kullie M , Borbor W , Laney AS , Blackley DJ , Christie A , Dokubo EK , Lo TQ , Coulter S , Baller A , Vonhm BT , Bemah P , Lomax S , Yeiah A , Wapoe-Sackie Y , Mann J , Clement P , Davies-Wayne G , Hamblion E , Wolfe C , Williams D , Gasasira A , Kateh F , Nyenswah TG , Galvani AP . PLoS Med 2017 14 (1) e1002227 Alison Galvani and colleagues describe a community-based protocol to improve cooperation with Ebola testing as well as contact tracing, quarantining, and treatment. |
Raccoon roundworm infection associated with central nervous system disease and ocular disease - six states, 2013-2015
Sircar AD , Abanyie F , Blumberg D , Chin-Hong P , Coulter KS , Cunningham D , Huskins WC , Langelier C , Reid M , Scott BJ , Shirley DA , Babik JM , Belova A , Sapp SG , McAuliffe I , Rivera HN , Yabsley MJ , Montgomery SP . MMWR Morb Mortal Wkly Rep 2016 65 (35) 930-933 Baylisascaris procyonis, predominantly found in raccoons, is a ubiquitous roundworm found throughout North America. Although raccoons are typically asymptomatic when infected with the parasite, the larval form of Baylisascaris procyonis can result in fatal human disease or severe neurologic outcomes if not treated rapidly. In the United States, Baylisascaris procyonis is more commonly enzootic in raccoons in the midwestern and northeastern regions and along the West Coast. However, since 2002, infections have been documented in other states (Florida and Georgia) and regions. Baylisascariasis is not a nationally notifiable disease in the United States, and little is known about how commonly it occurs or the range of clinical disease in humans. Case reports of seven human baylisascariasis cases in the United States diagnosed by Baylisascaris procyonis immunoblot testing at CDC are described, including review of clinical history and laboratory data. Although all seven patients survived, approximately half were left with severe neurologic deficits. Prevention through close monitoring of children at play, frequent handwashing, and clearing of raccoon latrines (communal sites where raccoons defecate) are critical interventions in curbing Baylisascaris infections. Early treatment of suspected cases is critical to prevent permanent sequelae. |
Reduced evolutionary rate in reemerged Ebola virus transmission chains.
Blackley DJ , Wiley MR , Ladner JT , Fallah M , Lo T , Gilbert ML , Gregory C , D'Ambrozio J , Coulter S , Mate S , Balogun Z , Kugelman J , Nwachukwu W , Prieto K , Yeiah A , Amegashie F , Kearney B , Wisniewski M , Saindon J , Schroth G , Fakoli L , Diclaro JW 2nd , Kuhn JH , Hensley LE , Jahrling PB , Stroher U , Nichol ST , Massaquoi M , Kateh F , Clement P , Gasasira A , Bolay F , Monroe SS , Rambaut A , Sanchez-Lockhart M , Scott Laney A , Nyenswah T , Christie A , Palacios G . Sci Adv 2016 2 (4) e1600378 On 29 June 2015, Liberia's respite from Ebola virus disease (EVD) was interrupted for the second time by a renewed outbreak ("flare-up") of seven confirmed cases. We demonstrate that, similar to the March 2015 flare-up associated with sexual transmission, this new flare-up was a reemergence of a Liberian transmission chain originating from a persistently infected source rather than a reintroduction from a reservoir or a neighboring country with active transmission. Although distinct, Ebola virus (EBOV) genomes from both flare-ups exhibit significantly low genetic divergence, indicating a reduced rate of EBOV evolution during persistent infection. Using this rate of change as a signature, we identified two additional EVD clusters that possibly arose from persistently infected sources. These findings highlight the risk of EVD flare-ups even after an outbreak is declared over. |
Comparison of cell counting methods in rodent pulmonary toxicity studies: automated and manual protocols and considerations for experimental design
Zeidler-Erdely PC , Antonini JM , Meighan TG , Young SH , Eye TJ , Hammer MA , Erdely A . Inhal Toxicol 2016 28 (9) 1-11 Pulmonary toxicity studies often use bronchoalveolar lavage (BAL) to investigate potential adverse lung responses to a particulate exposure. The BAL cellular fraction is counted, using automated (i.e. Coulter Counter(R)), flow cytometry or manual (i.e. hemocytometer) methods, to determine inflammatory cell influx. The goal of the study was to compare the different counting methods to determine which is optimal for examining BAL cell influx after exposure by inhalation or intratracheal instillation (ITI) to different particles with varying inherent pulmonary toxicities in both rat and mouse models. General findings indicate that total BAL cell counts using the automated and manual methods tended to agree after inhalation or ITI exposure to particle samples that are relatively nontoxic or at later time points after exposure to a pneumotoxic particle when the response resolves. However, when the initial lung inflammation and cytotoxicity was high after exposure to a pneumotoxic particle, significant differences were observed when comparing cell counts from the automated, flow cytometry and manual methods. When using total BAL cell count for differential calculations from the automated method, depending on the cell diameter size range cutoff, the data suggest that the number of lung polymorphonuclear leukocytes (PMN) varies. Importantly, the automated counts, regardless of the size cutoff, still indicated a greater number of total lung PMN when compared with the manual method, which agreed more closely with flow cytometry. The results suggest that either the manual method or flow cytometry would be better suited for BAL studies where cytotoxicity is an unknown variable. |
The burden of drug-resistant tuberculosis in Papua New Guinea: Results of a large population-based survey
Aia P , Kal M , Lavu E , John LN , Johnson K , Coulter C , Ershova J , Tosas O , Zignol M , Ahmadova S , Islam T . PLoS One 2016 11 (3) e0149806 BACKGROUND: Reliable estimates of the burden of multidrug-resistant tuberculosis (MDR-TB) are crucial for effective control and prevention of tuberculosis (TB). Papua New Guinea (PNG) is a high TB burden country with limited information on the magnitude of the MDR-TB problem. METHODS: A cross-sectional study was conducted in four PNG provinces: Madang, Morobe, National Capital District and Western Province. Patient sputum samples were tested for rifampicin resistance by the Xpert MTB/RIF assay and those showing the presence of resistance underwent phenotypic susceptibility testing to first- and second-line anti-TB drugs including streptomycin, isoniazid, rifampicin, ethambutol, pyrazinamide, ofloxacin, amikacin, kanamycin and capreomycin. RESULTS: Among 1,182 TB patients enrolled in the study, MDR-TB was detected in 20 new (2.7%; 95% confidence intervals [CI] 1.1-4.3%) and 24 previously treated (19.1%; 95%CI: 8.5-29.8%) TB cases. No case of extensively drug-resistant TB (XDR-TB) was detected. Thirty percent (6/20) of new and 33.3% (8/24) of previously treated cases with MDR-TB were detected in a single cluster in Western Province. CONCLUSION: In PNG the proportion of MDR-TB in new cases is slightly lower than the regional average of 4.4% (95%CI: 2.6-6.3%). A large proportion of MDR-TB cases were identified from a single hospital in Western Province, suggesting that the prevalence of MDR-TB across the country is heterogeneous. Future surveys should further explore this finding. The survey also helped strengthening the use of smear microscopy and Xpert MTB/RIF testing as diagnostic tools for TB in the country. |
A meta-analysis of the performance of the Pima(TM) CD4 for point of care testing
Scott LE , Campbell J , Westerman L , Kestens L , Vojnov L , Kohastsu L , Nkengasong J , Peter T , Stevens W . BMC Med 2015 13 168 BACKGROUND: The Alere point-of-care (POC) Pima CD4 analyzer allows for decentralized testing and expansion to testing antiretroviral therapy (ART) eligibility. A consortium conducted a pooled multi-data technical performance analysis of the Pima CD4. METHODS: Primary data (11,803 paired observations) comprised 22 independent studies between 2009-2012 from the Caribbean, Asia, Sub-Saharan Africa, USA and Europe, using 6 laboratory-based reference technologies. Data were analyzed as categorical (including binary) and numerical (absolute) observations using a bivariate and/or univariate random effects model when appropriate. RESULTS: At a median reference CD4 of 383 cells/mul the mean Pima CD4 bias is -23 cells/mul (average bias across all CD4 ranges is 10 % for venous and 15 % for capillary testing). Sensitivity of the Pima CD4 is 93 % (95 % confidence interval [CI] 91.4 % - 94.9 %) at 350 cells/mul and 96 % (CI 95.2 % - 96.9 %) at 500 cells/mul, with no significant difference between venous and capillary testing. Sensitivity reduced to 86 % (CI 82 % - 89 %) at 100 cells/mul (for Cryptococcal antigen (CrAg) screening), with a significant difference between venous (88 %, CI: 85 % - 91 %) and capillary (79 %, CI: 73 % - 84 %) testing. Total CD4 misclassification is 2.3 % cases at 100 cells/mul, 11.0 % at 350 cells/mul and 9.5 % at 500 cells/mul, due to higher false positive rates which resulted in more patients identified for treatment. This increased by 1.2 %, 2.8 % and 1.8 %, respectively, for capillary testing. There was no difference in Pima CD4 misclassification between the meta-analysis data and a population subset of HIV+ ART naive individuals, nor in misclassification among operator cadres. The Pima CD4 was most similar to Beckman Coulter PanLeucogated CD4, Becton Dickinson FACSCalibur and FACSCount, and less similar to Partec CyFlow reference technologies. CONCLUSIONS: The Pima CD4 may be recommended using venous-derived specimens for screening (100 cells/mul) for reflex CrAg screening and for HIV ART eligibility at 350 cells/mul and 500 cells/mul thresholds using both capillary and venous derived specimens. These meta-analysis findings add to the knowledge of acceptance criteria of the Pima CD4 and future POC tests, but implementation and impact will require full costing analysis. |
Controlling the last known cluster of Ebola virus disease - Liberia, January-February 2015
Nyenswah T , Fallah M , Sieh S , Kollie K , Badio M , Gray A , Dilah P , Shannon M , Duwor S , Ihekweazu C , Cordier-Lasalle T , Shinde SA , Hamblion E , Davies-Wayne G , Ratnesh M , Dye C , Yoder JS , McElroy P , Hoots B , Christie A , Vertefeuille J , Olsen SJ , Laney AS , Neal JJ , Navin TR , Coulter S , Pordell P , Lo T , Kinkade C , Mahoney F . MMWR Morb Mortal Wkly Rep 2015 64 (18) 500-4 As one of the three West African countries highly affected by the 2014-2015 Ebola virus disease (Ebola) epidemic, Liberia reported approximately 10,000 cases. The Ebola epidemic in Liberia was marked by intense urban transmission, multiple community outbreaks with source cases occurring in patients coming from the urban areas, and outbreaks in health care facilities (HCFs). This report, based on data from routine case investigations and contact tracing, describes efforts to stop the last known chain of Ebola transmission in Liberia. The index patient became ill on December 29, 2014, and the last of 21 associated cases was in a patient admitted into an Ebola treatment unit (ETU) on February 18, 2015. The chain of transmission was stopped because of early detection of new cases; identification, monitoring, and support of contacts in acceptable settings; effective triage within the health care system; and rapid isolation of symptomatic contacts. In addition, a "sector" approach, which divided Montserrado County into geographic units, facilitated the ability of response teams to rapidly respond to community needs. In the final stages of the outbreak, intensive coordination among partners and engagement of community leaders were needed to stop transmission in densely populated Montserrado County. A companion report describes the efforts to enhance infection prevention and control efforts in HCFs. After February 19, no additional clusters of Ebola cases have been detected in Liberia. On May 9, the World Health Organization declared the end of the Ebola outbreak in Liberia. |
Hemoglobin and hip fracture risk in older non-Hispanic white adults
Looker AC . Osteoporos Int 2014 25 (10) 2389-98 The relationship between hemoglobin and hip fracture was examined in older non-Hispanic white adults from the third National Health and Nutrition Examination Survey (NHANES III). Both low and high hemoglobin values were associated with increased hip fracture risk before and after adjusting for selected risk factors. INTRODUCTION: The few studies to date that have examined the relationship between hemoglobin and fracture risk have focused on low hemoglobin values. The present study examined hip fracture risk across the hemoglobin distribution in older non-Hispanic white adults from the third National Health and Nutrition Examination Survey (NHANES III, 1988-1994). METHODS: Hemoglobin was measured using a Coulter S-plus Jr.(R) (Coulter Electronics, Hialeah, FL) in 2,122 non-Hispanic whites age 65 years and older. Hip fracture cases were identified using linked Medicare and mortality records obtained through 2007. Cox proportional hazards models were used to assess the best-fitting model and to estimate the hazards ratio (HR) for hip fracture by hemoglobin decile before and after adjusting for selected confounders. RESULTS: There were 239 hip fracture cases in the analytic sample. The best fitting model was quadratic. When compared to values in the middle of the distribution, those with hemoglobin in the lowest and highest deciles had increased hip fracture risk (HRlowest decile = 2.96, 95 % confidence interval (CI) 1.44-6.08; HRhighest decile = 2.06, 95 % CI 1.09-3.92) after adjusting for age and sex. Both HRs remained significant after adjusting for additional confounders (HRlowest decile = 2.24, 95 % CI 1.09-3.92; HRhighest decile = 2.37, 95 % CI 1.35-4.16). CONCLUSIONS: Both low and high hemoglobin values were associated with increased hip fracture risk. The mechanism underlying the relationship is not clear, but there were some suggestions that it may differ for low versus high hemoglobin. |
Rifampicin-resistant Mycobacterium tuberculosis: susceptibility to isoniazid and other anti-tuberculosis drugs
Kurbatova EV , Cavanaugh JS , Shah NS , Wright A , Kim H , Metchock B , Van Deun A , Barrera L , Boulahbal F , Richter E , Martin-Casabona N , Arias F , Zemanova I , Drobniewski F , Santos Silva A , Coulter C , Lumb R , Cegielski JP . Int J Tuberc Lung Dis 2012 16 (3) 355-357 Based on data from 14 Supranational Tuberculosis (TB) Reference Laboratories worldwide, the proportion of rifampicin (RMP) resistant isolates that were isoniazid (INH) susceptible by phenotypic drug susceptibility testing varied widely (0.5-11.6%). RMP-resistant isolates that were INH-susceptible had significantly lower rates of resistance to other first- and second-line anti-tuberculosis drugs (except rifabutin) compared to multidrug-resistant isolates. RMP resistance is not a lways a good proxy for a presumptive diagnosis of multidrug-resistant TB, which has implications for use of molecular assays that identify only RMP resistanceassociated DNA mutations. (2012 The Union.) |
Cholesterol and phytosterols differentially regulate the expression of caveolin 1 and a downstream prostate cell growth-suppressor gene
Ifere GO , Equan A , Gordon K , Nagappan P , Igietseme JU , Ananaba GA . Cancer Epidemiol 2010 34 (4) 461-71 BACKGROUND: The purpose of our study was to show the distinction between the apoptotic and anti-proliferative signaling of phytosterols and cholesterol-enrichment in prostate cancer cell lines, mediated by the differential transcription of caveolin-1, and N-myc downstream-regulated gene 1 (NDRG1), a pro-apoptotic androgen-regulated tumor suppressor. METHODS: PC-3 and DU145 cells were treated with sterols (cholesterol and phytosterols) for 72h, followed by trypan blue dye-exclusion measurement of necrosis and cell growth measured with a Coulter counter. Sterol induction of cell growth-suppressor gene expression was evaluated by mRNA transcription using RT-PCR, while cell cycle analysis was performed by FACS analysis. Altered expression of Ndrg1 protein was confirmed by Western blot analysis. Apoptosis was evaluated by real time RT-PCR amplification of P53, Bcl-2 gene and its related pro- and anti-apoptotic family members. RESULTS: Physiological doses (16microM) of cholesterol and phytosterols were not cytotoxic in these cells. Cholesterol-enrichment promoted cell growth (P<0.05), while phytosterols significantly induced growth-suppression (P<0.05) and apoptosis. Cell cycle analysis showed that contrary to cholesterol, phytosterols decreased mitotic subpopulations. We demonstrated for the first time that cholesterols concertedly attenuated the expression of caveolin-1 (cav-1) and NDRG1 genes in both prostate cancer cell lines. Phytosterols had the opposite effect by inducing overexpression of cav-1, a known mediator of androgen-dependent signals that presumably control cell growth or apoptosis. CONCLUSIONS: Cholesterol and phytosterol treatment differentially regulated the growth of prostate cancer cells and the expression of p53 and cav-1, a gene that regulates androgen-regulated signals. These sterols also differentially regulated cell cycle arrest, downstream pro-apoptotic androgen-regulated tumor suppressor, NDRG1 suggesting that cav-1 may mediate pro-apoptotic NDRG1 signals. Elucidation of the mechanism for sterol modulation of growth and apoptosis signaling may reveal potential targets for cancer prevention and/or chemotherapeutic intervention. Sterol regulation of NDRG1 transcription suggests its potential as biomarker for prediction of neoplasms that would be responsive to chemoprevention by phytosterols. |
Identification of an unusual Brucella strain (BO2) from a lung biopsy in a 52 year-old patient with chronic destructive pneumonia
Tiller RV , Gee JE , Lonsway DR , Gribble S , Bell SC , Jennison AV , Bates J , Coulter C , Hoffmaster AR , De BK . BMC Microbiol 2010 10 23 BACKGROUND: Brucellosis is primarily a zoonotic disease caused by Brucella species. There are currently ten Brucella spp. including the recently identified novel B. inopinata sp. isolated from a wound associated with a breast implant infection. In this study we report on the identification of an unusual Brucella-like strain (BO2) isolated from a lung biopsy in a 52-year-old patient in Australia with a clinical history of chronic destructive pneumonia. RESULTS: Standard biochemical profiles confirmed that the unusual strain was a member of the Brucella genus and the full-length 16S rRNA gene sequence was 100% identical to the recently identified B. inopinata sp. nov. (type strain BO1(T)). Additional sequence analysis of the recA, omp2a and 2b genes; and multiple locus sequence analysis (MLSA) demonstrated that strain BO2 exhibited significant similarity to the B. inopinata sp. compared to any of the other Brucella or Ochrobactrum species. Genotyping based on multiple-locus variable-number tandem repeat analysis (MLVA) established that the BO2 and BO1(T) strains form a distinct phylogenetic cluster separate from the other Brucella spp. CONCLUSION: Based on these molecular and microbiological characterizations, we propose that the BO2 strain is a novel lineage of the newly described B. inopinata species. |
Multilaboratory validation study of standardized multiple-locus variable-number tandem repeat analysis protocol for shiga toxin-producing escherichia coli O157: a novel approach to normalize fragment size data between capillary electrophoresis platforms
Hyytia-Trees E , Lafon P , Vauterin P , Ribot EM . Foodborne Pathog Dis 2009 7 (2) 129-36 The PulseNet USA subtyping network recently established a standardized protocol for multiple-locus variable-number tandem repeat analysis (MLVA) to characterize Shiga toxin-producing Escherichia coli O157. To enable data comparisons from different laboratories in the same database, reproducibility and high quality of the data must be ensured. The aim of this study was to test the robustness and reproducibility of the proposed standardized protocol by subjecting it to a multilaboratory validation process and to address any discrepancies that may have arisen from the study. A set of 50 strains was tested in 10 PulseNet participating laboratories that used capillary electrophoresis instruments from two manufacturers. Six out of the 10 laboratories were able to generate correct MLVA types for 46 (92%) or more strains. The discrepancies in MLVA type assignment were caused mainly by difficulties in optimizing polymerase chain reactions that were attributed to technical inexperience of the staff and suboptimal quality of reagents and instrumentation. It was concluded that proper training of staff must be an integral part of technology transfer. The interlaboratory reproducibility of fragment sizing was excellent when the same capillary electrophoresis platform was used. However, sizing discrepancies of up to six base pairs for the same fragment were detected between the two platforms. These discrepancies were attributed to different dye and polymer chemistries employed by the manufacturers. A novel software script was developed to assign alleles based on two platform-specific (Beckman Coulter CEQ8000 and Applied Biosystems Genetic Analyzer 3130xl) look-up tables containing fragment size ranges for all alleles. The new allele assignment method was validated at the PulseNet central laboratory using a diverse set of 502 Shiga toxin-producing Escherichia coli O157 isolates. The validation confirmed that the script reliably assigned the same allele for the same fragment regardless of the platform used to size the fragment. |
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