Last data update: Jun 24, 2024. (Total: 47078 publications since 2009)
Records 1-26 (of 26 Records) |
Query Trace: Granade T [original query] |
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Analysis of the Federal Section 317 Immunization Program and routine adult immunization activities, United States, 2022-2023
Granade CJ , Crawford NE , Banks M , Graitcer S . Public Health Rep 2024 333549241236085 OBJECTIVES: The federal Section 317 Immunization Program, administered by the Centers for Disease Control and Prevention (CDC), provides funding to support adult immunization efforts; however, current information on program implementation at the jurisdictional level is limited. We assessed the use of Section 317 and other funding sources to support routine adult immunization activities among the 64 immunization programs ("awardees"). METHODS: We conducted a survey and key informant interviews with awardees in October to December 2022 to collect quantitative and qualitative data on current adult vaccine purchase and program operation activities funded by Section 317 and other funding sources. We assessed total vaccine cost and data on vaccine purchase projections for each awardee with CDC's Cost and Affordability Tool for 2023. RESULTS: Immunization program managers or their designees from 62 of 64 awardees (97%) completed the survey; 12 awardees participated in key informant interviews. Of 62 awardees, 32 (52%) used a single funding source to support adult vaccine purchases, of which 29 (91%) used only Section 317 funds, 21 (34%) reported not planning to purchase ≥1 age-based recommended vaccine for adults in 2023, and 33 (53%) reported using Section 317 funds only to support adult immunization program operations. Key informant interviews showed varied operational activities among awardees, but 8 awardees stated the need for additional staff to expand adult immunization program services in health care provider education (n = 5), program administration (n = 5), and site visits (n = 6). CONCLUSIONS: Additional efforts are needed to understand how to better support routine adult immunization activities implemented at the jurisdictional level. |
Evaluation of the VioOne HIV profile supplemental assay
Franz BJ , Register H , Sullivan V , Warber K , Granade TC , Cornaby C , Magee ME , Denny TN , Lockwood D , Schmitz JL . J Clin Microbiol 2024 e0083623 We evaluated the reproducibility, sensitivity, and specificity data for two versions of the VioOne HIV Profile Supplemental Assay and compared these results back to similar results for the Geenius HIV 1/2 Supplemental Assay that are publicly available. Our study concluded that the VioOne HIV Profile Supplemental Assay compared favorably with the Geenius HIV 1/2 Supplemental Assay, thus providing an additional option for clinical laboratories to improve and expand their HIV testing capabilities. |
CDC COVID-19 vaccination program: Healthcare provider compliance with COVID-19 vaccine requirements and recommendations
Surtees TC , Granade CJ , Wells C , Banks M , Lucas P , Graitcer SB . Vaccine 2023 The COVID-19 Vaccination Provider Oversight (CVPO) program was implemented by the Centers for Disease Control and Prevention (CDC) to ensure the proper management and administration of COVID-19 vaccines by healthcare providers participating in the CDC COVID-19 Vaccination Program. As part of the CVPO program, the 64 CDC-funded immunization program awardees conducted site visits with participating healthcare providers. We evaluated healthcare provider adherence to CVPO program requirements between May 2021 and May 2023. CVPO program site visit data was collected using a REDCap database. The proportion of site visits conducted by U.S. Department of Health and Human Services (HHS) region was calculated. Chi-square statistics for healthcare provider compliance with CVPO program requirements were presented to assess variation in compliance by provider type. The proportion of healthcare providers receiving a site visit ranged from 7.9 % to 37.2 % across HHS regions. Healthcare provider compliance was high for COVID-19 vaccine preparation, administration, and error reporting categories (>90 %). Healthcare provider compliance was lowest for vaccine storage and handling and reporting requirements (79.9 % and 82.6 %, respectively). Public health providers demonstrated significantly higher overall compliance as compared to all other included healthcare provider types (p-value < 0.05). The observed high healthcare provider compliance, coupled with thorough follow-up efforts by awardees to address any non-compliance concerns, highlights the success of jurisdictions supporting healthcare providers with proper vaccine management, administration, and safety procedures. Further research can strengthen vaccine storage, handling, and administration practices for future widespread vaccination efforts. |
A monoclonal antibody for the detection of the antiretroviral drug emtricitabine
Youngpairoj AS , Vanderford TH , Reed MS , Granade TC , Pau CP , Pohl J , Switzer WM , Heneine W . AIDS 2022 36 (13) 1890-1893 Antibody-based testing for emtricitabine (FTC), a critical component of pre-exposure prophylaxis and antiretroviral therapy would provide low-cost detection for clinical monitoring to improve adherence. We developed a monoclonal antibody (5D2) to FTC and demonstrated its high specificity and physiologically relevant linear range of detection in a competitive enzyme immunoassay (EIA). Thus, this monoclonal antibody is a key reagent that will enable simple and low-cost lateral flow assays and EIAs for adherence monitoring. |
Racial and ethnic disparities in adult vaccination: A review of the state of evidence
Granade CJ , Lindley MC , Jatlaoui T , Asif AF , Jones-Jack N . Health Equity 2022 6 (1) 206-223 Background: Adult vaccination coverage remains low in the United States, particularly among racial and ethnic minority populations. Objective: To conduct a comprehensive literature review of research studies assessing racial and ethnic disparities in adult vaccination. Search Methods: We conducted a search of PubMed, Cochrane Library, ClinicalTrials.gov, and reference lists of relevant articles. Selection Criteria: Research studies were eligible for inclusion if they met the following criteria: (1) study based in the United States, (2) evaluated receipt of routine immunizations in adult populations, (3) used within-study comparison of race/ethnic groups, and (4) eligible for at least one author-defined PICO (patient, intervention, comparison, and outcome) question. Data Collection and Analysis: Preliminary abstract review was conducted by two authors. Following complete abstraction of articles using a standardized template, abstraction notes and determinations were reviewed by all authors; disagreements regarding article inclusion/exclusion were resolved by majority rule. The Social Ecological Model framework was used to complete a narrative review of observational studies to summarize factors associated with disparities; a systematic review was used to evaluate eligible intervention studies. Results: Ninety-five studies were included in the final analysis and summarized qualitatively within two main topic areas: (1) factors associated with documented racial-ethnic disparities in adult vaccination and (2) interventions aimed to reduce disparities or to improve vaccination coverage among racial-ethnic minority groups. Of the 12 included intervention studies, only 3 studies provided direct evidence and were of Level II, fair quality; the remaining 9 studies met the criteria for indirect evidence (Level I or II, fair or poor quality). Conclusions: A considerable amount of observational research evaluating factors associated with racial and ethnic disparities in adult vaccination is available. However, intervention studies aimed at reducing these disparities are limited, are of poor quality, and insufficiently address known reasons for low vaccination uptake among racial and ethnic minority adults. © Charleigh J. Granade et al., 2022; Published by Mary Ann Liebert, Inc. 2022. |
Availability of Adult Vaccination Services by Provider Type and Setting
Granade CJ , McCord RF , Bhatti AA , Lindley MC . Am J Prev Med 2021 60 (5) 692-700 INTRODUCTION: Knowledge regarding the benefits for adult vaccination services under Medicaid's fee-for-service arrangement is dated; little is known regarding the availability of vaccination services for adult Medicaid beneficiaries in MCO arrangements. This study evaluates the availability of provider reimbursement benefits for adult vaccination services under fee-for-service and MCO arrangements for different types of healthcare providers and settings. METHODS: A total of 43 Medicaid directors across the 50 U.S. states and the District of Columbia participated in a semistructured survey conducted from June 2018 to June 2019 (43/51). The frequency of Medicaid fee-for-service and MCO arrangements reporting reimbursement for adult vaccination services by various provider types and settings were assessed in 2019. Elements of vaccination services examined in this study were vaccine purchase, vaccine administration, and vaccination-related counseling. RESULTS: Under fee-for-service, 41 Medicaid programs reimburse primary care providers for adult vaccine purchase (41/43); fewer programs reimburse vaccine administration and vaccination-related counseling (33/43 and 30/43, respectively). Similar results were observed for obstetricians-gynecologists, nurse practitioners, and pharmacies. Although 24 fee-for-service (24/43) and 23 MCO (23/34) arrangements cover adult vaccination services in most settings, long-term care facilities have the lowest reported reimbursement eligibility. CONCLUSIONS: In most jurisdictions, vaccination services for adult Medicaid beneficiaries are available for a variety of healthcare provider types and settings under both fee-for-service and MCO arrangements. However, because provider reimbursement benefits remain inconsistent for adult vaccination counseling services and within long-term care facilities, access to adult vaccination services may be reduced for Medicaid beneficiaries who depend on these resources. |
Development and optimization of thermal contrast amplification lateral flow immunoassays for ultrasensitive HIV p24 protein detection
Zhan L , Granade T , Liu Y , Wei X , Youngpairoj A , Sullivan V , Johnson J , Bischof J . Microsyst Nanoeng 2020 6 (1) 54 Detection of human immunodeficiency virus (HIV) p24 protein at a single pg/ml concentration in point-of-care (POC) settings is important because it can facilitate acute HIV infection diagnosis with a detection sensitivity approaching that of laboratory-based assays. However, the limit of detection (LOD) of lateral flow immunoassays (LFAs), the most prominent POC diagnostic platform, falls short of that of laboratory protein detection methods such as enzyme-linked immunosorbent assay (ELISA). Here, we report the development and optimization of a thermal contrast amplification (TCA) LFA that will allow ultrasensitive detection of 8 pg/ml p24 protein spiked into human serum at POC, approaching the LOD of a laboratory test. To achieve this aim, we pursued several innovations as follows: (a) defining a new quantitative figure of merit for LFA design based on the specific to nonspecific binding ratio (BR); (b) using different sizes and shapes of gold nanoparticles (GNPs) in the systematic optimization of TCA LFA designs; and (c) exploring new laser wavelengths and power regimes for TCA LFA designs. First, we optimized the blocking buffer for the membrane and running buffer by quantitatively measuring the BR using a TCA reader. The TCA reader interprets the thermal signal (i.e., temperature) of GNPs within the membrane when irradiated by a laser at the plasmon resonance wavelength of the particle. This process results in higher detection and quantitation of GNPs than in traditional visual detection (i.e., color intensity). Further, we investigated the effect of laser power (30, 100, 200 mW), GNP size and shape (30 and 100 nm gold spheres, 150 nm gold-silica shells), and laser wavelength (532, 800 nm). Applying these innovations to a new TCA LFA design, we demonstrated that 100 nm spheres with a 100 mW 532 nm laser provided the best performance (i.e., LOD = 8 pg/ml). This LOD is significantly better than that of the current colorimetric LFA and is in the range of the laboratory-based p24 ELISA. In summary, this TCA LFA for p24 protein shows promise for detecting acute HIV infection in POC settings. |
Implementation of the Standards for Adult Immunization Practice: A survey of U.S. health care providers
Granade CJ , Parker Fiebelkorn A , Black CL , Lutz CS , Srivastav A , Bridges CB , Ball SW , Devlin RG , Cloud AJ , Kim DK . Vaccine 2020 38 (33) 5305-5312 The revised Standards for Adult Immunization Practice ("Standards"), published in 2014, recommend routine vaccination assessment, strong provider recommendation, vaccine administration or referral, and documentation of vaccines administered into immunization information systems (IIS). We assessed clinician and pharmacist implementation of the Standards in the United States from 2016 to 2018. Participating clinicians (family and internal medicine physicians, obstetricians-gynecologists, specialty physicians, physician assistants, and nurse practitioners) and pharmacists responded using an internet panel survey. Weighted proportion of clinicians and pharmacists reporting full implementation of each component of the Standards were calculated. Adjusted prevalence ratio (APR) estimates of practice characteristics associated with self-reported implementation of the Standards are also presented. Across all medical specialties, the percentages of clinicians and pharmacists implementing the vaccine assessment and recommendation components of the Standards were >80.0%. However, due to low IIS documentation, full implementation of the Standards was low overall, ranging from 30.4% for specialty medicine to 45.8% in family medicine clinicians. The presence of an immunization champion (APR, 1.40 [95% confidence interval {CI}, 1.26 to 1.54]), use of standing orders (APR, 1.41 [95% CI, 1.27 to 1.57]), and use of a patient reminder-recall system (APR, 1.39 [95% CI, 1.26 to 1.54]) were positively associated with adherence to the Standards by clinicians. Similar results were observed for pharmacists. Nonetheless, vaccination improvement strategies, i.e., having standing orders in place, empowering an immunization champion, and using patient recall-reminder systems were underutilized in clinical settings; full implementation of the Standards was inconsistent across all health care provider practices. |
State policies on access to vaccination services for low-income adults
Granade CJ , McCord RF , Bhatti AA , Lindley MC . JAMA Netw Open 2020 3 (4) e203316 Importance: State vaccination benefits coverage and access for adult Medicaid beneficiaries vary substantially. Multiple studies have documented lower vaccination uptake in publicly insured adults compared with privately insured adults. Objective: To evaluate adult Medicaid beneficiaries' access to adult immunization services through review of vaccination benefits coverage in Medicaid programs across the 50 states and the District of Columbia. Design, Setting, and Participants: A public domain document review with supplemental semistructured telephone survey was conducted between June 1, 2018, and June 14, 2019, to evaluate vaccination services benefits in fee-for-service and managed care organization arrangements for adult Medicaid beneficiaries in the 50 states and the District of Columbia (total, 51 Medicaid programs). Exposures: Document review of benefits coverage for adult immunization services and supplemental survey with validation of document review findings. Main Outcomes and Measures: Benefits coverage for adult Medicaid beneficiaries and reimbursement amounts for vaccine purchase and administration. Results: Public domain document review was completed for all 51 jurisdictions. Among these, 44 Medicaid programs (86%) validated document review findings and completed the survey. Only 22 Medicaid programs (43%) covered all 13 Advisory Committee on Immunization Practices-recommended adult immunizations under both fee-for-service and managed care organization arrangements. Most fee-for-service arrangements (37 of 49) reimbursed health care professionals using any of the 4 approved vaccine administration codes; however, 8 of 49 programs did not separately reimburse for vaccine administration to adult Medicaid beneficiaries. Depending on administration route, median reimbursement for adult vaccine administration ranged from $9.81 to $13.98 per dose. Median per-dose reimbursement for adult vaccine purchase was highest for 9-valent human papillomavirus vaccine ($204.87) and lowest for Haemophilus influenzae type b vaccine ($18.09). Median reimbursement was below the private sector price for 7 of the 13 included vaccines. Conclusions and Relevance: Even in programs with complete vaccination benefits coverage, reimbursement amounts to health care professionals for vaccine purchase and administration may not fully cover vaccination provision costs. Reimbursement amounts below costs may reduce incentives for health care professionals to vaccinate low-income adults and thereby limit Medicaid adult beneficiary access to vaccination. |
Trends in HIV-2 diagnoses and use of the HIV-1/HIV-2 differentiation test - United States, 2010-2017
Peruski AH , Wesolowski LG , Delaney KP , Chavez PR , Owen SM , Granade TC , Sullivan V , Switzer WM , Dong X , Brooks JT , Joyce MP . MMWR Morb Mortal Wkly Rep 2020 69 (3) 63-66 Since 2014, the recommended laboratory testing algorithm for diagnosing human immunodeficiency virus (HIV) infection has included a supplemental HIV-1/HIV-2 differentiation test to confirm infection type on the basis of the presence of type-specific antibodies (1). Correctly identifying HIV-1 and HIV-2 infections is vital because their epidemiology and clinical management differ. To describe the percentage of diagnoses for which an HIV-1/HIV-2 differentiation test result was reported and to categorize HIV type based on laboratory test results, 2010-2017 data from CDC's National HIV Surveillance System (NHSS) were analyzed. During 2010-2017, a substantial increase in the number of HIV-1/HIV-2 differentiation test results were reported to NHSS, consistent with implementation of the HIV laboratory-based testing algorithm recommended in 2014. However, >99.9% of all HIV infections identified in the United States were categorized as HIV-1, and the number of HIV-2 diagnoses (mono-infection or dual-infection) remained extremely low (<0.03% of all HIV infections). In addition, the overall number of false positive HIV-2 test results produced by the HIV-1/HIV-2 differentiation increased. The diagnostic value of a confirmatory antibody differentiation test in a setting with sensitive and specific screening tests and few HIV-2 infections might be limited. Evaluation and consideration of other HIV tests approved by the Food and Drug Administration (FDA) that might increase efficiencies in the CDC and Association of Public Health Laboratories-recommended HIV testing algorithm are warranted. |
A strategy for PrEP clinicians to manage ambiguous HIV test results during follow-up visits
Smith DK , Switzer WM , Peters P , Delaney KP , Granade TC , Masciotra S , Shouse L , Brooks JT . Open Forum Infect Dis 2018 5 (8) ofy180 Prompt determination of HIV infection status is critical during follow-up visits for patients taking pre-exposure prophylaxis (PrEP) medication. Those who are uninfected can then continue safely taking PrEP, and those few who have acquired HIV infection can initiate an effective treatment regimen. However, a few recent cases have been reported of ambiguous HIV test results using common testing algorithms in PrEP patients. We review published reports of such cases and testing options that can be used to clarify true HIV status in these situations. In addition, we review the benefits and risks of 3 antiretroviral management options in these patients: (1) continue PrEP while conducting additional HIV tests, (2) initiate antiretroviral therapy for presumptive HIV infection while conducting confirmatory tests, or (3) discontinue PrEP to reassess HIV status after a brief antiretroviral-free interval. A clinical consultation resource is also provided. |
Characterization of real-time microarrays for simultaneous detection of HIV-1, HIV-2, and hepatitis viruses.
Granade TC , Kodani M , Wells SK , Youngpairoj AS , Masciotra S , Curtis KM , Kamili S , Owen SM . J Virol Methods 2018 259 60-65 Real-time PCR assays for nucleic acid testing (NAT) of hepatitis viruses A-E and for HIV-1 and HIV-2 have been developed; however, a multiplex assay that can simultaneously detect all of these agents is not yet available. Standardized TaqMan assays for detection of hepatitis viruses A-E have been described and applied to TaqMan Array Cards (TAC) which are capable of multiple pathogen detection using a single set of optimized PCR conditions. Assays for three gene regions of HIV-1 (long-terminal repeat (LTR), gag, and polymerase) and HIV-2 (overlap of LTR and gag, protease and integrase) were designed using the hepatitis assay conditions. Nucleic acid extracts of HIV-1-infected samples (44 plasma, 41 whole blood, 20 HIV-1 viral stocks) were tested on the TAC cards; 98 were reactive (92%) with 70 in multiple gene regions. Twenty-four of the 27 (89%) HIV-2 specimens (10 plasma, 1 PBMC lysate, 6 whole blood and 10 plasmids containing HIV-2 polymerase) were detected on TAC. No HIV or hepatitis virus sequences were detected in 30 HIV-negative samples (specificity 100%). Three HBV and 18 HCV co-infections were identified in the HIV-1-infected specimens. Multi-pathogen detection using TAC could provide a rapid, sensitive and more efficient method of surveying for a variety of infectious disease nucleic acids. |
Improved Subtyping of Staphylococcus aureus Clonal Complex 8 Strains Based on Whole-Genome Phylogenetic Analysis.
Bowers JR , Driebe EM , Albrecht V , McDougal LK , Granade M , Roe CC , Lemmer D , Rasheed JK , Engelthaler DM , Keim P , Limbago BM . mSphere 2018 3 (3) Strains of Staphylococcus aureus in clonal complex 8 (CC8), including USA300, USA500, and the Iberian clone, are prevalent pathogens in the United States, both inside and outside health care settings. Methods for typing CC8 strains are becoming obsolete as the strains evolve and diversify, and whole-genome sequencing has shown that some strain types fall into multiple sublineages within CC8. In this study, we attempt to clarify the strain nomenclature of CC8, classifying the major strain types based on whole-genome sequence phylogenetics using both methicillin-resistant S. aureus (MRSA) and methicillin-susceptible S. aureus (MSSA) genomes. We show that isolates of the Archaic and Iberian clones from decades ago make up the most basal clade of the main CC8 lineages and that at least one successful lineage of CC8, made up mostly of MSSA, diverged before the other well-known strain types USA500 and USA300. We also show that the USA500 type includes two clades separated by the previously described "Canadian epidemic MRSA" strain CMRSA9, that one clade containing USA500 also contains the USA300 clade, and that the USA300-0114 strain type is not a monophyletic group. Additionally, we present a rapid, simple CC8 strain-typing scheme using real-time PCR assays that target single nucleotide polymorphisms (SNPs) derived from our CC8 phylogeny and show the significant benefit of using more stable genomic markers based on evolutionary lineages over traditional S. aureus typing techniques. This more accurate and accessible S. aureus typing system may improve surveillance and better inform the epidemiology of this very important pathogen.IMPORTANCEStaphylococcus aureus is a major human pathogen worldwide in both community and health care settings. Surveillance for S. aureus strains is important to our understanding of their spread and to informing infection prevention and control. Confusion surrounding the strain nomenclature of one of the most prevalent lineages of S. aureus, clonal complex 8 (CC8), and the imprecision of current tools for typing S. aureus make surveillance and source tracing difficult and sometimes misleading. In this study, we clarify the CC8 strain designations and propose a new typing scheme for CC8 isolates that is rapid and easy to use. This typing scheme is based on relatively stable genomic markers, and we demonstrate its superiority over traditional typing techniques. This scheme has the potential to greatly improve epidemiological investigations of S. aureus. |
1970s and 'Patient 0' HIV-1 genomes illuminate early HIV/AIDS history in North America.
Worobey M , Watts TD , McKay RA , Suchard MA , Granade T , Teuwen DE , Koblin BA , Heneine W , Lemey P , Jaffe HW . Nature 2016 539 (7627) 98-101 The emergence of HIV-1 group M subtype B in North American men who have sex with men was a key turning point in the HIV/AIDS pandemic. Phylogenetic studies have suggested cryptic subtype B circulation in the United States (US) throughout the 1970s and an even older presence in the Caribbean. However, these temporal and geographical inferences, based upon partial HIV-1 genomes that postdate the recognition of AIDS in 1981, remain contentious and the earliest movements of the virus within the US are unknown. We serologically screened >2,000 1970s serum samples and developed a highly sensitive approach for recovering viral RNA from degraded archival samples. Here, we report eight coding-complete genomes from US serum samples from 1978-1979-eight of the nine oldest HIV-1 group M genomes to date. This early, full-genome 'snapshot' reveals that the US HIV-1 epidemic exhibited extensive genetic diversity in the 1970s but also provides strong evidence for its emergence from a pre-existing Caribbean epidemic. Bayesian phylogenetic analyses estimate the jump to the US at around 1970 and place the ancestral US virus in New York City with 0.99 posterior probability support, strongly suggesting this was the crucial hub of early US HIV/AIDS diversification. Logistic growth coalescent models reveal epidemic doubling times of 0.86 and 1.12 years for the US and Caribbean, respectively, suggesting rapid early expansion in each location. Comparisons with more recent data reveal many of these insights to be unattainable without archival, full-genome sequences. We also recovered the HIV-1 genome from the individual known as 'Patient 0' (ref. 5) and found neither biological nor historical evidence that he was the primary case in the US or for subtype B as a whole. We discuss the genesis and persistence of this belief in the light of these evolutionary insights. |
Dual simian foamy virus/human immunodeficiency virus type 1 infections in persons from Cote d'Ivoire
Switzer WM , Tang S , Zheng H , Shankar A , Sprinkle PS , Sullivan V , Granade TC , Heneine W . PLoS One 2016 11 (6) e0157709 Zoonotic transmission of simian retroviruses in West-Central Africa occurring in primate hunters has resulted in pandemic spread of human immunodeficiency viruses (HIVs) and human T-lymphotropic viruses (HTLVs). While simian foamy virus (SFV) and simian T- lymphotropic virus (STLV)-like infection were reported in healthy persons exposed to nonhuman primates (NHPs) in West-Central Africa, less is known about the distribution of these viruses in Western Africa and in hospitalized populations. We serologically screened for SFV and STLV infection using 1,529 specimens collected between 1985 and 1997 from Cote d'Ivoire patients with high HIV prevalence. PCR amplification and analysis of SFV, STLV, and HIV/SIV sequences from PBMCs was used to investigate possible simian origin of infection. We confirmed SFV antibodies in three persons (0.2%), two of whom were HIV-1-infected. SFV polymerase (pol) and LTR sequences were detected in PBMC DNA available for one HIV-infected person. Phylogenetic comparisons with new SFV sequences from African guenons showed infection likely originated from a Chlorocebus sabaeus monkey endemic to Cote d'Ivoire. 4.6% of persons were HTLV seropositive and PCR testing of PBMCs from 15 HTLV seroreactive persons identified nine with HTLV-1 and one with HTLV-2 LTR sequences. Phylogenetic analysis showed that two persons had STLV-1-like infections, seven were HTLV-1, and one was an HTLV-2 infection. 310/858 (53%), 8/858 (0.93%), and 18/858 (2.1%) were HIV-1, HIV-2, and HIV-positive but undifferentiated by serology, respectively. No SIV sequences were found in persons with HIV-2 antibodies (n = 1) or with undifferentiated HIV results (n = 7). We document SFV, STLV-1-like, and dual SFV/HIV infection in Cote d'Ivoire expanding the geographic range for zoonotic simian retrovirus transmission to West Africa. These findings highlight the need to define the public health consequences of these infections. Studying dual HIV-1/SFV infections in immunocompromised populations may provide a new opportunity to better understand SFV pathogenicity and transmissibility in humans. |
Reference panel of cloned HIV-2 plasmid DNA for nucleic acid assay development, evaluation, and quality monitoring.
Youngpairoj AS , Curtis KA , Wells SK , Pau CP , Granade TC , Owen SM . J Clin Virol 2014 61 (2) 293-7 BACKGROUND: Currently, no FDA-approved HIV-2 nucleic acid assay is commercially available in the United States, although several laboratories have developed in-house assays to confirm HIV-2 infections. A major limitation in the development of novel HIV-2 diagnostic assays is the lack of reference materials that can be used to evaluate, optimize, and monitor assay performance. STUDY DESIGN: Eleven viral stocks of HIV-2 isolates from various West African countries, including the Ivory Coast, Senegal, and Guinea-Bissau, were used to clone the entire LTR and pol regions from each virus. RESULTS: We successfully cloned, sequenced, and group classified 22 HIV-2 DNA plasmids including 11 full length LTR ( approximately 849bp) and 11 pol ( approximately 2995bp) sequences. There were eight HIV-2 group A and three group B in both the LTR and pol regions. CONCLUSIONS: This reference panel provides a robust, quantifiable, renewable, and non-infectious set of reagents that can be used for the development and evaluation of new HIV-2 molecular diagnostic assays and quality assurance and quality control reagents for use in the clinical laboratories. |
Likely female-to-female sexual transmission of HIV - Texas, 2012
Chan SK , Thornton LR , Chronister KJ , Meyer J , Wolverton M , Johnson CK , Arafat RR , Joyce PM , Switzer WM , Heneine W , Shankar A , Granade T , Owen MS , Sprinkle P , Sullivan V . MMWR Morb Mortal Wkly Rep 2014 63 (10) 209-12 In August 2012, the Houston Department of Health contacted CDC regarding the rare transmission of human immunodeficiency virus (HIV) likely by sexual contact between two women. The case was investigated, and laboratory testing confirmed that the woman with newly diagnosed HIV infection had a virus virtually identical to that of her female partner, who was diagnosed previously with HIV and who had stopped receiving antiretroviral treatment in 2010. This report describes this case of HIV infection, likely acquired by female-to-female sexual transmission during the 6-month monogamous relationship of the HIV-discordant couple (one negative, one positive). The woman with newly acquired infection did not report any other recognized risk factors for HIV infection, and the viruses infecting the two women had ≥98% sequence identity in three genes. The couple had not received any preventive counseling before acquisition of the virus by the woman who had tested negative for HIV. HIV-discordant couples should receive counseling regarding safer sex practices, and HIV-infected partners should be linked to and retained in medical care. |
Use of rapid HIV assays as supplemental tests in specimens with repeatedly reactive screening immunoassay results not confirmed by HIV-1 Western blot
Wesolowski LG , Delaney KP , Meyer WA 3rd , Blatt AJ , Bennett B , Chavez P , Granade TC , Owen M . J Clin Virol 2013 58 (1) 240-4 BACKGROUND: An alternate HIV testing algorithm has been proposed which includes a fourth-generation immunoassay followed by an HIV-1/HIV-2 antibody differentiation supplemental test for reactive specimens and a nucleic acid test (NAT) for specimens with discordant results. OBJECTIVE: To evaluate the performance of five rapid tests (Alere Clearview, Bio-Rad Multispot, OraSure OraQuick, MedMira Reveal, and Trinity Biotech Unigold) as the supplemental antibody assay in the algorithm. STUDY DESIGN: A total of 3273 serum and plasma specimens that were third-generation immunoassay repeatedly reactive and Western blot (WB) negative or indeterminate were tested with rapid tests and NAT. Specimens were classified by NAT: (1) HIV-1 infected (NAT-reactive; n=184, 5.6%), (2) HIV-status unknown (NAT nonreactive; n=3078, 94.2%) or by Multispot, (3) HIV-2 positive (n=5), and (4) HIV-1 and HIV-2 positive (n=6). Excluding HIV-2 positive specimens, we calculated the proportion of reactive rapid tests among specimens with reactive and nonreactive NAT. RESULTS: The proportion of infected specimens with reactive rapid test results and negative or indeterminate WB ranged from 30.4% (56) to 47.8% (88) depending on the rapid test. From 1% to 2% of NAT-negative specimens had reactive rapid test results. CONCLUSIONS: In these diagnostically challenging specimens, all rapid tests identified infections that were missed by the Western blot, but only Multispot could differentiate HIV-1 from HIV-2. Regardless of which rapid test is used as a supplemental test in the alternative algorithm, false-positive algorithm results (i.e., reactive screening and rapid test in uninfected person) may occur, which will need to be resolved during the baseline medical evaluation. |
Development of a novel rapid HIV test for simultaneous detection of recent or long-term HIV type 1 infection using a single testing device
Granade TC , Nguyen S , Kuehl DS , Parekh BS . AIDS Res Hum Retroviruses 2013 29 (1) 61-7 Laboratory assays for the detection of recent HIV infection for HIV incidence surveillance are essential to HIV prevention efforts worldwide because they can identify populations with a high incidence and allow targeting of resources and monitoring of incidence trends over time. This study describes the development of a novel rapid HIV-1 incidence-prevalence (I-P) test that can be used for the simultaneous detection and discrimination of prevalent (long-term) or incident (recent) HIV infections using a single device. A lateral flow assay was developed that uses a multisubtype recombinant gp41 protein applied at two concentrations of antigen (high and low). Prevalent and incident HIV-1 infections can be distinguished based on differential antibody binding at the two antigen concentrations. High level/high avidity antibodies present in prevalent infections bind to and are detected at both antigen concentrations while low level/low avidity antibodies present in recent HIV infections are detected only at the higher antigen concentration line. A total of 205 HIV-positive specimens with known status (recent=105, long-term=100), including 57 specimens from seroconversion panels, were tested by the rapid I-P assay and the results were compared to the HIV-1 BED capture enzyme immunoassay (CEIA). There was a 95.1% agreement of final classification (recent or long-term) with the BED assay (kappa=0.910) (mean recency period=162 days) and a high correlation between the intensity score of the low antigen line with the BED OD-n (Pearson correlation=0.89). The new rapid I-P test has great potential to simplify HIV surveillance efforts by simultaneously providing information on both HIV prevalence and incidence using a single, rapid test device. |
Protocol for the use of a rapid real-time PCR method for the detection of HIV-1 proviral DNA using double-stranded primer.
Pau CP , Wells SK , Granade TC . Methods Mol Biol 2012 903 263-71 This chapter describes a real-time PCR method for the detection of HIV-1 proviral DNA in whole blood samples using a novel double-stranded primer system. The assay utilizes a simple commercially available DNA extraction method and a rapid and easy-to-perform real-time PCR protocol to consistently detect a minimum of four copies of HIV-1 group M proviral DNA in as little as 90 min after sample (whole blood) collection. Co-amplification of the human RNase P gene serves as an internal control to monitor the efficiency of both the DNA extraction and amplification. Once the assay is validated properly, it may be suitable as an alternative confirmation test for HIV-1 infections in a variety of HIV testing venues including the mother-to-child transmission testing sites, clinics, and diagnostic testing centers. |
Assessing the incidence of ciguatera fish poisoning with two surveys conducted in Culebra, Puerto Rico, during 2005 and 2006
Azziz-Baumgartner E , Luber G , Conklin L , Tosteson TR , Granade HR , Dickey RW , Backer LC . Environ Health Perspect 2012 120 (4) 526-9 BACKGROUND: Although ciguatera fish poisoning (CFP) is the most common seafood intoxication worldwide, its burden has been difficult to establish because there are no biomarkers to diagnose human exposure. OBJECTIVE: We explored the incidence CFP, proportion of CFP case-patients with laboratory confirmed ciguatoxic meal remnants, cost of CFP illness, and potential risk factors for CFP. METHODS: During 2005 and again during 2006, we conducted a census of all occupied households in the island of Culebra, Puerto Rico, where locally caught fish are a staple food. We defined CFP case-patients as persons with gastrointestinal symptoms (i.e., abdominal pain, vomiting, diarrhea, or nausea) and neurological symptoms (i.e., extremity paresthesia, arthralgia, myalgia, malaise, pruritus, headache, dizziness, metallic taste, visual disturbance, circumoral paresthesia, or temperature reversal, or toothache) or systemic symptoms (e.g., bradycardia) within 72 hours of eating a fish during the previous year. Participants were asked to save fish remnants eaten by cases for ciguatoxins analysis at the Food and Drug Administration laboratory in Dauphin Island. RESULTS: We surveyed 340 households during 2005 and 335 households during 2006. The estimated annual incidence of possible CFP was 4.0/1000 person-years and probable CFP was 7.5/1000 person-years. One of three fish samples submitted by probable case-patients was positive for ciguatoxins. None of the case-patients required respiratory support. Households that typically consumed barracuda were more likely to report CFP (p = 0.02). CONCLUSIONS: Our estimates, which are consistent with previous studies using similar case-finding, contribute to the overall information available to support public health decision-making about CFP prevention. |
Comparison of alternative interpretive criteria for the HIV-1 Western blot and results of the Multispot HIV-1/HIV-2 Rapid Test for classifying HIV-1 and HIV-2 infections
Nasrullah M , Ethridge SF , Delaney KP , Wesolowski LG , Granade TC , Schwendemann J , Boromisa RD , Heffelfinger JD , Owen SM , Branson BM . J Clin Virol 2011 52 Suppl 1 S23-7 BACKGROUND: HIV-1 Western blot (WB) may be positive in specimens from persons with HIV-2 infection due to cross-reactive antibodies. HIV-1 and HIV-2 infections may be identified using assays designed to differentiate HIV-1 and HIV-2 antibody reactivity. OBJECTIVES: To evaluate the ability of the current CDC WB criteria, alternative more stringent HIV-1 WB criteria (2 env plus one gag or pol band) and the Multispot HIV-1/HIV-2 Rapid Test to accurately differentiate HIV-1 and HIV-2 infections. STUDY DESIGN: Two panels were used to determine the ability of each method to properly classify HIV-1 and HIV-2 infections: an HIV-2 panel (n=114) determined to be HIV-2 antibody-positive by both Multispot and by a validated HIV-2 WB, and 2135 HIV-1/HIV-2 immunoassay repeatedly reactive (IA-RR) specimens from the New York State Department of Health Laboratory (NYS). RESULTS: By CDC WB criteria, 53 (46.5%) HIV-2 panel specimens were HIV-1 WB positive, 60 (52.6%) were indeterminate, and 1 (0.9%) was negative; the alternative WB criteria re-classified 75.5% of the positives as indeterminate. Among 2135 NYS IA-RR specimens, the alternative WB criteria increased the proportion of indeterminates by 0.8%. Only 6 (0.3%) of the NYS specimens were determined to be HIV-2 infections; all 6 were classified either as HIV-1 positive or indeterminate by both WB criteria, but were classified as HIV-2 (n=4) or HIV-1/2 undifferentiated (n=2) by Multispot. CONCLUSIONS: The alternative WB criteria classified most of the HIV-2 specimens that were HIV-1 positive by CDC criteria as indeterminate, but also slightly increased the proportion of HIV-1 specimens classified as indeterminate. The WB indeterminate specimens would require further testing or follow-up to resolve the infection status, whereas Multispot directly distinguished HIV-1 from HIV-2. |
Rapid detection and differentiation of antibodies to HIV-1 and HIV-2 using multivalent antigens and magnetic immunochromatography testing (MICT)
Granade TC , Workman S , Wells SK , Holder AN , Owen SM , Pau CP . Clin Vaccine Immunol 2010 17 (6) 1034-9 A simplified lateral flow assay for the detection of antibodies to HIV using magnetic bead conjugates and multi-branched peptides from both HIV-1 and HIV-2 was developed. Magnetic immunochromatography testing (MICT) uses a standard lateral-flow platform that incorporates magnetic bead conjugates for quantitative measurement of the magnetic field distortion associated with the bound magnetic conjugate (reported as adjusted magnetic units, MAR). The results of the optimized MICT assay were compared to standard enzyme immunoassay (EIA) and Western blot (WB) results using a blinded 649-member panel of specimens from the US, Cameroon, and West Africa. The panel was comprised of samples from individuals infected with various HIV-1 subtypes (n=234), HIV-2 (n=65) and HIV-seronegative specimens (n=350). Additionally, thirteen HIV-1 sero-conversion panels (total specimens=85), a worldwide panel containing seven of the major circulating HIV-1 subtypes (n=18), an HIV-2 panel, an HIV-1/HIV-2 mixed panel, and 100 prospective specimens were tested with completely concordant results. Assay reproducibility (observed MAR) for both intra- and inter-run testing was excellent with coefficients of variation <12%. MICT can provide a rapid, low-cost method of determining HIV antibody status requiring no subjective interpretations. |
A rapid real-time PCR assay for the detection of HIV-1 proviral DNA using double-stranded primer
Pau CP , Wells SK , Rudolph DL , Owen SM , Granade TC . J Virol Methods 2009 164 55-62 In this study, a rapid real-time PCR assay to detect HIV-1 proviral DNA in whole blood was developed using a novel double-stranded primer that does not require a target-specific fluorescent probe or intercalating dye systems. Co-amplification of a human gene RNase P served as the internal control to monitor the efficiency of the DNA extraction and PCR amplification. The HIV-1 amplification efficiency was 100% and could amplify 1 copy of HIV-1 DNA 64% of the time and all attempts to amplify 4 copies were successful in less than 51min. All 22 HIV-1 sero-positive and 20 sero-negative whole blood specimens tested were classified correctly by this assay. In addition, 22 cultured PBMC specimens infected with various HIV-1 subtypes or CRF (A=2, AC=1, B=4, C=3, D=3, AE=2, F=1, BF=2, G=4) were amplified equally well with a similar threshold cycle (C(t)) number (22.9+/-1.2). The high amplification efficiency and short PCR cycles were in part due to the short target sequence amplified by eliminating the probe-binding sequence between the primers. This assay may be useful as an alternative confirmation test in a variety of HIV testing venues. |
Seroprevalence of human immunodeficiency virus in the US household population aged 18-49 years: The National Health and Nutrition Examination Surveys, 1999-2006
McQuillan GM , Kruszon-Moran D , Granade T , Feldman JW . J Acquir Immune Defic Syndr 2010 53 (1) 117-23 OBJECTIVE: To monitor trends in HIV seroprevalence in the United States, HIV testing was included in the National Health and Nutrition Examination Survey (NHANES) conducted from 1999 to 2006. METHODS: From 1999 to 2006, 11,928 participants aged 18-49 years were tested for HIV antibody. Prevalence estimates were weighted to account for oversampling and nonresponse. RESULTS: There were 67 HIV antibody-reactive individuals for a seroprevalence of 0.5% [95% confidence interval (CI) 0.3-0.6]. In the only age subgroup directly comparable between surveys (18-39 years), HIV seroprevalence remained constant from NHANES III (1988-1994) to NHANES 1999-2002 and 2003-2006. In NHANES 1999-2006, non-Hispanic blacks had significantly higher HIV seroprevalence (2.0%, 95% CI 1.5-2.7) compared with individuals in all other race/ethnic groups combined. Seroprevalence was also higher in each race/ethnic group among men who have sex with men (9.4% 95% CI 5.0-17.1), among persons who had detectable antibody to herpes simplex type-two (1.9% 95% CI 1.4-2.8), among those who had 50 or more lifetime sex partners (3.4%, 95% CI 1.7-6.7), and among those who never married (0.8%, 95% CI 0.5-1.3). CONCLUSIONS: In this household-based population, seroprevalence did not significantly change from NHANES III to NHANES 1999-2006. Non-Hispanic blacks had significantly higher prevalence of infection compared with other race/ethnic groups. Male-to-male sex and the presence of HSV-2 antibody were the strongest predictors of HIV infection. |
Rapid detection of HIV-1 p24 antigen using magnetic immuno-chromatography (MICT)
Workman S , Wells SK , Pau CP , Owen SM , Dong XF , LaBorde R , Granade TC . J Virol Methods 2009 160 14-21 Detection of human immunodeficiency virus (HIV) infections has been enhanced by incorporating p24 antigen detection with current HIV antibody detection using enzyme immunoassays (EIAs). However, screening for HIV antibodies has increased through the use of rapid, lateral-flow HIV antibody detection assays that currently do not have the capability to detect HIV p24 antigen. In this report, a lateral-flow based assay using super-paramagnetic particles as the detection marker was developed for the detection of HIV-1 p24 antigen. This magnetic immuno-chromatographic test (MICT) uses an inexpensive, low-maintenance instrument that detects the magnetic moment of the super-paramagnetic particles in a magnetic field. MICT is simple to perform, provides a numerical output for easier determination of reactive results and can be completed in 40 min. The lower limit of detection for HIV-1 p24 spiked into assay sample buffer and 50% plasma was 30 pg/ml for both. Detection of HIV-1 p24 antigen at 50 pg/ml was reproducible in both inter-run and intra-run assays with coefficients of variation of <13%. Furthermore, the MICT p24 assay was able to detect intact virus spiked into 50% plasma (lower detection limit of [similar to]250,000 viral RNA copies/ml). MICT detection of increasing HIV-1 p24 levels in commercially available seroconversion panels by MICT was only slightly later than that detected by much more complex EIAs. MICT could provide a simple, low-cost, and portable method for rapid HIV-1 p24 detection in a variety of testing environments. |
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