Last data update: May 06, 2024. (Total: 46732 publications since 2009)
Records 1-7 (of 7 Records) |
Query Trace: Yufenyuy EL[original query] |
---|
Evaluation of the Nigeria national HIV rapid testing algorithm
Iriemenam NC , Mpamugo A , Ikpeazu A , Okunoye OO , Onokevbagbe E , Bassey OO , Tapdiyel J , Alagi MA , Meribe C , Ahmed ML , Ikwulono G , Aguolu R , Ashefor G , Nzelu C , Ehoche A , Ezra B , Obioha C , Baffa Sule I , Adedokun O , Mba N , Ihekweazu C , Charurat M , Lindsay B , Stafford KA , Ibrahim D , Swaminathan M , Yufenyuy EL , Parekh BS , Adebajo S , Abimiku A , Okoye MI . PLOS Glob Public Health 2022 2 (11) e0001077 Human Immunodeficiency Virus (HIV) diagnosis remains the gateway to HIV care and treatment. However, due to changes in HIV prevalence and testing coverage across different geopolitical zones, it is crucial to evaluate the national HIV testing algorithm as false positivity due to low prevalence could be detrimental to both the client and the service delivery. Therefore, we evaluated the performance of the national HIV rapid testing algorithm using specimens collected from multiple HIV testing services (HTS) sites and compared the results from different HIV prevalence levels across the six geopolitical zones of Nigeria. The evaluation employed a dual approach, retrospective, and prospective. The retrospective evaluation focused on a desktop review of program data (n = 492,880) collated from patients attending routine HTS from six geopolitical zones of Nigeria between January 2017 and December 2019. The prospective component utilized samples (n = 2,895) collected from the field at the HTS and tested using the current national serial HIV rapid testing algorithm. These samples were transported to the National Reference Laboratory (NRL), Abuja, and were re-tested using the national HIV rapid testing algorithm and HIV-1/2 supplementary assays (Geenius to confirm positives and resolve discordance and multiplex assay). The retrospective component of the study revealed that the overall proportion of HIV positives, based on the selected areas, was 5.7% (28,319/492,880) within the study period, and the discordant rate between tests 1 and 2 was 1.1%. The prospective component of the study indicated no significant differences between the test performed at the field using the national HIV rapid testing algorithm and the re-testing performed at the NRL. The comparison between the test performed at the field using the national HIV rapid testing algorithm and Geenius HIV-1/2 supplementary assay showed an agreement rate of 95.2%, while that of the NRL was 99.3%. In addition, the comparison of the field results with HIV multiplex assay indicated a sensitivity of 96.6%, the specificity of 98.2%, PPV of 97.0%, and Kappa Statistic of 0.95, and that of the NRL with HIV multiplex assay was 99.2%, 99.4%, 99.0%, and 0.99, respectively. Results show that the Nigeria national serial HIV rapid testing algorithm performed very well across the target settings. However, the algorithm's performance in the field was lower than the performance outcomes under a controlled environment in the NRL. There is a need to target testers in the field for routine continuous quality improvement implementation, including refresher trainings as necessary. |
A stable dried tube specimen for quality assurance and training programs for HIV rapid test for recent infection
Di Germanio C , Yufenyuy EL , Hampton DC , Thorbrogger C , Parekh BS , Norris PJ . Microbiol Spectr 2023 11 (1) e0339822 The HIV epidemic is still one of the world's most serious public health challenges, affecting about 38 million people worldwide, especially in sub-Saharan African and Southeast Asian countries. In recent years, tests have been developed to discriminate recent from long-term infection in HIV-infected populations, and these tools can help identify new outbreaks and networks of transmission and target prevention and treatment plans. New rapid tests for recent infection are being deployed in point-of-care settings; however, quality assurance programs need to be implemented to ensure consistency and reliability of the results. We have developed a dried tube specimen (DTS) stabilized with disaccharide trehalose as a quality control reagent for rapid recency testing that can be stored unrefrigerated prior to reconstitution at temperatures up to 37°C for up to 12 weeks. Analysis of 10 trehalose-stabilized DTSs showed that they maintained the same recency classification in all of the samples stored at 4°C and 37°C up to 12 weeks and at 56°C for 2 weeks, while the DTSs prepared without trehalose changed their classification from long-term to recent or recent to negative after storage at 37°C for 12 weeks. Development of DTS quality control reagents will facilitate proficiency and training programs, particularly in settings without cold chain capability in field environments. IMPORTANCE Implementation of stabilized dried tube specimens (DTSs) for quality control and training would facilitate HIV recency programs, especially in point-of-care settings without cold chain availability. This study shows that addition of the disaccharide trehalose to DTSs prior to drying the samples increased stability of the samples across a range of temperatures. This finding provides an affordable way to increase the availability of these key reagents for quality control in resource-constrained settings. |
Performance evaluation of the Asante Rapid Recency Assay for verification of HIV diagnosis and detection of recent HIV-1 infections: implications for epidemic control
Yufenyuy EL , Detorio M , Dobbs T , Patel HK , Jackson K , Shanmugam Vedapuri , Parekh BS . PLoS Glob Public Health 2022 2 (4) e0000316 We previously described development of a rapid test for recent infection (RTRI) that can diagnose HIV infection and detect HIV-1 recent infections in a single device. This technology was transferred to a commercial partner as Asante Rapid Recency Assay (ARRA). We evaluated performance of the ARRA kits in the laboratory using a well-characterized panel of specimens. The plasma specimen panel (N=1500) included HIV-1 (N=570), HIV-2 (N=10), and HIV-negatives (N=920) representing multiple subtypes and geographic locations. Reference diagnostic data were generated using the Bio-Rad HIV-1-2-O EIA/Western blot algorithm with further serotyping performed using the Multispot HIV-1/2 assay. The LAg-Avidity EIA was used to generate reference data on recent and long-term infection for HIV-1 positive specimens at a normalized optical density (ODn) cutoff of 2.0 corresponding to a mean duration of about 6 months. All specimens were tested with ARRA according to the manufacturer's recommendations. Test strips were also read for line intensities using a reader and results were correlated with visual interpretation. ARRA's positive verification line (PVL) correctly classified 575 of 580 HIV-positive and 910 of 920 negative specimens resulting in a sensitivity of 99.1% (95% CI: 98.0-99.6) and specificity of 98.9% (95% CI: 98.1-99.4), respectively. The reader-based classification was similar for PVL with sensitivity of 99.3% (576/580) and specificity of 98.8% (909/920). ARRA's long-term line (LTL) classified 109 of 565 HIV-1 specimens as recent and 456 as long-term compared to 98 as recent and 467 as long-term (LT) by LAg-Avidity EIA (cutoff ODn=2.0), suggesting a mean duration of recent infection (MDRI) close to 6 months. Agreement of ARRA with LAg recent cases was 81.6% (80/98) and LT cases was 93.8% (438/467), with an overall agreement of 91.7% (kappa=0.72). The reader (cutoff 2.9) classified 109/566 specimens as recent infections compared to 99 by the LAg-Avidity EIA for recency agreement of 81.8% (81/99), LT agreement of 9% (439/467) with overall agreement of 91.9% (kappa=0.72). The agreement between visual interpretation and strip reader was 99.9% (95% CI: 99.6-99.9) for the PVL and 98.1% (95% CI: 96.6-98.9) for the LTL. ARRA performed well with HIV diagnostic sensitivity >99% and specificity >98%. Its ability to identify recent infections is comparable to the LA-Avidity EIA corresponding to an MDRI of about 6 months. This point-of-care assay has implications for real-time surveillance of new infections among newly diagnosed individuals for targeted prevention and interrupting ongoing transmission thus accelerating epidemic control. |
Development of a Bead-Based Multiplex Assay for Use in Multianalyte Screening and Surveillance of HIV, Viral Hepatitis, Syphilis, and Herpes.
Yufenyuy EL , Vedapuri S , Zheng A , Cooley G , Danavall D , Mayur S , Kodani M , Chen C , Tun Y , Fakile YF , Martin D , Kamili S , Karem K , Parekh BS . J Clin Microbiol 2022 60 (5) e0234821 Diagnostic assays that can simultaneously determine the presence of infection with multiple pathogens are key for diagnosis and surveillance. Current multiplex diagnostic assays are complex and often have limited availability. We developed a simple, multianalyte, pathogen detection assay for screening and serosurveillance using the Luminex Magpix platform that is high throughput and can be helpful in monitoring multiple diseases. The Luminex bead-based 10-plex immunoassay for the detection of HIV-1, HIV-2, Treponema pallidum, hepatitis B virus (HBV), hepatitis C virus (HCV), herpes simplex virus 1 (HSV-1), and HSV-2 infections was accomplished by coupling beads with specific antigens to detect IgG antibodies in plasma or serum samples. Each coupled antigen was systematically optimized, and the performance was evaluated using a panel of well-characterized specimens (n=417) that contained antibodies to HIV-1, HIV-2, T. pallidum, HBV, HCV, HSV-1, and HSV-2. The multiplex assay had a sensitivity of 92.2% (95% Clopper-Pearson confidence interval [CI], 90.2 to 94.0%) and a specificity of 98.1% (95% CI, 97.6 to 98.7%). The sensitivities and specificities for disease-specific biomarker detection ranged from 68.7 to 100% and 95.6 to 100%, respectively. The results showed that the 10-plex immunoassay had an overall agreement of 96.7% (95% CI, 96.7 to 97.3%) with reference tests and a corresponding kappa value of 0.91 (95% CI, 0.90 to 0.93). Kappa values for the individual pathogens ranged from 0.69 to 1.00. The assay is robust and allows the simultaneous detection of antibodies to multiple antigens using a small sample volume in a high-throughput format. This assay has the potential to simplify disease surveillance by providing an alternative to expensive and highly specialized individual tests. |
A Comprehensive Approach to Assuring Quality of Laboratory Testing in HIV Surveys: Lessons Learned From the Population-Based HIV Impact Assessment Project
Patel HK , Duong YT , Birhanu S , Dobbs T , Lupoli K , Moore C , Detorio M , Sleeman K , Manjengwa J , Wray-Gordon F , Yavo D , Jackson K , Domaoal RA , Yufenyuy EL , Vedapuri S , Ndongmo CB , Ogollah FM , Dzinamarira T , Rubinstein P , Sachathep KK , Metz M , Longwe H , Saito S , Brown K , Voetsch AC , Parekh BS . J Acquir Immune Defic Syndr 2021 87 S17-s27 BACKGROUND: Conducting HIV surveys in resource-limited settings is challenging because of logistics, limited availability of trained personnel, and complexity of testing. We described the procedures and systems deemed critical to ensure high-quality laboratory data in the population-based HIV impact assessments and large-scale household surveys. METHODS: Laboratory professionals were engaged in every stage of the surveys, including protocol development, site assessments, procurement, training, quality assurance, monitoring, analysis, and reporting writing. A tiered network of household, satellite laboratories, and central laboratories, accompanied with trainings, optimized process for blood specimen collection, storage, transport, and real-time monitoring of specimen quality, and test results at each level proved critical in maintaining specimen integrity and high-quality testing. A plausibility review of aggregate merged data was conducted to confirm associations between key variables as a final quality check for quality of laboratory results. RESULTS: Overall, we conducted a hands-on training for 3355 survey staff across 13 surveys, with 160-387 personnel trained per survey on biomarker processes. Extensive training and monitoring demonstrated that overall, 99% of specimens had adequate volume and 99.8% had no hemolysis, indicating high quality. We implemented quality control and proficiency testing for testing, resolved discrepancies, verified >300 Pima CD4 instruments, and monitored user errors. Aggregate data review for plausibility further confirmed the high quality of testing. CONCLUSIONS: Ongoing engagement of laboratory personnel to oversee processes at all levels of the surveys is critical for successful national surveys. High-quality population-based HIV impact assessments laboratory data ensured reliable results and demonstrated the impact of HIV programs in 13 countries. |
HIV-1 Recent Infection Testing Algorithm With Antiretroviral Drug Detection to Improve Accuracy of Incidence Estimates
Voetsch AC , Duong YT , Stupp P , Saito S , McCracken S , Dobbs T , Winterhalter FS , Williams DB , Mengistu A , Mugurungi O , Chikwanda P , Musuka G , Ndongmo CB , Dlamini S , Nuwagaba-Biribonwoha H , Pasipamire M , Tegbaru B , Eshetu F , Biraro S , Ward J , Aibo D , Kabala A , Mgomella GS , Malewo O , Mushi J , Payne D , Mengistu Y , Asiimwe F , Shang JD , Dokubo EK , Eno LT , Zoung-Kanyi Bissek AC , Kingwara L , Junghae M , Kiiru JN , Mwesigwa RCN , Balachandra S , Lobognon R , Kampira E , Detorio M , Yufenyuy EL , Brown K , Patel HK , Parekh BS . J Acquir Immune Defic Syndr 2021 87 S73-s80 BACKGROUND: HIV-1 incidence calculation currently includes recency classification by HIV-1 incidence assay and unsuppressed viral load (VL ≥ 1000 copies/mL) in a recent infection testing algorithm (RITA). However, persons with recent classification not virally suppressed and taking antiretroviral (ARV) medication may be misclassified. SETTING: We used data from 13 African household surveys to describe the impact of an ARV-adjusted RITA on HIV-1 incidence estimates. METHODS: HIV-seropositive samples were tested for recency using the HIV-1 Limiting Antigen (LAg)-Avidity enzyme immunoassay, HIV-1 viral load, ARVs used in each country, and ARV drug resistance. LAg-recent result was defined as normalized optical density values ≤1.5. We compared HIV-1 incidence estimates using 2 RITA: RITA1: LAg-recent + VL ≥ 1000 copies/mL and RITA2: RITA1 + undetectable ARV. We explored RITA2 with self-reported ARV use and with clinical history. RESULTS: Overall, 357 adult HIV-positive participants were classified as having recent infection with RITA1. RITA2 reclassified 55 (15.4%) persons with detectable ARV as having long-term infection. Those with detectable ARV were significantly more likely to be aware of their HIV-positive status (84% vs. 10%) and had higher levels of drug resistance (74% vs. 26%) than those without detectable ARV. RITA2 incidence was lower than RITA1 incidence (range, 0%-30% decrease), resulting in decreased estimated new infections from 390,000 to 341,000 across the 13 countries. Incidence estimates were similar using detectable or self-reported ARV (R2 > 0.995). CONCLUSIONS: Including ARV in RITA2 improved the accuracy of HIV-1 incidence estimates by removing participants with likely long-term HIV infection. |
Development of a multiplex assay for concurrent diagnoses and detection of HIV-1, HIV-2, and recent HIV-1 infection in a single test
Yufenyuy EL , Parekh B . AIDS Res Hum Retroviruses 2018 34 (12) 1017-1027 Laboratory assays that can accurately distinguish recent (occurring within the past year) from long-standing (>1 year) HIV infection are crucial for understanding HIV transmission dynamics in a population. However, often these efforts are confounded by inaccurate HIV diagnosis and the presence of HIV-2 in the population being surveyed. This study describes development of a multiplex assay that can simultaneously perform HIV diagnosis, HIV serotyping and detection of recent HIV-1 infection in a single well. HIV diagnosis and HIV-2 serotyping were accomplished by coupling beads with an HIV-1 p24-gp41 fusion protein and HIV-2 peptide from gp36 immunodominant region, respectively. HIV-1 recent infection detection was accomplished by coupling beads with limiting amounts of multi-subtype gp41 immunodominant protein, rIDR-M. Assay conditions, including concentration of coupled antigens, were systematically optimized using well-characterized specimens with known HIV-status (positive or negative), HIV-2 specimens, and recent or long-term HIV-1 classification based on LAg-Avidity EIA in a stepwise manner. Beads were then combined in a multiplex assay to evaluate its performance using large panel of specimens (n=1500) that included HIV-1 positive (n=570, recent = 78, long-term= 492), HIV-2 positive (n= 31) and seronegative individuals (n=899). The diagnostic component of the assay performed with high sensitivity (99.8%) and specificity (99.7%), while the HIV-2 serotyping sensitivity and specificity were 96.7% and 100%, respectively. There was a high correlation (R=0.84) between the LAg-Avidity EIA and the multiplex assay for recent infection detection. The assay showed high inter- and intra- assay reproducibility with % coefficient of variation of <10% in the dynamic range. The multiplex assay has the ability to diagnose HIV infection, perform serotyping and detect and distinguish recent from long-term HIV infections, all in a single well. This novel assay has the potential to simplify HIV surveillance by reducing the multiple steps that are otherwise required. |
- Page last reviewed:Feb 1, 2024
- Page last updated:May 06, 2024
- Content source:
- Powered by CDC PHGKB Infrastructure