Evaluation of dried blood spot protocols with the Bio-Rad GS HIV Combo Ag/Ab EIA and Geenius™ HIV 1/2 Supplemental Assay
| Autor: | S. Michele Owen, M. Kathleen Shriver, Laura G. Wesolowski, Steve Ethridge, Silvina Masciotra, Linda M. Styer, Amanda Smith, Monica M. Parker, Geoff Davis, Wei Luo, Joanne Mei, Gabriela Paz-Bailey, LiXia Li |
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| Rok vydání: | 2017 |
| Předmět: |
0301 basic medicine
medicine.medical_specialty Serial dilution HIV Antigens 030106 microbiology Population HIV Infections HIV Antibodies Sensitivity and Specificity Gastroenterology Immunoenzyme Techniques 03 medical and health sciences McNemar's test Risk Factors Virology Internal medicine Humans Medicine education education.field_of_study Venipuncture medicine.diagnostic_test biology business.industry AIDS Serodiagnosis virus diseases nervous system diseases Dried blood spot surgical procedures operative Infectious Diseases Immunoassay Epidemiological Monitoring HIV-2 HIV-1 biology.protein RNA Viral Supplemental Testing Dried Blood Spot Testing Reagent Kits Diagnostic Antibody business Algorithms |
| Zdroj: | Journal of Clinical Virology. 91:84-89 |
| ISSN: | 1386-6532 |
| Popis: | Objective FDA-approved antigen/antibody combo and HIV-1/2 differentiation supplemental tests do not have claims for dried blood spot (DBS) use. We compared two DBS-modified protocols, the Bio-Rad GS HIV Combo Ag/Ab (BRC) EIA and Geenius™ HIV-1/2 (Geenius) Supplemental Assay, to plasma protocols and evaluated them in the CDC/APHL HIV diagnostic algorithm. Methods BRC-DBS p24 analytical sensitivity was calculated from serial dilutions of p24. DBS specimens included 11 HIV-1 seroconverters, 151 HIV-1-positive individuals, including 20 on antiretroviral therapy, 31 HIV-2-positive and one HIV-1/HIV-2-positive individuals. BRC-reactive specimens were tested with Geenius using the same DBS eluate. Matched plasma specimens were tested with BRC, an IgG/IgM immunoassay and Geenius. DBS and plasma results were compared using the McNemar's test. A DBS-algorithm applied to 348 DBS from high-risk individuals who participated in surveillance was compared to HIV status based on local testing algorithms. Results BRC-DBS detects p24 at a concentration 18 times higher than in plasma. In seroconverters, BRC-DBS detected more infections than the IgG/IgM immunoassay in plasma ( p = 0 . 0133), but fewer infections than BRC-plasma ( p = 0 . 0133) . In addition, the BRC/Geenius-plasma algorithm identified more HIV-1 infections than the BRC/Geenius-DBS algorithm ( p = 0 . 0455) . The DBS protocols correctly identified HIV status for established HIV-1 infections, including those on therapy, HIV-2 infections, and surveillance specimens. Conclusions The DBS protocols exhibited promising performance and allowed rapid supplemental testing. Although the DBS algorithm missed some early infections, it showed similar results when applied to specimens from a high-risk population. Implementation of a DBS algorithm would benefit testing programs without capacity for venipuncture. |
| Databáze: | OpenAIRE |
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