Performance evaluation of the Bio-Rad Laboratories GS HIV Combo Ag/Ab EIA, a 4th generation HIV assay for the simultaneous detection of HIV p24 antigen and antibodies to HIV-1 (groups M and O) and HIV-2 in human serum or plasma
| Autor: | Elizabeth O. Mitchell, Sheila A. Peel, Sally Liska, Carol Ferrera, Christopher Bentsen, Lisa McLaughlin, M. Kathleen Shriver, Paul D. Swenson, Robert Myers, Stephane Gadelle |
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| Rok vydání: | 2011 |
| Předmět: |
Serum
Sexually transmitted disease HIV Core Protein p24 HIV Infections HIV Antibodies Sensitivity and Specificity law.invention Immunoenzyme Techniques Plasma Antigen Risk Factors law Virology HIV Seropositivity Humans Medicine Seroconversion Polymerase chain reaction biology business.industry virus diseases Liter Nucleic acid amplification technique United States Infectious Diseases HIV-2 HIV p24 Antigen Immunology HIV-1 biology.protein Reagent Kits Diagnostic Antibody business Nucleic Acid Amplification Techniques |
| Zdroj: | Journal of Clinical Virology. 52:S57-S61 |
| ISSN: | 1386-6532 |
| DOI: | 10.1016/j.jcv.2011.09.023 |
| Popis: | Background A multi-center study was conducted to evaluate the Bio-Rad GS HIV Combo Ag/Ab EIA, a 4th generation HIV-1/HIV-2 assay for the simultaneous detection of HIV p24 antigen and antibodies to HIV-1 (groups M and O) and HIV-2 in human serum or plasma in adult and pediatric populations. Objectives The objectives of the study were to assess assay performance for the detection of acute HIV infections; sensitivity in known HIV positive samples; percent agreement with HIV status; specificity in low and high risk individuals of unknown HIV status; and to compare assay performance to a 3rd generation HIV assay. Study design The evaluation included testing 9150 samples at four U.S. clinical trial sites, using three kit lots. Unlinked samples were from routine testing, repositories or purchased from vendors. Results GS HIV Combo Ag/Ab EIA detection in samples from individuals in two separate populations with acute HIV infection was 95.2% (20/21) and 86.4% (38/44). Sensitivity was 100% (1603/1603) in known antibody positive [HIV-1 Groups M and O, and HIV-2] samples. HIV p24 antigen detection was 100% (53/53) in HIV-1 culture supernatants. HIV-1 seroconversion panel detection improved by a range of 0–20 days compared to a 3rd generation HIV test. Specificity was 99.9% (5989/5996) in low risk, 99.9% (959/960) in high risk and 100% (100/100) in pediatric populations. Conclusion The GS HIV Combo Ag/Ab EIA significantly reduced the diagnostic window when compared to the 3rd generation screening assay, enabling earlier diagnosis of HIV infection. The performance parameters of the Bio-Rad GS HIV Combo Ag/Ab EIA are well suited for use in HIV diagnostic settings. |
| Databáze: | OpenAIRE |
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