Table 2.
FDA-approved tests for HIV in 2017
| Performance in Established HIV-1 Infection§ | ||||||
|---|---|---|---|---|---|---|
| Test (Manufacturer) | Type* | Specimens† | Minutes to result | CLIA complexity (waivers)‡ | Sensitivity (95% CI) | Specificity (95% CI) |
| p24/IgM/IgG sensitive laboratory test | ||||||
| ADVIA Centaur HIV Ag/Ab Combo (Siemens) | Auto CMIA | P, S | <60 | Moderate | 100 (99.61, 100) | 99.72 (99.56, 99.84) |
| ARCHITECT HIV Ag/Ab Combo (Abbott) | Auto CMIA | P, S | <30 | Moderate | 100 (99.63, 100) | 99.8 (99.6, 99.9) |
| BioPlex 2200 HIV Ag-Ab (Bio-Rad) | Auto MFIA | P, S | 45 | Moderate | 100 (9.72, 100) | 99.92 (99.82, 99.97) |
| GS HIV Combo Ag/Ab EIA (Bio-Rad) | Manual/semi-auto EIA | P, S | >180 | High | 100 (99.7, 100) | 99.9 (99.8, 99.9) |
| p24/IgM/IgG sensitive POC test | ||||||
| Determine HIV-1/2 Ag/Ab Combo (Alere) | Rapid LF | P, S, WB | 20 | Moderate (WB) | 99.9 (99.4, 100) | 98.9–100 (97.7, 100) |
| IgM/IgG sensitive laboratory test | ||||||
| ADVIA Centaur HIV 1/O/2 Enhanced (Siemens) | Auto CMIA | P, S | <60 | Moderate | 100 (99.7, 100) | 99.9 (99.8, 100) |
| GS HIV-1/2 PLUS O EIA (Bio-Rad) | Manual/semi-auto EIA | P, S | >180 | High | 100 (99.8, 100) | 99.9 (99.8, 100) |
| VITROS Anti-HIV 1+2 (Ortho) | Auto CIA | P, S | <60 | High | 100 (99.7, 100) | 99.6 (99.1, 99.9) |
| IgM/IgG sensitive POC test | ||||||
| INSTI HIV-1/HIV-2 Rapid (BioLytical) | Rapid FT | P, WB | <2 | Moderate (WB) | 99.9 (99.5, 100) | 100 (99.7, 100) |
| Uni-Gold Recombigen HIV (Trinity BioTech) | Rapid LF | P, S, WB | 10 | Moderate (WB) | 100 (99.5, 100) | 99.8 (99.3, 100) |
| IgG sensitive laboratory test | ||||||
| Avioq HIV-1 Microelisa System (Avioq) | Auto EIA | P, S, DBS, OF | >180 | High | 100 (99.6, 100) | 100 (99.9, 100) |
| IgG sensitive POC test | ||||||
| Clearview HIV 1/2 STAT-PAK (Alere) | Rapid LF | P, S, WB | 15 | Moderate (WB) | 99.7 (98.9, 100) | 99.9 (99.6, 100) |
| DPP HIV-1/2 (Chembio) | Rapid LF | P, S, WB, OF | 15 | Moderate (WB) | 99.9 (99.4, 99.9) | 99.9 (99.7, 99.9) |
| OraQuick ADVANCE Rapid HIV-1/2 (OraSure) | Rapid LF | P, WB, OF | 20 | Moderate (WB & OF) | 99.6 (98.9, 99.8) | 99.9 (99.6, 99.9) |
| Reveal G3 Rapid HIV-1 Antibody (MedMira) | Rapid FT | P, S | <2 | Moderate | 99.8 (99.0, 100) | 98.6–99.1 (98.4, 99.8) |
| SURE CHECK HIV 1/2 ‖ (Chembio) | Rapid LF | P, S, WB | 15 | Moderate (WB) | 99.7 (98.9, 100) | 99.9 (99.6, 100) |
| Supplemental test | ||||||
| Geenius HIV-1/2 Ab Supplemental (Bio-Rad) | Rapid LF | P, S, WB | 20 | High | 99.3 (97.6, 99.8) | 4.3% indeterminate |
| Aptima HIV-1 RNA Qualitative (Hologic) | NAT (TMA) | P, S | >180 | High | 100 (99.6, 100) | – |
Data from CDC, accessed 26 February 2017: https://www.cdc.gov/hiv/pdf/testing/hiv-tests-laboratory-use.pdf and https://www.cdc.gov/hiv/pdf/testing/rapid-hiv-tests-clinical-moderate-complexity.pdf and https://www.cdc.gov/hiv/pdf/testing/supplemental-hiv-tests-laboratory-use.pdf. Abbreviations: Auto, automated; CIA, chemiluminescent immunoassay; CMIA, chemiluminescent microparticle immunoassay; CLIA, Clinical Laboratory Improvement Amendments; EIA, enzyme immunoassay; FT, flow-through; LF, lateral flow; MFIA, multiplex flow immunoassay; NAT, nucleic acid test; RNA, ribonucleic acid; TMA, transcription-mediated amplification
Abbreviations: DBS, dried blood spot; OF, oral fluid; P, plasma; S, serum; WB, whole blood
Requirements for laboratory training are waived for the specimen type(s) listed in parentheses (i.e., unprocessed samples direct from patients). Data from Branson.5
Sensitivity and specificity in the table reflect performance of the individual assay in established (i.e., seropositive) HIV infection.
Before 2016, this test was marketed as Clearview COMPLETE HIV 1/2 (Alere)