Selected HIV-1 NAT tests approved by the FDA13
| Manufacturer . | Test name . | Method . | Approved intended use for HIV-1 . | Patients tested postinfusion . |
|---|---|---|---|---|
| Abbott Molecular Inc | Abbott RealTime HIV-1 | Quantitative PCR | Patient monitoring | Not applicable |
| Hologic, Inc | Aptima HIV-1 RNA Qualitative Assay | Transcription-mediated amplification | Diagnosis | Patient 2 (N, v5) |
| Patient 3 (N, v5) | ||||
| Patient 4 (N, v5) | ||||
| Roche Diagnostic Systems | Amplicor HIV-1 Monitor Test | Quantitative PCR | Patient monitoring | Not applicable |
| Roche Molecular Diagnostics | COBAS AmpliPrep/COBAS TaqMan HIV-1 Test | Quantitative PCR | Patient monitoring | Patient 1 (P/N, v2.0) |
| Patient 2 (P, v2.0) | ||||
| Patient 3 (P, v2.0) | ||||
| Patient 4 (P, v2.0) | ||||
| Roche Molecular Systems | COBAS AmpliScreen HIV-1 Test v1.5 | Qualitative PCR | Donor screening | Not applicable |
| Manufacturer . | Test name . | Method . | Approved intended use for HIV-1 . | Patients tested postinfusion . |
|---|---|---|---|---|
| Abbott Molecular Inc | Abbott RealTime HIV-1 | Quantitative PCR | Patient monitoring | Not applicable |
| Hologic, Inc | Aptima HIV-1 RNA Qualitative Assay | Transcription-mediated amplification | Diagnosis | Patient 2 (N, v5) |
| Patient 3 (N, v5) | ||||
| Patient 4 (N, v5) | ||||
| Roche Diagnostic Systems | Amplicor HIV-1 Monitor Test | Quantitative PCR | Patient monitoring | Not applicable |
| Roche Molecular Diagnostics | COBAS AmpliPrep/COBAS TaqMan HIV-1 Test | Quantitative PCR | Patient monitoring | Patient 1 (P/N, v2.0) |
| Patient 2 (P, v2.0) | ||||
| Patient 3 (P, v2.0) | ||||
| Patient 4 (P, v2.0) | ||||
| Roche Molecular Systems | COBAS AmpliScreen HIV-1 Test v1.5 | Qualitative PCR | Donor screening | Not applicable |
N, negative; P, positive.