TABLE 2.
Point-of-care HIV viral load assays that are commercially available or in late developmenta
| Manufacturer | Assay | HIV type(s) | Amplification/detection | Analytic sensitivity (copies/ml) | Testing timeb (min) | Sample type and vol | Instrument dimensions | Test instrument | WHO PQ, CE-IVD | Marketed |
|---|---|---|---|---|---|---|---|---|---|---|
| Abbott Inc. (formerly Alere) | m-PIMA (formerly Alere q HIV-1/2 Detect) | HIV-1 groups M/N and O, HIV-2c | RT-PCR/real time with competitive reporter hybridization | 800–1,000 | <70 | Plasma, 50 μl | 220 by 200 by 310 mm; weight, 7.8 kg | 1 unit | Yes, yes | Only in nonregulated markets |
| Cepheid | Xpert HIV-1 Viral Load | HIV-1 groups M, N, and Od | RT-PCR/real time with molecular beacons | 40 | 90 | Plasma, 1 ml | 102 by 305 by 298 mm; weight, 8.2 kg | 1 unit | Yes, yes | Yes |
| Diagnostics for the Real World | SAMBA I PSQ | HIV-1 | NASBA/ICS | 1,000 | 90 | Plasma, 200 μl | Display module: 215 by 170 by 180 mm Assay module: 190 by 330 by 330 mm Display module: 2.1 kg Assay module: 9.9 kg |
2 units | No, yes | Yes |
| Diagnostics for the Real World | SAMBA II WBSQ | HIV-1 | NASBA/ICS | 1,000 | 90 | Blood, 120 μl | Display module: 215 by 170 by 180 mm Assay module: 190 by 330 by 330 mm Display module: 2.1 kg Assay module: 9.9 kg |
2 units | No, yes | No |
| Molbio Diagnostics | TrueNat HIV Viral Load | HIV-1, group M | RT-PCR/real time with conventional TaqMan probes | 500 | 55 | Plasma, 500 μl Blood, 250 μl |
240 by 300 by 120 mm; weight, 3 kg | 2 units | No, no | No |
Abbreviations: WHO, World Health Organization; PQ, prequalification; CE-IVD, Conformité Européene in vitro diagnostic; TAT, turnaround time; PSQ, plasma semiquantitative; WBSQ, whole-blood semiquantitative; RT-PCR, reverse transcription PCR; NASBA, nucleic acid sequence-based amplification; ICS, immunochromatographic strip.
Testing time does not include time for plasma separation.
Limits of detection for m-PIMA: HIV-1 group M, 342 copies/ml (95% CI, 279 to 451) and 595 IU/ml (95% CI, 487 to 785); HIV-1 group O, 228 copies/ml (95% CI, 187 to 295); HIV-2 group A, 364 copies/ml (95% CI, 292 to 484) and 200 IU/ml (95% CI, 160 to 260).
Diagnostic sensitivity at limit of detection with WHO 3rd International Standard, 18.3 copies/ml; diagnostic specificity, 100% (95% CI, 96.7 to 100.0); limit of quantitation, 40 copies/ml.