TABLE 2

Point-of-care HIV viral load assays that are commercially available or in late developmenta

ManufacturerAssayHIV type(s)Amplification/detectionAnalytic sensitivity (copies/ml)Testing timeb (min)Sample type and volInstrument dimensionsTest instrumentWHO PQ, CE-IVDMarketed
Abbott Inc. (formerly Alere)m-PIMA (formerly Alere q HIV-1/2 Detect)HIV-1 groups M/N and O, HIV-2cRT-PCR/real time with competitive reporter hybridization800–1,000<70Plasma, 50 μl220 by 200 by 310 mm; weight, 7.8 kg1 unitYes, yesOnly in nonregulated markets
CepheidXpert HIV-1 Viral LoadHIV-1 groups M, N, and OdRT-PCR/real time with molecular beacons4090Plasma, 1 ml102 by 305 by 298 mm; weight, 8.2 kg1 unitYes, yesYes
Diagnostics for the Real WorldSAMBA I PSQHIV-1NASBA/ICS1,00090Plasma, 200 μlDisplay 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 unitsNo, yesYes
Diagnostics for the Real WorldSAMBA II WBSQHIV-1NASBA/ICS1,00090Blood, 120 μlDisplay 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 unitsNo, yesNo
Molbio DiagnosticsTrueNat HIV Viral LoadHIV-1, group MRT-PCR/real time with conventional TaqMan probes50055Plasma, 500 μl
Blood, 250 μl
240 by 300 by 120 mm; weight, 3 kg2 unitsNo, noNo
  • a 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.

  • b Testing time does not include time for plasma separation.

  • c 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).

  • d 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.