Table 1

Sensitivity, linearity, and precision results for the ART assay

Specimen sourceNominal VL (log10 IU/ml)aNo. testedNo. detectableMean (SD) VL (log10 IU/ml)CV (%)
Panelb030Target not detected
1.041210<1.08c
1.5212121.26 (0.17)d13.9
2.2012121.63 (0.11)6.7
2.79992.21 (0.08)3.8
3.67993.23 (0.13)4.0
4.71994.29 (0.05)1.1
5.28994.81 (0.07)1.4
5.72995.29 (0.07)1.4
6.73996.38 (0.09)1.5
Patiente0.8955<1.08c
1.89551.66 (0.1)5.9
2.89552.65 (0.08)2.9
3.89553.68 (0.04)1.2
4.89554.68 (0.11)2.3
5.89555.72 (0.09)1.5
6.89336.61 (0.005)0.1
7.89557.89 (0.03)0.4
  • a For the panel specimens, the assay-specific nominal VL (provided by the manufacturer) was used; for the patient dilution series, the reported nominal viral load is the mean of experimental values for undiluted replicates.

  • b Specimens from the SeraCare panel (see Materials and Methods); nominal VL values are based on the manufacturer's results with the ART assay.

  • c All results were above the limit of detection but below the limit of quantitation.

  • d Mean of 7 results above the limit of quantitation.

  • e Serial 10-fold dilutions of a patient specimen with a high viral load; the nominal VL was calculated by averaging all VL results (n = 5) from the undiluted specimen (7.89 log10 IU/ml) and adjusting for the dilution factor.