Analytical characteristics and comparative evaluation of Aptima HIV-1 Quant Dx assay with Ampliprep/COBAS TaqMan HIV-1 test v2.0

Table 5 Assessment of inter-instrument, inter-operator, inter-lot, inter-day, inter-run, intra-run and total variability of Aptima HIV-1 Quant Dx in various HIV-1 RNA concentrations

			Inter-instrument		Inter-operator		Inter-lot		Inter-day		Inter-run		Intra-run		Total
Panel	N	Mean	SD	CV (%)	SD	CV (%)	SD	CV (%)	SD	CV (%)	SD	CV (%)	SD	CV (%)	SD	CV (%)
Panel	N	Log	SD	CV (%)	SD	CV (%)	SD	CV (%)	SD	CV (%)	SD	CV (%)	SD	CV (%)	SD	CV (%)
5E1 copies/mL	41^a	1.66	0.075	4.52	0.033	1.99	0	0	0	0	0	0	0.119	7.12	0.144	8.67
1E2 copies/mL	74^a	1.82	0	0	0	0	0.014	0.77	0	0	0.102	5.6	0.148	8.14	0.18	9.91
1E3 copies/mL	81	2.75	0.035	1.26	0	0	0	0	0	0	0.041	1.5	0.098	3.57	0.112	4.08
1E4 copies/mL	81	3.81	0.011	0.28	0.013	0.35	0	0	0.013	0.35	0.05	1.31	0.039	1.04	0.067	1.77
1E5 copies/mL	81	4.96	0.01	0.21	0	0	0	0	0	0	0.042	0.84	0.051	1.03	0.067	1.35
1E6 copies/mL	78^b	6	0.008	0.14	0.001	0.02	0	0	0	0	0.048	0.79	0.027	0.44	0.055	0.92
1E7 copies/mL	81	6.89	0	0	0	0	0.026	0.38	0	0	0.033	0.47	0.046	0.67	0.062	0.9

Note: 1. Variability from some factors may be numerically negative, which can occur if the variability due to those factors is very small. When this occurs, SD = 0 and CV = 0 %
^athe 50 and 100 copies/mL sample has lower N because some results were below the limit of quantification
^b3 results were invalid and not included in the analysis

ISSN: 1743-422X