Analytical Performances of Human Immunodeficiency Virus Type 1 RNA-Based Amplix® Real-Time PCR Platform for HIV-1 RNA Quantification

Table 1

Lower limit of detection of the HIV-1 RNA-based Amplix real-time PCR assay using the 3rd WHO HIV-1 subtype B international standard (National Institute for Biological Standards and Control) at 185,000 IU/mL (e.g., 5.04 log copies/mL), estimated at 28.1 HIV-1 RNA copies/mL (95% CI, 20.1–82.8 copies/mL)^µ.

Level	HIV-1 RNA (copies/mL)	Number tested	Number positivity	Rate (%)
1	100	41	41	100
2	75	37	37	100
3	50	45	45	100
4	40	50	48	96
5	30	65	63	97
6	20	58	56	96
7	10	49	27	55

lower limit of detection was calculated by PROBIT regression analysis using SPSS software.