Table 2.
Detection of acute infections by the old and new versions of the Alere RDT in plasma specimens from acutely HIV-1-infected, treatment-naïve, immunoblot-positive patients (Fiebig IV–VI) compared to quantitative PCR, 4G-EIA, and p24 Ag assay
| Fiebig stage | PCR (c/mL) | Old RDT | New RDT | 4G-EIA | p24CA-EIA (pg/ml) | HIV subtype | ||
|---|---|---|---|---|---|---|---|---|
| Antibody | p24 Ag | Antibody | p24 Ag | (CMIA index) | ||||
| IV | 320,000 | (+) | − | + | − | 38 | 169 | N/A |
| IV | 1,080,000 | (+) | − | (+) | − | 15 | 336 | B |
| IV | 2,890,000 | N/A | N/A | (+) | (+) | 49 | 786 | B |
| IV | 3,410,000 | (+) | − | + | − | 33 | 817 | B |
| IV | 4,200,000 | (+) | − | (+) | − | 38 | 542 | B |
| IV | 5,190,000 | N/A | N/A | (+) | + | 120 | 851 | B |
| IV | 6,430,000 | N/A | N/A | (+) | + | 74 | 849 | B |
| IV | 6,720,000 | N/A | N/A | (+) | + | 202 | 858 | B |
| IV | > 10,000,000 | N/A | N/A | − | + | 1109 | 909 | C |
| V | 11,300 | N/A | N/A | + | − | 38 | − | B |
| V | 31,400 | (+) | − | + | − | 13 | − | B |
| V | 446,000 | N/A | N/A | + | − | 21 | 118 | B |
| V | 801,000 | N/A | N/A | (+) | − | 12 | 299 | B |
| V | 845,000 | N/A | N/A | + | − | 46 | 317 | A1 |
| V | 1,010,000 | N/A | N/A | + | − | 160 | 276 | URF |
| V | 1,200,000 | (+) | − | (+) | − | 13 | 426 | CRF02_AG |
| V | 1,210,000 | + | − | + | − | 51 | 524 | B |
| V | 1,380,000 | + | − | + | − | 33 | 886 | B |
| V | 1,950,000 | N/A | N/A | (+) | (+) | 27 | 485 | B |
| V | 3,000,000 | N/A | N/A | + | (+) | 93 | 726 | CRF01_AE |
| V | 3,450,000 | N/A | N/A | + | + | 66 | 804 | B |
| V | 4,420,000 | N/A | N/A | + | (+) | 77 | 897 | B |
| V | > 10,000,000 | N/A | N/A | (+) | (+) | 232 | 906 | URF |
| VI | 22,500 | N/A | N/A | + | − | 36 | − | B |
| VI | 24,400 | N/A | N/A | + | − | 49 | − | B |
| VI | 878,000 | N/A | N/A | + | − | 102 | 473 | B |
| VI | 1,690,000 | N/A | N/A | + | − | 93 | 62 | URF |
| 8/8 positive (100%) | 27/27 positive (100%) | |||||||
The COBAS Ampliprep/COBAS TaqMan HIV Test v2.0 (PCR), the INNOTEST® HIV Antigen mAb (p24CA-EIA), and the ARCHITECT HIV Ag/Ab Combo (4G-EIA) were performed on plasma specimens before measuring RDT reactivity. Immunoblot reactivity in the specimens was examined via the New LAV Blot I Assay or the INNO-LIA HIV I/II Score. The HIV-1 subtype was determined by Sanger sequencing of the pol/rt region as described previously [39]. + strong reactive; (+) weak reactive; − non-reactive; N/A not acquired (The old RTD was no longer available for a subset of specimens that was tested in 2019)