TABLE 2.
Summary of GART resistance interpretation and codon and base percent concordances for 20 originala versus dilutedb samples using the TruGene HIV-1 genotyping kit and OpenGene DNA sequencing system
| Drug class or protein | Concordance (%) (n) of:
|
||||
|---|---|---|---|---|---|
| Resistance interpretationsc | Codon mutationsd | All codonsd | Base mutationse | All basese | |
| NRTI/NtRTI | 96.4 (140) | 94.5 (91)f | 98.9 (440) | 95.5 (112)f | 99.6 (1,320) |
| NNRTI | 95.0 (60) | 93.9 (33)f | 99.3 (280) | 91.7 (36)f | 99.6 (840) |
| PI | 98.6 (140) | 95.9 (123) | 98.8 (400) | 94.7 (133) | 99.4 (1,200) |
| RT | 93.4 (303) | 99.5 (4,200) | 91.1 (652) | 99.5 (12,600) | |
| PR | 92.1 (277) | 99.0 (1,920) | 89.4 (414) | 99.2 (5,760) | |
HIV-1 viral load: median, 13,933 copies/ml; range, 1,032 to 345,560 copies/ml (bDNA).
HIV-1 viral load: median, 136 copies/ml; range, <75 to 254 copies/ml (bDNA).
GuideLines 9.0 rules released by Bayer December 2004 for the analysis of seven NRTI/NtRTI, three NNRTI, and seven PI antiretroviral class drugs. A total of five NRTI/NtRTI, three NNRTI and two PI resistance interpretations were discordant.
210 reverse transcriptase gene codons were analyzed per test including 22 NRTI/NtRTI and 14 NNRTI resistance gene codons, and 96 protease gene codons were analyzed per test including 20 PI resistance gene codons. The median number of all codon mutations per clinical sample was 28 (range, 18 to 49). A total of 5 NRTI/NtRTI, 2 NNRTI, 5 PI, 20 reverse transcriptase, and 22 protease gene codons were discordant.
Base calls of original versus diluted samples were judged concordant if they agreed on the presence or absence of mutations from the wild type. The median number of all base mutations per clinical sample was 51 (range, 40 to 73). A total of 5 NRTI/NtRTI, 3 NNRTI, 7 PI, 58 reverse transcriptase, and 44 protease base calls were discordant.
Four RT Y181C mutations counted in both RT drug classes as per GuideLines 9.0 rule.