Saravanan S, Vidya M, Balakrishnan P, Kumarasamy N, Solomon Sunil S, Solomon S, Kantor Rami, Katzenstein David, Ramratnam Bharat, Mayer Kenneth H
YRG Centre for AIDS Research and Education, Chennai 600 113, India.
J Virol Methods. 2009 Aug;159(2):211-6. doi: 10.1016/j.jviromet.2009.03.021. Epub 2009 Apr 2.
Commercial HIV-1 genotypic resistance assays are very expensive, particularly for use in resource-constrained settings like India. Hence a cost effective in-house assay for drug resistance was validated against the standard ViroSeq HIV-1 Genotyping System 2.0 (Celera Diagnostics, CA, USA). A total of 50 samples were used for this evaluation (21 proficiency panels and 29 clinical isolates). Known resistance positions within HIV-1 protease (PR) region (1-99 codons) and HIV-1 reverse-transcriptase (RT) region (1-240 codons) were included. The results were analysed for each codon as follows: (i) concordant; (ii) partially concordant; (iii) indeterminate and (iv) discordant. A total of 2750 codons (55 codons per patient samplex50 samples) associated with drug resistance (1050 PR and 1700 RT) were analysed. For PR, 99% of the codon results were concordant and 1% were partially concordant. For RT, 99% of the codon results were concordant, 0.9% were partially concordant and 0.1% were discordant. No indeterminate results were observed and the results were reproducible. Overall, the in-house assay provided comparable results to those of US FDA approved ViroSeq, which costs about a half of the commercial assay ($ 100 vs. $ 230), making it suitable for resource-limited settings.
商用HIV-1基因型耐药性检测非常昂贵，尤其是在印度这样资源有限的环境中使用时。因此，针对标准的ViroSeq HIV-1基因分型系统2.0（美国加利福尼亚州Celera诊断公司），验证了一种具有成本效益的内部耐药性检测方法。总共50个样本用于此次评估（21个能力验证样本组和29个临床分离株）。HIV-1蛋白酶（PR）区域（1 - 99密码子）和HIV-1逆转录酶（RT）区域（1 - 240密码子）内的已知耐药位点均被纳入。对每个密码子的结果进行如下分析：（i）一致；（ii）部分一致；（iii）不确定；（iv）不一致。总共分析了与耐药性相关的2750个密码子（每个患者样本55个密码子×50个样本）（1050个PR密码子和1700个RT密码子）。对于PR，99%的密码子结果一致，1%部分一致。对于RT，99%的密码子结果一致，0.9%部分一致，0.1%不一致。未观察到不确定结果，且结果具有可重复性。总体而言，内部检测方法提供的结果与美国食品药品监督管理局批准的ViroSeq相当，而其成本约为商业检测的一半（100美元对230美元），使其适用于资源有限的环境。
