Evaluation of two human immunodeficiency virus-1 genotyping systems: ViroSeq 2.0 and an in-house method.

Evaluation of two human immunodeficiency virus-1 genotyping systems: ViroSeq 2.0 and an in-house method.
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DOI:
10.1016/j.jviromet.2009.03.021
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发表时间:
2009-08
影响因子:
3.1
通讯作者:
Mayer KH
Mayer KH
中科院分区:
医学4区
文献类型:
--
作者:
Saravanan S;Vidya M;Balakrishnan P;Kumarasamy N;Solomon SS;Solomon S;Kantor R;Katzenstein D;Ramratnam B;Mayer KH

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商业HIV-1基因型耐药检测非常昂贵,特别是在印度等资源受限的环境中使用。因此,采用标准ViroSeq™HIV-1基因分型系统2.0 (Celera Diagnostics, CA, USA)验证了一种具有成本效益的内部耐药检测方法。总共使用了50个样本进行评估(21个熟练程度小组和29个临床分离株)。包括HIV-1蛋白酶(PR)区(1-99个密码子)和HIV-1逆转录酶(RT)区(1-240个密码子)内已知的抗性位点。对每个密码子的分析结果如下:(i)一致性;(ii)部分一致;(iii)不确定和(iv)不一致。共分析了2750个与耐药相关的密码子(每个患者样本55个密码子× 50个样本)(1050个PR和1700个RT)。对于PR, 99%的密码子结果一致,1%的密码子结果部分一致。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,结果可重复性好。总体而言,内部分析提供的结果与美国FDA批准的ViroSeq™相当,其成本约为商业分析的一半(100美元对230美元),使其适合资源有限的环境。
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 sample × 50 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.
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