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首页> 外文期刊>Journal of Clinical Microbiology >Improved Sensitivity of a Dual-Target HIV-1 Qualitative Test for Plasma and Dried Blood Spots
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Improved Sensitivity of a Dual-Target HIV-1 Qualitative Test for Plasma and Dried Blood Spots

机译：血浆和干血斑双重目标HIV-1定性测试的敏感性提高

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The use of nucleic acid detection for HIV type 1 (HIV-1) detection is strongly recommended in infants <18 months of age, in whom serology is unreliable. This study evaluated the Cobas AmpliPrep/Cobas TaqMan HIV-1 Qualitative Test v2.0 (TaqMan HIV-1 Qual Test, v2.0), a dual-target total nucleic acid real-time PCR assay. The limit of detection (LOD) of the new test in plasma and dried blood spots (DBS) was determined with the 2nd International HIV-1 RNA WHO standard. The specificity of the assay was tested with EDTA plasma (n = 1,301) and DBS from HIV-negative adults (n = 1,000). The sensitivity was determined using HIV-1-positive samples (n = 169 adult EDTA plasma, n = 172 adult DBS, and n = 100 infant DBS) that included group M, subtypes A to H, CRF01_AE, CRF02_AG, and groups O and N. All positive specimens and a subset of the negative specimens were also tested with the Abbott RealTime HIV-1 Qual assay (RealTime). The LOD of the TaqMan assay was 20 copies/ml in plasma and 300 copies/ml in DBS, with specificities of 99.8% in plasma and 99.9% in DBS. The TaqMan assay results were 100% concordant with RealTime results in EDTA plasma samples and in 100 HIV-1-negative adult DBS. Among 172 HIV-1-positive DBS from adults, the TaqMan assay showed positive results for all DBS while RealTime missed five DBS with low target concentrations. Infant DBS results were 100% concordant. The improved sensitivity of the Cobas AmpliPrep/Cobas TaqMan HIV-1 Qualitative Test, v2.0, compared to current commercially available assays may enable earlier diagnosis and treatment in adults and infants. The dual-target test may ensure HIV-1 detection even if a mutation is present in one of the two target regions. The DBS sample matrix facilitates virological testing in remote areas.
机译：强烈建议在血清学检查不可靠的18岁以下婴儿中，将核酸检测用于1型HIV（HIV-1）检测。这项研究评估了Cobas AmpliPrep / Cobas TaqMan HIV-1定性测试v2.0（TaqMan HIV-1质量测试，v2.0），这是一种双目标总核酸实时PCR检测方法。使用第二项国际HIV-1 RNA WHO标准确定血浆和干血斑（DBS）中新检测的检测限（LOD）。用EDTA血浆（ n = 1,301）和来自HIV阴性成年人的DBS（ n = 1,000）测试了测定的特异性。使用HIV-1阳性样本（ n = 169个成人EDTA血浆， n = 172个成人DBS和 n = 100包括M组，A至H亚型，CRF01_AE，CRF02_AG以及O和N组的婴儿DBS。还对所有阳性标本和一部分阴性标本进行了雅培RealTi m e HIV检测-1质量分析（RealTi m e）。 TaqMan测定的LOD在血浆中为20拷贝/ ml，在DBS中为300拷贝/ ml，在血浆中的特异性为99.8％，在DBS中的特异性为99.9％。 TaqMan测定结果与EDTA血浆样品和100例HIV-1阴性成人DBS中的RealTi m e结果100％一致。在172个成年人的HIV-1阳性DBS中，TaqMan分析显示所有DBS均为阳性，而RealTi m e错过了五个目标浓度低的DBS。婴儿DBS结果100％一致。与目前市售的检测方法相比，Cobas AmpliPrep / Cobas TaqMan HIV-1定性测试v2.0的灵敏度提高了，可以在成人和婴儿中进行早期诊断和治疗。即使在两个目标区域之一中存在突变，双重目标测试也可以确保检测到HIV-1。 DBS样品矩阵有助于在偏远地区进行病毒学测试。

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