A pilot evaluation of whole blood finger-prick sampling for point-of-care HIV viral load measurement: the UNICORN study.
A pilot evaluation of whole blood finger-prick sampling for point-of-care HIV viral load measurement: the UNICORN study.
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DOI：
10.1038/s41598-017-13287-2
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发表时间：
2017-10-20
影响因子：
4.6
通讯作者：
Frater J
中科院分区：
文献类型：
--
作者：
Fidler S;Lewis H;Meyerowitz J;Kuldanek K;Thornhill J;Muir D;Bonnissent A;Timson G;Frater J
全球需要艾滋病毒病毒载量护理点(PoC)分析来监测接受抗逆转录病毒治疗的患者。独角兽是第一个使用标签外方案的研究，使用全血手指刺伤样本，使用诊所微离心机进行简单的三分钟旋转测试。对40名HIV阳性参与者，20名可检测到的血浆病毒载量(PVL)(20拷贝/毫升)和20名不可检测的血浆病毒载量(PVL)进行了两次PoC检测。使用100 的L指刺血样，将造父显影Xpert HIV-1病毒载量和HIV-1Qual试剂盒与实验室PVL评估(TaqMan，Roche)进行比较。对于TaqMan无法检测到病毒血症的参与者，在没有离心的情况下与TaqMan平台的一致性很差，只有40%的人使用Xpert VL检测不到，25%的人使用Qual检测没有检测到。旋转3 分钟后，两种方法都不能检测到100%的样品，这与TaqMan方法完全一致。当包括自旋时，定义的检测下限为1000拷贝/毫升，与TaqMan平台有100%的一致性，具有很强的相关性(对于两种检测方法，p <； 均为0.0001)。当包括一个简单的微离心步骤时，指刺PoC检测是一种快速而准确的评估HIV病毒血症的方法，与经过验证的实验室方法具有很好的一致性。
There is a global need for HIV viral load point-of-care (PoC) assays to monitor patients receiving antiretroviral therapy. UNICORN was the first study of an off-label protocol using whole blood finger-prick samples tested with and without a simple three minute spin using a clinic-room microcentrifuge. Two PoC assays were evaluated in 40 HIV-positive participants, 20 with detectable and 20 with undetectable plasma viral load (pVL) (<20 copies/ml). Using 100 µl finger-prick blood samples, the Cepheid Xpert HIV-1 Viral Load and HIV-1 Qual cartridges were compared with laboratory pVL assessment (TaqMan, Roche). For participants with undetectable viraemia by TaqMan, there was poor concordance without centrifugation with the TaqMan platform with only 40% ‘undetectable’ using Xpert VL and 25% ‘not detected’ using the Qual assay. After a 3 minute spin, 100% of samples were undetectable using either assay, showing full concordance with the TaqMan assay. Defining a lower limit of detection of 1000 copies/ml when including a spin, there was 100% concordance with the TaqMan platform with strong correlation (rho 0.95 and 0.94; p < 0.0001 for both assays). When including a simple microcentrifugation step, finger-prick PoC testing was a quick and accurate approach for assessing HIV viraemia, with excellent concordance with validated laboratory approaches.
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作者：
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