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首页> 美国卫生研究院文献>The Open AIDS Journal >Field Evaluation of Calypte’s AWARE™ Blood Serum Plasma (BSP) and Oral Mucosal Transudate (OMT) Rapid Tests for Detecting Antibodies to HIV-1 and 2 in Plasma and Oral Fluid
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Field Evaluation of Calypte’s AWARE™ Blood Serum Plasma (BSP) and Oral Mucosal Transudate (OMT) Rapid Tests for Detecting Antibodies to HIV-1 and 2 in Plasma and Oral Fluid

机译：Calypte的AWARE™血清血浆（BSP）和口腔粘膜渗出液（OMT）快速测试的现场评估用于检测血浆和口腔液中的HIV-1和2抗体

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As programs to prevent and care for HIV-infected persons are scaled-up in Africa, there is the need for continuous evaluation of the performance of test kits that could best support these programs. The present study evaluated the sensitivity, specificity, ease of use, and cost of AWARE ™ Blood Serum Plasma (BSP) and Oral Mucosal Transudate (OMT) Rapid HIV-1/2 test kits using real-time and archived samples of HIV-infected persons from Cameroon. Matched whole blood and OMT specimens were collected prospectively from HIV-positive and HIV-negative persons from different regions of Cameroon and tested using the AWARE ™ BSP and OMT test kits, respectively. These results were compared to the gold standard that included a combination of Determine HIV-1/2 and Enzygnost HIV-1/2. The BSP Rapid test kit was further evaluated using well characterized panels of HIV-2 and HIV-1 group O samples. Cost and end-user analysis of the OMT test kit was done by comparing its actual cost, consumables, safety, bench time and manipulation with other test kits. Of the 732 matched samples, 412 (56.3%) and 320 (43.7%) were from females and males, respectively. Of these samples, 23 (3.1%) gave discordant results between Determine HIV-1/2 and Enzygnost HIV1/2 and were excluded from the analysis. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the AWARE™ BSP were 100%. The AWARE™ OMT had 98.8% sensitivity, 98.9% specificity, 98.0% PPV and 99.4% NPV. The results of a well-characterized archived panel of HIV-2 (n=7) and HIV-1 group O (n=3) samples using the AWARE™ BSP Rapid test kit gave 100% concordance. Total per patient cost of the AWARE OMT rapid test kit was US$4.72 compared to a mean cost of US $7.33 ± 0.11 for the other test kits. Both the AWARE™ BSP and OMT Rapid test kits demonstrated high sensitivities and specificities on all samples tested and were well adapted for use in resource-constrained settings with high HIV heterogeneity such as Cameroon. The AWARE ™ HIV-1/2 OMT Rapid test kit appears to be the cheapest, safest and easiest to use compared with other available test kits.
机译：由于在非洲扩大了预防和护理艾滋病毒感染者的计划，因此需要持续评估最能支持这些计划的测试套件的性能。本研究通过实时评估AWARE ™血清血浆（BSP）和口腔粘膜渗出液（OMT）快速HIV-1 / 2检测试剂盒的敏感性，特异性，易用性和成本和来自喀麦隆的艾滋病毒感染者的存档样本。从喀麦隆不同地区的HIV阳性和HIV阴性者前瞻性采集相配的全血和OMT标本，并分别使用AWARE ™ BSP和OMT测试套件进行测试。将这些结果与包括确定HIV-1 / 2和Enzygnost HIV-1 / 2的组合的黄金标准进行了比较。使用特征明确的HIV-2和HIV-1 O组样本对BSP快速测试试剂盒进行了进一步评估。通过将OMT测试套件的实际成本，消耗品，安全性，工作时间和操作与其他测试套件进行比较，进行了成本和最终用户分析。在732个匹配的样本中，分别有412个（56.3％）和320个（43.7％）来自女性和男性。在这些样本中，有23个（3.1％）在确定的HIV-1 / 2和Enzygnost HIV1 / 2之间给出了不一致的结果，因此被排除在分析之外。 AWARE ™ BSP的敏感性，特异性，阳性预测值（PPV）和阴性预测值（NPV）为100％。 AWARE ™ OMT具有98.8％的敏感性，98.9％的特异性，98.0％的PPV和99.4％的NPV。使用AWARE ™ BSP快速测试试剂盒对HIV-2（n = 7）和HIV-1 O组（n = 3）样品进行了很好的存档，结果具有100％的一致性。 AWARE OMT快速测试套件的每位患者总成本为4.72美元，而其他测试套件的平均成本为7.33美元±0.11。 AWARE ™ BSP和OMT快速测试试剂盒对所有测试样品均显示出高灵敏度和特异性，并且非常适合在资源有限的HIV高异质性环境中使用，例如喀麦隆。与其他可用的测试套件相比，AWARE ™ HIV-1 / 2 OMT快速测试套件似乎是最便宜，最安全和最容易使用的。

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