PDF(Pubmed)
Abstract：
Scaling up of newer innovations that address the limitations of the dried blood spot and the logistics of plasma monitoring is needed. We employed a multi-site, cross-sectional assessment of the plasma separation card (PSC) on blood specimens collected from all consenting adults, assenting young and pediatric patients living with HIV from 10 primary healthcare clinics in South Africa. Venous blood for EDTA-plasma samples was collected and analyzed according to the standard of care assay, while collected capillary blood for the PSC samples was analyzed using the Roche COBAS AmpliPrep/Cobas TaqMan (CAP/CTM) HIV-1 Test at the National Reference laboratories. McNemar tests assessed the differences in concordance between the centrifuged plasma and dried plasma spots. The usability of PSC by blood spotting, PSC preparation, and pre-analytical work was assessed by collecting seven-point Likert-scale data from healthcare and laboratory workers. We enrolled 538 patients, mostly adults [n = 515, 95.7% (95% CI: 93.7%-97.1%)] and females [n = 322, 64.2% (95% CI: 60.0%-68.1%)]. Overall, 536 paired samples were collected using both PSC- and EDTA-plasma diagnostics, and 502 paired PSC- and EDTA-plasma samples assessed. Concordance between the paired samples was obtained for 446 samples. Analysis of these 446 paired samples at 1,000 copies per milliliter threshold yielded an overall sensitivity of 87.5% [95% CI: 73.2%-95.8%] and specificity of 99.3% [95% CI: 97.9%-99.8%]. Laboratory staff reported technical difficulties in most tasks. The usability of the PSC by healthcare workers was favorable. For policymakers to consider PSC scale-up for viral load monitoring, technical challenges around using PSC at the clinic and laboratory level need to be addressed.
OBJECTIVE: Findings from this manuscript emphasize the reliability of the plasma separation card (PSC), a novel diagnostic method that can be implemented in healthcare facilities in resource-constrained settings. The agreement of the PSC with the standard of care EDTA plasma for viral load monitoring is high. Since the findings showed that these tests were highly specific, we recommend a scale-up of PSC in South Africa for diagnosis of treatment failure.
OBJECTIVE: Findings from this manuscript emphasize the reliability of the plasma separation card (PSC), a novel diagnostic method that can be implemented in healthcare facilities in resource-constrained settings. The agreement of the PSC with the standard of care EDTA plasma for viral load monitoring is high. Since the findings showed that these tests were highly specific, we recommend a scale-up of PSC in South Africa for diagnosis of treatment failure.
摘要：
需要扩大新的创新，以解决干血点的局限性和血浆监测的后勤问题。我们雇佣了一个多站点，对从所有同意的成年人收集的血液样本进行血浆分离卡（PSC）的横断面评估，从南非的10个初级保健诊所认可感染艾滋病毒的年轻和儿科患者。收集用于EDTA-血浆样品的静脉血并根据护理测定标准进行分析。在国家参考实验室，使用RocheCOBASAmpliPrep/CobasTaqMan（CAP/CTM）HIV-1测试分析了收集的PSC样本的毛细血管血液。McNemar试验评估了离心血浆和干燥血浆斑点之间一致性的差异。通过血斑PSC的可用性，PSC准备,通过从医疗保健和实验室工作人员收集7点Likert量表数据来评估分析前工作。我们招募了538名患者，大多数为成人[n=515,95.7%(95%CI:93.7%-97.1%)]和女性[n=322,64.2%(95%CI:60.0%-68.1%)]。总的来说,使用PSC和EDTA血浆诊断收集了536个配对样品，和502配对PSC-和EDTA-血浆样品进行评估。对于446个样品,获得配对样品之间的一致性。以每毫升1,000个拷贝阈值对这446个配对样品进行分析,产生87.5%[95%CI:73.2%-95.8%]的总体灵敏度和99.3%[95%CI:97.9%-99.8%]的特异性。实验室工作人员报告了大多数任务中的技术困难。医护人员对PSC的可用性是有利的。政策制定者考虑PSC扩大病毒载量监测，需要解决在诊所和实验室级别使用PSC的技术挑战。
目的：本手稿的发现强调了血浆分离卡（PSC）的可靠性，一种新的诊断方法，可以在资源受限的医疗机构中实施。PSC与用于病毒载量监测的护理标准EDTA血浆的一致性很高。由于研究结果表明这些测试是高度特异性的，我们建议在南非扩大PSC的规模以诊断治疗失败.
目的：本手稿的发现强调了血浆分离卡（PSC）的可靠性，一种新的诊断方法，可以在资源受限的医疗机构中实施。PSC与用于病毒载量监测的护理标准EDTA血浆的一致性很高。由于研究结果表明这些测试是高度特异性的，我们建议在南非扩大PSC的规模以诊断治疗失败.
