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干血斑标本用于 HIV-1 病毒载量检测的诊断准确性:系统评价和荟萃分析。

Diagnostic Accuracy of Dried Plasma Spot Specimens for HIV-1 Viral Load Testing: A Systematic Review and Meta-analysis.

机构信息

Fred Hutchinson Cancer Research Center, Seattle, WA.

Clinton Health Access Initiative, Boston, MA.

出版信息

J Acquir Immune Defic Syndr. 2022 Mar 1;89(3):261-273. doi: 10.1097/QAI.0000000000002855.

Abstract

BACKGROUND

Dried plasma spot specimens may be a viable alternative to traditional liquid plasma in field settings, but the diagnostic accuracy is not well understood.

METHODS

Standard databases (PubMed and Medline), conferences, and gray literature were searched until January 2019. The quality of evidence was evaluated using the Standards for Reporting Studies of Diagnostic Accuracy and Quality Assessment of Diagnostic Accuracy Studies-2 criteria. We used univariate and bivariate random effects models to determine misclassification, sensitivity, and specificity across multiple thresholds, overall and for each viral load technology, and to account for between-study variation.

RESULTS

We identified 23 studies for inclusion in the systematic review that compared the diagnostic accuracy of dried plasma spots with that of plasma. Primary data from 16 of the 23 studies were shared and included in the meta-analysis, representing 18 countries, totaling 1847 paired dried plasma spot:plasma data points. The mean bias of dried plasma spot specimens compared with that of plasma was 0.28 log10 copies/mL, whereas the difference in median viral load was 2.25 log10 copies/mL. More dried plasma spot values were undetectable compared with plasma values (43.6% vs. 29.8%). Analyzing all technologies together, the sensitivity and specificity of dried plasma spot specimens were >92% across all treatment failure thresholds compared and total misclassification <5.4% across all treatment failure thresholds compared. Some technologies had lower sensitivity or specificity; however, the results were typically consistent across treatment failure thresholds.

DISCUSSION

Overall, dried plasma spot specimens performed relatively well compared with plasma with sensitivity and specificity values greater than 90% and misclassification rates less than 10% across all treatment failure thresholds reviewed.

摘要

背景

干血斑标本在现场环境中可能是传统液态血浆的可行替代品,但诊断准确性尚不清楚。

方法

标准数据库(PubMed 和 Medline)、会议和灰色文献进行了搜索,直到 2019 年 1 月。使用诊断准确性研究报告标准和诊断准确性研究质量评估标准评估证据质量。我们使用单变量和双变量随机效应模型来确定多个阈值、总体和每种病毒载量技术的错误分类、敏感性和特异性,并考虑研究之间的差异。

结果

我们确定了 23 项研究进行系统评价,比较了干血斑与血浆的诊断准确性。23 项研究中的 16 项研究共享并纳入了荟萃分析,代表了 18 个国家,共包括 1847 对干血斑:血浆数据点。与血浆相比,干血斑标本的平均偏差为 0.28log10 拷贝/ml,而中位数病毒载量的差异为 2.25log10 拷贝/ml。与血浆值相比,更多的干血斑值不可检测(43.6%比 29.8%)。分析所有技术,干血斑标本的敏感性和特异性在所有治疗失败阈值下均>92%,总错误分类率在所有治疗失败阈值下均<5.4%。一些技术的敏感性或特异性较低;然而,结果通常在治疗失败阈值上是一致的。

讨论

总体而言,与血浆相比,干血斑标本的表现相对较好,在所有评估的治疗失败阈值下,敏感性和特异性值均大于 90%,错误分类率小于 10%。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ed12/8826610/e066ce25432d/qai-89-261-g001.jpg

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