卡塔尔医疗机构中艾滋病毒和梅毒感染的筛查和诊断检测方案：评估和建议。
Screening and diagnostic testing protocols for HIV and Syphilis infections in health care setting in Qatar: Evaluation and recommendations.
机构信息
Department of Biomedical Science, College of Health Sciences, QU Health, Qatar University, Doha, Qatar.
Biomedical Research Center, Qatar University, Doha, Qatar.
出版信息
PLoS One. 2023 Feb 7;18(2):e0278079. doi: 10.1371/journal.pone.0278079. eCollection 2023.
BACKGROUND
HIV and Syphilis are common STIs, which have become a concern and burden on healthcare systems, as many infections go untreated and lead to potentially serious complications. HIV is usually diagnosed with Western blot, PCR, and p24 antigen testing. Whereas, Syphilis is mainly diagnosed through clinical findings and serologic testing. The Medical Commission Department (MC) under MOPH is responsible for screening all newcomers to Qatar, aiming to keep the country free from serious infectious diseases.
OBJECTIVE
We aimed to evaluate the diagnostic efficiency of the protocols used in the MC for screening HIV and Syphilis infections.
METHODS
We conducted a retrospective study of samples analyzed by 4th Generation ARCHITECT® HIV Ag/Ab Combo and Rapid Plasma Reagin (RPR) between January to December 2019. ARCHITECT® HIV Ag/Ab Combo positive samples were confirmed by INNO-LIA™ HIVI/II and RT-PCR. RPR-reactive samples were confirmed by ARCHITECT® Syphilis Treponema pallidium Antibody (Syphilis TPA) assay.
RESULTS
For HIV, data were collected from 585,587 individuals, of which 595 (0.1%) were positive by the ARCHITECT® HIV Ag/Ab Combo (Analyzer A). When all initially positive sera were re-tested on newly collected blood samples using different ARCHITECT® HIV Ag/Ab Combo analyzer (analyzer B), 99.8% (594/595) of samples were also positive, suggesting high reproducibility. The positive predictive value (PPV) between ARCHITECT® HIV Ag/Ab Combo and the INNO-LIA™ HIVI/II confirmatory assay was 31.8%. The PPV between ARCHITECT® HIV Ag/Ab Combo and HIV-PCR assay was 26.8%. Retrospective data for Syphilis were collected from a total of 97,298 individuals who visited the MC, of which 198 (0.20%) were initially positive by RPR. The PPV between RPR and Syphilis TPA confirmatory assay was 36.6%.
CONCLUSION
Despite the high rate of false positivity using ARCHITECT® HIV Ag/Ab Combo and RPR screening assays, both assays have proven to be highly effective as screening testing methods.
背景
HIV 和梅毒是常见的性传播感染（STI），由于许多感染未得到治疗，导致潜在的严重并发症，因此成为医疗系统关注和负担。HIV 通常通过 Western blot、PCR 和 p24 抗原检测进行诊断。而梅毒主要通过临床发现和血清学检测进行诊断。澳门卫生局医疗委员会（MC）负责筛查所有新来卡塔尔的人，旨在使该国免受严重传染病的影响。
目的
我们旨在评估 MC 用于筛查 HIV 和梅毒感染的方案的诊断效率。
方法
我们对 2019 年 1 月至 12 月期间使用第四代 ARCHITECT® HIV Ag/Ab Combo 和快速血浆反应素（RPR）进行分析的样本进行了回顾性研究。ARCHITECT® HIV Ag/Ab Combo 阳性样本通过 INNO-LIA™ HIVI/II 和 RT-PCR 进行确认。RPR 反应性样本通过 ARCHITECT®梅毒螺旋体抗体（梅毒 TPA）检测进行确认。
结果
对于 HIV，从 585587 个人中收集数据，其中 595 人（0.1%）通过 ARCHITECT® HIV Ag/Ab Combo（分析仪 A）呈阳性。当使用新采集的血液样本对最初所有阳性血清重新进行不同的 ARCHITECT® HIV Ag/Ab Combo 分析仪（分析仪 B）检测时，99.8%（594/595）的样本也呈阳性，表明高度重现性。ARCHITECT® HIV Ag/Ab Combo 与 INNO-LIA™ HIVI/II 确认检测之间的阳性预测值（PPV）为 31.8%。ARCHITECT® HIV Ag/Ab Combo 与 HIV-PCR 检测之间的 PPV 为 26.8%。MC 共采集了总共 97298 名就诊者的梅毒回溯数据，其中 198 人（0.20%）RPR 初筛阳性。RPR 与梅毒 TPA 确认检测之间的 PPV 为 36.6%。
结论
尽管 ARCHITECT® HIV Ag/Ab Combo 和 RPR 筛选检测的假阳性率很高，但这两种检测方法都已被证明是非常有效的筛查检测方法。
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