对两种用于鉴定传染性梅毒的护理点检测试剂盒进行实验室评估。

Raymond Sw Tsang, Michelle Shuel, Kristy Hayden, Paul Van Caeseele, Derek Stein
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引用次数: 0

摘要

背景:梅毒是一种性传播疾病,临床表现不典型。用于确诊的常规实验室检测不够快速,无法影响临床治疗决策和接触者追踪。快速护理点检测(POCT)可用于控制传染病,但目前加拿大还没有用于梅毒检测的 POCT。本研究旨在评估两种用于检测传染性梅毒的POCT(RevealTM快速TP(苍白螺旋体)抗体检测试剂盒和DPP®梅毒筛查与确认试剂盒):方法:100 份已知梅毒血清学状态的血清样本,根据三聚体和非三聚体检测结果,由两名独立操作员在实验室用两种 POCT 进行盲法分析。对结果进行分析,以评估它们检测传染性梅毒的能力:结果:Reveal快速TP抗体POCT的总体灵敏度为95.0%,特异性为83.3%,而DPP梅毒筛查和确认POCT的灵敏度为87.5%,特异性为98.3%。对于性病研究实验室(VDRL)滴度大于1:4的活动梅毒样本,两种POCT的灵敏度均为100%,但对于VDRL滴度较低的样本,灵敏度则有所下降。在 11.3%-25.0%的三价淋球菌抗体阳性样本中,这两种 POCT 都给出了弱反应或极弱反应的结果:此次实验室评估表明,两种检测梅毒的 POCT 检测结果都很有希望。要确认这一初步结果,还需要进一步的实地评估。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Laboratory evaluation of two point-of-care test kits for the identification of infectious syphilis.

Background: Syphilis is a sexually transmitted disease that can have atypical clinical presentations. Conventional laboratory tests to confirm the diagnosis are not rapid enough to affect clinical decision on treatment and contact tracing. Rapid point-of-care tests (POCT) can be useful for control of infectious diseases; however, no POCT for syphilis detection is currently available in Canada. The aim of this study is to evaluate two POCTs (RevealTM Rapid TP (Treponema pallidum) Antibody test and DPP® Syphilis Screen and Confirm test) for detection of infectious syphilis.

Methods: One hundred serum samples with known syphilis serological status, based on treponemal and non-treponemal test results, were analysed in the laboratory with two POCTs by two independent operators in a blind fashion. Results were analysed to evaluate their ability to detect infectious syphilis.

Results: The Reveal Rapid TP Antibody POCT showed an overall sensitivity of 95.0% and a specificity of 83.3%, while the DPP Syphilis Screen and Confirm POCT showed a sensitivity of 87.5% and a specificity of 98.3%. Both POCTs gave a sensitivity of 100% on active syphilis samples with Venereal Disease Research Laboratory (VDRL) titres of greater than 1:4, but their sensitivities decreased for samples with low VDRL titres. Both POCTs gave weakly or very weakly reactive results on 11.3%-25.0% of the treponemal antibody positive samples.

Conclusion: This laboratory evaluation has shown promising results for both POCTs to detect infectious syphilis. Further evaluations in the field would be required to confirm this preliminary finding.

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