基于实验室的四种梅毒快速即时检测方法的评估。
A laboratory-based evaluation of four rapid point-of-care tests for syphilis.
作者信息
Causer Louise M, Kaldor John M, Fairley Christopher K, Donovan Basil, Karapanagiotidis Theo, Leslie David E, Robertson Peter W, McNulty Anna M, Anderson David, Wand Handan, Conway Damian P, Denham Ian, Ryan Claire, Guy Rebecca J
机构信息
Kirby Institute, University of New South Wales, Sydney, Australia.
School of Population and Global Health, University of Melbourne, Carlton, Australia.
出版信息
PLoS One. 2014 Mar 11;9(3):e91504. doi: 10.1371/journal.pone.0091504. eCollection 2014.
BACKGROUND
Syphilis point-of-care tests may reduce morbidity and ongoing transmission by increasing the proportion of people rapidly treated. Syphilis stage and co-infection with HIV may influence test performance. We evaluated four commercially available syphilis point-of-care devices in a head-to-head comparison using sera from laboratories in Australia.
METHODS
Point-of-care tests were evaluated using sera stored at Sydney and Melbourne laboratories. Sensitivity and specificity were calculated by standard methods, comparing point-of-care results to treponemal immunoassay (IA) reference test results. Additional analyses by clinical syphilis stage, HIV status, and non-treponemal antibody titre were performed. Non-overlapping 95% confidence intervals (CI) were considered statistically significant differences in estimates.
RESULTS
In total 1203 specimens were tested (736 IA-reactive, 467 IA-nonreactive). Point-of-care test sensitivities were: Determine 97.3%(95%CI:95.8-98.3), Onsite 92.5%(90.3-94.3), DPP 89.8%(87.3-91.9) and Bioline 87.8%(85.1-90.0). Specificities were: Determine 96.4%(94.1-97.8), Onsite 92.5%(90.3-94.3), DPP 98.3%(96.5-99.2), and Bioline 98.5%(96.8-99.3). Sensitivity of the Determine test was 100% for primary and 100% for secondary syphilis. The three other tests had reduced sensitivity among primary (80.4-90.2%) compared to secondary syphilis (94.3-98.6%). No significant differences in sensitivity were observed by HIV status. Test sensitivities were significantly higher among high-RPR titre (RPR ≥ 8) (range: 94.6-99.5%) than RPR non-reactive infections (range: 76.3-92.9%).
CONCLUSIONS
The Determine test had the highest sensitivity overall. All tests were most sensitive among high-RPR titre infections. Point-of-care tests have a role in syphilis control programs however in developed countries with established laboratory infrastructures, the lower sensitivities of some tests observed in primary syphilis suggest these would need to be supplemented with additional tests among populations where syphilis incidence is high to avoid missing early syphilis cases.
背景
梅毒即时检测可通过增加快速接受治疗的人数比例来降低发病率和持续传播。梅毒分期及合并感染HIV可能会影响检测性能。我们使用来自澳大利亚各实验室的血清，对四种市售梅毒即时检测设备进行了直接比较评估。
方法
使用悉尼和墨尔本实验室保存的血清对即时检测进行评估。通过标准方法计算灵敏度和特异性，将即时检测结果与梅毒螺旋体免疫测定（IA）参考检测结果进行比较。还按临床梅毒分期、HIV感染状况和非梅毒螺旋体抗体滴度进行了额外分析。不重叠的95%置信区间（CI）被视为估计值的统计学显著差异。
结果
共检测了1203份标本（736份IA反应性标本，467份IA非反应性标本）。即时检测的灵敏度分别为：Determine 97.3%（95%CI：95.8 - 98.3）、Onsite 92.5%（90.3 - 94.3）、DPP 89.8%（87.3 - 91.9）和Bioline 87.8%（85.1 - 90.0）。特异性分别为：Determine 96.4%（94.1 - 97.8）、Onsite 92.5%（90.3 - 94.3）、DPP 98.3%（96.5 - 99.2）和Bioline 98.5%（96.8 - 99.3）。Determine检测对一期梅毒的灵敏度为100%，对二期梅毒的灵敏度也为100%。与二期梅毒（94.3 - 98.6%）相比，其他三种检测对一期梅毒的灵敏度有所降低（80.4 - 90.2%）。按HIV感染状况未观察到灵敏度的显著差异。高RPR滴度（RPR≥8）人群中的检测灵敏度（范围：94.6 - 99.
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