梅毒诊断用新化学发光免疫分析法的评估。
Evaluation of a new chemiluminescence immunoassay for diagnosis of syphilis.
机构信息
The Laboratory of Shanghai Skin Diseases and STD Hospital, Shanghai, China.
出版信息
Eur J Med Res. 2010 Feb 26;15(2):66-9. doi: 10.1186/2047-783x-15-2-66.
OBJECTIVE
To assess the sensitivity, specificity, and feasibility of a new chemiluminescence immunoassay (CLIA) in the diagnosis of syphilis.
METHODS
At first, a retrospective study was conducted, using 135 documented cases of syphilis and 30 potentially interfering samples and 80 normal sera. A prospective study was also performed by testing 2, 071 unselected samples for routine screening for syphilis. CLIA was compared with a nontreponemal test (TRUST) and a treponemal test (TPPA).
RESULTS
There was an agreement of 100% between CLIA and TPPA in the respective study. The percentage of agreement among the 245 sera tested was 100.0%. Compared with TPPA, the specificity of CLIA was 99.9% (1817/1819), the sensitivity of CLIA was 100.0% (244/244) in the prospective study. CLIA showed 99.5% agreement with TPPA by testing 2, 071 unselected samples. And CLIA seemed to be more sensitive than TPPA in detecting the samples of primary syphilis.
CONCLUSIONS
CLIA is easy to perform and the indicator results are objective and unequivocal. It may be suitable for large-scale screening as a treponemal test substituted for TPPA.
目的
评估一种新的化学发光免疫分析（CLIA）在梅毒诊断中的灵敏度、特异性和可行性。
方法
首先进行了一项回顾性研究，使用了 135 例确诊的梅毒病例和 30 例可能存在干扰的样本以及 80 例正常血清。还通过对 2071 例未经选择的样本进行常规梅毒筛查进行了前瞻性研究。CLIA 与非梅毒螺旋体试验（TRUST）和梅毒螺旋体试验（TPPA）进行了比较。
结果
在各自的研究中，CLIA 与 TPPA 的一致性为 100%。在测试的 245 份血清中，一致性百分比为 100.0%。与 TPPA 相比，CLIA 的特异性为 99.9%（1817/1819），前瞻性研究中的灵敏度为 100.0%（244/244）。在对 2071 例未经选择的样本进行测试时，CLIA 与 TPPA 的一致性为 99.5%。CLIA 在检测原发性梅毒样本时似乎比 TPPA 更敏感。
结论
CLIA 易于操作，指标结果客观明确。它可能适合作为 TPPA 的替代物进行大规模筛查。
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