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매독의 3가지 신속 검사법 및 ARCHITECT Syphilis TP의 비교적 평가

A Comparative Evaluation of Three Rapid Tests of Syphilis and ARCHITECT Syphilis TP

김원식
대한임상검사과학회 (Korean Society for Clinical Laboratory Science)|2011.03|대한임상검사과학회지 (Korean Journal of Clinical Laboratory Science)|제43권 제1호|pp. 1-5

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Abstract

The infection rate of syphilis is still increasing in the world especially in developing countries and the infection is often seen in large amounts of clinical specimens. For the diagnosis of this disease, Rapid Plasma Reagin (RPR)/ Venereal Disease Research Laboratory (VDRL) has still been used as one of major primary methods to diagnose syphilis even though the test readings are somewhat subjective with high false positive rates. Recently, the automatic ARCHITECT Syphilis TP, which is based on the detection of the TP-specific antibodies, has been introduced in many laboratories. Therefore, the clinical assessment of the method is needed to provide primary diagnosis of syphilis at the moment. We evaluated 3 different manual rapid kits and ARCHITECT Syphilis TP comparing with RPR/FTA-ABS and analysed their diagnostic properties. From February 2006 to April 2008, 203 positive and 250 negative specimens, obtained from Chungbuk National University Hospital were used for the evaluation. In the evaluation between manual rapid kits, their specificities were as high as 99.2 ~ 99.6% while their sensitivities were observed with little differences; 98.0% (199/203) for Kit A, 96.6% (196/203) for Kit B, and 97.4% (197/203) for Kit S. In the case of ARCHITECT Syphilis TP test, it showed 100% specificity (250/250) and 98.5% sensitivity (249/250). Kappa values comparing with RPR/FTA-ABS were 0.978 for Kit A, 0.964 for Kit B and Kit S, and 0.987 for ARCHITECT Syphilis TP. From our evaluation, we found out that manual rapid tests and ARCHITECT Syphilis TP have very good clinical accuracies and high kappa agreements with RPR/FTA-ABS. Due to its automation and quick simultaneous diagnosis with another serological markers, we suggest that the ARCHITECT Syphilis TP is one of best suitable method for the primary diagnosis of syphilis and that it might be able to replace RPR method in the laboratories.

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