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KMID : 0390320140240010075
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Chungbuk Medical Journal
2014 Volume.24 No. 1 p.75 ~ p.80
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Evaluation of the Performance of Rapid Plasma Reagin (RPR) Assay as Automated Syphilis Test
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Son Bo-Ra
Shin Kyeong-Seob
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Abstract
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Purpose: We evaluated the performance characteristics of Mediace Rapid Plasma Reagin (RPR) (Seikisui Chemical Co., Ltd, Japan), an automated and quantitative method for the syphilis diagnosis.
Materials and Methods: 188 samples were analyzed, including 68 sera from patient with positive results in manual RPR card (ASAN Pharm. Co., Ltd., Seoul, Korea). To evaluate the performance of Mediace RPR assay, a precision, linearity and comparison study with manual RPR card, TPLA and FTA-ABS were analyzed.
Results: Within-run and between-run coefficients of variation were 4.48% and 4.84%, respectively. Linearity ranged from 0 to 7.3 R.U. In comparison study with manual RPR, TPLA and FTA-ABS IgM, the sensitivity and specificity of Mediace RPR assay was 100% and 96.9%, respectively. Overall agreement with RPR card was 96.8%.
Conclusions: The performance of Mediace RPR assay, including precision, linearity, sensitivity and specificity, were excellent. Therefore, the routine application of this test to screen syphilis may be useful in the clinical laboratory.
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KEYWORD
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Automated Mediace RPR assy, Manual RPR card, Syphilis, Evaluation
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