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생화학 자동분석기용 Mediace RPR 검사의 성능 및 위양성 평가

Evaluation of Performance and False Positivity of Mediace RPR Test that Uses a Chemistry Autoanalyzer

송은영|이상곤|최영숙|윤여민|신수|한규섭|노재광|고학현
대한진단검사의학회 (Korean Society For Laboratory Medicine)|2008.08|Annals of Laboratory Medicine|제28권 제4호|pp. 312-318

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참고문헌

주제분류병리학

초록

Abstract

Background : We evaluated the performance and false positive rate of Mediace RPR test (Sekisui, Japan), a newly introduced nontreponemal test using a chemistry autoanalyzer. Methods : The sensitivity of Mediace RPR test was analyzed using sera from 50 patients with syphilis in different stages (8 primary, 7 secondary, and 35 latent), 14 sera positive with fluorescent treponemal antibody absorption (FTA-ABS) IgM, and 74 sera positive with conventional rapid plasma regain (RPR) card test (Asan, Korea) and also positive with Treponema pallidum hemagglutination (TPHA) test or FTA-ABS IgG test. The specificity was analyzed on 108 healthy blood donors. We also performed RPR card test on 302 sera that had been tested positive with Mediace RPR test and also performed TPHA or FTA-ABS IgG test to analyze the false positive rate of Mediace RPR test. A cutoff value of 0.5 R.U. (RPR unit) was used for Mediace RPR test. Results : Mediace RPR test on syphilitic sera of different stages (primary, secondary, and latent stages) and FTA-ABS IgM positive sera showed a sensitivity of 100%, 100%, 82.9% and 100%, respectively. Among the 74 sera positive with conventional RPR card test and TPHA or FTA-ABS IgG test, 55 were positive with Mediace test. The specificity of Mediace RPR test on blood donors was 97.2%. Among the 302 sera positive with Mediace RPR test, 137 sera (45.4%) were negative by RPR card and TPHA/FTA-ABS IgG tests. Conclusions : Although the sensitivities of Mediace RPR were good for primary and secondary syphilis, due to its high negative rate of Mediace RPR over the conventional RPR positive samples, further studies are necessary whether it can replace conventional nontreponemal test for screening purpose. Moreover, in view of the high false positive rate, positive results by Mediace RPR test should be confirmed with treponemal tests. (Korean J Lab Med 2008;28:312-8)

참고문헌 (14)

  1. Smith MB, "Spirochete infections in: Clinical Diagnosis and Management by Laboratory Methods", pp.1131~1143 (2001), W.B. Saunders
  2. Kinjyo T, "Laboratory-based evaluation of latex-agglutination turbidemetric assay by Mediace RPR on P Module of Hitachi autoanalyzer 7600 to quantitatively determine serum RPR antibody", Jap J Clin Lab Assoc, 30, pp.257~262 (2005)
  3. Kawai K, "The possibility of assessing the stage of infection by using Sekisui’s automated TPLA and RPR", J Clin Lab Instrum Reag, 26, pp.301~304 (2003)
  4. Kume T., "The clinical utility of quantitation for anti-lipoidal antibody in serum using a latex agglutination immunoassay on an automatic analyzer", Jap J Clin Lab Assoc, 28, pp.254~255 (2003)
  5. Osato K, "Clinical evaluation of latex agglutination test kits for detecting anti-syphilitic lipoidal antibodies and anti-treponemal antibodies", Jap J Sex Transm Dis, 13, pp.124~130 (2002)
  6. 허희진, "자동화 매독검사인 Mediace Rapid Plasma Reagin과 Treponemapallidum Latex Agglutination 양성 결과 분석", Annals of Laboratory Medicine, 27(5), pp.324~329 (2007), 대한진단검사의학회
  7. Centers for Disease Control and Prevention, "Case definitions for infectious conditions under public health surveillance", MMWR Recomm Rep, 46(RR-10), pp.1~55 (1997)
  8. Wicher K, "Laboratory methods of diagnosis of syphilis for the beginning of the third millennium", Microbes Infect, 1, pp.1035~1049 (1999)
  9. National Committee for Clinical Laboratory Standards, "Preliminary evaluation of quantitative clinical laboratory methods; Approved guideline EP10-A", NCCLS, ~ (1998)
  10. National Committee for Clinical Laboratory Standards, "Evaluation of the linearity of quantitative measurement procedures; a statistical approach. Approved guideline EP6-A", NCCLS, ~ (2003)
  11. Centers for Disease Control and Prevention, "Sexually transmitted diseases treatment guidelines", MMWR Recomm Rep, 55(RR-11), pp.1~94 (2006)
  12. Screening Guidelines Steering Group, "Sexually Transmitted Infections: UK National Screening and Testing Guidelines", Screening Guidelines Steering Committee, ~ (2006)
  13. "European Guideline on the Management of Syphilis 2007" (2008)[URL]
  14. Larsen, SA, "Laboratory diagnosis and interpretation of tests for syphilis", Clin Microbiol Rev, 8, pp.1~21 (1995)

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