• Title/Summary/Keyword: Mediace RPR

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Comparison of RPR Card and Mediace RPR test by KFDA Guideline

  • Lee, Hae Soon
    • Korean Journal of Clinical Laboratory Science
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    • v.44 no.3
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    • pp.124-127
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    • 2012
  • Syphilis is an infectious and sexually transmitted chronic disease caused by Treponema pallidum. On the basis of clinical findings, the disease has been divided into a series of overlapping stages, which are used to help guide treatment and follow-up. Persons who have syphilis might seek treatment for signs or symptoms of primary infection, secondary infection and tertiary infection. Latent infections are detected by serologic testing. A presumptive diagnosis of syphilis is possible with the use of two types of serologic tests: nontreponemal tests and treponemal tests assay. The use of only one type of serologic test is insufficient for diagnosis, because each type of test has limitations, including the possibility of false-positive test results in persons without syphilis. KFDA published Koreans guideline of Sexually transmitted infections in 2011. Two hundred samples were tested by RPR card test and Mediace RPR test with simultaneously. The agreement between RPR card test and Mediace RPR test was 95%, the discrepant samples was 5%. The characteristics of 10 discrepant samples was RPR card Positive and Mediace RPR negative nine samples, RPR card negative and Mediace RPR positive one sample. The nine samples were confirmed as FTA-ABS by KFDA guideline of syphilis test algorism, all IgM test was Negative, all IgG test was reactive. So, these cases were past or latent syphilis. The one sample was false-positive reaction.

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Evaluation of Clinical Utility and Biologic False Positive (BFP) Rates in Automated Syphilis Test Kits for Syphilis Screening (자동화 매독검사 키트의 임상적 유용성 및 생물학적 위양성률의 평가)

  • Kim, Sung-Man;Lee, Jehoon
    • Korean Journal of Clinical Laboratory Science
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    • v.41 no.1
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    • pp.42-46
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    • 2009
  • Unlike most bacteria, Treponema pallidum subspecies cannot be readily isolated or sustained in cell culture for numerous generations. In korea, two non treponemal tests are currently considered as standard; the VDRL slide test and RPR card test. These tests are based on an antigen composed of an alcoholic solution containing measured amount of cardiolipin, cholesterol, and sufficient purified lecithin to produce reactivity. The nontreponemal reagin tests measure immunoglobulin M (IgM) and IgG to lipoidal material released from damaged host cells as well as to lipoprotein-like material and possibly by cardiolipin released from the treponemes. The object of the evaluation was to evaluate the performance of the Mediace RPR kit on the automated biochemistry analyzer system as a method for screen method of syphilis as well as to identify BFP possibility. For evaluation of routine screening test, a total 2,380 specimens tested by Mediace RPR from 28th Oct, 2007 to 22th Feb, 2008. For evaluation of BFP possiblility, we measured samples which have potential BFP reaction in Syphilis test such as ANA (anti-nuclear antibody) positive (135 samples), CRP (C-reactive protein) positive (100 samples), RF (Rheumatoid factor) positive (26 samples), and other potential BFP cases (17 samples) including total 278 samples. These samples were tested quantitative test Mediace RPR with Hitachi 7600 P module. For comparison with current manual test, VDRL slide test were performed. Of these 2380 specimens, 2350 were negative, 30 were positive, and one were positive with TPHA. Both methods agreed for 2356 (98.9%) samples. Of the 30 samples showed positive results over 1.0 R.U, 6 samples showed positive results with VDRL test. Of these 6 samples, 1 samples showed positive with TPHA test. The combination of the Automated Biochemistry analyzer and VDRL test for retest can be increase efficiency of syphilis screening test.

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