BACKGROUND: Current status of external quality assessment (EQA) of laboratory tests for syphilis in Korea was analyzed to find out the problems that should be improved in the future. METHODS: Based on the data from the external quality assessment program performed twice a year by the Immunoserology Subcommittee of the Korean Association of Quality Assurance for Clinical Laboratory from the year 2004 to 2006, discordance rates were analyzed according to the test method and commercial kit used. RESULTS: Among the laboratories participating in the EQA program for syphilis test, about 90% of them used non-treponemal tests and about 55% treponemal tests. The non-treponemal tests included RPR (rapid plasma reagin) and VDRL tests used in 88% (363/412) and 11% (45/412), respectively, of the laboratories. The discordance rates were 2.2% for RPR test and 3.6% for VDRL. For the treponemal tests, Treponema pallidum hemagglutination assay (TPHA) was used in 60-76% and Immunochromatography assay (ICA) in about 30% of the laboratories in 2006. A high discordance rate of over 10% was reported in both TPHA and in ICA methods, possibly due to a low titer (1:1 in VDRL) of EQA samples in 2005. Analysis of the accumulated data from year 2004 to 2006 showed that the discordance rates of TPHA, ICA, and FTA-ABS were 4.6%, 3.7%, and 2.7%, respectively. CONCLUSIONS: For syphilis tests, RPR test, TPHA, and ICA are mainly used in Korea. A high discordance rate is still reported in TPHA and ICA, especially when testing samples with a low titer. Further analysis of data and education of laboratory personnel are needed for the improvement of the EQA program.
Enzyme-Linked Immunosorbent Assay ; False Positive Reactions ; Fluorescent Treponemal Antibody-Absorption Test ; Humans ; Korea ; Quality Control ; Reagent Kits, Diagnostic ; Syphilis/*diagnosis ; Syphilis Serodiagnosis/methods/*standards ; Treponema Immobilization Test

BACKGROUND: Automated analyzer-based nontreponemal serological tests for syphilis (STS) have been used for several decades. OBJECTIVE: In this study, we evaluated serological responses to treatment and proposed clinical guidelines for automated STS. METHODS: This retrospective cohort study analyzed human immunodeficiency virus-negative syphilis patients who were diagnosed with automated rapid plasma reagin (auto RPR) tests as a nontreponemal STS, and who also received the fluorescent treponemal antibody-absorption test as a confirmatory test. The ratio of auto RPR values after treatment against those at baseline was defined as the auto RPR ratio for the analysis of the serological response to treatment. The cutoff value for reliable seroreversion prediction was assessed with receiver-operating-characteristic curves. RESULTS: Overall, 89.7% of participants (78/87) seroreverted and 10.3% of participants (9/87) remained serofast during the two-year follow-up period. We were unable to describe trends in the changes among auto RPR values within six months after treatment because of high variation. All of the patients who had an auto RPR ratio ≥1.0 after six months continuously had positive serologic results during their 24-month follow-up and were classified as a serofast group. The receiver-operating-characteristic curves revealed a 25% reduction in auto RPR values nine months after treatment and predicted seroreversion with a sensitivity of 96.2% and a specificity of 100%. CONCLUSION: The most important primary checkpoint for syphilis treatment response is an increase in automated nontreponemal STS six months after treatment. Thus, we recommend monitoring the treatment response with an auto RPR.
Cohort Studies ; Fluorescent Treponemal Antibody-Absorption Test ; Follow-Up Studies ; Humans* ; Plasma ; Retrospective Studies ; Sensitivity and Specificity ; Serologic Tests* ; Sexually Transmitted Diseases ; Syphilis Serodiagnosis ; Syphilis* ; Treponema pallidum

BACKGROUND: The aim of the study was to establish a new syphilis test algorithm using Architect Syphilis TP (Abbott Japan, Japan: AST), a fully automated treponemal antibody test, as a screening test in a university hospital laboratory. We evaluated performance characteristics of AST in various patient groups. METHODS: A total of 1,357 serum samples obtained from patients at a university hospital from June to August, 2008 were categorized into checkup, preoperative, other diseases, diagnosis (clinically suspected of syphilis), and follow up groups. We compared the results of AST with those of RPR (N=1,276) or Treponema pallidum hemagglutination assay (TPHA, N=81). Samples with discrepant results between RPR or TPHA and AST were retested by fluorescent treponemal antibody absorption test (FTA-ABS) and all patients' clinical records were thoroughly reviewed. RESULTS: The positive rate of AST was significantly higher than that of RPR in preoperative and other diseases groups and was the same as that of RPR in diagnosis group. There were no significant differences in check up and follow up groups. The results of AST showed 97.4% (1,243/1,276) and 97.5% (79/81) concordance rates with those of RPR and TPHA, respectively. Among 26 RPR-AST discrepant and FTA-ABS confirmed cases, there were 20 RPR false-negatives, 4 RPR false-positives, 1 AST false-negative, and 1 AST false-positive. CONCLUSIONS: Based on the results and literature review, we established a new syphilis test algorithm using AST as a screening test, which would be helpful for detection of more syphilis patients including latent infections.
Adolescent ; Adult ; Aged ; Aged, 80 and over ; Algorithms ; Autoanalysis ; Child ; Child, Preschool ; False Positive Reactions ; Female ; Fluorescent Treponemal Antibody-Absorption Test/methods ; Hemagglutination Tests/methods ; Humans ; Male ; Middle Aged ; Reagent Kits, Diagnostic ; Sensitivity and Specificity ; Syphilis/*diagnosis ; Syphilis Serodiagnosis/*methods

Humans ; Infant, Newborn ; Syphilis Serodiagnosis ; Syphilis, Congenital ; diagnosis

No abstract available.
Human ; Korea ; Quality Control ; Syphilis Serodiagnosis/*methods/standards

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.
Autoanalysis/methods ; False Positive Reactions ; Humans ; ROC Curve ; Sensitivity and Specificity ; Syphilis/*diagnosis ; Syphilis Serodiagnosis/*methods

OBJECTIVE: To Establish the shielding threshold value of TP antibody ELISA for unpaid blood donors, so as to shield true positive blood donors from returning to team management. METHODS: The real serological status of 517 samples with anti-TP ELISA reactivity was determined by confirmation test of Treponema pallidum particle agglutination (TPPA). The shielding threshold of TP antibody was preliminarily determined by using 99% specificity of ROC and 95% positive predictive value of percentile method, respectively. 283 TP antibody reactivity specimens routinely tested in our laboratory were selected to determine the applicability of the initial shielding values obtained by the two methods, and finally to determine the shielding threshold values of TP antibody donors. RESULTS: The specific S/CO values of reagent A 99% were 13.33-16.18, that of reagent B 99% was 6.34, that of reagent B 99% was 13.17-19.85, and that of 95% was 6.62. Empirical evidence: 99% specific threshold shielding true positive rates of reagents A and B were 100%, 95% positive expected value shielding true positive rates were 98.4%, 99%. Final determination of 99% specific shielding threshold as a low value of blood donors shielding threshold. The shielding limits of reagent A and B were 13.33 and 13.17. CONCLUSION The shielding threshold of TP antibody ELISA for blood donors established in this study can help to reduce the number of blood donors returning to team management.
Blood Donors ; Enzyme-Linked Immunosorbent Assay ; Humans ; Syphilis ; Syphilis Serodiagnosis ; Treponema pallidum

BACKGROUND: We compared two automated Rapid Plasma Reagin (RPR) assay kits with a manual RPR assay kit to evaluate the possibility of using the two automated RPR assays as an alternative to the manual RPR assay for a quantitative monitoring. METHODS: One hundred eighty-five samples were analyzed, including 16 sera from patients with primary, secondary, and latent syphilis. Measured RPR unit (R.U.) values of two automated RPR assay kits, Mediace RPR (Sekisui Chemical Co., Ltd, Japan) and HBi Auto RPR (HBI Co., Ltd, Korea), were compared with the RPR titers of Macro-Vue RPR card test (Becton Dickinson BD Microbiology systems, USA). As a confirmatory test, Anti-Treponema pallidum EUROLINE WB (IgG) and Anti-Treponema pallidum EUROLINE WB (IgM) (Euroimmun, Germany) were used. RESULTS: There was a prozone effect with Mediace RPR at RPR titer (card test) of 1:16, but not with HBi Auto RPR. The R.U. values of the two automated RPR assays did not show proportional increase to the RPR titer. Agreement between manual RPR and two automated RPR assay kits, Mediace RPR assay and HBi Auto RPR assay, were 83.8% and 83.2%, respectively. CONCLUSIONS: The two automated RPR assay kits could not be used as an alternative to manual RPR test for quantitative analysis of RPR titer. As Mediace RPR shows a prozone effect at relatively low RPR titer, caution is needed in the interpretation of the measured values.
Automation ; Female ; Humans ; Male ; Reagent Kits, Diagnostic ; Reagins/*blood ; Sensitivity and Specificity ; Syphilis/*diagnosis ; Syphilis Serodiagnosis/*methods ; Treponema pallidum

BACKGROUND: We analyzed the positive rates of Mediace Rapid Plasma Reagin (RPR) (Sekisui, Japan) and Mediace Treponema pallidum Latex Agglutination (TPLA) (Sekisui) assays. Positive results were compared to those of immunochromatography assay (ICA) and fluorescent treponemal antibody absorption (FTA-ABS) tests. METHODS: We used samples of patients visited at a university hospital from April 2010 to May 2011. The rates of positive results were calculated with 36,343 RPR results and 5,934 TPLA results. In addition, 237 positive samples with Mediace RPR or TPLA were re-tested with ICA and FTA-ABS. Mediace RPR and TPLA tests were performed with Toshiba 200-FR Neo (Toshiba, Japan). RESULTS: The rates of positive results were 0.47% (169/36,343) and 3.52% (209/5,934) with RPR and TPLA, respectively. Among the 237 sera that tested positive with RPR or TPLA, 76 were RPR(+)/TPLA(+), 28 were RPR(+)/TPLA(-), and 133 were RPR(-)/TPLA(+). When compared to the ICA results, 86.84% (66/76) of the RPR(+)/TPLA(+) sera were ICA(+), 3.57% (1/28) of the RPR(+)/TPLA(-) sera were ICA(+), and 54.89% (73/133) of the RPR(-)/TPLA(+) sera were ICA(+). Only 67.11% of the TPLA(+) sera demonstrated positive FTA-ABS results. However, 100% of the TPLA(-) sera yielded negative FTA-ABS results. ICA and FTA-ABS had a 96.59% positive agreement rate and an 80.68% negative agreement rate. CONCLUSIONS: These results demonstrate that Mediace TPLA has a low positive agreement rate with FTA-ABS. Although Mediace RPR and TPLA have advantages associated with automated methods, positive results should be confirmed with other treponemal tests, due to the high false positive rates.
Absorption ; Agglutination ; Humans ; Immunochromatography ; Latex ; Plasma ; Syphilis Serodiagnosis ; Treponema ; Treponema pallidum

During the period from January to December 1976, 12,489 VDRL (Venereal Disease Research Laboratory) and 2,965 FTA-ABS (Fluorescent Treponemal Antibody Absorption) tests were made. The reactive VDRL tests represented 3.6% of the total tested and the reactive rate of the FTA-ABS was 17.4%. The reactive VDRL and FTA-ABS tests represented 422 patients with clinically known diseases. The purpose of this study was to correlate the serologic findings with clinical problems. We divided the patients into three groups: 1. those with clinically diagnosed syphilis, 2. those with a history or physical findings compatible with syphilis, 3. those with no clinical evidence of syphilis. In groups 1 and 2, which represented 27% and 36.7%, respectively, a close correlation occurred between the two tests, both being reactive in 93-98% of the patients. However the VDRL was more informative than the FTA-ABS in determining clinical stages. In group 3, representing 36.3% of the reactive tests, the agreement between the two tests dropped to 77%; the FTA-ABS test was reactive in an additional 32 cases, 21% more than the VDRL. These discrepancies may well be due to the greater sensitivity of the FTA-ABS test in very early or late syphilis when there are no clinically recognizable manifestations. However the possibility of false positive FTA-ABS reactions could not be ruled out.
Adult ; Comparative Study ; Evaluation Studies ; Female ; Fluorescent Antibody Technique* ; Human ; Korea ; Male ; Middle Age ; Syphilis Serodiagnosis*