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*

OBJECTIVETo evaluate the accuracy and precision of 2 kinds of anti-treponema pallidum (anti-TP) ELISA reagents in our laboratory for detecting the anti-TP in voluntary blood donors, so as to provide the data support for use of ELISA reagents after introduction of chemiluminescene immunoassay (CLIA).

METHODSThe route detection of anti-TP was performed by using 2 kinds of ELISA reagents, then 546 responsive positive samples detected by anti-TP ELISA were collected, and the infections status of samples confirmed by treponema pallidum particle agglutination (TPPA) test was identified. The confirmed results of responsive samples detected by 2 kinds of anti-TP ELISA reagents were compared, the accuracy of 2 kinds of anti-TP ELISA reagents was analyzed by drawing ROC and comparing area under curve (AUC), and precision of 2 kinds of anti-TP ELISA reagents was compared by statistical analysis of quality control data from 7.1 2016 to 6.30 2017.

RESULTSThere were no statistical difference in confirmed positive rate of responsive samples and weak positive samples between 2 kinds of anti-TP ELISA reagents. The responsive samples detected by 2 kinds of anti-TP ELISA reagents accounted for 85.53%(467/546) of all responsive samples, the positive rate confirmed by TPPA test was 82.87%. 44 responsive samples detected by anti-TP ELISA reagent A and 35 responsive samples detected by anti-TP ELISA reagent B were confirmed to be negative by TPPA test. Comparison of AUC showed that the accuracy of 2 kinds of anti-TP ELISA reagents was more high, the difference between 2 reagents was not statistically significant. The coefficient of variation (CV) of anti-TP ELISA reagent A and B was 14.98% and 18.04% respectively, which met the precision requirement of ELISA test.

CONCLUSIONThe accuracy and precision of 2 kinds of anti-TP ELISA reagents used in our laboratory are similar, and using any one of anti-TP ELISA reagents all can satisfy the requirements of blood screening.

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

There are many serologic tests for syphilis. By means of the usual serologic tests, it is not possible to differentiate between patients who need therapy and those who are cured. In this paper I want to discuss the scientific developments and demonstrate the results of immunologic research in syphilis, which makes it possible to differentiate between treated and untreated cases.
Antibodies, Bacterial/analysis ; Chromatography, Gel ; Electrophoresis, Starch Gel ; Fluorescent Antibody Technique ; Hemagglutination Tests ; Human ; Immunoglobulin G/analysis ; Immunoglobulin M/analysis ; Syphilis/immunology* ; Syphilis Serodiagnosis* ; Treponema pallidum/immunology