Performance Evaluation of 'Dong-A Syphilis' EIA kit / 대한수혈학회지

ABSTRACT

BACKGROUND: 'Dong-A Syphilis' enzyme immunoassay(EIA) kit for detecting antibodies against T. pallidum was recently introduced. The performance of 'Dong-A Syphilis' in precision, sensitivity and specificity was evaluated to know the adequacy in substituting for VDRL as a primary screening test. METHODS: Intra and inter-run precision were evaluated by positive and negative controls and 4 other concentrations which were made by mixing positive controls with negative controls. Sensitivity and specificity were evaluated using 120 samples positive in both VDRL and FTA-ABS and using 487 samples negative in VDRL, respectively. Positive rates of EIA and VDRL among 342 persons who visited health promotion center in Asan Medical Center were compared. RESLUTS: Intra-run precision was between 2.2% and 5.5%, and inter-run precision between 9.9% and 15.6%. Sensitivity and specificity were 99.2% and 99.7%, respectively. EIA showed higher positive rate (5.8%) than VDRL (3.5%). 11 samples (3.2%) were reactive only in both EIA and FTA-ABS. CONCLUSION: The performance of 'Dong-A syphilis' EIA was so good in precision, sensitivity and specificty that the EIA kit could substitute for VDRL as a primary screening test for syphilis. EIA screening for syphilis would be more appropriate for a person to promote his own health in that it could detect untreated past infection.