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.