The EP documents established by Clinical and Laboratory Standards Institute (CLSI) were referred to evaluate the analytic performance. A total of 110 syphilitic positive and 78 syphilitic negative sera were detected by Mediace TPLA,and the results were compared with those of chemiluminescence microparticle immunoassay (CMIA).

The total coefficients of variation (CV) were 8.77%, 3.94% and 6.57% respectively at the concentration levels of 8.0, 28.6 and 166.0T.U.. The linear range was from 0 to 250 T.U., and the total recovery rate was 95.31%. The results were not significantly affected by hemolysis (hemoglobin<4.8 g/L), lipidemia (triglyceride<8 mmol/L), jaundice (bilirubin <20 μmol/L) and rheumatoid factor (<450 IU/mL). The results of 30 antinuclear antibody (ANA) positive patients, 10 hepatitis patients and 10 pregnant women were all negative. When the results of CMIA were defined as the reference standard,the sensitivity of Mediace TPLA was 99%, the specificity was 100%, and the cut-off value was 10 T.U..

Mediace TPLA has excellent anti-interference ability, repeatability, high accuracy, wide linear range and specificity. It can also be used in automated biochemical analyzers.