Correlation of Treponemal Chemiluminescent Microparticle Immunoassay Screening Test Signal Strength Values With Reactivity of Confirmatory Testing.

Abstract

Automated chemiluminescent microparticle immunoassays (CMIAs) are the most common first step at high-volume laboratories for syphilis screening. If the initial screening test is reactive, 1 more treponemal test is required, resulting in increased cost. In this multicenter study, we aimed to determine the correlation between the CMIA signal-to-cutoff ratio (S/Co) and the confirmatory tests to reduce unnecessary confirmatory testing. Eight hospitals from 5 provinces participated in this study. All laboratories used Architect Syphilis TP CMIA (Abbott Diagnostics, Abbott Park, IL) for initial screening. Treponema pallidum hemagglutination (TPHA), rapid plasma reagin (RPR), and fluorescent treponemal antibody absorption (FTA-ABS) were used as confirmatory tests according to the reverse or European Centre for Disease Prevention and Control algorithms. A receiver operating characteristic analysis was used to determine the optimal S/Co ratio to predict the confirmation results. We evaluated 129,346 serum samples screened by CMIA between January 2018 and December 2020. A total of 2468 samples were reactive; 2247 (91%) of them were confirmed to be positive and 221 (9%) were negative. Of the 2468 reactive specimens, 1747 (70.8%) had an S/Co ratio ≥10.4. When the S/Co ratios were ≥7.2 and ≥10.4, the specificity values were determined to be 95% and 100%, respectively. In a subgroup of 75 CMIA-positive patients, FTA-ABS was performed and 62 were positive. Among these FTA-ABS-positive patients, 24 had an S/Co ratio <10.4, and negative TPHA and RPR. We propose a potentially cost-effective reverse screening algorithm with a treponemal CMIA S/Co ratio ≥10.4, obviating the need for secondary treponemal testing in about 71% of the screening-reactive samples. This would substantially reduce the confirmatory testing volume and laboratory expenses. However, in high-risk group patients with CMIA positive results, S/Co ratio <10.4, and negative TPHA and RPR, FTA-ABS may be used for confirmation.