Interlaboratory comparison of the toluidine red unheated serum test antigen preparation

The toluidine red unheated serum test (TRUST) antigen, a macroscopic flocculation test antigen developed by Pettit et al. (J. Clin. Microbiol. 18:1141-1145, 1983) by modifying the color-coded antigen of Kasatiya and Lambert (Appl. Microbiol. 28:317-318, 1974), was compared with the Venereal Disease Research Laboratory (VDRL) slide and rapid plasma reagin (RPR) 18-mm circle card tests for sensitivity, specificity, and reproducibility. Two lots of TRUST antigen were prepared by two laboratories in the Centers for Disease Control. Both laboratories performed the TRUST and VDRL slide test on serum samples from 1,102 patients attending the DeKalb County, Georgia, Sexually Transmitted Disease Clinic. In addition, one laboratory performed the RPR card test. Reactive sera were quantitated in the three nontreponemal tests and confirmed with the fluorescent treponemal antibody absorption test. The sensitivity in untreated syphilis for all nontreponemal tests involved was 98.4%. The specificity for these tests was 98.6%. The qualitative reproducibility among the four lots of TRUST antigen, VDRL slide, and RPR card tests was 98.2%. Only 20 sera showed discrepant results. Intralaboratory reproducibility of the two TRUST antigens was 100% for one laboratory and 99.6% for the other. Interlaboratory reproducibility for the four lots of TRUST and the VDRL slide test was 99%. Quantitative agreement +/- 1 dilution between the TRUST and RPR card test was 92.3%, and quantitative agreement +/- 1 dilution for the TRUST and RPR card test versus the VDRL slide test averaged 50%. The TRUST appeared to be comparable to the RPR card test in all parameters compared.