Evaluation of automated large-scale screening tests for syphilis.

Two methods of performing serological screening tests for syphilis are compared. One consisted of the Venereal Diseases Reference Laboratory (VDRL) slide test, the cardiolipin Wassermann reaction (CWR), and the Reiter protein complement fixation test (RPCFT) performed manually; the other was a fully automated system using two Technicon AutoAnalyzers (AAII), one for the automated reagin test (ART) and the other for automated complement fixation tests. The absorbed fluorescent treponemal antibody test (FTA-ABS) was used as a final arbiter in all cases found to be seropositive by either method. A pooled antigen consisting of a mixture of cardiolipin and Reiter protein was used for the automated complement fixation test, thus increasing the scope and capacity of the system. The AutoAnalyzer was shown to be capable of performing 400 cardiolipin and Reiter complement fixation tests and 700 automated reagin tests in an 8-hour day. Modification of the complement fixation test method to take advantage of the highly sensitive colorimeter resulted in a significant increase in sensitivity and a corresponding saving in reagents. Of the 7843 sera tested, 258 gave a positive result in one or more of the screening tests. The automated test detected many more Reiter positive sera (127) than the manual test (83). Conversely, fewer CWR positive sera were detected by the automated test (60) than by the manual test (82). There was little difference between the number of positive sera detected by the ART (73) and the VDRL slide test (71). In 19 instances the automated tests detected positive sera which registered as completely negative in the manual tests, and four seropositive cases which the automated tests had failed to detect were detected by the manual tests, and four seropositive cases which the automated tests had failed to detect were detected by the manual tests. It was concluded that a combination of the ART and automated Reiter protein complement fixation test (ARPCFT) would be ideal for use in a large-scale screening programme for the detection of syphilis.