Confirmation of the Syva MicroTrak enzyme immunoassay for chlamydia trachomatis by Syva Direct Fluorescent Antibody Test.

Colorado Department of Public Health and Environment, University of Colorado Health Sciences Center, Denver, USA.

BACKGROUND AND OBJECTIVES: The Syva Micro Trak enzyme immunoassay (EIA) is used widely for screening women infected with Chlamydia trachomatis. Confirmatory tests used in conjunction with EIA screening have shown that false-positive results are common. GOALS: To evaluate the specificity of the Syva MicroTrak EIA by confirmation of positive specimens with the Syva Direct Fluorescent Specimen Test. STUDY DESIGN: Of 6,039 endocervical specimens collected from women attending Colorado family planning clinics, 328 positive EIA results (5.4%) were obtained by Syva MicroTrak EIA. A random subset of 136 positive specimens was tested by Syva Direct Specimen Test. Twenty of 136 specimens (14.7%) negative by Syva Direct Specimen testing were also tested by Syva blocking antibody tests (9 of 20 positive, 45%) and Roche Amplicor polymerase chain reaction (PCR; 6 of 20 positive, 30%). Of 20 specimens positive by Syva MicroTrak EIA and negative by Syva Direct Specimen Test, 11 (55%) were also negative by blocking antibody and PCR, including three specimens with initial EIA sample-to-cutoff ratios greater than 2. CONCLUSIONS: Confirmatory testing of Syva MicroTrak EIA positive specimens with Syva Direct Specimen Test showed that 14.7% were false positive. Coupling the Syva Direct Specimen test with either blocking antibody or PCR reduces the rate of false-positive results to 8%.

PMID: 8946630 [PubMed - indexed for MEDLINE]