Evaluation of the microparticle enzyme immunoassay Abbott IMx Select Chlamydia and the importance of urethral site sampling to detect Chlamydia trachomatis in women.

Objective: To evaluate the commercial microparticle enzyme immunoassay (MEIA), Abbott IMx Select Chlamydia, for the detection of Chlamydia trachomatis in women and to compare its performance with endocervical cell culture. Also, to determine whether sampling the urethral site is an important part of chlamydial diagnosis in women.

Setting: The Auckland, Manukau, and Waitakere Sexual Health Clinics, Auckland, New Zealand and the Department of Clinical Microbiology, Auckland Hospital, Auckland, New Zealand.

Patients: The study population consisted of 622 consecutive women who attended the three sexual health clinics.

Methods: The IMx Chlamydia assay was performed on an IMx analyser, following a specimen treatment procedure. All reactive samples from the IMx Chlamydia assay were confirmed using the IMx Chlamydia blocking antibody reagent. The Syva direct fluorescent antibody (DFA) test was used to aid in resolving discrepancies. The cell culture technique was performed in shell vials using cycloheximide treated McCoy cells, which were stained using a fluorescein conjugated monoclonal antibody.

Results: When compared against the endocervical cell culture, the IMx Chlamydia had a sensitivity of 82.1% (23/28) and a specificity of 99.3% (590/594). When compared against an expanded gold standard, the IMx Chlamydia and endocervical cell culture had sensitivities of 84.4% (27/32) and 87.5% (28/32), specificities of 100% (590/590) and 100% (590/590), positive predictive values of 100% (27/27) and 100% (28/28), negative predictive values of 99.2% (590/595) and 99.3% (590/594), and accuracies of 99.2% (617/622) and 99.4% (618/622), respectively. The prevalence rate by endocervical cell culture and the expanded gold standard were 4.5% and 5.1%, respectively. Additional urethral cell culture testing revealed a further nine patients positive from this site only, giving a 28% (9/32) increase in the number of patients diagnosed for chlamydia, thus giving an overall prevalence of 6.6% (41/622).

Conclusions: The IMx Chlamydia assay is an easy and rapid test to perform, it is cost effective, and shows similar performance to endocervical cell culture in the female population studied and is thus an excellent alternative to culture for the diagnosis of C trachomatis. The study also showed the importance of urethral site sampling in these women, as endocervical testing alone will underestimate the prevalence of chlamydial genital infection.