[Evaluation of two methodologies for Chlamydia trachomatis detection in cervical samples of two clinics].

Objective

To compare the positive rates of Chlamydia trachomatis (CT) in gynecological clinic and reproductive medicine clinic by detecting cervical samples from two clinics with three assays of different methodologies. To determine the performances of enzyme assay and immunochromatography (ICA) assay compared to the real-time PCR assay.

Methods

Seven hundred and eleven samples of gynecological clinic from May 2014 to May 2015 and 711 samples of reproductive medicine clinic from June 2014 to April 2015 were collected in Henan Province People's Hospital. Three cervical swabs were collected from each participant. The three samples were eluted with saline water then mixed. The samples were detected with three methodologies respectively after dividing the mixture into three.

Results

The positive rates of CT in gynecological clinic and reproductive medicine clinic were 9.98% (71/711) and 4.22% (30/711) by real-time PCR assay, 10.83% (77/711) and 5.06% (36/711) by enzyme assay, 4.78% (34/711) and 2.11% (15/711) by ICA assay. The sensitivity and specificity were 85.1% (86/101) and 98.0% (1 294/1 321) by enzyme assay. The sensitivity of ICA assay was 45.5% (46/101) and specificity was 99.8% (1 318/1 321) compared to the real-time PCR assay.

Conclusion

The positive rate of CT in gynecological clinic was markedly higher than that in reproductive medicine clinic (P<0.05). The ICA assay, while exhibiting a high specificity, had unacceptably low sensitivity compared to real-time PCR assay. The enzyme assay had higher sensitivity but slightly worse specificity.