Performance of the AnyplexTM CT/NG Real-time Detection for extra-genital Chlamydia trachomatis and Neisseria gonorrhoeae detection
DOI:
https://doi.org/10.14456/dcj.2022.67Keywords:
Chlamydia trachomatis, Neisseria gonorrhoeae, extra-genital, AnyplexTM CT/NG Real-time DetectionAbstract
trachomatis and N. gonorrhoeae are the two most common sexually transmitted infections. Although these pathogens can be treated with antibiotics, infection with C. trachomatis and N. gonorrhoeae is frequently asymptomatic. Therefore, it often goes undetected and is left untreated, representing an important health concern, especially when infection occurs in extra-genital sites. Culture method has remained the ‘gold standard’ for N. gonorrhoeae detection, while nucleic acid amplification tests have increasingly become a preferred method. Therefore, the objective of this study is to evaluate the performance of AnyplexTM CT/NG Real-time Detection in comparison with the routine methods for the detection of C. trachomatis and N. gonorrhoeae from extra-genital specimens. Thirty C. trachomatis positive and thirty C. trachomatis negative samples tested by in-house real time PCR and thirty N. gonorrhoeae positive and thirty N. gonorrhoeae negative samples tested by culture during January 2019 - January 2020 were selected. All 120 samples were amplified by AnyplexTM CT/NG Real-time Detection. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were analyzed. The sensitivity, specificity, PPV and NPV of AnyplexTM CT/NG Real-time Detection for C. trachomatis compared with in-house real time PCR was 100%, 93.33%, 93.75%, 100%, respectively. In the meantime, the performance of this kit for N. gonorrhoeae was 100% in all parameters, compared with culture and in-house real time PCR. Two discrepancy results for C. trachomatis detection were found, which were negative by in-house real time PCR, but positive by the commercial PCR kits. Furthermore, we also found six samples were reported as CT/NG co-infection by AnyplexTM CT/NG Real-time Detection. 3 of 6 samples were positive for N. gonorrhoeae from culture method. The AnyplexTM CT/NG Real-time Detection result was also positive for C. trachomatis, whereas the routine method result was negative. In addition, another 3 samples were positive for C. trachomatis by in-house real time PCR method. The AnyplexTM CT/NG Real-time Detection result was also positive for N. gonorrhoeae, whereas the routine method result was negative. C. trachomatis negative by in-house real time PCR, while another 3 samples were N. gonorrhoeae negative by culture. These results indicated that AnyplexTM CT/NG Real-time Detection has efficiency to detect pathogen’s DNA, although pathogen died, and has highly acceptable performance characteristics for the detection of C. trachomatis and N. gonorrhoeae in extra-genital specimens.
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