Abstract
Multiplex molecular panels are replacing conventional methods for the detection of sexually transmitted infections. In the current study, we evaluated the performance of two commercial multiplex assays, EUROArray STI and Allplex STI essential assays, for detecting six sexually transmitted infections. The diagnostic performance of the EUROArray STI and Allplex STI essential assays was evaluated against a panel of 105 positive DNA samples identified by in-house real-time PCR assays including Ureaplasma parvum, Ureaplasma urealyticum, Mycoplasma hominis, Trichomonas vaginalis, Chlamydia trachomatis, and Neisseria gonorrhea. Samples from healthy subjects, negative for any microorganism, were used as negative controls. Of the 105 positive specimens, 103 (98%) were tested positive by Allplex and 102 (97%) by EUROArray. Among the 51 negative samples that were tested by in house assay, 48 (94%) were tested negative by Allplex assay and 43 (84%) by EUROArray assay. The overall sensitivity of EUROArray and Allplex were 97.1% and 98.1% with an accuracy of 92.9% and 96.7%, respectively. The overall assay specificity was 94.1% for Allplex assay and 84.3% for EUROArray assay, The sensitivity of both kits to all targeted microorganisms ranged from 55.6% to 100%, with the lowest sensitivity noted for Trichomonas vaginalis. Diagnostic performance varies depending on the method used to detect the targeted pathogens, the assay manipulation, and the cost. This study showed sensitivity, specificity, and accuracy characteristics for two kits commonly used to detect STIs, which will guide the choice for an appropriate multiplex PCR platform.
Highlights
Multiplex molecular panels are replacing conventional methods for the detection of sexually transmitted infections
Sexually transmitted infections (STI) Commercial detection assays Two commercial assays were used for sensitivity/specificity analysis: the commercial multiplex real time PCR assay (Allplex STI essential assay, Seegene, Seoul, Korea) and the commercial fluorescence-based DNA microarray assay (EUROArray STI, EUROIMMUN, Lübeck, Germany)
The overall performance of the two assays was compared for their accuracy, sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) (Table 1)
Summary
Multiplex molecular panels are replacing conventional methods for the detection of sexually transmitted infections. We evaluated the performance of two commercial multiplex assays, EUROArray STI and Allplex STI essential assays, for detecting six sexually transmitted infections. Methodology: The diagnostic performance of the EUROArray STI and Allplex STI essential assays was evaluated against a panel of 105 positive DNA samples identified by in-house real-time PCR assays including Ureaplasma parvum, Ureaplasma urealyticum, Mycoplasma hominis, Trichomonas vaginalis, Chlamydia trachomatis, and Neisseria gonorrhea. The overall assay specificity was 94.1% for Allplex assay and 84.3% for EUROArray assay, The sensitivity of both kits to all targeted microorganisms ranged from 55.6% to 100%, with the lowest sensitivity noted for Trichomonas vaginalis. These techniques were replaced by nucleic acid amplification tests (NAAT) [19–24], which are currently recommended for screening and clinical diagnosis; they proved to be more sensitive and more specific than conventional assays
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