Comparison of an in-house real-time duplex PCR assay with commercial HOLOGIC® APTIMA assays for the detection of Neisseria gonorrhoeae and Chlamydia trachomatis in urine and extra-genital specimens

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dc.contributor.authorVenter, Johanna M E
dc.contributor.authorMahlangu, Precious M
dc.contributor.authorMüller, Etienne E
dc.contributor.authorLewis, David A
dc.contributor.authorRebe, Kevin
dc.contributor.authorStruthers, Helen
dc.contributor.authorMcIntyre, James
dc.contributor.authorKularatne, Ranmini S
dc.date.accessioned2019-01-28T07:52:12Z
dc.date.available2019-01-28T07:52:12Z
dc.date.issued2019-01-03
dc.date.updated2019-01-21T12:26:11Z
dc.description.abstractAbstract Background Extra-genital Neisseria gonorrhoeae and Chlamydia trachomatis infections are mostly asymptomatic, and important reservoir sites of infection as they often go undetected and may be more difficult to eradicate with recommended therapeutic regimens. Commercial nucleic acid amplification tests (NAATs) have not received regulatory approval for the detection of N. gonorrhoeae and C. trachomatis in extra-genital specimens. The HOLOGIC® APTIMA Combo2 assay for N. gonorrhoeae and C. trachomatis has performed well in evaluations using extra-genital specimens. Methods We assessed the performance of an in-house real-time duplex PCR assay for the detection of N. gonorrhoeae and C. trachomatis in urine and extra-genital specimens using the HOLOGIC® APTIMA assays as gold standard comparators. Urine, oropharyngeal and ano-rectal specimens were collected from each of 200 men-who-have-sex-with-men (MSM) between December 2011 and July 2012. Results For N. gonorrhoeae detection, the in-house PCR assay showed 98.5–100% correlation agreement with the APTIMA assays, depending on specimen type. Sensitivity for N. gonorrhoeae detection was 82.4% for ano-rectal specimens, 83.3% for oropharyngeal specimens, and 85.7% for urine; and specificity was 100% with all specimen types. The positive predictive value (PPV) for N. gonorrhoeae detection was 100% and the negative predictive value (NPV) varied with sample type, ranging from 98.5–99.5%. For C. trachomatis detection, correlation between the assays was 100% for all specimen types. The sensitivity, specificity, PPV and NPV of the in-house PCR assay was 100% for C. trachomatis detection, irrespective of specimen type. Conclusion The in-house duplex real-time PCR assay showed acceptable performance characteristics in comparison with the APTIMA® assays for the detection of extra-genital N. gonorrhoeae and C. trachomatis.
dc.identifier.apacitationVenter, J. M. E., Mahlangu, P. M., Müller, E. E., Lewis, D. A., Rebe, K., Struthers, H., ... Kularatne, R. S. (2019). Comparison of an in-house real-time duplex PCR assay with commercial HOLOGIC® APTIMA assays for the detection of Neisseria gonorrhoeae and Chlamydia trachomatis in urine and extra-genital specimens. <i>BMC Infectious Diseases</i>, http://hdl.handle.net/11427/29170en_ZA
dc.identifier.chicagocitationVenter, Johanna M E, Precious M Mahlangu, Etienne E Müller, David A Lewis, Kevin Rebe, Helen Struthers, James McIntyre, and Ranmini S Kularatne "Comparison of an in-house real-time duplex PCR assay with commercial HOLOGIC® APTIMA assays for the detection of Neisseria gonorrhoeae and Chlamydia trachomatis in urine and extra-genital specimens." <i>BMC Infectious Diseases</i> (2019) http://hdl.handle.net/11427/29170en_ZA
dc.identifier.citationVenter, J. M., Mahlangu, P. M., Müller, E. E., Lewis, D. A., Rebe, K., Struthers, H., ... & Kularatne, R. S. (2019). Comparison of an in-house real-time duplex PCR assay with commercial HOLOGIC® APTIMA assays for the detection of Neisseria gonorrhoeae and Chlamydia trachomatis in urine and extra-genital specimens. BMC infectious diseases, 19(1), 6.
dc.identifier.ris TY - Journal Article AU - Venter, Johanna M E AU - Mahlangu, Precious M AU - Müller, Etienne E AU - Lewis, David A AU - Rebe, Kevin AU - Struthers, Helen AU - McIntyre, James AU - Kularatne, Ranmini S AB - Abstract Background Extra-genital Neisseria gonorrhoeae and Chlamydia trachomatis infections are mostly asymptomatic, and important reservoir sites of infection as they often go undetected and may be more difficult to eradicate with recommended therapeutic regimens. Commercial nucleic acid amplification tests (NAATs) have not received regulatory approval for the detection of N. gonorrhoeae and C. trachomatis in extra-genital specimens. The HOLOGIC® APTIMA Combo2 assay for N. gonorrhoeae and C. trachomatis has performed well in evaluations using extra-genital specimens. Methods We assessed the performance of an in-house real-time duplex PCR assay for the detection of N. gonorrhoeae and C. trachomatis in urine and extra-genital specimens using the HOLOGIC® APTIMA assays as gold standard comparators. Urine, oropharyngeal and ano-rectal specimens were collected from each of 200 men-who-have-sex-with-men (MSM) between December 2011 and July 2012. Results For N. gonorrhoeae detection, the in-house PCR assay showed 98.5–100% correlation agreement with the APTIMA assays, depending on specimen type. Sensitivity for N. gonorrhoeae detection was 82.4% for ano-rectal specimens, 83.3% for oropharyngeal specimens, and 85.7% for urine; and specificity was 100% with all specimen types. The positive predictive value (PPV) for N. gonorrhoeae detection was 100% and the negative predictive value (NPV) varied with sample type, ranging from 98.5–99.5%. For C. trachomatis detection, correlation between the assays was 100% for all specimen types. The sensitivity, specificity, PPV and NPV of the in-house PCR assay was 100% for C. trachomatis detection, irrespective of specimen type. Conclusion The in-house duplex real-time PCR assay showed acceptable performance characteristics in comparison with the APTIMA® assays for the detection of extra-genital N. gonorrhoeae and C. trachomatis. DA - 2019-01-03 DB - OpenUCT DP - University of Cape Town J1 - BMC Infectious Diseases LK - https://open.uct.ac.za PY - 2019 T1 - Comparison of an in-house real-time duplex PCR assay with commercial HOLOGIC® APTIMA assays for the detection of Neisseria gonorrhoeae and Chlamydia trachomatis in urine and extra-genital specimens TI - Comparison of an in-house real-time duplex PCR assay with commercial HOLOGIC® APTIMA assays for the detection of Neisseria gonorrhoeae and Chlamydia trachomatis in urine and extra-genital specimens UR - http://hdl.handle.net/11427/29170 ER - en_ZA
dc.identifier.urihttps://doi.org/10.1186/s12879-018-3629-0
dc.identifier.urihttp://hdl.handle.net/11427/29170
dc.identifier.vancouvercitationVenter JME, Mahlangu PM, Müller EE, Lewis DA, Rebe K, Struthers H, et al. Comparison of an in-house real-time duplex PCR assay with commercial HOLOGIC® APTIMA assays for the detection of Neisseria gonorrhoeae and Chlamydia trachomatis in urine and extra-genital specimens. BMC Infectious Diseases. 2019; http://hdl.handle.net/11427/29170.en_ZA
dc.language.rfc3066en
dc.rights.holderThe Author(s).
dc.sourceBMC Infectious Diseases
dc.source.urihttps://bmcinfectdis.biomedcentral.com/
dc.titleComparison of an in-house real-time duplex PCR assay with commercial HOLOGIC® APTIMA assays for the detection of Neisseria gonorrhoeae and Chlamydia trachomatis in urine and extra-genital specimens
dc.typeJournal Article
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