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Clinical and analytical evaluation of the APTIMA Mycoplasma genitalium assay on the Panther instrument (HOLOGIC)
Örebro University, School of Health Sciences.
2017 (English)Independent thesis Advanced level (degree of Master (Two Years)), 20 credits / 30 HE creditsStudent thesis
Abstract [en]

Objectives Mycoplasma genitalium (MG) is a frequent etiology of urethritis and cervicitis, which can result in severe reproductive complications. Resistance in MG to first-line (azithromycin) and second-line (moxifloxacin) treatment has rapidly increased. Our aims were to examine the sensitivity and specificity of the new CE/IVD APTIMA MG assay (Hologic) and a research-use-only (RUO) APTIMA MG assay; and the prevalence of MG, C. trachomatis and N. gonorrhoeae; in Denmark, Norway and Sweden in 2016.

Methods From February 2016 to February 2017, urogenital specimens and extra-genital specimens (only in Denmark) from consecutive attendees at three STD clinics in Denmark, Norway and Sweden, were tested with the new CE/IVD APTIMA MG assay, RUO APTIMA MG assay, APTIMA CT/NG assay, and an in house TaqMan real-time mgpB qPCR. For analytical evaluation, genome-sequenced MG and other mycoplasma species in different concentration were tested.

Results In total, 5269 evaluable patients were included. The rate of MG infected patients was 7.2% (4.9-9.8% in the different countries). The sensitivity of the CE/IVD APTIMA MG assay, RUO APTIMA MG assay and mgpB qPCR ranged between 99.1-100%, 99.1-100%, and 73.2-81.6%, respectively, in the countries. The specificity of the CE/IVD APTIMA MG assay, RUO APTIMA MG assay and mgpB qPCR ranged between 99.6-99.96%, 100%, and 99.7-100%, respectively.

Conclusions Both the APTIMA MG assays had a superior sensitivity compared to the mgpB qPCR. The prevalence of MG was high and increased testing using validated and quality assured molecular tests for MG is crucial.

Place, publisher, year, edition, pages
2017.
National Category
Biomedical Laboratory Science/Technology
Identifiers
URN: urn:nbn:se:oru:diva-58602OAI: oai:DiVA.org:oru-58602DiVA: diva2:1120830
Subject / course
Biomedicinsk laboratorievetenskap
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Examiners
Available from: 2017-07-07 Created: 2017-07-07 Last updated: 2017-10-18Bibliographically approved

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CiteExportLink to record
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Citation style
  • apa
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