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WHO laboratory validation of Xpert((R)) CT/NG and Xpert((R)) TV on the GeneXpert system verifies high performances
Örebro University, School of Medical Sciences. Örebro University Hospital. WHO Collaborating Centre for Gonorrhoea and Other Sexually Transmitted Infections, National Reference Laboratory for Sexually Transmitted Infections, Department of Laboratory Medicine.
Clinical Laboratory Department, Ternopil Regional Clinical Dermatovenerologic Dispensary, Ternopil, Ukraine.
Örebro University, School of Medical Sciences. WHO Collaborating Centre for Gonorrhoea and Other Sexually Transmitted Infections, National Reference Laboratory for Sexually Transmitted Infections, Department of Laboratory Medicine.
Department of Reproductive Health and Research, World Health Organization (WHO), Geneva, Switzerland.
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2018 (English)In: Acta Pathologica, Microbiologica et Immunologica Scandinavica (APMIS), ISSN 0903-4641, E-ISSN 1600-0463, Vol. 126, no 12, p. 907-912Article in journal (Refereed) Published
Abstract [en]

Effective tests for diagnosis of sexually transmitted infections (STIs), used point of care to inform treatment and management decisions, are urgently needed. We evaluated the analytical sensitivity and specificity of the Xpert((R)) CT/NG and Xpert((R)) TV tests, examining 339 samples spiked with phenotypically and/or genetically diverse strains of Neisseria gonorrhoeae, Chlamydia trachomatis, and Trichomonas vaginalis, and other related species that may cross-react. The APTIMA Combo 2 test and APTIMA TV test were used as reference tests. The analytical sensitivity for all three agents in the Xpert((R)) CT/NG and Xpert((R)) TV tests was <= 10(2) genome equivalents/reaction. The analytical specificity of both tests was high. False-positive results were identified in the Xpert((R)) TV test when challenging with high concentrations of Trichomonas tenax, Trichomonas gallinae, Trichomonas stableri, and Trichomonas aotus. However, the clinical relevance of these cross-reactions can likely be neglected, because these species have not been identified in urogenital samples from humans. In conclusion, the analytical sensitivity and specificity of the user-friendly Xpert((R)) CT/NG and Xpert((R)) TV tests on the GeneXpert system were high. The results support the use of specimens from also extra-genital sites, for example, pharynx and rectum. However, appropriate clinical validations are additionally required.

Place, publisher, year, edition, pages
John Wiley & Sons, 2018. Vol. 126, no 12, p. 907-912
Keywords [en]
GeneXpert, Xpert((R)) CT/NG, Xpert((R)) TV, point of care, Neisseria gonorrhoeae, Chlamydia trachomatis, Trichomonas vaginalis
National Category
Immunology in the medical area Microbiology in the medical area
Identifiers
URN: urn:nbn:se:oru:diva-70362DOI: 10.1111/apm.12902ISI: 000450513700004PubMedID: 30456870Scopus ID: 2-s2.0-85056739969OAI: oai:DiVA.org:oru-70362DiVA, id: diva2:1266792
Note

Funding Agencies:

Department of Reproductive Health and Research, World Health Organization (WHO), Geneva, Switzerland  

Örebro County Council Research Committee, Örebro, Sweden  

Foundation for Medical Research at Örebro University Hospital, Örebro, Sweden  

Available from: 2018-11-29 Created: 2018-11-29 Last updated: 2018-11-29Bibliographically approved

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Jacobsson, SusanneGolparian, DanielUnemo, Magnus

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Immunology in the medical areaMicrobiology in the medical area

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