WHO laboratory validation of Xpert((R)) CT/NG and Xpert((R)) TV on the GeneXpert system verifies high performances

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Jacobsson, Susanne,1974-Örebro universitet,Institutionen för medicinska vetenskaper,Region Örebro län,WHO Collaborating Centre for Gonorrhoea and Other Sexually Transmitted Infections, National Reference Laboratory for Sexually Transmitted Infections, Department of Laboratory Medicine (author)

WHO laboratory validation of Xpert((R)) CT/NG and Xpert((R)) TV on the GeneXpert system verifies high performances

Article/chapterEnglish2018

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2018-11-19
John Wiley & Sons,2018
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LIBRIS-ID:oai:DiVA.org:oru-70362
https://urn.kb.se/resolve?urn=urn:nbn:se:oru:diva-70362URI
https://doi.org/10.1111/apm.12902DOI

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Language:English
Summary in:English

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Subject category:ref swepub-contenttype
Subject category:art swepub-publicationtype

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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
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.

Subject headings and genre

MEDICIN OCH HÄLSOVETENSKAP Medicinska och farmaceutiska grundvetenskaper Immunologi inom det medicinska området hsv//swe
MEDICAL AND HEALTH SCIENCES Basic Medicine Immunology in the medical area hsv//eng
MEDICIN OCH HÄLSOVETENSKAP Medicinska och farmaceutiska grundvetenskaper Mikrobiologi inom det medicinska området hsv//swe
MEDICAL AND HEALTH SCIENCES Basic Medicine Microbiology in the medical area hsv//eng
GeneXpert
Xpert((R)) CT/NG
Xpert((R)) TV
point of care
Neisseria gonorrhoeae
Chlamydia trachomatis
Trichomonas vaginalis

Added entries (persons, corporate bodies, meetings, titles ...)

Boiko, IrynaClinical Laboratory Department, Ternopil Regional Clinical Dermatovenerologic Dispensary, Ternopil, Ukraine (author)
Golparian, Daniel,1984-Örebro universitet,Institutionen för medicinska vetenskaper,WHO Collaborating Centre for Gonorrhoea and Other Sexually Transmitted Infections, National Reference Laboratory for Sexually Transmitted Infections, Department of Laboratory Medicine(Swepub:oru)degn (author)
Blondeel, KarelDepartment of Reproductive Health and Research, World Health Organization (WHO), Geneva, Switzerland (author)
Kiarie, JamesDepartment of Reproductive Health and Research, World Health Organization (WHO), Geneva, Switzerland (author)
Toskin, IgorDepartment of Reproductive Health and Research, World Health Organization (WHO), Geneva, Switzerland (author)
Peeling, Rosanna W.London School of Hygiene and Tropical Medicine (LSHTM), London, UK (author)
Unemo, Magnus,1970-Örebro universitet,Institutionen för medicinska vetenskaper,Region Örebro län,WHO Collaborating Centre for Gonorrhoea and Other Sexually Transmitted Infections, National Reference Laboratory for Sexually Transmitted Infections, Department of Laboratory Medicine(Swepub:oru)muo (author)
Örebro universitetInstitutionen för medicinska vetenskaper (creator_code:org_t)

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In:Acta Pathologica, Microbiologica et Immunologica Scandinavica (APMIS): John Wiley & Sons126:12, s. 907-9120903-46411600-0463

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