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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
WHO laboratory validation of Xpert® CT/NG and Xpert® TV on the GeneXpert system verifies high performances
APMIS, Volume 126, No. 12, Year 2018
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Description
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® CT/NG and Xpert® 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® CT/NG and Xpert® TV tests was ≤102 genome equivalents/reaction. The analytical specificity of both tests was high. False-positive results were identified in the Xpert® 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® CT/NG and Xpert® 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. © 2018 APMIS. Published by John Wiley & Sons Ltd
Authors & Co-Authors
Jacobsson, Susanne
Sweden, Orebro
Örebro Universitet
Golparian, Daniel
Sweden, Orebro
Örebro Universitet
Blondeel, Karel
Switzerland, Geneva
Organisation Mondiale de la Santé
Kiarie, James Njogu
Switzerland, Geneva
Organisation Mondiale de la Santé
Toskin, Igor A.
Switzerland, Geneva
Organisation Mondiale de la Santé
Peeling, Rosanna Wai Wan
United Kingdom, London
London School of Hygiene & Tropical Medicine
Unemo, Magnus
Sweden, Orebro
Örebro Universitet
Statistics
Citations: 33
Authors: 7
Affiliations: 3
Identifiers
Doi:
10.1111/apm.12902
ISSN:
09034641
Research Areas
Sexual And Reproductive Health