Diagnostic accuracy study of a novel blood-based assay for identification of tuberculosis in people living with HIV
A nonsputum triage test to rule out tuberculosis (TB) disease is a WHO high-priority diagnostic, and a combinatory score based on a 3-gene host signature has shown promise in discriminating TB from other illnesses. We evaluated the accuracy of an early-prototype cartridge assay (“Xpert MTB Host Resp...
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| Hauptverfasser: | , , , , , , , , , , , |
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| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
18 February 2021
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| In: |
Journal of clinical microbiology
Year: 2021, Jahrgang: 59, Heft: 3, Pages: 1-11 |
| ISSN: | 1098-660X |
| DOI: | 10.1128/JCM.01643-20 |
| Online-Zugang: | Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1128/JCM.01643-20 Verlag, lizenzpflichtig, Volltext: https://jcm.asm.org/content/59/3/e01643-20 
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| Verfasserangaben: | Erik Södersten, Stefano Ongarello, Anna Mantsoki, Romain Wyss, David H. Persing, Sara Banderby, Linda Strömqvist Meuzelaar, Jacqueline Prieto, Devasena Gnanashanmugam, Purvesh Khatri, Samuel G. Schumacher, Claudia M. Denkinger |
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| 245 | 1 | 0 | |a Diagnostic accuracy study of a novel blood-based assay for identification of tuberculosis in people living with HIV |c Erik Södersten, Stefano Ongarello, Anna Mantsoki, Romain Wyss, David H. Persing, Sara Banderby, Linda Strömqvist Meuzelaar, Jacqueline Prieto, Devasena Gnanashanmugam, Purvesh Khatri, Samuel G. Schumacher, Claudia M. Denkinger |
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| 520 | |a A nonsputum triage test to rule out tuberculosis (TB) disease is a WHO high-priority diagnostic, and a combinatory score based on a 3-gene host signature has shown promise in discriminating TB from other illnesses. We evaluated the accuracy of an early-prototype cartridge assay (“Xpert MTB Host Response” or Xpert-MTB-HR-Prototype) of this 3-gene signature on biobanked blood samples from people living with HIV (PLHIV) against a comprehensive microbiological reference standard (CMRS) and against Xpert MTB/RIF on the first sputum sample alone. We depict results based on performance targets set by the WHO in comparison with a laboratory-based C-reactive protein (CRP) assay. Of 201 patients included, 67 were culture positive for Mycobacterium tuberculosis. The areas under the concentration-time curve (AUCs) for Xpert-MTB-HR-Prototype were 0.89 (confidence interval [CI], 0.83 to 0.94) against the CMRS and 0.94 (CI, 0.89 to 0.98) against Xpert MTB/RIF. Considering Xpert-MTB-HR-Prototype as a triage test (at the nearest upper value of sensitivity to 90%), specificities were 55.8% (CI, 47.2 to 64.1%) compared to the CMRS and 85.9% (CI, 79.3 to 90.7%) compared to Xpert MTB/RIF as confirmatory tests. Considering Xpert-MTB-HR-Prototype as a stand-alone diagnostic test, at a specificity near 95%, the test achieved a sensitivity of 65.7% (CI, 53.7 to 75.9%), while the CRP assay achieved a sensitivity of only 13.6% (CI, 7.3 to 23.4%). In this first accuracy study of a prototype blood-based host marker assay, we show the possible value of the assay for triage and diagnosis in PLHIV. | ||
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| 700 | 1 | |a Mantsoki, Anna |e VerfasserIn |4 aut | |
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