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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: Södersten, Erik (VerfasserIn) , Ongarello, Stefano (VerfasserIn) , Mantsoki, Anna (VerfasserIn) , Wyss, Romain (VerfasserIn) , Persing, David H. (VerfasserIn) , Banderby, Sara (VerfasserIn) , Meuzelaar, Linda Strömqvist (VerfasserIn) , Prieto, Jacqueline (VerfasserIn) , Gnanashanmugam, Devasena (VerfasserIn) , Khatri, Purvesh (VerfasserIn) , Schumacher, Samuel G. (VerfasserIn) , Denkinger, Claudia M. (VerfasserIn)
Dokumenttyp: Article (Journal)
Sprache:Englisch
Veröffentlicht: 18 February 2021
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
Volltext
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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Zusammenfassung: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.
Beschreibung:Gesehen am 01.04.2021
Beschreibung:Online Resource
ISSN:1098-660X
DOI:10.1128/JCM.01643-20

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