Xpert Ultra testing of blood in severe HIV-associated tuberculosis to detect and measure Mycobacterium tuberculosis blood stream infection: a diagnostic and disease biomarker cohort study

Xpert Ultra 检测严重 HIV 相关结核病患者的血液,以检测和测量结核分枝杆菌血流感染:一项诊断和疾病生物标志物队列研究

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作者:Linda Boloko, Charlotte Schutz, Nomfundo Sibiya, Avuyonke Balfour, Amy Ward, Muki Shey, Mark P Nicol, Rosie Burton, Robert J Wilkinson, Gary Maartens, Graeme Meintjes, David A Barr

Background

Mycobacterium tuberculosis bloodstream infection is a leading cause of death in people living with HIV and disseminated bacillary load might be a key driver of disease severity. We aimed to assess Xpert MTB/RIF Ultra (Xpert Ultra) testing of blood as a diagnostic for M tuberculosis bloodstream infection and investigate cycle threshold as a quantitative disease biomarker.

Methods

In this cohort study, we obtained biobanked blood samples from a large and well characterised cohort of adult patients admitted to hospital in Western Cape, South Africa with suspected HIV-associated tuberculosis and a CD4 count less than 350 cells per μL. Patients already receiving antituberculosis therapy were excluded. Samples were obtained on recruitment within 72 h of admission to hospital, and patients were followed up for 12 weeks to determine survival. We tested the biobanked blood samples using the Xpert Ultra platform after lysis and wash processing of the blood. We assessed diagnostic yield (proportion of cases detected, with unavailable test

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