AUTHOR=Karuniawati Anis , Burhan Erlina , Koendhori Eko Budi , Sari Desvita , Haryanto Budi , Nuryastuti Titik , Gayatri A. A. A. Yuli , Bahrun Uleng , Kusumawati R. Lia , Sugiyono Retna Indah , Susanto Nugroho Harry , Diana Aly , Kosasih Herman , Naysilla Adhella Menur , Lokida Dewi , Neal Aaron , Siddiqui Sophia , Lau Chuen-Yen , Karyana Muhammad 

TITLE=Performance of Xpert MTB/RIF and sputum microscopy compared to sputum culture for diagnosis of tuberculosis in seven hospitals in Indonesia

JOURNAL=Frontiers in Medicine

VOLUME=9

YEAR=2023

URL=https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2022.909198

DOI=10.3389/fmed.2022.909198

ISSN=2296-858X

ABSTRACT=<sec><title>Introduction</title><p>Tuberculosis (TB) is a major public health concern in Indonesia, where the incidence was 301 cases per 100,000 inhabitants in 2020 and the prevalence of multi-drug resistant (MDR) TB is increasing. Diagnostic testing approaches vary across Indonesia due to resource limitations. Acid-fast bacilli (AFB) smear is widely used, though Xpert MTB/RIF has been the preferred assay for detecting TB and rifampicin resistance since 2012 due to higher sensitivity and ability to rapidly identify rifampicin resistance. However, &lt;1,000 Xpert instruments were available in Indonesia as of 2020 and the Xpert supply chain has suffered interruptions.</p></sec><sec><title>Methods</title><p>We compared the performance of Xpert MTB/RIF and AFB smear to facilitate optimization of TB case identification. We analyzed baseline data from a cohort study of adults with pulmonary TB conducted at seven hospitals across Indonesia. We evaluated sensitivity and specificity of AFB smear and Xpert MTB/RIF using <italic>Mycobacterium tuberculosis</italic> (Mtb) culture as the gold standard, factors associated with assay results, and consistency of Xpert MTB/RIF with drug susceptibility test (DST) in detecting rifampicin resistance.</p></sec><sec><title>Results</title><p>Sensitivity of AFB smear was significantly lower than Xpert MTB/RIF (86.2 vs. 97.4%, <italic>p</italic>-value &lt;0.001), but specificity was significantly better (86.7 vs. 73.3%, <italic>p</italic>-value &lt;0.001). Performance varied by hospital. Positivity rate for AFB smear and Mtb culture was higher in subjects with pulmonary cavities and in morning sputum samples. Consistency of Xpert MTB/RIF with DST was lower in those with rifampicin- sensitive TB by DST.</p></sec><sec><title>Discussion</title><p>Additional evaluation using sputa from primary and secondary Indonesian health centers will increase the generalizability of the assessment of AFB smear and Xpert MTB/RIF performance, and better inform health policy.</p></sec><sec><title>Clinical trial registration</title><p>[<ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/" xmlns:xlink="http://www.w3.org/1999/xlink">https://clinicaltrials.gov/</ext-link>], identifier [NCT027 58236].</p></sec>