Diagnostic accuracy of the NOVA Tuberculosis Total Antibody Rapid test for detection of pulmonary tuberculosis and infection with Mycobacterium tuberculosis.
Diagnostic accuracy of the NOVA Tuberculosis Total Antibody Rapid test for detection of pulmonary tuberculosis and infection with Mycobacterium tuberculosis.
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NOVA 结核总抗体快速检测检测肺结核和结核分枝杆菌感染的诊断准确性。
DOI：
10.1016/j.jctube.2023.100362
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发表时间：
2023
影响因子：
2
通讯作者：
Nakiyingi,Lydia
中科院分区：
文献类型：
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作者：
Nsubuga,Gideon;Kennedy,Samuel;Rani,Yasha;Hafiz,Zibran;Kim,Soyeon;Ruhwald,Morten;Alland,David;Ellner,Jerrold;Joloba,Moses;Dorman,SusanE;Penn-Nicholson,Adam;Nakiyingi,Lydia
背景NOVA结核病总抗体快速检测试剂盒是一种市售的侧流血清学检测试剂盒，旨在用于辅助诊断结核病。我们进行了一项研究，以评估该检测方法诊断活动性肺结核病和检测M。MethodsThis study used existing frozen plasma samples that had been obtained previously from consenting HIV negative adults in Cambodia，South Africa，and Vietnam whose tuberculosis status was rigorously characterized using sputum mycobacterium culture and blood interferon gamma release assay.由经过专门培训的实验室工作人员在单个实验室中进行研究性试验，以根据生产商的程序进行试验。此外，测试带的强度进行了主观assessed.ResultsPlasma标本从150名参与者进行了测试。所有测试尝试均产生阳性或阴性的确定结果。对于活动性肺结核病的诊断，试验的敏感性和特异性分别为40.0%（20/50，95%置信区间[CI] 27.6%至53.8%）和85.0%（95% CI 76.7%至90.7%）。用于M.结核感染的敏感性和特异性分别为28.0%（95%CI 20.5%~ 37.2%）和86.0%（95%CI 73.8%~ 93.0%）。在35个阳性测试中，没有统计学显著的带强度趋势被发现跨参与者组（p = 0.17）。ConclusionStudy结果不支持NOVA结核病测试在当前结核病诊断算法中的作用。
BackgroundThe NOVA Tuberculosis Total Antibody Rapid Test is a commercially available lateral flow serological assay that is intended to be used as an aid in the diagnosis of tuberculosis. We conducted a study to estimate diagnostic accuracy of this assay for diagnosis of active pulmonary tuberculosis disease and for detection ofM. tuberculosisinfection.MethodsThis study used existing frozen plasma specimens that had been obtained previously from consenting HIV-negative adults in Cambodia, South Africa, and Vietnam whose tuberculosis status was rigorously characterized using sputum mycobacterial cultures and blood interferon gamma release assay. The investigational assay was performed in a single laboratory by laboratory staff specifically trained to conduct the assays according to the manufacturer’s procedures. In addition, intensity of the test band was subjectively assessed.ResultsPlasma specimens from 150 participants were tested. All testing attempts yielded a determinate result of either positive or negative. For diagnosis of active pulmonary tuberculosis disease, test sensitivity and specificity were 40.0 % (20/50, 95 % confidence interval [CI] 27.6 % to 53.8 %) and 85.0 % (95 % CI 76.7 % to 90.7 %), respectively. For detection ofM. tuberculosisinfection, test sensitivity and specificity were 28.0 % (95 % CI 20.5 % to 37.2 %) and 86.0 % (95 % CI 73.8 % to 93.0 %), respectively. Among the 35 positive tests, no statistically significant band intensity trend was found across participant groups (p = 0.17).ConclusionStudy findings do not support a role for the NOVA Tuberculosis Test in current tuberculosis diagnostic algorithms.