Nsubuga Gideon, Kennedy Samuel, Rani Yasha, Hafiz Zibran, Kim Soyeon, Ruhwald Morten, Alland David, Ellner Jerrold, Joloba Moses, Dorman Susan E, Penn-Nicholson Adam, Nakiyingi Lydia
College of Health Sciences, Makerere University, Kampala, Uganda.
Medical University of South Carolina, Charleston, SC, USA.
J Clin Tuberc Other Mycobact Dis. 2023 Mar 21;31:100362. doi: 10.1016/j.jctube.2023.100362. eCollection 2023 May.
The 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 of infection.
This 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.
Plasma 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 of infection, 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).
Study findings do not support a role for the NOVA Tuberculosis Test in current tuberculosis diagnostic algorithms.
诺瓦结核总抗体快速检测是一种市售的侧向流动血清学检测方法，旨在辅助结核病的诊断。我们开展了一项研究，以评估该检测方法对活动性肺结核病诊断和感染检测的诊断准确性。
本研究使用了先前从柬埔寨、南非和越南同意参与的HIV阴性成年人中获取的冷冻血浆标本，这些人的结核病状况通过痰分枝杆菌培养和血液干扰素γ释放检测进行了严格鉴定。研究检测在一个实验室由经过专门培训、按照制造商程序进行检测的实验室工作人员进行。此外，对检测条带的强度进行了主观评估。
对150名参与者的血浆标本进行了检测。所有检测尝试均得出阳性或阴性的确定结果。对于活动性肺结核病的诊断，检测的敏感性和特异性分别为40.0%（20/50，95%置信区间[CI]为27.6%至53.8%）和85.0%（95%CI为76.7%至90.7%）。对于感染检测，检测的敏感性和特异性分别为28.0%（95%CI为20.5%至37.2%）和86.0%（95%CI为73.8%至93.0%）。在35次阳性检测中，各参与者组之间未发现检测条带强度有统计学意义的趋势（p = 0.17）。
研究结果不支持诺瓦结核检测在当前结核病诊断算法中发挥作用。
