丙型肝炎快速抗体检测中效率与准确性的平衡:一项整群随机交叉试验的见解

Balancing Efficiency and Accuracy in Hepatitis C Rapid Antibody Testing: Insights From a Cluster Randomised Crossover Trial.

作者信息

Heath K, Guzman R, Elsum I, Wade A J, Allardice K, Kasza J, Bryant M, Thompson A J, Stoové M, Snelling T, Scott N, Spelman T, Anderson D A, Richmond J, Howell J, Andric N, Dietze P, Higgs P, Sacks-Davis R, Forbes A, Hellard M E, Pedrana A E, Doyle J S

机构信息

Burnet Institute, Melbourne, Victoria, Australia.

Monash University, School of Public Health and Preventive Medicine, Melbourne, Victoria, Australia.

出版信息

J Viral Hepat. 2025 Aug;32(8):e70043. doi: 10.1111/jvh.70043.

Abstract

Hepatitis C remains a significant global health problem, particularly among people who inject drugs. To achieve Australia's 2030 elimination targets, efficient testing strategies are needed. The OraQuick rapid antibody test provides results in 20 min, but many non-viraemic individuals with resolved infections test positive, potentially leading to unnecessary confirmatory RNA testing. Reducing the read time to five minutes has been proposed to reduce false positives and improve efficiency, but its impact on viremia detection is unclear. This study utilised data from the QuickStart study, a randomised controlled trial investigating different rapid testing pathways and a same-day test-and-treat model. Participants underwent OraQuick rapid antibody testing with results read at both five and 20 min, followed by confirmatory RNA testing. Among 298 participants with OraQuick and RNA test results, the 20-min OraQuick test was positive for all 79 viraemic individuals and 156 non-viraemic individuals. At five minutes, positive results decreased to 77 (97.5%) of viraemic and 135 (87%) non-viraemic individuals with positive 20-min results. Using a five-minute result to trigger RNA testing would have reduced unnecessary RNA testing by 13% in our cohort at the cost of missing 2.5% of viraemic individuals. A five-minute read time could improve efficiency by reducing unnecessary RNA testing, but confirmatory RNA testing remains essential to distinguish active from resolved infections. The balance between efficiency and accuracy may vary contextually, reflecting differing rates of resolved infections. This approach may be beneficial in resource-limited settings, but the potential for missed viremia must be considered. Trial Registration: ClinicalTrials.gov number; NCT05016609.

摘要

丙型肝炎仍然是一个重大的全球健康问题,在注射吸毒者中尤为突出。为实现澳大利亚2030年的消除目标,需要有效的检测策略。OraQuick快速抗体检测可在20分钟内出结果,但许多感染已消除的非病毒血症个体检测呈阳性,这可能导致不必要的RNA确认检测。有人提议将读取时间缩短至5分钟,以减少假阳性并提高效率,但其对病毒血症检测的影响尚不清楚。本研究利用了QuickStart研究的数据,该研究是一项随机对照试验,调查了不同的快速检测途径和当日检测与治疗模式。参与者接受了OraQuick快速抗体检测,分别在5分钟和20分钟读取结果,随后进行RNA确认检测。在298名有OraQuick和RNA检测结果的参与者中,20分钟的OraQuick检测对所有79名病毒血症个体和156名非病毒血症个体均呈阳性。在5分钟时,病毒血症个体中呈阳性结果的降至77例(97.5%),20分钟结果为阳性的非病毒血症个体中降至135例(87%)。在我们的队列中,以5分钟的结果触发RNA检测可减少13%的不必要RNA检测,但代价是遗漏2.5%的病毒血症个体。5分钟的读取时间可通过减少不必要的RNA检测提高效率,但RNA确认检测对于区分现症感染和已消除感染仍然至关重要。效率和准确性之间的平衡可能因情况而异,反映出不同的感染消除率。这种方法在资源有限的环境中可能有益,但必须考虑遗漏病毒血症的可能性。试验注册:ClinicalTrials.gov编号;NCT05016609。

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