Chapko Michael K, Sloan Kevin L, Davison John W, Dufour D Robert, Bankson Daniel D, Rigsby Michael, Dominitz Jason A
Northwest Hepatitis C Resource Center, Veterans Affairs Puget Sound Health Care System, Seattle, WA, USA.
Am J Gastroenterol. 2005 Mar;100(3):607-15. doi: 10.1111/j.1572-0241.2005.40531.x.
This paper compares nine strategies for determining hepatitis C antibody and viral status. They combine two tests for antibodies (enzyme immunoassays (EIA), recombinant immunoblot assays (RIBA)) and one for viremia (reverse transcription polymerase chain reaction (PCR)). Using optical density to divide EIA results into three categories (high positive, low positive, negative) was also considered.
Decision analysis compared strategies on cost as well as sensitivity and specificity with regard to antibody and viral status. Parameters in the decision tree included antibody prevalence, proportion viremic, sensitivity, specificity, and cost of individual tests.
The two best strategies are EIA followed by PCR (EIA-->PCR); and EIA with three levels of optical density (EIA-OD), followed by RIBA for EIA-OD low positives, and then PCR for all positives (EIA-OD-->RIBA-->PCR). EIA-->PCR has equal viral sensitivity, slightly lower cost, slightly higher antibody sensitivity, but lower antibody specificity compared to EIA-OD-->RIBA-->PCR. The cost per false antibody positive avoided using EIA-OD-->RIBA-->PCR rather than EIA-->PCR is $36 when prevalence is 5%, and $193 when prevalence is 50%. Using EIA-OD-->RIBA-->PCR rather than EIA-->PCR results in 112 false antibody positives avoided for every true antibody positive missed when prevalence is 5%; this ratio is 18:1 when prevalence is 25%; and 6:1 when prevalence is 50%.
EIA-OD-->RIBA-->PCR is the best choice when prevalence in the tested group is below 20%. As prevalence increases, the choice of EIA-OD-->RIBA-->PCR versus EIA-->PCR will depend on the relative importance of avoiding false antibody positives versus missing true antibody positives. Our analysis makes explicit the magnitude of this trade-off.
本文比较了九种用于确定丙型肝炎抗体和病毒状态的策略。这些策略结合了两种抗体检测方法(酶免疫测定(EIA)、重组免疫印迹测定(RIBA))和一种病毒血症检测方法(逆转录聚合酶链反应(PCR))。还考虑了使用光密度将EIA结果分为三类(高阳性、低阳性、阴性)。
决策分析在成本以及抗体和病毒状态的敏感性和特异性方面对各策略进行了比较。决策树中的参数包括抗体流行率、病毒血症比例、敏感性、特异性以及各个检测的成本。
两种最佳策略是先进行EIA然后进行PCR(EIA→PCR);以及具有三个光密度水平的EIA(EIA-OD),对于EIA-OD低阳性结果接着进行RIBA检测,然后对所有阳性结果进行PCR检测(EIA-OD→RIBA→PCR)。与EIA-OD→RIBA→PCR相比,EIA→PCR具有相同的病毒敏感性、略低的成本、略高的抗体敏感性,但抗体特异性较低。当流行率为5%时,使用EIA-OD→RIBA→PCR而非EIA→PCR避免每例假抗体阳性的成本为36美元,当流行率为50%时为193美元。当流行率为5%时,使用EIA-OD→RIBA→PCR而非EIA→PCR,每漏检一例真抗体阳性可避免112例假抗体阳性;当流行率为25%时,该比例为18:1;当流行率为50%时,该比例为6:1。
当检测组中的流行率低于20%时,EIA-OD→RIBA→PCR是最佳选择。随着流行率的增加,选择EIA-OD→RIBA→PCR还是EIA→PCR将取决于避免假抗体阳性与漏检真抗体阳性的相对重要性。我们的分析明确了这种权衡的程度。