Potential preanalytical and analytical vulnerabilities in the laboratory diagnosis of coronavirus disease 2019 (COVID-19)
Potential preanalytical and analytical vulnerabilities in the laboratory diagnosis of coronavirus disease 2019 (COVID-19)
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DOI：
10.1515/cclm-2020-0285
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发表时间：
2020-07-01
影响因子：
6.8
通讯作者：
Plebani, Mario
中科院分区：
文献类型：
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作者：
Lippi, Giuseppe;Simundic, Ana-Maria;Plebani, Mario
新型人畜共患冠状病毒疫情正在全球蔓延。这种大流行性疾病现已被定义为2019年新型冠状病毒病（COVID-19），并由严重急性呼吸道综合征冠状病毒2（SARS-CoV-2）持续。由于目前SARS-CoV-2感染病原学诊断的金标准是呼吸道标本的（真实的时间）逆转录聚合酶链反应（rRT-PCR），因此该技术的诊断准确性应被视为首要前提。总体而言，潜在的RT-PCR漏洞包括一般的分析前问题，如识别问题，拭子收集、处理、运输和储存程序不当，收集不适当或不充分的材料（质量或数量），干扰物质的存在，人工错误，以及具体方面，如样本污染和接受抗逆转录病毒治疗的患者检测。一些分析问题也可能导致危害诊断准确性，包括诊断窗口之外的检测、活跃的病毒重组、使用未经充分验证的检测试剂、协调不足、仪器故障以及沿着其他特定技术问题。因此，可以确定一些实用的适应症，以最大限度地减少诊断错误的风险，包括通过将临床证据与胸部计算机断层扫描（CT）和RT-PCR结果相结合来提高诊断准确性，根据流行病学、临床和放射学因素解释RT-PCR结果，记忆和测试上部RT-PCR检测结果阴性且高度怀疑或可能感染的患者的（或下）呼吸道标本，传播关于标本（尤其是拭子）采集、管理和储存的明确说明，同时完善分子靶标并完全遵守分析程序，包括质量保证。
A novel zoonotic coronavirus outbreak is spreading all over the world. This pandemic disease has now been defined as novel coronavirus disease 2019 (COVID-19), and is sustained by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). As the current gold standard for the etiological diagnosis of SARS-CoV-2 infection is (real time) reverse transcription polymerase chain reaction (rRT-PCR) on respiratory tract specimens, the diagnostic accuracy of this technique shall be considered a foremost prerequisite. Overall, potential RT-PCR vulnerabilities include general preanalytical issues such as identification problems, inadequate procedures for collection, handling, transport and storage of the swabs, collection of inappropriate or inadequate material (for quality or volume), presence of interfering substances, manual errors, as well as specific aspects such as sample contamination and testing patients receiving antiretroviral therapy. Some analytical problems may also contribute to jeopardize the diagnostic accuracy, including testing outside the diagnostic window, active viral recombination, use of inadequately validated assays, insufficient harmonization, instrument malfunctioning, along with other specific technical issues. Some practical indications can hence be identified for minimizing the risk of diagnostic errors, encompassing the improvement of diagnostic accuracy by combining clinical evidence with results of chest computed tomography (CT) and RT-PCR, interpretation of RT-PCR results according to epidemiologic, clinical and radiological factors, recollection and testing of upper (or lower) respiratory specimens in patients with negative RT-PCR test results and high suspicion or probability of infection, dissemination of clear instructions for specimen (especially swab) collection, management and storage, together with refinement of molecular target(s) and thorough compliance with analytical procedures, including quality assurance.