兽医诊断实验室参与者在实验室间比较研究中成功检测到 SARS-CoV-2 的德尔塔和奥密克戎变异株。
Successful Detection of Delta and Omicron Variants of SARS-CoV-2 by Veterinary Diagnostic Laboratory Participants in an Interlaboratory Comparison Exercise.
机构信息
Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration, Bedford Park, IL, United States.
Center for Veterinary Medicine, U.S. Food and Drug Administration, Laurel, MD, United States.
出版信息
J Appl Lab Med. 2023 Jul 5;8(4):726-741. doi: 10.1093/jalm/jfad018.
BACKGROUND
Throughout the COVID-19 pandemic, veterinary diagnostic laboratories have tested diagnostic samples for SARS-CoV-2 both in animals and over 6 million human samples. An evaluation of the performance of those laboratories is needed using blinded test samples to ensure that laboratories report reliable data to the public. This interlaboratory comparison exercise (ILC3) builds on 2 prior exercises to assess whether veterinary diagnostic laboratories can detect Delta and Omicron variants spiked in canine nasal matrix or viral transport medium.
METHODS
The ILC organizer was an independent laboratory that prepared inactivated Delta variant at levels of 25 to 1000 copies per 50 µL of nasal matrix for blinded analysis. Omicron variant at 1000 copies per 50 µL of transport medium was also included. Feline infectious peritonitis virus (FIPV) RNA was used as a confounder for specificity assessment. Fourteen test samples were prepared for each participant. Participants used their routine diagnostic procedures for RNA extraction and real-time reverse transcriptase-PCR. Results were analyzed according to International Organization for Standardization (ISO) 16140-2:2016.
RESULTS
Overall, laboratories demonstrated 93% detection for Delta and 97% for Omicron at 1000 copies per 50 µL. Specificity was 97% for blank samples and 100% for blank samples with FIPV. No differences in Cycle Threshold (Ct) values were significant for samples with the same virus levels between N1 and N2 markers, nor between the 2 variants.
CONCLUSIONS
The results indicated that all ILC3 participants were able to detect both Delta and Omicron variants. The canine nasal matrix did not significantly affect SARS-CoV-2 detection.
背景
在整个 COVID-19 大流行期间，兽医诊断实验室对动物和超过 600 万份人类样本进行了 SARS-CoV-2 的诊断样本检测。需要使用盲样评估这些实验室的性能，以确保实验室向公众报告可靠的数据。这项实验室间比较研究（ILC3）是在前两次评估的基础上进行的，旨在评估兽医诊断实验室是否能够检测到犬鼻基质或病毒运输介质中添加的 Delta 和 Omicron 变体。
方法
ILC 组织者是一个独立的实验室，为盲样分析制备了水平为 25 至 1000 拷贝/50 µL 的 Delta 变体灭活物。还包括 1000 拷贝/50 µL 运输介质的 Omicron 变体。猫传染性腹膜炎病毒（FIPV）RNA 用于特异性评估的混杂因素。为每个参与者准备了 14 个测试样本。参与者使用他们的常规诊断程序进行 RNA 提取和实时逆转录聚合酶链反应。结果根据国际标准化组织（ISO）16140-2：2016 进行分析。
结果
总体而言，实验室在 1000 拷贝/50 µL 时对 Delta 的检测率为 93%，对 Omicron 的检测率为 97%。空白样本的特异性为 97%，空白样本加 FIPV 的特异性为 100%。在 N1 和 N2 标记物之间具有相同病毒水平的样本之间，以及在两种变体之间，循环阈值（Ct）值的差异没有统计学意义。
结论
结果表明，所有 ILC3 参与者都能够检测到 Delta 和 Omicron 变体。犬鼻基质对 SARS-CoV-2 的检测没有显著影响。
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