Department of Laboratory Medicine, Virology Division, University of Washington, Seattle, WA, United States.
Vaccine and Infectious Diseases Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States.
J Clin Virol. 2020 Jul;128:104438. doi: 10.1016/j.jcv.2020.104438. Epub 2020 May 13.
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) has caused considerable disruption across the world, resulting in more than 235,000 deaths since December 2019. SARS-CoV-2 has a wide tropism and detection of the virus has been described in multiple specimen types, including various respiratory secretions, cerebrospinal fluid, and stool.
To evaluate the accuracy and sensitivity of a laboratory modified CDCbased SARS-CoV-2 N1 and N2 assay across a range of sample types. Study Design We compared the matrix effect on the analytical sensitivity of SARS-CoV-2 detection by qRT-PCR in nasal swabs collected in viral transport medium (VTM), bronchoalveolar lavage (BAL), sputum, plasma, cerebral spinal fluid (CSF), stool, VTM, phosphate buffered saline (PBS), and Hanks' Balanced Salt Solution (HBSS). Initial limits of detection (LoD) were subsequently narrowed to confirm an LoD for each specimen type and target gene.
LoDs were established using a modified CDC-based laboratory developed test and ranged from a mean CT cut-off of 33.8-35.7 (10-20 copies/reaction) for the N1 gene target, and 34.0-36.2 (1-10 copies/reaction) for N2. Alternatives to VTM such as PBS and HBSS had comparable LoDs. The N2 gene target was found to be most sensitive in CSF.
A modified CDC-based laboratory developed test is able to detect SARSCoV- 2 accurately with similar sensitivity across all sample types tested.
严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）自 2019 年 12 月以来在全球范围内造成了严重破坏，导致超过 23.5 万人死亡。SARS-CoV-2 具有广泛的嗜性，已在多种标本类型中检测到该病毒，包括各种呼吸道分泌物、脑脊液和粪便。
评估实验室改良的基于美国疾病控制与预防中心（CDC）的 SARS-CoV-2 N1 和 N2 检测方法在多种样本类型中的准确性和灵敏度。
我们比较了 qRT-PCR 在鼻拭子中检测 SARS-CoV-2 时，病毒转运培养基（VTM）、支气管肺泡灌洗液（BAL）、痰液、血浆、脑脊液（CSF）、粪便、VTM、磷酸盐缓冲盐水（PBS）和 Hank's 平衡盐溶液（HBSS）中对分析灵敏度的基质效应。随后，将初始检测限（LoD）缩小到确认每种标本类型和靶基因的 LoD。
使用改良的基于美国疾病控制与预防中心的实验室开发的测试确定了 LoD，范围为 N1 基因目标的平均 CT 截止值为 33.8-35.7（10-20 拷贝/反应），N2 为 34.0-36.2（1-10 拷贝/反应）。替代 VTM 的 PBS 和 HBSS 具有类似的 LoD。N2 基因目标在 CSF 中最敏感。
改良的基于美国疾病控制与预防中心的实验室开发的测试能够准确检测 SARS-CoV-2，在所有测试的样本类型中具有相似的灵敏度。
