利用细胞培养上清液和临床标本分析七种 SARS-CoV-2 快速抗原检测试剂盒在检测奥密克戎（B.1.1.529）与德尔塔（B.1.617.2）变异株方面的性能。
Analysis of seven SARS-CoV-2 rapid antigen tests in detecting omicron (B.1.1.529) versus delta (B.1.617.2) using cell culture supernatants and clinical specimens.
机构信息
Public Health Microbiology Unit, Bavarian Health and Food Safety Authority, Oberschleißheim, Germany.
Unit of Molecular Biologic Analytics and Biogenetics, Bavarian Health and Food Safety Authority, Oberschleißheim, Germany.
出版信息
Infection. 2023 Feb;51(1):239-245. doi: 10.1007/s15010-022-01844-5. Epub 2022 May 20.
PURPOSE
Omicron is rapidly spreading as a new SARS-CoV-2 variant of concern (VOC). The question whether this new variant has an impact on SARS-CoV-2 rapid antigen test (RAT) performance is of utmost importance. To obtain an initial estimate regarding differences of RATs in detecting omicron and delta, seven commonly used SARS-CoV-2 RATs from different manufacturers were analysed using cell culture supernatants and clinical specimens.
METHODS
For this purpose, cell culture-expanded omicron and delta preparations were serially diluted in Dulbecco's modified Eagle's Medium (DMEM) and the Limit of Detection (LoD) for both VOCs was determined. Additionally, clinical specimens stored in viral transport media or saline (n = 51) were investigated to complement in vitro results with cell culture supernatants. Ct values and RNA concentrations were determined via quantitative reverse transcription polymerase chain reaction (RT-qPCR).
RESULTS
The in vitro determination of the LoD showed no obvious differences in detection of omicron and delta for the RATs examined. The LoD in this study was at a dilution level of 1:1,000 (corresponding to 3.0-5.6 × 10 RNA copies/mL) for tests I-V and at a dilution level of 1:100 (corresponding to 3.7-4.9 × 10 RNA copies/mL) for tests VI and VII. Based on clinical specimens, no obvious differences were observed between RAT positivity rates when comparing omicron to delta in this study setting. Overall positivity rates varied between manufacturers with 30-81% for omicron and 42-71% for delta. Test VII was only conducted in vitro with cell culture supernatants for feasibility reasons. In the range of Ct < 23, positivity rates were 50-100% for omicron and 67-93% for delta.
CONCLUSION
In this study, RATs from various manufacturers were investigated, which displayed no obvious differences in terms of analytical LoD in vitro and RAT positivity rates based on clinical samples comparing the VOCs omicron and delta. However, differences between tests produced by various manufacturers were detected. In terms of clinical samples, a focus of this study was on specimens with high virus concentrations. Further systematic, clinical and laboratory studies utilizing large datasets are urgently needed to confirm reliable performance in terms of sensitivity and specificity for all individual RATs and SARS-CoV-2 variants.
目的
奥密克戎作为一种新的关注变异株（VOC）迅速传播。新变体是否会影响 SARS-CoV-2 快速抗原检测（RAT）性能是至关重要的。为了初步评估 RAT 在检测奥密克戎和德尔塔方面的差异，使用来自不同制造商的七种常用 SARS-CoV-2 RAT 对细胞培养上清液和临床标本进行了分析。
方法
为此，在 Dulbecco 改良 Eagle 培养基（DMEM）中连续稀释细胞培养扩增的奥密克戎和德尔塔制剂，并确定这两种 VOC 的检测限（LoD）。此外，还对储存在病毒运输介质或盐水中的临床标本（n=51）进行了调查，以补充细胞培养上清液的体外结果。通过定量逆转录聚合酶链反应（RT-qPCR）测定 Ct 值和 RNA 浓度。
结果
体外 LoD 的测定显示，检查的 RAT 对奥密克戎和德尔塔的检测没有明显差异。本研究中的 LoD 为 1:1000（对应于 3.0-5.6×10 RNA 拷贝/mL），用于测试 I-V，1:100（对应于 3.7-4.9×10 RNA 拷贝/mL）用于测试 VI 和 VII。基于临床标本，在本研究设定中，比较奥密克戎和德尔塔时，RAT 阳性率没有明显差异。总体阳性率因制造商而异，奥密克戎为 30-81%，德尔塔为 42-71%。由于可行性原因，仅对 VII 号测试进行了细胞培养上清液的体外检测。在 Ct<23 的范围内，奥密克戎的阳性率为 50-100%，德尔塔的阳性率为 67-93%。
结论
在这项研究中，对来自不同制造商的 RAT 进行了调查，结果显示，在体外分析 LoD 和基于临床样本比较 VOC 奥密克戎和德尔塔的 RAT 阳性率方面，没有明显差异。然而，不同制造商生产的测试之间存在差异。在临床样本方面，本研究的重点是病毒浓度高的标本。需要进一步进行系统的、临床的和实验室的研究，利用大型数据集来确认所有单个 RAT 和 SARS-CoV-2 变体的敏感性和特异性的可靠性能。
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