Ten rapid antigen tests for SARS-CoV-2 widely differ in their ability to detect Omicron-BA.4 and -BA.5.

IF 5.5 3区 医学 Q1 IMMUNOLOGY
Medical Microbiology and Immunology Pub Date : 2023-10-01 Epub Date: 2023-08-10 DOI:10.1007/s00430-023-00775-8
Franziska Krenn, Christopher Dächert, Irina Badell, Gaia Lupoli, Gamze Naz Öztan, Tianle Feng, Nikolas Schneider, Melanie Huber, Hanna Both, Patricia M Späth, Maximilian Muenchhoff, Alexander Graf, Stefan Krebs, Helmut Blum, Jürgen Durner, Ludwig Czibere, Lars Kaderali, Oliver T Keppler, Hanna-Mari Baldauf, Andreas Osterman
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引用次数: 0

Abstract

Since late 2021, the variant landscape of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been dominated by the variant of concern (VoC) Omicron and its sublineages. We and others have shown that the detection of Omicron-BA.1 and -BA.2-positive respiratory specimens by rapid antigen tests (RATs) is impaired compared to Delta VoC-containing samples. Here, in a single-center retrospective laboratory study, we evaluated the performance of ten most commonly used RATs for the detection of Omicron-BA.4 and -BA.5 infections. We used 171 respiratory swab specimens from SARS-CoV-2 RNA-positive patients, of which 71 were classified as BA.4 and 100 as BA.5. All swabs were collected between July and September 2022. 50 SARS-CoV-2 PCR-negative samples from healthy individuals, collected in October 2022, showed high specificity in 9 out of 10 RATs. When assessing analytical sensitivity using clinical specimens, the 50% limit of detection (LoD50) ranged from 7.6 × 104 to 3.3 × 106 RNA copies subjected to the RATs for BA.4 compared to 6.8 × 104 to 3.0 × 106 for BA.5. Overall, intra-assay differences for the detection of these two Omicron subvariants were not significant for both respiratory swabs and tissue culture-expanded virus isolates. In contrast, marked heterogeneity was observed among the ten RATs: to be positive in these point-of-care tests, up to 443-fold (BA.4) and up to 56-fold (BA.5) higher viral loads were required for the worst performing RAT compared to the best performing RAT. True-positive rates for Omicron-BA.4- or -BA.5-containing specimens in the highest viral load category (Ct values < 25) ranged from 94.3 to 34.3%, dropping to 25.6 to 0% for samples with intermediate Ct values (25-30). We conclude that the high heterogeneity in the performance of commonly used RATs remains a challenge for the general public to obtain reliable results in the evolving Omicron subvariant-driven pandemic.

Abstract Image

10种针对严重急性呼吸系统综合征冠状病毒2型的快速抗原检测在检测奥密克戎BA.4和-BA.5的能力上存在很大差异。
自2021年底以来,严重急性呼吸综合征冠状病毒2型(严重急性呼吸系统综合征冠状病毒-2型)的变种格局一直由令人担忧的奥密克戎变种及其亚系主导。我们和其他人已经表明,与含有德尔塔VoC的样本相比,通过快速抗原测试(RAT)检测奥密克戎BA.1和BAA.2阳性呼吸道样本的能力受损。在这里,在一项单中心回顾性实验室研究中,我们评估了十种最常用的RAT检测奥密克戎BA.4和-BA.5感染的性能。我们使用了171份来自严重急性呼吸系统综合征冠状病毒2型RNA阳性患者的呼吸道拭子样本,其中71份被归类为BA.4,100份被归类于BA.5。所有拭子均于2022年7月至9月采集。2022年10月收集的50份来自健康个体的严重急性呼吸系统综合征冠状病毒2型PCR阴性样本,在10例RAT中有9例显示出高特异性。当使用临床样本评估分析灵敏度时,50%的检测限(LoD50)范围为7.6 × 104至3.3 × 106个RNA拷贝接受BA.4的RAT,而6.8 × 104至3.0 × BA.5为106。总体而言,对于呼吸拭子和组织培养扩增的病毒分离株,检测这两种奥密克戎亚变体的批内差异均不显著。相反,在10种RAT中观察到显著的异质性:要在这些护理点测试中呈阳性,与表现最好的RAT相比,表现最差的RAT需要高达443倍(BA.4)和56倍(BA.5)的病毒载量。最高病毒载量类别中含奥密克戎BA.4或BA.5的标本的真阳性率(Ct值 t值(25-30)。我们得出的结论是,常用RAT性能的高度异质性仍然是公众在奥密克戎亚变异株驱动的疫情中获得可靠结果的挑战。
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来源期刊
CiteScore
10.60
自引率
0.00%
发文量
29
审稿时长
1 months
期刊介绍: Medical Microbiology and Immunology (MMIM) publishes key findings on all aspects of the interrelationship between infectious agents and the immune system of their hosts. The journal´s main focus is original research work on intrinsic, innate or adaptive immune responses to viral, bacterial, fungal and parasitic (protozoan and helminthic) infections and on the virulence of the respective infectious pathogens. MMIM covers basic, translational as well as clinical research in infectious diseases and infectious disease immunology. Basic research using cell cultures, organoid, and animal models are welcome, provided that the models have a clinical correlate and address a relevant medical question. The journal also considers manuscripts on the epidemiology of infectious diseases, including the emergence and epidemic spreading of pathogens and the development of resistance to anti-infective therapies, and on novel vaccines and other innovative measurements of prevention. The following categories of manuscripts will not be considered for publication in MMIM: submissions of preliminary work, of merely descriptive data sets without investigation of mechanisms or of limited global interest, manuscripts on existing or novel anti-infective compounds, which focus on pharmaceutical or pharmacological aspects of the drugs, manuscripts on existing or modified vaccines, unless they report on experimental or clinical efficacy studies or provide new immunological information on their mode of action, manuscripts on the diagnostics of infectious diseases, unless they offer a novel concept to solve a pending diagnostic problem, case reports or case series, unless they are embedded in a study that focuses on the anti-infectious immune response and/or on the virulence of a pathogen.
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