Canetti Diana, Dell'Acqua Raffaele, Riccardi Niccolò, Della Torre Liviana, Bigoloni Alba, Muccini Camilla, Bruzzesi Elena, Ranzenigo Martina, Chiurlo Matteo, Racca Sara, Galli Cristina, Castagna Antonella, Tambussi Giuseppe, Lazzarin Adriano
Clinic of Infectious Diseases, IRCCS San Raffaele Scientific Institute, Milan, Italy.
StopTB Italia Onlus, Milan, Italy.
New Microbiol. 2020 Oct;43(4):161-165. Epub 2020 Oct 31.
We describe the outcome of a Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) IgG/IgM rapid test, and discuss the potential suitability of antibody testing. Retrospective single cohort study on patients with suspected Coronavirus Disease 2019 (COVID-19) and asymptomatic Healthcare Workers, enrolled from March to April 2020. Subjects had quantitative PCR (qPCR) test for detection of SARS-CoV-2 via nasal swab and serological testing using the COVID-19 IgG/ IgM Rapid Test (PRIMA Lab SA) immunochromatographic assay. Some subjects underwent chemiluminescence immunoassay (CLIA) after rapid test. The aim of the study was to analyse the proportion of those who developed a positive IgM/IgG response for SARS-CoV-2. The correspondence between the results from rapid testing and CLIA, when available, was evaluated. 97 subjects underwent qPCR for SARS-CoV-2 through nasal swab, which resulted positive in 40/43 (93.0%) of symptomatic patients, 2/40 (5%) of asymptomatic HCW, in no subjects with suspected COVID- 19 (clinical and radiological findings) then excluded by repeated nasal swabs and alternative diagnosis (COVID-19-negative patients, CNPs), and in 6/6 (100%) of patients with confirmed diagnosis and negative follow-up nasal swabs (COVID-19-recovered patients, CRPs). IgM resulted positive in 8/43 (18.6%) of symptomatic patients and in 1/6 (16.7%) of CRPs. IgG resulted positive in 36/43 (83.7%) of symptomatic patients, 2/40 (5%) of HCW, and in 1/8 (12.5%) and 6/6 (100%) of CNPs and CRPs, respectively. A comparison between an IgG/IgM Rapid Test and a following CLIA test showed consistency in negative results in 25/28 of HCW and 8/8 of CNPs tested. Our preliminary data support the role of IgG/IgM Rapid Test (PRIMA Lab SA) immunochromatographic assay as a point-of-care test that may complement molecular tests in the screening of SARS-CoV-2 carriers. The test may gain particular relevance in shortening the time needed to refer patients to a COVID or non-COVID Hospital area and to achieve diagnosis in patients with persistently negative nasal swabs.
我们描述了严重急性呼吸综合征冠状病毒2（SARS-CoV-2）IgG/IgM快速检测的结果，并讨论了抗体检测的潜在适用性。对2020年3月至4月期间纳入的疑似2019冠状病毒病（COVID-19）患者和无症状医护人员进行回顾性单队列研究。受试者通过鼻拭子进行定量聚合酶链反应（qPCR）检测以检测SARS-CoV-2，并使用COVID-19 IgG/IgM快速检测（PRIMA Lab SA）免疫层析法进行血清学检测。部分受试者在快速检测后进行了化学发光免疫分析（CLIA）。该研究的目的是分析SARS-CoV-2 IgM/IgG反应呈阳性者的比例。评估了快速检测结果与CLIA结果（如有）之间的一致性。97名受试者通过鼻拭子进行了SARS-CoV-2的qPCR检测，结果显示，有症状患者中40/43（93.0%）呈阳性，无症状医护人员中2/40（5%）呈阳性，在所有因重复鼻拭子检测及其他诊断（COVID-19阴性患者，CNP）而排除的疑似COVID-19（临床和影像学检查结果）患者中均未呈阳性，在确诊且后续鼻拭子检测为阴性的患者（COVID-19康复患者，CRP）中6/6（100%）呈阳性。IgM在有症状患者中8/43（18.6%）呈阳性，在CRP中1/6（16.7%）呈阳性。IgG在有症状患者中36/43（83.7%）呈阳性，在医护人员中2/40（5%）呈阳性，在CNP和CRP中分别为1/8（12.5%）和6/6（100%）呈阳性。对IgG/IgM快速检测与后续CLIA检测结果的比较显示，在接受检测的25/28名医护人员和8/8名CNP中，阴性结果具有一致性。我们的初步数据支持IgG/IgM快速检测（PRIMA Lab SA）免疫层析法作为一种即时检测方法在筛查SARS-CoV-2携带者时可补充分子检测的作用。该检测在缩短将患者转诊至COVID或非COVID医院区域所需时间以及对鼻拭子持续阴性的患者进行诊断方面可能具有特别重要的意义。
