Characterizing antibody (Ab)-mediated immune response to SARS-CoV-2 is fundamental to understanding COVID-19 epidemiology, reinfection potential, and vaccine development, particularly in immunocompromised patients. The first report of SARS-CoV-2 directed Abs demonstrated that 100% of 34 hospitalized patients developed virus-specific IgM and IgG by 3 weeks following symptom onset with rising IgG titers during weeks 4 through 7 (end of study period) [1]. A subsequent series of 285 patients with COVID-19 demonstrated that 100% developed virusspecific IgG 17–19 days after symptom onset [2]. While studies with short follow-up have demonstrated that lower proportions of patients develop anti-SARS-CoV-2 IgG [3, 4], studies with follow-up extending into the period of expected peak IgG levels have confirmed high rates of antiSARS-CoV-2 IgG development (98–100%; peak ~day 30) [5–7]. Persistence of Ab responses requires further study. Given genomic similarity between SARS-CoV-2 and SARS-CoV, dynamics of SARS-CoV Ab response may be relevant; IgG peaked between months 2 and 4 and declined thereafter, though antigen-specific IgG was persistently detected up to 24 months [8, 9]. Data of this nature are not yet available for SARS-CoV-2. Much remains unknown about neutralizing capacity of Ab and clinical relevance of Ab responses for immune status. Notably, most data on serologic response to SARS-CoV-2 have come from immunocompetent adults. In contrast, a small series of ten cancer patients (mixed histology) showed a seroconversion rate of 30% (3/10) at 15 days following documented positive RT-PCR, though data on seroconversion at later timepoints were not available [10]. Notably, of the seven seronegative patients with PCR-based COVID-19 diagnosis, six had received cytotoxic therapy or major surgery in the preceding 4 weeks [10]. Ab responses in patients with chronic lymphocytic leukemia (CLL) are of particular interest given cellular and humoral immunodeficiencies resulting from the disease and CLL-directed therapies [11]. While robust epidemiologic data regarding risk of SARS-CoV-2 infection are not yet available, case fatality rates in series of CLL patients with symptomatic COVID-19 are 30–33% [12, 13]. Furthermore, studies of seroconversion in response to vaccines in patients with CLL have demonstrated suboptimal responses [14]. Thus, patients with CLL are at risk for severe COVID-19 given their underlying immunodeficiency, often advanced age, and potentially suboptimal serologic response to infection or related vaccine. To characterize immune response to COVID-19 in patients with CLL, we identified all patients who receive care for an antecedent diagnosis of CLL at Memorial Sloan Kettering Cancer Center diagnosed with COVID-19 via PCR for SARS-CoV-2 RNA from a nasopharyngeal swab between March 18 and April 29, 2020. We retrospectively examined patients subsequently tested for anti-SARS-CoV-2 IgG Ab utilizing the Abbott Architect SARS-CoV-2 IgG assay (Abbott Park, IL, USA) to detect serum IgG Abs directed against the nucleocapsid protein of SARS-CoV-2 in routine clinical practice. We examined baseline characteristics, CLLdirected therapy history, and details regarding COVID-19 testing and clinical course. Patients were defined as having severe COVID-19 if they required supplemental oxygen and/ * Lindsey E. Roeker roekerl@mskcc.org

/pdf/anti-sars-cov-2-antibody-response-in-patients-with-chronic-4i1nt9wcax.pdf

Anti-SARS-CoV-2 antibody response in patients with chronic lymphocytic leukemia.

Aim: The aim of this study was to investigate the utility of serological tests for the diagnosis of COVID-19 during the first week of symptom onset in patients confirmed with the real-time RT-PCR. Materials &amp; methods: A systematic review and meta-analysis of 58 publications were performed using data obtained from Academic Search Ultimate, Africa-wide, Scopus, Web of Science and MEDLINE. Results: We found that the highest pooled sensitivities were obtained with ELISA immunoglobulin (Ig)M and IgG and chemiluminescence immunoassay IgM tests. Conclusion: Serological tests have low sensitivity within the first week of symptom onset and cannot replace nucleic acid amplification tests. However, serological assays can be used to support nucleic acid amplification tests. 

A systematic review and meta-analysis of the sensitivity of antibody tests for the laboratory confirmation of COVID-19

http://www.ijidonline.com/article/S1201971222001308/pdf

Performance evaluation of novel fluorescent-based lateral flow immunoassay (LFIA) for rapid detection and quantification of total anti-SARS-CoV-2 S-RBD binding antibodies in infected individuals

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is still in an epidemic situation, which poses a serious threat to the safety of people and property. Rapid diagnosis and isolation of infected individuals are one of the important methods to control virus transmission. Existing lateral flow immunoassay techniques have the advantages of rapid, sensitive, and easy operation, and some new options have emerged with the continuous development of nanotechnology. Such as lateral flow immunoassay test strips based on colorimetric-fluorescent dual-mode and gold nanoparticles, Surface Enhanced Raman Scattering, etc., these technologies have played an important role in the rapid diagnosis of COVID-19. In this paper, we summarize the current research progress of lateral flow immunoassay in the field of Severe Acute Respiratory Syndrome Coronavirus 2 infection diagnosis, analyze the performance of Severe Acute Respiratory Syndrome Coronavirus 2 lateral flow immunoassay products, review the advantages and limitations of different detection methods and markers, and then explore the competitive CRISPR-based nucleic acid chromatography detection method. This method combines the advantages of gene editing and lateral flow immunoassay and can achieve rapid and highly sensitive lateral flow immunoassay detection of target nucleic acids, which is expected to be the most representative method for community and clinical point-of-care testing. We hope that researchers will be inspired by this review and strive to solve the problems in the design of highly sensitive targets, the selection of detection methods, and the enhancement of CRISPR technology, to truly achieve rapid, sensitive, convenient, and specific detection of novel coronaviruses, thus promoting the development of novel coronavirus diagnosis and contributing our modest contribution to the world’s fight against epidemics.

Rapid detection of SARS-CoV-2: The gradual boom of lateral flow immunoassay

The ongoing COVID-19 epidemic has made a huge impact on health, economies, and societies all over the world. Although RT-PCR-based nucleic acid detection has been primarily used in the diagnosis of COVID-19, it is time-consuming with limited application scenarios and must be operated by qualified personnel. Antibody test, particularly point-of-care antibody testing, is a suitable complement to nucleic acid test as it provides rapid, portable, and cost-effective detection of infections. In this study, a rapid antibody test kit was developed based on fluorescence immunochromatography for the sensitive, accurate, and automated detection of IgM and IgG antibodies against SARS-CoV-2 in human serum, plasma, and whole blood samples within 10 minutes. The sensitivity, specificity, precision, and stability of the test kit were of good performance. No cross-activity and no interference was observed. In the multiple-center parallel study, 223 samples from hospitalized patients were used to evaluate the clinical specificity of the test. Both SARS-CoV-2 IgM and IgG achieved a clinical specificity of 98.21%. The clinical sensitivities of SARS-CoV-2 IgM and IgG were 79.54% and 87.45%, respectively, among 733 RT-PCR confirmed SARS-Cov-2 samples. For the combined IgM and IgG assays, the sensitivity and specificity were 89.22% and 96.86%, respectively. Our results demonstrate that the combined use of IgM and IgG could serve as a more suitable alternative detection method for COVID-19 patients, and the developed kit is of great public health significance for the prevention and control of the COVID-19 pandemic. This article is protected by copyright. All rights reserved.

https://onlinelibrary.wiley.com/doi/pdf/10.1002/jmv.26696

Development, Performance Evaluation and Clinical Application of A Rapid SARS-CoV-2 IgM and IgG Test Kit Based on Automated Fluorescence Immunoassay.

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Development, Performance Evaluation and Clinical Application of A Rapid SARS-CoV-2 IgM and IgG Test Kit Based on Automated Fluorescence Immunoassay.