A Peptide-based Magnetic Chemiluminescence Enzyme Immunoassay for Serological Diagnosis of Corona Virus Disease 2019 (COVID-19)

Cai, Xue-Fei; Chen, Juan; Hu, Jieli; Long, Quanxin; Deng, Haijun; Fan, Kai; Liao, Pu; Liu, Beizhong; Wu, Guicheng; Chen, Yao-Kai; Li, Zhijie; Wang, Kun; Zhang, Xiaoli; Tian, Weizhong; Xiang, Junyi; Du, Hongxin; Wang, Jing; Hu, Yuan; Tang, Ni; Lin, Yong; Ren, Ji-Hua; Huang, Luyi; Wei, Jie; Gan, Chun-Yang; Chen, Yanmeng; Gao, Qi; Chen, Amei; He, Chaojun; Wang, Daoxin; Hu, Ping; Zhou, Fachun; Huang, Aiping; Liu, Ping; Wang, Deqiang

doi:10.1101/2020.02.22.20026617

“…In total, 4696 records based on screening of titles or abstracts and 235 after full text review were excluded. Forty studies totalling 73 study arms15161718192021222324252627282930313233343536373839404142434445464748495051525354 met the inclusion criteria. Table 1 summarises the studies by test method; the sum of the number of studies exceeds 40 because some evaluated more than one method.…”

Section: Resultsmentioning

confidence: 99%

“…Table 1 summarises the studies by test method; the sum of the number of studies exceeds 40 because some evaluated more than one method. Seventy per cent (28/40) of the studies were from China,16171819202122232425262728293031323334353839404145464748 8% (3/40) from Italy,153643 and the remainder from the United States (3/40),425052 Denmark (1/40),51 Spain (1/40),37 Sweden (1/40),53 Japan (1/40),44 the United Kingdom (1/40),49 and Germany (1/40) 5433…”

Section: Resultsmentioning

confidence: 99%

Diagnostic accuracy of serological tests for covid-19: systematic review and meta-analysis

Bastos

¹

,

Tavaziva

²

,

Abidi

³

et al. 2020

BMJ

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AbstractObjectiveTo determine the diagnostic accuracy of serological tests for coronavirus disease-2019 (covid-19).DesignSystematic review and meta-analysis.Data sourcesMedline, bioRxiv, and medRxiv from 1 January to 30 April 2020, using subject headings or subheadings combined with text words for the concepts of covid-19 and serological tests for covid-19.Eligibility criteria and data analysisEligible studies measured sensitivity or specificity, or both of a covid-19 serological test compared with a reference standard of viral culture or reverse transcriptase polymerase chain reaction. Studies were excluded with fewer than five participants or samples. Risk of bias was assessed using quality assessment of diagnostic accuracy studies 2 (QUADAS-2). Pooled sensitivity and specificity were estimated using random effects bivariate meta-analyses.Main outcome measuresThe primary outcome was overall sensitivity and specificity, stratified by method of serological testing (enzyme linked immunosorbent assays (ELISAs), lateral flow immunoassays (LFIAs), or chemiluminescent immunoassays (CLIAs)) and immunoglobulin class (IgG, IgM, or both). Secondary outcomes were stratum specific sensitivity and specificity within subgroups defined by study or participant characteristics, including time since symptom onset.Results5016 references were identified and 40 studies included. 49 risk of bias assessments were carried out (one for each population and method evaluated). High risk of patient selection bias was found in 98% (48/49) of assessments and high or unclear risk of bias from performance or interpretation of the serological test in 73% (36/49). Only 10% (4/40) of studies included outpatients. Only two studies evaluated tests at the point of care. For each method of testing, pooled sensitivity and specificity were not associated with the immunoglobulin class measured. The pooled sensitivity of ELISAs measuring IgG or IgM was 84.3% (95% confidence interval 75.6% to 90.9%), of LFIAs was 66.0% (49.3% to 79.3%), and of CLIAs was 97.8% (46.2% to 100%). In all analyses, pooled sensitivity was lower for LFIAs, the potential point-of-care method. Pooled specificities ranged from 96.6% to 99.7%. Of the samples used for estimating specificity, 83% (10 465/12 547) were from populations tested before the epidemic or not suspected of having covid-19. Among LFIAs, pooled sensitivity of commercial kits (65.0%, 49.0% to 78.2%) was lower than that of non-commercial tests (88.2%, 83.6% to 91.3%). Heterogeneity was seen in all analyses. Sensitivity was higher at least three weeks after symptom onset (ranging from 69.9% to 98.9%) compared with within the first week (from 13.4% to 50.3%).ConclusionHigher quality clinical studies assessing the diagnostic accuracy of serological tests for covid-19 are urgently needed. Currently, available evidence does not support the continued use of existing point-of-care serological tests.Study registrationPROSPERO CRD42020179452.

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“…Chemiluminescent immunoassay (CLIA) is a modified version of ELISA where luminescence is measured for the detection of pathogens (Figure 2(b)). It is a quantitative test that can measure the number of IgG, IgM, and IgA antibodies [44]. This test allows the mixing of patient samples with viral specific proteins.…”

Section: Serological Testsmentioning

confidence: 99%

Diagnostic approaches in COVID-19: clinical updates

Asrani

¹

,

Eapen

²

,

Chia

³

et al. 2020

Expert Review of Respiratory Medicine

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Introduction: COVID-19 is a recent emerging pandemic whose prognosis is still unclear. Diagnostic tools are the main players that not only indicate a possible infection but can further restrict the transmission and can determine the extent to which disease progression would occur. Areas covered: In this paper, we have performed a narrative and critical review on different technology-based diagnostic strategies such as molecular approaches including real-time reverse transcriptase PCR, serological testing through enzyme-linked immunosorbent assay, laboratory and point of care devices, radiology-based detection through computed tomography and chest X-ray, and viral cell cultures on Vero E6 cell lines are discussed in detail to address COVID-19. This review further provides an overview of emergency use authorized immunodiagnostic and molecular diagnostic kits and POC devices by FDA for timely and efficient conduction of diagnostic tests. The majority of the literature cited in this paper is collected from guidelines on protocols and other considerations on diagnostic strategies of COVID-19 issued by WHO, CDC, and FDA under emergency authorization. Expert opinion: Such information holds importance to the health professionals in conducting error-free diagnostic tests and researches in producing better clinical strategies by addressing the limitations associated with the available methods.

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“…The ongoing global pandemic of Coronavirus Disease-2019 (COVID- 19) has rapidly spread with globally over 3.7 million confirmed cases and over 259,000 total deaths as of May 5, 2020 [1]. Severe Acute pneumonia [2][3][4]. However some other individuals are asymptomatic carriers [5][6][7].…”

Section: Introductionmentioning

confidence: 99%

SARS-CoV-2 antibody characterization in emergency department, hospitalized and convalescent patients by two semi-quantitative immunoassays

Yang

¹

,

Racine‐Brzostek

²

,

Lee

³

et al. 2020

Clinica Chimica Acta

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Background: In the ongoing COVID-19 pandemic, there is an urgent need for comprehensive performance evaluation and clinical utility assessment of serological assays to understand the immune response to SARS-CoV-2. Methods: IgM/IgG and total antibodies against SARS-CoV-2 were measured by a cyclic enhanced fluorescence assay (CEFA) and a microsphere immunoassay (MIA), respectively. Independent performance evaluation included imprecision, reproducibility, specificity and cross-reactivity (CEFA n = 320, MIA n = 364). Clinical utility was evaluated by both methods in 87 patients at initial emergency department visit, 28 during subsequent hospitalizations (106 serial samples), and 145 convalescent patients. Totally 916 patients and 994 samples were evaluated. Results: Agreement of CEFA and MIA was 90.4%-94.5% (Kappa: 0.81-0.89) in 302 samples. CEFA and MIA detected SARS-CoV-2 antibodies in 26.2% and 26.3%, respectively, of ED patients. Detection rates increased over time reaching 100% after 21 days post-symptom onset. Longitudinal antibody kinetic changes by CEFA and MIA measurements correlated well and exhibited three types of seroconversion. Convalescent sera showed a wide range of antibody levels. Conclusion: Rigorously validated CEFA and MIA assays are reliable for detecting antibodies to SARS-CoV-2 and show promising clinical utility when evaluating immune response in hospitalized and convalescent patients, but are not useful for early screening at patient's initial ED visit. Respiratory Syndrome Coronavirus (SARS-CoV-2), the cause of COVID-19, is highly contagious and can result in significant mortality among susceptible individuals with comorbidities. Acute symptoms and signs of SARS-CoV-2 infection are highly nonspecific and include fever, cough, fatigue, myalgia, and dyspnea with some patients progressing to

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A Peptide-based Magnetic Chemiluminescence Enzyme Immunoassay for Serological Diagnosis of Corona Virus Disease 2019 (COVID-19)

Cited by 41 publications

References 11 publications

Diagnostic accuracy of serological tests for covid-19: systematic review and meta-analysis

Diagnostic accuracy of serological tests for covid-19: systematic review and meta-analysis

Diagnostic approaches in COVID-19: clinical updates

SARS-CoV-2 antibody characterization in emergency department, hospitalized and convalescent patients by two semi-quantitative immunoassays

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