Diagnostic Performance of Three Serological Assays for Anti-SARS-CoV-2 Antibody Detection

Abstract: Objective: To evaluate the diagnostic performance of Electrochemiluminescence (ECLIA) enzyme linked immunosorbent (ELISA) and lateral flow Immunofluorescence (LFIA) for anti-SARS-COV-2 antibody detection. Materials and Methods: Sensitivity was calculated with convalescent plasma (CP) donor’s samples. Specificity was checked by using pre-pandemic October 2019 samples. All samples were tested for anti-SARS-COV-2 antibody by using Electrochemiluminescence (ECLIA), Enzyme Linked Immunosorbent Assay (ELISA) and Lateral flow Immunofluorescence (LFIA) assay. Results: Total 55 patients were included, 45 patients were CP donors and 10 were Pre-Pandemic October 2019 samples archived from our blood bank. The ECLIA-total antibody, ELISA-IgG and LLFIA-IgG were positive in 41 (91.1%), 34 (75.5%) and 44 (97.75%) respectively. The highest sensitivity was observed for LFIA with highest specificity among all three assays. There was almost perfect agreement between LFIA and ECLIA (k=0.936, p<0.001) but there was fair agreement between LFIA and ELISA (k=0.412, p=0.001) and ECLIA and ELISA (k=0.357, p=0.001). Conclusion: The LFIA showed a higher sensitivity and specificity in comparison with ECLIA and ELISA. It might be due to fact that LFIA detect antibody against ncleocapsid and spike protein as well of SARS- COV-2 virus, while ECLIA and ELISA detects antibodies only against “N” Protein of SARS- COV-2 virus. Keywords: Convalescent plasma donors, Lateral flow Immunofluorescence assay, Electrochemiluminescence assay, Enzyme linked immunosorbent assay, Performance.

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A Comparative Study of Assay Performance of Commercial Hepatitis E Virus Enzyme-Linked Immunosorbent Assay Kits in Australian Blood Donor Samples

Journal of Blood Transfusion ◽

10.1155/2016/9647675 ◽

2016 ◽

Vol 2016 ◽

pp. 1-6 ◽

Cited By ~ 14

Author(s):

Ashish C. Shrestha ◽

Robert L. P. Flower ◽

Clive R. Seed ◽

Susan L. Stramer ◽

Helen M. Faddy

Keyword(s):

Blood Donor ◽

Disease Burden ◽

Hepatitis E Virus ◽

Hepatitis E ◽

Antibody Detection ◽

Enzyme Linked Immunosorbent Assay ◽

Poor Agreement ◽

Igm Elisa ◽

Assay Performance ◽

Antibody Elisa

Hepatitis E virus (HEV) is transfusion-transmissible and therefore poses a risk to blood transfusion safety. Seroprevalence studies are useful for estimating disease burden and determining risk factors. Considerable variability in the sensitivity of HEV antibody detection assays exists. This study aimed to compare the performances of commercially available HEV enzyme-linked immunosorbent assays (ELISA) in Australian blood donor samples. Plasma samples that tested positive (n=194) or negative (n=200) for HEV IgG (Wantai HEV IgG ELISA) were selected. Of the 194 HEV IgG positive samples, 4 were positive for HEV IgM (Wantai HEV IgM ELISA). All samples were tested with the MP Diagnostics: HEV IgG ELISA, total (IgG, IgM, and IgA) HEV antibody ELISA, and HEV IgM ELISA. Of the 194 Wantai HEV IgG positive samples, 92 (47%) tested positive with the MP Diagnostics HEV IgG ELISA (κ=0.47) and 126 (65%) with MP Diagnostics total HEV antibody assay (κ=0.65). There was poor agreement between Wantai and MP Diagnostics HEV IgM assays. This study demonstrated poor agreement between the assays tested. These observations are consistent with previous reports demonstrating significant variability between HEV ELISAs, highlighting that results of HEV serology should be interpreted with caution.

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Use of the COOH Portion of the Nucleocapsid Protein in an Antigen-Capturing Enzyme-Linked Immunosorbent Assay for Specific and Sensitive Detection of Severe Acute Respiratory Syndrome Coronavirus

Clinical and Diagnostic Laboratory Immunology ◽

10.1128/cdli.12.3.474-476.2005 ◽

2005 ◽

Vol 12 (3) ◽

pp. 474-476 ◽

Cited By ~ 9

Author(s):

Maofeng Qiu ◽

Jin Wang ◽

Hongxia Wang ◽

Zeliang Chen ◽

Erhei Dai ◽

...

Keyword(s):

Amino Acids ◽

Severe Acute Respiratory Syndrome ◽

Epidemiological Study ◽

Immunosorbent Assay ◽

Nucleocapsid Protein ◽

Antibody Detection ◽

Enzyme Linked Immunosorbent Assay ◽

Sars Coronavirus ◽

Specific Test ◽

N Protein

ABSTRACT Antibody detection with a recombinant COOH portion of the severe acute respiratory syndrome (SARS) coronavirus nucleocapsid (N) protein, N13 (amino acids 221 to 422), was demonstrated to be more specific and sensitive than that with the full-length N protein, and an N13-based antigen-capturing enzyme-linked immunosorbent assay providing a convenient and specific test for serodiagnosis and epidemiological study of SARS was developed.

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Development of an Enzyme-Linked Immunosorbent Assay-Based Test with a Cocktail of Nucleocapsid and Spike Proteins for Detection of Severe Acute Respiratory Syndrome-Associated Coronavirus-Specific Antibody

Clinical and Vaccine Immunology ◽

10.1128/cvi.00252-08 ◽

2008 ◽

Vol 16 (2) ◽

pp. 241-245 ◽

Cited By ~ 8

Author(s):

Luis G. Giménez ◽

Jose Rojas ◽

Almudena Rojas ◽

Joaquín Mendoza ◽

Ana G. Camacho

Keyword(s):

Severe Acute Respiratory Syndrome ◽

Immunosorbent Assay ◽

Immunofluorescence Assay ◽

Antibody Detection ◽

Enzyme Linked Immunosorbent Assay ◽

Recombinant Polypeptide ◽

Igm Antibody ◽

Set Up ◽

The Individual ◽

Recombinant Polypeptides

ABSTRACT A new enzyme-linked immunosorbent assay (ELISA)-based immunoglobulin G (IgG)-plus-IgM antibody detection test for severe acute respiratory syndrome (SARS) has been developed by using a cocktail of four recombinant polypeptides as the antigen. These recombinant fragments were designed as parts of two different structural proteins from SARS-associated coronavirus (SARS-CoV). One recombinant polypeptide, S251-683, was designed as part of the spike glycoprotein, and the other three polypeptides comprised almost the whole nucleocapsid protein, avoiding the last 25 C-terminal amino acids. Immunization with a cocktail of these four polypeptides yielded a specific polyclonal antibody that is able to recognize SARS-CoV-infected cells by an immunofluorescence assay. This polypeptide cocktail was also used to set up an ELISA-based IgG-plus-IgM antibody detection test, which showed 99% specificity and 90% sensitivity upon evaluation using sera from 100 healthy negative controls and 20 SARS patients. Separate immunoreactivity assays with each recombinant polypeptide demonstrated that a combination of N and S protein fragments was more suitable than the individual peptides for developing a serological assay for SARS-CoV.

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Comparative Analysis of the Euroimmun CXCL13 Enzyme-Linked Immunosorbent Assay and the ReaScan Lateral Flow Immunoassay for Diagnosis of Lyme Neuroborreliosis

Journal of Clinical Microbiology ◽

10.1128/jcm.00207-20 ◽

2020 ◽

Vol 58 (9) ◽

Author(s):

Katharina Ziegler ◽

Anca Rath ◽

Christoph Schoerner ◽

Renate Meyer ◽

Thomas Bertsch ◽

...

Keyword(s):

Immunosorbent Assay ◽

Roc Curve ◽

Point Of Care ◽

Lateral Flow ◽

Lyme Neuroborreliosis ◽

Diagnostic Tools ◽

Lateral Flow Immunoassay ◽

Enzyme Linked Immunosorbent Assay ◽

European Federation ◽

Point Of Care Test

ABSTRACT Diagnosis of Lyme neuroborreliosis (LNB) is challenging, as long as Borrelia-specific intrathecal antibodies are not yet detectable. The chemokine CXCL13 is elevated in the cerebrospinal fluid (CSF) of LNB patients. Here, we compared the performances of the Euroimmun CXCL13 enzyme-linked immunosorbent assay (CXCL13 ELISA) and the ReaScan CXCL13 lateral flow immunoassay (CXCL13 LFA), a rapid point-of-care test, to support the diagnosis of LNB. In a dual-center case-control study, CSF samples from 90 patients (34 with definite LNB, 10 with possible LNB, and 46 with other central nervous system [CNS] diseases [non-LNB group]) were analyzed with the CXCL13 ELISA and the CXCL13 LFA. Classification of patients followed the European Federation of Neurological Societies (EFNS) guidelines on LNB. The CXCL13 ELISA detected elevated CXCL13 levels in all patients with definite LNB (median, 1,409 pg/ml) compared to the non-LNB controls (median, 20.7 pg/ml; P < 0.0001), with a sensitivity of 100% and a specificity of 84.8% (cutoff value, 78.6 pg/ml; area under the receiver operating characteristic [ROC] curve, 0.93). Similarly, the CXCL13 LFA yielded elevated CXCL13 levels in 31 patients with definite LNB (median arbitrary value, 223.5) compared to the non-LNB control patients (median arbitrary value, 0; P < 0.0001) and had a sensitivity and specificity of 91.2% and 93.5%, respectively (cutoff arbitrary value, 22.5; area under the ROC curve, 0.94). The correlation between the CXCL13 levels obtained by ELISA and LFA was strong (Spearman correlation coefficient r = 0.89; P < 0.0001). The CXCL13 ELISA and the CXCL13 LFA are comparable diagnostic tools for the detection of CXCL13 in the CSF of patients with definite LNB. The advantage of the CXCL13 LFA is the shorter time to result.

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