Serological Determinants of COVID-19

Abstract Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection spreaded rapidly worldwide, as far as it has become a global pandemic. Therefore, the introduction of serological tests useful for the determination of IgM and IgG antibodies, it has become the main diagnostic tool, useful for tracking the spread of the virus and consequently its containment. In our study we compared point of care test (POCT) lateral flow immunoassay (FIA) vs automated chemiluminescent immunoassay (CLIA), in order to assess their specificity and sensibility against COVID-19 antibodies detection. Results: We find that different specificities and sensitivities for IgG and IgM tests. Notably IgM POCT FIA method vs CLIA method (gold standard) has a low sensitivity (0.526), while POCT FIA method vs CLIA method (gold standard) test has a much higher sensitivity (0.937); further, with respect of IgG, FIA and CLIA could arguably provide the same information. Conclusions: FIA method could be helpful in assessing in short time, the possible contagiousness of subjects that for work reasons cannot guarantee “social distancing”.

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Serological determinants of COVID-19

Biology Direct ◽

10.1186/s13062-020-00276-1 ◽

2020 ◽

Vol 15 (1) ◽

Author(s):

Annalisa Noce ◽

Maria Luisa Santoro ◽

Giulia Marrone ◽

Cartesio D’Agostini ◽

Ivano Amelio ◽

...

Keyword(s):

Gold Standard ◽

Point Of Care ◽

Standard Test ◽

Serological Tests ◽

Point Of Care Test ◽

Global Pandemic ◽

Chemiluminescent Immunoassay ◽

Low Sensitivity ◽

Short Time

Abstract Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection spreaded rapidly worldwide, as far as it has become a global pandemic. Therefore, the introduction of serological tests for determination of IgM and IgG antibodies has become the main diagnostic tool, useful for tracking the spread of the virus and for consequently allowing its containment. In our study we compared point of care test (POCT) lateral flow immunoassay (FIA) vs automated chemiluminescent immunoassay (CLIA), in order to assess their specificity and sensibility for COVID-19 antibodies detection. Results We find that different specificities and sensitivities for IgM and IgG tests. Notably IgM POCT FIA method vs CLIA method (gold standard) has a low sensitivity (0.526), while IgG POCT FIA method vs CLIA method (gold standard) test has a much higher sensitivity (0.937); further, with respect of IgG, FIA and CLIA could arguably provide equivalent information. Conclusions FIA method could be helpful in assessing in short time, the possible contagiousness of subjects that for work reasons cannot guarantee “social distancing”.

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Recent Advances in the Evaluation of Serological Assays for the Diagnosis of SARS-CoV-2 Infection and COVID-19

Frontiers in Public Health ◽

10.3389/fpubh.2020.620222 ◽

2021 ◽

Vol 8 ◽

Author(s):

Angela Chiereghin ◽

Rocco Maurizio Zagari ◽

Silvia Galli ◽

Alessandra Moroni ◽

Liliana Gabrielli ◽

...

Keyword(s):

Point Of Care ◽

Standard Test ◽

Enzyme Linked Immunosorbent Assay ◽

Nasopharyngeal Swab ◽

Pcr Assay ◽

Serological Tests ◽

Retrospective Diagnosis ◽

Specific Igg ◽

Low Sensitivity ◽

Few Data

Introduction: Few data on the diagnostic performance of serological tests for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection are currently available. We evaluated sensitivity and specificity of five different widely used commercial serological assays for the detection of SARS-CoV-2–specific IgG, IgM, and IgA antibodies using reverse transcriptase-PCR assay in nasopharyngeal swab as reference standard test.Methods: A total of 337 plasma samples collected in the period April–June 2020 from SARS-CoV-2 RT-PCR positive (n = 207) and negative (n = 130) subjects were investigated by one point-of-care lateral flow immunochromatographic assay (LFIA IgG and IgM, Technogenetics) and four fully automated assays: two chemiluminescence immunoassays (CLIA-iFlash IgG and IgM, Shenzhen YHLO Biotech and CLIA-LIAISON® XL IgG, DiaSorin), one electrochemiluminescence immunoassay (ECLIA-Elecsys® total predominant IgG, Roche), and one enzyme-linked immunosorbent assay (ELISA IgA, Euroimmune).Results: The overall sensitivity of all IgG serological assays was >80% and the specificity was >97%. The sensitivity of IgG assays was lower within 2 weeks from the onset of symptoms ranging from 70.8 to 80%. The LFIA and CLIA-iFlash IgM showed an overall low sensitivity of 47.6 and 54.6%, while the specificity was 98.5 and 96.2%, respectively. The ELISA IgA yielded a sensitivity of 84.3% and specificity of 81.7%. However, the ELISA IgA result was indeterminate in 11.7% of cases.Conclusions: IgG serological assays seem to be a reliable tool for the retrospective diagnosis of SARS-CoV-2 infection. IgM assays seem to have a low sensitivity and IgA assay is limited by a substantial rate of indeterminate results.

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Immediate determination of ACPA and rheumatoid factor - a novel point of care test for detection of anti-MCV antibodies and rheumatoid factor using a lateral-flow immunoassay

Arthritis Research & Therapy ◽

10.1186/ar3057 ◽

2010 ◽

Vol 12 (3) ◽

pp. R120 ◽

Cited By ~ 18

Author(s):

Franziska Renger ◽

Holger Bang ◽

Eugen Feist ◽

Gert Fredenhagen ◽

Alexander Natusch ◽

...

Keyword(s):

Rheumatoid Factor ◽

Point Of Care ◽

Lateral Flow ◽

Lateral Flow Immunoassay ◽

Point Of Care Test

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Point-of-Care Test for Detection of Urogenital Chlamydia in Women Shows Low Sensitivity. A Performance Evaluation Study in Two Clinics in Suriname

PLoS ONE ◽

10.1371/journal.pone.0032122 ◽

2012 ◽

Vol 7 (2) ◽

pp. e32122 ◽

Cited By ~ 40

Author(s):

Jannie J. van der Helm ◽

Leslie O. A. Sabajo ◽

Antoon W. Grunberg ◽

Servaas A. Morré ◽

Arjen G. C. L. Speksnijder ◽

...

Keyword(s):

Performance Evaluation ◽

Point Of Care ◽

Evaluation Study ◽

Point Of Care Test ◽

Low Sensitivity ◽

A Performance

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Comparison between B·R·A·H·M·S PCT direct, a new sensitive point-of-care testing device for rapid quantification of procalcitonin in emergency department patients and established reference methods – a prospective multinational trial

Clinical Chemistry and Laboratory Medicine (CCLM) ◽

10.1515/cclm-2015-0437 ◽

2016 ◽

Vol 54 (4) ◽

Cited By ~ 14

Author(s):

Alexander Kutz ◽

Pierre Hausfater ◽

Michael Oppert ◽

Murat Alan ◽

Eva Grolimund ◽

...

Keyword(s):

Emergency Department ◽

Diagnostic Accuracy ◽

Whole Blood ◽

Point Of Care ◽

Venous Blood ◽

Reference Method ◽

Point Of Care Test ◽

Emergency Department Patients ◽

Work Up

AbstractProcalcitonin (PCT) is increasingly being used for the diagnostic and prognostic work up of patients with suspected infections in the emergency department (ED). Recently, B·R·A·H·M·S PCT direct, the first high sensitive point-of-care test (POCT), has been developed for fast PCT measurement on capillary or venous blood samples.This is a prospective, international comparison study conducted in three European EDs. Consecutive patients with suspicion of bacterial infection were included. Duplicate determination of PCT was performed in capillary (fingertip) and venous whole blood (EDTA), and compared to the reference method. The diagnostic accuracy was evaluated by correlation and concordance analyses.Three hundred and three patients were included over a 6-month period (60.4% male, median age 65.2 years). The correlation between capillary or venous whole blood and the reference method was excellent: rThis study found a high diagnostic accuracy and a faster time to result of B·R·A·H·M·S PCT direct in the ED setting, allowing shortening time to therapy and a more wide-spread use of PCT.

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Multicentre evaluation of a new point-of-care test for the determination of CK-MB in whole blood

Clinical Chemistry and Laboratory Medicine (CCLM) ◽

10.1515/cclm.2008.127 ◽

2008 ◽

Vol 46 (5) ◽

Cited By ~ 1

Author(s):

Evangelos Giannitsis ◽

Hannsjörg Baum ◽

Thomas Bertsch ◽

Martin Juchum ◽

Margit Müller-Bardorff ◽

...

Keyword(s):

Whole Blood ◽

Point Of Care ◽

Point Of Care Test

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COVID-19 Serological Tests: How Well Do They Actually Perform?

Diagnostics ◽

10.3390/diagnostics10070453 ◽

2020 ◽

Vol 10 (7) ◽

pp. 453 ◽

Cited By ~ 13

Author(s):

Abdi Ghaffari ◽

Robyn Meurant ◽

Ali Ardakani

Keyword(s):

Diagnostic Tests ◽

Public Health Policy ◽

Point Of Care ◽

Serological Testing ◽

Serological Tests ◽

Actual Performance ◽

Mortality And Morbidity ◽

Global Pandemic ◽

Initial Discovery ◽

Significant Mortality

In only a few months after initial discovery in Wuhan, China, SARS-CoV-2 and the associated coronavirus disease 2019 (COVID-19) have become a global pandemic causing significant mortality and morbidity and implementation of strict isolation measures. In the absence of vaccines and effective therapeutics, reliable serological testing must be a key element of public health policy to control further spread of the disease and gradually remove quarantine measures. Serological diagnostic tests are being increasingly used to provide a broader understanding of COVID-19 incidence and to assess immunity status in the population. However, there are discrepancies between claimed and actual performance data for serological diagnostic tests on the market. In this study, we conducted a review of independent studies evaluating the performance of SARS-CoV-2 serological tests. We found significant variability in the accuracy of marketed tests and highlight several lab-based and point-of-care rapid serological tests with high levels of performance. The findings of this review highlight the need for ongoing independent evaluations of commercialized COVID-19 diagnostic tests.

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