Comparison of diagnostic accuracies of rapid serological tests and ELISA

September 8, 2020

Comparison of diagnostic accuracies of rapid serological tests and ELISA to molecular diagnostics in patients with suspected coronavirus disease 2019 presenting to the hospital

Objectives: To assess the diagnostic performance of rapid lateral flow immunochromatographic assays (LFAs) compared with an ELISA and nucleic acid amplification tests (NATs) in individuals with suspected coronavirus disease 2019 (COVID-19).
Methods: Patients presenting to a Dutch teaching hospital were eligible between 17 March and 10 April 2020, when they had respiratory symptoms that were suspected for COVID-19. The performances of six different LFAs were evaluated in plasma samples obtained on corresponding respiratory sample dates of NATs testing. Subsequently, the best performing LFA was evaluated in 228 patients and in 50 sera of a historical patient control group.
Results: In the pilot analysis, sensitivity characteristics of LFA were heterogeneous, ranging from 2/20 (10%; 95% CI 0%-23%) to 11/20 (55%; 95% CI 33%-77%). In the total cohort, Orient Gene Biotech COVID-19 IgG/IgM Rapid Test LFA had a sensitivity of 43/99 (43%; 95% CI 34%-53%) and specificity of 126/129 (98%; 95% CI 95%-100%).
Sensitivity increased to 31/52 (60%; 95% CI 46%-73%) in patients with at least 7 days of symptoms, and to 21/33 (64%; 95% CI 47%-80%) in patients with C-reactive protein (CRP) ≥100 mg/L. Sensitivity and specificity of Wantai SARS-CoV-2 Ab ELISA was 59/95 (62%; 95% CI 52%-72%) and 125/128 (98%; 95% CI 95%-100%) in all patients, respectively, but sensitivity increased to 38/48 (79%; 95% CI 68%-91%) in patients with at least 7 days of symptoms.
Conclusions: There is large variability in diagnostic test performance between rapid LFAs, but overall limited sensitivity and high specificity in acutely admitted patients. Sensitivity improved in patients with longer existing symptoms or high CRP. LFAs should only be considered as additional triage tools when these may lead to the improvement of hospital logistics.
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EUR 560
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SYK Assay Kit
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SRC Assay Kit
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EUR 535
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80210 96 rxns.
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Description: Tissue Extract, Cultured Cells

Diagnostic performance of seven rapid IgG/IgM antibody tests and the Euroimmun IgA/IgG ELISA in COVID-19 patients

Objectives: To evaluate the diagnostic performance of seven rapid IgG/IgM tests and the Euroimmun IgA/IgG ELISA for antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in COVID-19 patients.
Methods: Specificity was evaluated in 103 samples collected before January 2020. Sensitivity and time to seropositivity was evaluated in 167 samples from 94 patients with COVID-19 confirmed with RT-PCR on nasopharyngeal swab.
Results: Specificity (confidence interval) of lateral flow assays (LFAs) was ≥91.3% (84.0-95.5) for IgM, ≥90.3% (82.9-94.8) for IgG, and ≥85.4% (77.2-91.1) for the combination IgM OR IgG. Specificity of the ELISA was 96.1% (90.1-98.8) for IgG and only 73.8% (64.5-81.4) for IgA. Sensitivity 14-25 days after the onset of symptoms was between ≥92.1% (78.5-98.0) and 100% (95.7-100) for IgG LFA compared to 89.5% (75.3-96.4) for IgG ELISA. Positivity of IgM OR IgG for LFA resulted in a decrease in specificity compared to IgG alone without a gain in diagnostic performance, except for VivaDiag.
The results for IgM varied significantly between the LFAs with an average overall agreement of only 70% compared to 89% for IgG. The average dynamic trend to seropositivity for IgM was not shorter than for IgG. At the time of hospital admission the sensitivity of LFA was <60%.
Conclusions: Sensitivity for the detection of IgG antibodies 14-25 days after the onset of symptoms was ≥92.1% for all seven LFAs compared to 89.5% for the IgG ELISA. The results for IgM varied significantly, and including IgM antibodies in addition to IgG for the interpretation of LFAs did not improve the diagnostic performance.

Association of Genetic Polymorphisms Related to Johne’s Disease With Estimated Breeding Values of Holstein Sires for Milk ELISATest Scores

Background: Johne’s disease (JD) is a chronic intestinal inflammatory disease caused by Mycobacterium avium subsp. paratuberculosis (MAP) infection in ruminants. Since there are currently no effective vaccine or treatment options available to control JD, genetic selection may be an alternative strategy to enhance JD resistance.
Numerous Single Nucleotide Polymorphisms (SNPs) have been reported to be associated with MAP infection status based on published genome-wide association and candidate gene studies. The main objective of this study was to validate these SNPs that were previously identified to be associated with JD by testing their effect on Holstein bulls’ estimated breeding values (EBVs) for milk ELISA test scores, an indirect indicator of MAP infection status in cattle.
Results: Three SNPs, rs41810662, rs41617133 and rs110225854, located on Bos taurus autosomes (BTA) 16, 23 and 26, respectively, were confirmed as significantly associated with Holstein bulls’ EBVs for milk ELISA test score (FDR < 0.01) based on General Quasi Likelihood Scoring analysis (GQLS) analysis. Single-SNP regression analysis identified four SNPs that were associated with sire EBVs (FDR < 0.05).
This includes two SNPs that were common with GQLS (rs41810662 and rs41617133), with the other two SNPs being rs110494981 and rs136182707, located on BTA9 and BTA16, respectively.
Conclusions: The findings of this study validate the association of SNPs with JD MAP infection status and highlight the need to further investigate the genomic regions harboring these SNPs.

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CSB-PA153658-100ul 100ul
EUR 379.2
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ICK (Ab-159) Conjugated Antibody
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Rabbit polyclonal ICK (Ab-159) antibody
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Anti-V5 Antibody
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Anti-AU1 Antibody
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18820-01 100ug
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18830-01 100ug
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34041 100ug
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12403 100ug
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12403-100 100ug
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Anti-DNA Antibody
12403-1000 1mg
EUR 903

Anti-DNA Antibody
12403-500 500ug
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12404 100ug
EUR 230

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12404-100 100ug
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12404-1000 1mg
EUR 903

Anti-DNA Antibody
12404-500 500ug
EUR 460

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13012 100ug
EUR 518

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13014 100ug
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13016 100ug
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13018 100ug
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56209 100ug
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56248 100ug
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57011 100ug
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57012 100ug
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57013 100ug
EUR 606

Anti-BRCAA1 Antibody
34022 100ug
EUR 376

Anti-MADD Antibody
1150 100ug
EUR 445

Anti-ASK1 Antibody
1151 100ug
EUR 445

Anti-SUR1 Antibody
11567 100ug
EUR 466

Anti-KDEL Antibody
11076-200 200ug
EUR 700

Anti-HDEL Antibody
11077 100ug
EUR 479

Anti-HSF2 Antibody
11105 100ug
EUR 400

Anti-Aha1 Antibody
11140 100ug
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13911 100ug
EUR 503

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2115 100ug
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2117 100ug
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Anti-IKKα Antibody
2025 100ug
EUR 445

Anti-PDRG Antibody
34012 100ug
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Anti-WWOX Antibody
34016 100ug
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Anti-DOG1 Antibody
34036 100ug
EUR 372

Anti-HGAL Antibody
34044 100ug
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Anti-ROR2 Antibody
34045 100ug
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Anti-CD57 Antibody
34054 100ul
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Anti-PSAP Antibody
34070 100ul
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Anti-IDH1 Antibody
34074 100ul
EUR 308

Anti-MLH1 Antibody
34077 100ul
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Anti-DcR2 Antibody
2419 100ug
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28105 100ug
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28107 100ug
EUR 384

Anti-KOS1 Antibody
28108 100ug
EUR 384