Performance of two rapid point of care SARS-COV-2 antibody assays against laboratory-based automated chemiluminescent immunoassays for SARS-COV-2 IG-G, IG-M and total antibodies

Lau, Chin Shern; Hoo, S.P.; Liang, YL; Phua, Soon Kieng; Aw, Tar Choon

doi:10.1016/j.plabm.2021.e00201

Cited by 6 publications

(7 citation statements)

References 33 publications

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“…Although by themselves, the assay sensitivities are still insufficient for diagnosis even with optimized LORs, they can greatly improve the performance of antibody tests when used with another test in an orthogonal fashion. For example, when using lateral-flow immunoassays with sensitivities of 49.3% and specificities of 94.3%, the combined positive predictive value when used with an antigen test (sensitivity 56.2% and specificity of 99.5%) can be as high as 83.0% in a population with a disease prevalence of 0.5% [ 29 ]. As such, the use of optimized LORs in antibody testing will be a great boon should antibody tests be used in conjunction with RT-PCR testing, especially in areas of low disease prevalence.…”

Section: Discussionmentioning

confidence: 99%

Performance of the Roche/Snibe electrochemiluminescent anti-SARS-COV-2 spike assays compared to the Roche/Abbott IgG nucleocapsid and Abbott IgM spike assays

Lau

Wong

Hoo

et al. 2021

Practical Laboratory Medicine

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Section: Discussionmentioning

confidence: 99%

Performance of the Roche/Snibe electrochemiluminescent anti-SARS-COV-2 spike assays compared to the Roche/Abbott IgG nucleocapsid and Abbott IgM spike assays

Lau

Wong

Hoo

et al. 2021

Practical Laboratory Medicine

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“…However, there were no positive SARS-CoV-2 PCR tests among subjects with a reactive IgM test result. Reported sensitivities and specificities of the ST range from 60.7 to 98.7% and from 98.1 to 100%, respectively, in the literature [ 6 , 7 , 8 , 9 ]. However, regarding the use of finger prick testing, there are very limited data available.…”

Section: Methodsmentioning

confidence: 99%

Screening and Confirmatory Testing for SARS-CoV-2 Antibodies: Comparison of Health and Non-Health Workers in a Nationwide Healthcare Organization in Central Europe

Bartko

Zehetmayer

Weseslindtner

et al. 2021

JCM

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Despite being located close to the European epicenter of the COVID-19 pandemic in Italy, Austria has managed to control the first wave. In Austria, the largest health insurance fund covers 7 million people and has 12,000 employees, including 3700 healthcare workers (HCW). For patient and staff safety, transmission control measures were implemented and mass testing of employees for SARS-CoV-2 antibodies was conducted. An IgG SARS-CoV-2 rapid test on fingerstick blood was used as a screening test (ST), followed by serologic studies with 3 different immunoassays and confirmatory testing by a neutralization test (NT). Among 7858 employees, 144 had a positive ST and 88 were confirmed by a NT (1.12%, CI: 0.9–1.38%). The positive predictive value (PPV) of the ST was 69.3% (CI: 60.5–77.2). Interestingly, 40% of the NT positive serum samples were tested negative in all 3 immunoassays. Of the total sample, 2242 HCW (28.5%) were identified. Unexpectedly, there was no difference in the prevalence of NT positives in HCW compared to non-HCW (23/2242 vs. 65/5301, p = 0.53). SARS-CoV-2 antibody prevalence was not increased among HCW. Although HCW are at potentially increased risk for SARS-CoV-2 infection, transmission control measures in healthcare facilities appear sufficient to limit transmission of infection.

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“…Our findings showed much lower sensitivity of both tests. Lau et al (2021) evaluated two POCT Panbio and Roche. They displayed high specificity and sensitivity for Panbio and Roche of (98.7%, 97.2%) and (100%, 97.2%) respectively [35].…”

Section: Previousmentioning

confidence: 99%

“…Lau et al (2021) evaluated two POCT Panbio and Roche. They displayed high specificity and sensitivity for Panbio and Roche of (98.7%, 97.2%) and (100%, 97.2%) respectively [35]. Our findings were closely similar to Roche test but were much lower for Panbio.…”

Section: Previousmentioning

confidence: 99%

Comparative Evaluation of SARS-CoV-2 Rapid Immunochromatographic Test Assays with Chemiluminescent Immunoassay for the Diagnosis of COVID-19

Ismail

Halim

Mostafa

et al. 2021

Open Access Maced J Med Sci

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Background To date, the molecular assay is the gold-standard method for COVID-19 diagnosis. However, they are expensive and complex. There is a pressing necessity for developing other effective diagnostics for SARS‐CoV‐2 patients. Therefore, serological detection of antibodies against SARS‐CoV‐2 might provide a good alternative. Aim We aimed to compare and evaluate seven rapid diagnostic tests with Mindray chemiluminescent automated immunoassay as a reference method for SARS-CoV-2 antibodies detection. Methods: This study included the serum of a total of 49 attendees to the Reference Laboratory of Egyptian university hospitals during the period from April 2021 to May 2021. Anti-Covid-19 antibodies detection in serum samples was performed by Mindray fully automated system as our reference method and seven rapid antibody tests; Wondfo, Vazyme, Dynamiker, Panbio, Artron Maccura and Roche. Results: The chemiluminescent assay revealed 30 (61.2%) positive samples and 19 (38.8%) negative samples for COVID-19 IgG. For COVID-19 IgM, 11 (22.4%) samples were positive and 38 (77.6%) samples were negative. Anti-SARS-CoV-2 antibodies were not detected in any of the PCR negative individuals. The best diagnostic performance was demonstrated by Roche IgG and IgM, and Vazyme IgG and IgM antibody tests followed by Panbio. For Roche, the sensitivity and specificity for IgG and IgM were (83.3%, 89.5%) and (72.7%, 81.6%) respectively. Vazyme showed sensitivity and specificity for IgG and IgM were (77.8%, 85.7%) and (75%, 91.7%) respectively. Regards Panbio, the sensitivity and specificity for IgG and IgM were (63.6%, 87.5%) and (50%, 86.7%) respectively. Cohen’s Kappa values revealed a substantial agreement for Roche IgG, Vazyme IgG and IgM of (0.7076, 0.6250, 0.6667) respectively. The worst agreement was reported for Maccura IgG, Wondfo, and Dynamiker IgM with Cohen’s Kappa values of (0.2508, 0.1893, 0.0313) respectively. Conclusions: Rapid tests in our study exhibited heterogeneous diagnostic performances. Roche, Vazyme, and Panbio antibody tests showed promising results in concordance with our reference method with the best-reported results. On the other hand, the other tests were inferior and failed in providing valid and reliable results. Further studies are necessary to determine the practicality of these tests in different settings and communities.

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Performance of two rapid point of care SARS-COV-2 antibody assays against laboratory-based automated chemiluminescent immunoassays for SARS-COV-2 IG-G, IG-M and total antibodies

Cited by 6 publications

References 33 publications

Performance of the Roche/Snibe electrochemiluminescent anti-SARS-COV-2 spike assays compared to the Roche/Abbott IgG nucleocapsid and Abbott IgM spike assays

Performance of the Roche/Snibe electrochemiluminescent anti-SARS-COV-2 spike assays compared to the Roche/Abbott IgG nucleocapsid and Abbott IgM spike assays

Screening and Confirmatory Testing for SARS-CoV-2 Antibodies: Comparison of Health and Non-Health Workers in a Nationwide Healthcare Organization in Central Europe

Comparative Evaluation of SARS-CoV-2 Rapid Immunochromatographic Test Assays with Chemiluminescent Immunoassay for the Diagnosis of COVID-19

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