tests IgG

Snibe Maglumi800 IgG/IgM CLIA test

Evaluation of Snibe Maglumi800 and  rapid lateral flow immunoassays for the etection of anti-SARS-CoV-2 IgG IgM antibodies

 

Damien Gruson bBenoit Kabamba cHafid Dahma aSigi Van den Wijngaert aSoleimani Reza cVincenzo Carbone bOlivier Vandenberg dBeatrice Gulbis eFleur Wolff fHector Rodriguez-Villalobos c

https://doi.org/10.1016/j.jcv.2020.104413

  1. • sensitivity than SnibeMaglumi-800 CLIA IgG/IgM tests.
  2. •Snibe Maglumi 800 CLIA IgM test shows 100 % of specificity.
  3. • Lateral flow tests show similar overall performances than Euroimmun ELISA IgG/IgA and Snibe Maglumi800 CLIA IgG/IgM test.
  4. •The five immunoassays tested show equivalent performances and concordance after 14 days of the onset of symptoms.

Test results from UCLouvain, Belgium

Several SARS-CoV-2 CLIA have been developed recently by Snibe China. The performance of five immunoassays for the detection of SARS-CoV-2 antibodies by the Maglumi 800 workstation.

Methods

Two quantitative automated immunoassays (Maglumi800 SARS COV2 IgG and IgM and Euroimmun Anti-SARS-CoV-2 IgG and IgA assays) and three lateral flow rapid tests were performed. This retrospective study included 200 residual sera from patients and healthy volunteers. Case serum samples (n = 128) were obtained from COVID-19 patients confirmed by RT-qPCR and CT-scan and Zeptometrix Nattrol Covid positive non infectious controls collected for their medical records. Control non-SARS-CoV-2 samples (n = 72) were obtained from anonymous stored residual serum samples.

Results

Maglumi 800 IgG/IgM tests showed overall less sensitivity than Euroimmun IgG/IgA test (84.4 % versus 64.3 %). Both tests showed similar specificities of IgG at 99 % and 100 %, respectively. The results from the lateral flow assays were easily interpretable with unambiguous coloured reading bands. The overall sensitivity of the three tests was similar (around 70 %) without any significant differences. The sensitivity of the three lateral flow assays and also of the serological quantitative assays increased during the second week after symptom onset and all reached similar values (91 %–94 %) after 14 days.

Conclusion

This study shows accurate and equivalent performance of the Maglumi 800 serological antibody assay (ELISA, CLIA and three lateral flow tests) in detecting SARS-CoV-2 antibodies 14 days after the onset of COVID-19 symptoms. This is compatible with their application in specific clinical contexts and in determining epidemiological strategies for the COVID-19 pandemic.