BioMARIC SARS-CoV-2 Total Ab ELISA

A CE-Marked ELISA for the qualitative detection of Total Antibodies (IgA/IgG/IgM) against SARS-CoV-2 spike (S) protein receptor binding domain (RBD) in human serum and plasma (EDTA, heparin and citrate) samples. For Professional Use.

Documents (IFU, CoA, MSDS)

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Time course viral infection and antibody presence1

1Adapted from Sethuraman, N. et al. (2020). JAMA. Published online May 06, 2020.

Assay Principle

Assay features

  • Short assay time (95 minutes)
  • High throughput ELISA format
  • Broad specimen types (serum, EDTA-, citrate- and heparin-plasma)
  • Sample addition monitoring
  • User-friendly reagents (ready-to-use and colour coded)
  • Outstanding performance
  • Stability of 4 weeks after the first opening

Assay performance

Diagnostic Specificity
4 different countries (#352 samples)

100,0%*

(95% CI: 99,0%-100%)

Diagnostic Sensitivity
>14 days after onset of symptoms (#126 samples)

92,2%*

(95% CI: 95,7%-100,0%)

Cross-reactivity
Infections with common coronaviruses (HKU1, NL63, OC43, and 229E), other respiratory and other potentially cross-reacting pathogens (#34 samples)

No cross-reaction*

Interference
Potentially interfering substances such as lipids, red blood cells, rheumatoid factor, bilirubin (#32 samples negative and 20 samples positive for SARS-CoV-2 Ab)

No interference*

Limit of detection (LoD)
SARS-CoV-2 Ab WHO International standard 20/136

1,64 IU/ml*

Agreement with Performance panels
Standard Performance Panels WHO 20/268, 20/B770 and EURM-017 +18

100,00%*

* Details can be found in the instructions for use of the BioMARIC SARS-CoV-2 Total Ab ELISA