GSD NovaLisa® SARS-CoV-2 (COVID-19) quantitative IgG (96 tests)

New immunoassay for the quantitative and qualitative detection of specific IgG-class antibodies to the spike protein of SARS-CoV-2. It is intended to aid in the diagnosis of patients suspected of having COVID-19 disease or asymptomatic presentation of SARS-CoV-2, to monitor antibody levels during and after a COVID-19 infection, and to determine antibody levels before and after a COVID-19 vaccination.

• Quantitative determination of antibodies to the SARS-CoV-2 spike (S) protein
• Trimeric SARS-CoV-2 Spike antigen
• Intended as an aid to evaluate patients immune status and determine vaccine efficacy
• Calibrators correlate to First WHO International Standards for SARS-CoV-2
• Diagnostic sensitivity and specificity of 99.94% and 99.49% respectively
• Validated for serum, plasma, and finger prick (serum from capillary blood) samples
• CE-IVD

Excellent clinical performance: Diagnostic sensitivity and specificity of 99.94% and 100% respectively. These results were determined by carrying out a study with 392 samples from healthy blood donors, and 146 samples from COVID-19 RT-PCR confirmed patients (> 15 days after symptom onset).

International Standards: The calibrators included in the kit correlate to the “First WHO International Standard Anti-SARS-CoV-2 Immunoglobulin” NIBSC code: 20/136, recognised as the highest order of reference materials for biological substances.

Kit Contents: Microtiter plate, Sample Dilution Buffer, Citrate Stop Solution, Washing Buffer, Conjugate, TMB Substrate
Solution, Standards x 5, Negative and Positive Controls.