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RAPID SARS-CoV-2-IgG-QUANTITATIVE ELISA
Registration Certificate № RZN 2024/21 939
Enzyme-Linked Immunosorbent Assay for the quantitative detection of IgG antibodies to the receptor-binding domain (RBD) of the SARS-CoV-2 Spike protein in human serum or plasma
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The Current Diagnostic Landscape
COVID-19 remains a significant public health concern, despite the end of the emergency phase of the pandemic. According to WHO, nearly 780 million cases and more than 7.1 million deaths have been reported worldwide since December 2019, while the actual burden is likely higher.
SARS-CoV-2 continues to circulate globally, causing hospitalizations and deaths, especially among older adults, immunocompromised patients and people with chronic diseases. This highlights the need for accessible diagnostics and monitoring of immune response after infection or vaccination.
Clinical Impact & Benefits
01
ASSESSMENT OF IMMUNE RESPONS
Quantitative detection of IgG antibodies to the SARS-CoV-2 Spike RBD helps assess humoral immune response after infection or vaccination.
02
IDENTIFICATION OF LOW ANTIBODY LEVELS
The test helps identify low or borderline antibody levels and supports decisions on additional monitoring or revaccination in risk groups.
03
MONITORING OF HIGH-RISK GROUPS
IgG testing can be used to monitor immune status in vulnerable groups, including older adults, immunocompromised patients and people with chronic diseases.
Key Advantages
Quantitative anti-RBD IgG assessment
WHO-traceable results in BAU/mL
Wide measuring range: 10–5000 BAU/mL
High reproducibility: CV ≤ 8%
Technical Specifications
Total Incubation Time:
45−85 minutes
Cut-Off Value:
≤ 1.0 BAU/mL
Coefficient of Variation (CV):
8%
Compatibility: Fully compatible with ELISA analyzers
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