Anti-SARS-CoV-2 Mpro IgA ELISA kit CE/IVD

Introduction:
Indirect Immunoassay for detection of specific antibodies against SARS-CoV-2 (Covid-19)
- Exclusive Apecific SARS-CoV-2 Antigen (Mpro)
- Highly Sensitive and Specific Detection of covid-19 antibodies
- Reliable SARS-CoV-2 infection determination
- Aids in diagnosis & patient surveillance
- Designed for use with human serum and plasma samples
- Patented assay: EP203824958

INTENDED USE
Qualitative enzyme-linked immunosorbent assay of specific IgG antibodies against Covid-19 based on the ELISA technique. The 96-well ELISA plates are coated with the recombinant specific antigen (Mpro or also called 3CLpro) to bind the antibodies present in human serum and plasma samples (K2-EDTA, K3-EDTA, Heparin-Li, Sodium Citrate). The intended use of the assay is to assist in the identification of individuals with an adaptive immune response to SARS-CoV-2, indicating a previous or recent infection and contributing in combination with other tests (PCR or antigen), to the determination of the stage of infection. Additionally, this assay can be used in research, seroprevalence studies and epidemiological surveillance.

The vast majority of serological tests for specific antibodies to SARS-CoV-2 are based on serum detection of antibodies to either the S protein (the main target of neutralizing antibodies) or the N protein, which is known to be highly immunogenic protein in other coronaviruses and is the most widely used. In this sense, in an attempt to increase the diagnostic possibilities of COVID-19 patients, this assay is based on the detection of specific antibodies against one of the 16 non-structural proteins, specifically against the main viral protease (Mpro or 3CLpro), which plays a critical role in viral replication.

This is why it has been proposed as a target for specific inhibitors of virus replication7 and has also proved to be a powerful immunogen, allowing the detection of very low antibody titers.
Additionally, reactivity against Mpro protease in COVID-19 patients has been comparable to or stronger than reactivity against S or N protein,suggesting that humoral response against different virus antigens maybe heterogeneous among different patients.

Kit contents
96-wells Microplate (12x8). Multiwell strip microplate
Multiwell strip microplates upholstered with Sars-Cov-2 recombinant antigen in a vacuum-sealed bag.

50 ml Wash buffer (20X)
HEPES, NaCl and detergents. Contains Proclin300 as a preservative (< 0.0014%)

25 ml antibody and sample dilution buffer (1X - Ready to use).
Buffer that minimizes non-specific binding, cross-reactivity and matrix interference, with blue dye. Contains CMIT/MIT 3:1 as a preservative.

12 ml of tetramethylbenzidine (TMB) chromogenic substrate (1X - Ready to use

12 ml of stopping solution (1X - Ready to use) 0.5M sulphuric acid (H2SO4)
0.5M sulphuric acid (H2SO4)

1.5 ml of positive IgA control. Contains CMIT/MIT 3:1 as a preservative. Ready to use

1.5 mL negative control. Contains CMIT/MIT 3:1 as a preservative. Ready to use.

1.5 ml of calibrator. Contains CMIT/MIT 3:1 as a preservative. Ready to use.

120 μl of HRP-conjugated anti-human antibody (100X). Contains CMIT/MIT 3:1 as a preservative.