Immunoglobulins to SARS-CoV-2

In Vitro diagnostic ELISA based test kits for immunoglobulins M and G to SARS-Cov-2 in serum and plasma (EDTA, heparin, ACD or citrate).

SARS-CoV-2 detection

Test kits to monitor your employees’ health, objectively assess the number of infected individuals, form the pool of SARS-Cov-2 antibody donors.

Assay Principle

The principle is based on indirect non-competitive ELISA analysis. The study sample and control sample are incubated in the wells coated with arecombinant nucleocapsic protein. Immunoglobulins to this protein when presentin the sample bind specifically to the protein immobilized in the wells. Next, IgM-and IgG- class antibodies are detected with the help of a second antibody in aperoxidase conjugate. After incubation with the substrate and stop solution application, the optical density of the sample is measured at 450 nm. The measuredoptical density is directly related to the number of IgM and IgG in the tested and control samples.

Kit components

  • 1 Immunoadsorbent
  • Conjugate12 mL
  • Positive Control 0,5 mL
  • Negative Control 1 mL
  • Sample Diluent 50 mL/100 mL
  • Wash Concentrate(20x) 20 mL *
  • TMB Substrate 12 mL *
  • Stop Solution 12 mL *
* Components marked with * are interchangeable within their shelf- life if seriesnumber coincides.

Shelf-life

12 months at temperatures of 2 – 8°C.

Configuration

The Kit is confgured to analyze 46 unknown samples in negative control triplicate, positive control monoplicate. 96 defnitions in total.

SARS-Cov-2 ELISA Kits give the most accurate result to determine the state of the disease. ELISA method allows to qualitatively determine the IgM and IgG presence/absence in serum and plasma and shows positive or negative response to antibodies.

Positive IgM— IgM is the earliest antibody to appear. It is the first immuneresponse to fight a new infection. The presence of IgM means an active stage of the disease.

Positive IgG — IgG antibodies defense against virus. The presence of IgG means immune response development or shows the patient has already came through the disease.

Negative IgM and IgG indicate coronavirus disease absence or it’s seronegative period.

 
RNAIgMIgG 
No disease or latent stage
+Seronegative stage. Re-test in 7-10 days
+++Active disease stage
++Early disease stage. Re-test IgG in 7-10 days
++Disease or early recovery stage
+Came-through disease

Our test kits

Item code Item name Configuration
Е001-G-96 ELISA-IgG-SARS-CoV-2 96 wells (1 Immunoadsorbent)
Е001-G-480 ELISA-IgG-SARS-CoV-2 480 wells (5 Immunoadsorbents)
Е001-M-96 ELISA-IgM-SARS-CoV-2 96 wells (1 Immunoadsorbent)
Е001-M-480 ELISA-IgM-SARS-CoV-2 480 wells (5 Immunoadsorbents)

Assay procedure

1. An antigen (recombinant nucleocapsic protein) is immobilized at the wells bottom.

2. Add test samples to the microplate wells. Incubate the microplate for 30 minutes at a temperature range + 20 °C to + 25 °C for the IgG determination (at 37 °C if IgM is tested). Wash the microplate.

3. Add the conjugate. Incubate the microplate for 30 minutes at a temperature of +20 °C to + 25 °C. Wash the microplate.

4. Add TMB Substrate. Incubate the microplate at a temperature of + 20 °C to + 25 °C in a light-protected place for 15 minutes (color development observed).

5. Add Stop Solution to stop the enzyme reaction.

6. Measure the optical density at 450 nm.


In accordance with the statistics, the OD Value for positive samples are in the range 0.418–2.108 for the SARS-CoV-2 IgG ELISA and 0.315–1.116 for the SARS-CoV-2 IgM ELISA. The OD Value for negative samples are 0.086 – 0.271 for SARS-CoV-2 IgG ELISA and 0.104 – 0.251 for SARS-CoV-2 IgM ELISA.