VedaLab COVID-19-CHECK-1 IgG/IgM Antibody Cassette (CE Marked 10min Whole Blood/Serum/Plasma) x 20 Test Kit

The test detects the presence of specific antibodies related to COVID-19 in a sample of whole blood, serum or plasma. The test will show a positive result if it is able to detect the presence of either of 2 different antibodies: IgM and IgG.

If an individual is exposed to COVID-19, IgM is the first antibody to be produced in order to immediately help the human body to fight infection. There is a delay of approximately 8 – 11 days* post-infection before the IgM antibody is produced to a high enough level whereby it is detectable by testing which means that a test could return a negative result (see Limitations section). However, once this detectable level has been reached, when a test is performed it will return a positive result.

The IgG antibody is produced after the initial phase of the infection to help protect against repeat infection. This is detectable approximately 18 – 21 days* post-viral infection. Once a detectable level of IgG has been reached, when a test is performed it will return a positive result.

If just IgM is positive then it is likely that the disease is active. If the result is IgG positive, or both IgG and IgM positive, that suggests that the subject may have evidence of some immunity. A positive IgG test does not guarantee immunity to COVID-19, but it is an indication of exposure. See figure 1 Approximate IgM and IgG antibody levels over time – Not actual data – for illustration purposes only

If the test is negative for both IgM and IgG antibodies this means that the patient could be in the latent phase of the infection or has not been infected.

*NOTE: The time frame for detection of both IgM and IgG antibodies can vary depending upon which publications are referenced and the cohort of patients that were tested.

The test works with whole blood from a fingerprick. It can also be used with serum and plasma in laboratory settings. The full Instructions for Use (IFU) document can be found HERE.

Antibody testing determines if a person has had the infection in the past. This is done by detecting the presence of antibodies produced by the immune system against COVID-19.

Antigen tests look for pieces of proteins that make up the SARS-CoV-2 virus, helping to determine if the person has an active COVID-19 infection.

The test result should be read between 10 to 15 minutes after adding the diluent. Do not interpret the result after 15 minutes. The full Instructions for Use (IFU) document can be found HERE.

IgM POSITIVE:* Two lines appear. One coloured line should be in the control line region (C), and a coloured line appears in IgM test line region (T1). The result suggests the sample contains IgM antibodies specific to the SARS-CoV-2 and indicates a primary/recent infection.

IgG POSITIVE:* Two lines appear. One coloured line should be in the control line region (C), and a coloured line appears in IgG test line region (T2). The result suggests the sample contains IgG antibodies specific to the SARS-CoV-2 and may indicate a secondary infection or late stage of the disease.

IgG and IgM POSITIVE:* Three lines appear. One coloured line should be in the control line region (C), and two coloured lines should appear in the IgM test line region (T1) and the IgG test line region (T2). The colour intensities of the lines do not have to match. The result suggest the sample contains both IgM and IgG antibodies specific to the SARS-CoV-2 and may indicate an active or a secondary infection.

*NOTE: The intensity of the colour in the IgG and/or IgM test line region(s) will vary depending on the concentration of SARS-CoV-2 antibodies in the specimen. Therefore, any visible line in the test area either strong or weak (even much weaker than the control line) should be interpreted as positive.

NEGATIVE: One coloured line should be in the control line region (C). Thie result suggests the sample does not contain detectable IgM nor IgG directed against SARS-CoV-2.

INCONCLUSIVE: If there is no distinct colour band visible in the control zone (C), the test is inconclusive. It is recommended, in this case, to repeat the test with a new device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

Please note that individuals’ coexisting conditions need to be taken into consideration. People who have suppressed immunity due to illness or immunosuppressing drugs may not produce antibodies in sufficient levels to be detected by this method.

1. The COVID-19-CHECK-1 procedure and the interpretation of results must be closely followed. This assay is designed for detecting antibodies against SARS-CoV-2 in human serum, plasma and whole blood. Any results derived from the assay of other body fluids and from assay of pooled serum, plasma or whole blood may not be interpreted correctly, based on the current criteria. So, other body fluids and pooled samples cannot be assayed using COVID-19-CHECK-1.

2. For asymptomatic patients or when signs are not clearly interpretable, but a COVID-19 case is suspected, it is recommended to repeat the testing, in case of first negative result, 2 or 3 weeks later or to perform a PCR test.

3. As for any diagnostic procedure, the physician should evaluate the data obtained using this kit in the light of the other clinical information available.

4. COVID-19-CHECK-1 is a qualitative test that cannot be used to determine the anti-SARS-CoV-2 antibody concentration nor the rate of increase in antibody level.

5. An excess of biotin (vitamin B8) can lower the control line colour intensity or even lead to the control line disappearance if the biotin concentration level is very high.

6. SARS-CoV-2 infection in pregnant women may increase health risks to both mothers and infants during pregnancy.

7. In the early stage of the disease, IgM level could be below detectable levels.

8. The presence or the absence of antibodies cannot be used to determine the success or failure of a medical treatment.

9. Results in immunosuppressed patients should be interpreted with caution and need a medical advice.

10. If the test is negative and clinical symptoms persist, additional testing using other clinical methods is recommended. A negative result does not preclude the possibility of SARS-CoV-2 infection.

11. In the early onset of fever, anti-SARS-CoV-2 IgM concentrations may be below detectable levels. IgM may appear within 8-11 days post infection and then the concentration may decrease while IgG concentrations may increase. A positive result for IgM is indicative of primary SARS-CoV-2 infection, however a negative result does not at any time preclude the possibility of SARS-CoV-2 infection. Therefore IgM readings should be treated as advisory and should not be used as the sole criteria for the diagnosis of SARS-CoV-2.

12. COVID-19-CHECK-1 will only indicate the presence of SARS-CoV-2 antibodies in the specimen and should not be used as the sole criteria for the diagnosis of SARS-CoV-2.

The full Instructions for Use (IFU) document can be found HERE.

A clinical evaluation study was performed in France

According to the French HAS recommendations, the diagnostic sensitivity should be assessed in comparison to a PCR method while the diagnostic specificity should be assessed using samples collected prior the onset of the COVID-19 epidemic. The COVID-19-CHECK-1 test result is considered as being positive when either IgM or IgG or both are showing a positive result.

Diagnostic Sensitivity: Among the 140 serum samples and 12 whole blood samples tested by the PCR method, 105 serum samples and 12 whole blood samples were found positive. These samples were then tested with the COVID-19-CHECK-1 rapid test. The diagnostic sensitivity is calculated as follows: 91.45%

Diagnostic Specificity: 100 well-documented serum samples collected prior to September 2019 have been used for this study. 71 serum samples were collected from healthy individuals and 29 samples were obtained from individuals with pathologies (tumor markers with high concentration levels). Among the 100 serum samples, 97 of them showed negative results and 3 samples showed positive result when tested with the COVID-19-CHECK-1 test. The diagnostic specificity is calculated as follows 97 %

The overall Accuracy is calculated as follows: 94% *CI 95%: 95% Confidence interval.

Yes. The test is CE-marked for Medical Professional Use only in accordance with EU IVD regulations (IVDD 98/79/EC). A copy of the Manufacturer’s Declaration of Conformity is available HERE.

In accordance to the IVD directive, manufacturers or are only required to register a CE marked product for professional use with a single competent authority within the EU. As these tests are manufactured in France they are registered with the French Ministry of Solidarity and Health who are the French equivalent of the MHRA.

Therefore there is no requirement or need for additional registration with the MHRA and it is fully authorised to be sold in the UK in accordance with the IVD Directive (IVDD 98/79/EC).

No. The tests are supplied with all required components to perform 20 tests. The full Instructions for Use (IFU) document can be found HERE.

These tests are only available to customers who can demonstrate that they are buying on behalf of a business or charity and not for home use. Customers may be asked to confirm that the test will only be used in accordance with the instructions supplied by a Medical Healthcare Professional.