Accu-Tell COVID-19 IgG/IgM Antibody Test Cassette (CE Marked SARS-CoV-2 10min Whole Blood/Serum/Plasma Test) x 50 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 IgG/IgM Cassette (Whole Blood/Serum/Plasma) is for in vitro diagnostic use only. The test should be used for the detection of SARS-CoV-2 antibodies in whole blood, serum or plasma specimens only. Neither the quantitative value nor the rate of increase in SARS-CoV-2 antibody concentration can be determined by this qualitative test.

2. The COVID-19 IgG/IgM Cassette (Whole Blood/Serum/Plasma) 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.

3. In the early onset of fever, anti-SARS-COV-2 IgM concentrations may be below detectable levels. IgM may appear within 3-7 days after 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.

4. The continued presence or absence of antibodies cannot be used to determine the success or failure of therapy.

5. Results from immunosuppressed patients should be interpreted with caution.

6. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the Medical Healthcare Professional.

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

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

ACCU-TELL® COVID-19 IgG/IgM Cassette (Whole Blood/Serum/Plasma) was compared with clinical diagnosis (Confirmed). The study included 446 specimens for IgG and 456 specimens for IgM.

IgG Results
Diagnostic Sensitivity: 100.0% (95%CI: 96.1%~100.0%)*
Diagnostic Specificity: 99.5% (95%CI: 98.1%~99.9%)*
Accuracy: 99.6 %( 95%CI: 98.4%~99.9%)*
*Confidence Interval

IgM Results
Diagnostic Sensitivity: 91.8 %( 95%CI: 83.8%-96.6%)*
Diagnostic Specificity: 99.2 %( 95%CI: 97.7%~99.8%)*
Accuracy: 97.8 %( 95%CI: 96.0%~98.9%)*
*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 with 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 Germany they are registered with the German Federal Institute for Drugs and Medical Devices (BfArM) who are the German 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 IVD directive (IVDD 98/79/EC).

No. The tests are supplied with all required components to perform 50 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.