Accu-Tell SARS-CoV-2 Ag Rapid Test Cassette (CE Marked 10min COVID-19 Nasal Swab) x 20 Test Kit

This test is for detection of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in upper respiratory specimens during the acute phase of infection. The full Instructions for Use (IFU) document can be found HERE.

Nasopharyngeal swab (Nasal Swab). The full Instructions for Use (IFU) document can be found HERE.

A new form of testing for COVID-19, rapid antigen testing represents a major advance in bringing the pandemic under control.

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.

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.

The test result should be read between 10 to 20 minutes. Do not interpret the result after 20 minutes. The full Instructions for Use (IFU) document can be found HERE.

POSITIVE:* The presence of two lines as control line (C) and test line (T) within the result window indicates a positive result.

*NOTE: The intensity of the colour in the test line region will vary depending on the concentration of antigen 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: The presence of only control line (C) within the result window indicates a negative result.

INVALID: If the control line (C) is not visible within the result window after performing the test, the result is considered invalid.

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

1. This test cannot be used to detect virus other than SARSCoV-2. The Coronavirus Ag Rapid Test Cassette (Swab) is capable of detecting both viable and non-viable SARSCoV-2. The performance of the Coronavirus Ag Rapid Test Cassette (Swab) depends on antigen load and may not correlate with viral culture results performed on the same specimen.
2. Failure to follow the Test Procedure may adversely affect test performance and/or invalidate the test result.
3. If the test result is negative and clinical symptoms persist, additional testing is recommended. A negative result does not at any time rule out the presence of SARS-CoV-2 antigens in specimen, as they may be present below the minimum detection level of the test or if the sample was collected or handled incorrectly.
4. As with all diagnostic tests, a confirmed diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.
5. Positive test results do not rule out co-infections with other pathogens.
6. Positive test results do not differentiate between SARS-CoV and SARS-CoV-2.
7. Negative results should be treated as presumptive and confirmed with another testing method, if necessary, for clinical management or infection control.
8. As for any diagnostic procedure, the physician should evaluate the data obtained using this kit in the light of the other clinical information available.

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

A clinical evaluation study was performed achieving:

• 99.20% Specificity
• 95.00% Sensitivity
• 98.80% Accuracy

Yes. The test is CE-marked for Medical Professional Use only in accordance with EU IVD regulations (IVDD 98/79/EC).

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 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 an 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 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.