MöLab COVID-19 Rapid Antigen Test (CE Marked 15min Nasal Swab) x 10 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 15 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 in Germany comparing the MöLab COVID-19 Rapid Antigen Test to PCR testing, using a commercialized molecular assay. MöLab’s test produced outstanding results indicating incredible specificity, sensitivity, and accuracy.

Germany Evaluation:

Table 1: Germany Evaluation of the mo-screen Corona Antigen Test vs PCR:

• The Study was conducted in Germany
• All positive samples were taken from volunteers in Berlin, the negative samples from volunteers in Dusseldorf.
• The tests were then evaluated by the German Army in two separate medical facilities.

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 Manufacturers Declaration of Confirmity 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 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).

It is not necessary for tests to be approved by the MHRA for use in the private sector in the UK.

Quadratech Diagnostics as UK distributor for the möLab COVID-19 Rapid Antigen Test, have liaised with the MHRA directly and notified them that this product is being supplied for use by healthcare professionals in the UK. As part of this process, we have submitted all technical data and information that the MHRA have requested with full transparency. In return the MHRA have confirmed that the product meets the requirements of the Medical Devices Act 2003 and can be sold in the UK marketplace.

Separately, the MHRA also have a process for manufacturers to submit COVID-19 diagnostic tests to Public Health England (PHE) for their evaluation to identify if they wish to purchase them for use within the NHS. Within their “Target Product Profile: Point of are SARS-CoV-2 detection tests”, the MHRA have set specifications by which tests have to comply to either the “desired” or “acceptable” criteria in order to be considered for evaluation. One of these specifications is to display a readable result (assay end point stability) for a minimum of 30 minutes. The möLab COVID-19 Rapid Antigen Test has a result that is readable from 15 – 20 minutes after conducting the test. This means that the window to read the result (assay end point stability) is 5 minutes which is universally accepted for manual read point of care tests widely used within the NHS already. However, it does not meet the set requirements made by the MHRA who are concerned about the ability to read results within an NHS specific “busy testing environment”. As such we are not able to submit this test for PHE evaluation as it does not meet their specific requirements for use within an NHS environment.

The decision of the MHRA to set their own specifications solely for NHS use has no direct impact or consequence on private companies choosing what testing they wish to put in place for their own purposes. Private companies are under no obligation to only use test devices that the NHS use.

With over 37 years of experience and managed by the Schuermann family, möLab GmbH is one of the most trusted companies in Europe in healthcare diagnostics. Established in 1983 and based near Cologne, MöLab is one of the most established names in the German diagnostics industry. It is one of Europe’s leading manufacturers in immunological rapid diagnostics and therapeutic drug monitoring. Their success is built on their expertise and strict protocols. They maintain consistently high quality of products and services by applying a very strict criteria to the selection of suppliers and by constantly training their employees.

A key to their success is their continual focus on quality management with rigorous internal, external audits and quality checks which meet a myriad of ISO standards: EN ISO 13485:2016, EN ISO 14971:2012, EN 13975:2003, EN ISO 18113-1:2011, EN ISO18113-2:2011, EN 13612:2002, EN ISO 17511:2003, EN ISO 15193:2009, EN ISO15194:2009, EN 13641:2002, EN ISO 15223-1:2012 EN ISO 23640:2015 & EC 1272/2008.

No. The tests are supplied with all required components to perform 10 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.