A. Our Healgen rapid coronavirus tests WILL detect new variant The Healgen rapid COVID-19 tests available from MT Group are lateral flow tests which will continue to detect the presence of the virus, whether the patient is infected with the new variant of the virus or previous strains. Press reports regarding the new strain of COVID-19 indicate that it has evolved following a mutation of the spike protein. This is the part of the virus that attaches to human cells. If this proves to be the case with this latest mutation, this could explain why the virus is more infectious as it suggests that is better able to attach and infect human cells than the previous variant. We will be able to confirm this after tests are completed by Public Health England at Porton Down. In the meantime, there is no evidence that the new variant is undetectable using Healgen lateral flow tests. This is because of the way these lateral flow tests are designed to work. The COVID-19 virus is made up of a number of elements as the diagram shows. There are several detectable proteins including the Nucleocapsid (or N protein) which is bound to the RNA. Another is the Spike glycoprotein (S protein). All the lateral flow tests break up the virus into pieces by means of the extraction fluid. This enables the test to detect the N or the S proteins – the Healgen test looks for the N protein. This ensures that our Healgen testing kits will continue to offer highly accurate test results, meaning all our customers can continue to buy and use them with confidence.

A. Morgan Taylor Group is a supplier of the Healgen Coronavirus Ag Rapid test cassette (Swab). This is an in vitro immunochromatographic assay for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasopharyngeal (NP) swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first 10 days of symptom onset. It is intended to aid in the rapid diagnosis of Sars-CoV-2 infections. Negative results from patients with symptom onset beyond ten days, should be treated as presumptive and confirmation with molecular assay, if necessary, for patient management, may be performed. The Coronavirus Ag Rapid Test Cassette (SWAB) does not differentiate between SARS CoV and SARS-CoV-2.

A. Home pregnancy tests are good examples of a Lateral Flow Test (LFD) that are widely used by the public. In the case of the Healgen rapid COVID-19 tests, the lateral flow test works by inserting a swab deep into the nostril to obtain a sample, then placing the swab in extraction fluid (buffer) that releases viral proteins into the buffer (if they are present), after which the buffer fluid is dropped onto the test cassette (the plastic stick containing absorbent membrane). The sample travels along the absorbent membrane and as it does so if viral proteins are present they stick to specific antibodies and markers present in the membrane and they can be visualised as a line at the test line region (T). The absence of a test line (T) suggests a negative result. To serve as a control a red line always appears in the control line region (C) indicating proper use of the test. If the control line (C) does not appear the test is invalid and should be repeated using a new test.

A. MT Group is a supply chain partner to Healgen, based in UK which provides rapid COVID-19 testing kits. The Healgen test has a CE mark and is registered in Worldwide

A. The Healgen test was one of the first three assessed in thorough testing at Public Health England’s Porton Down research centre. Details can be found at the UK Government website using the link below. https://www.gov.uk/government/publications/assessment-and-procurement-of-coronavirus-covid-19-tests/lateral-flow-devices-results

A. The result of the test to show whether COVID-19 is present in the patient is indicated by respective lines on the test cassette. These will display within 15 minutes of the test cassette receiving the fluid containing the sample.

A. The Healgen rapid COVID-19 Self-Testing kits are designed for use by anyone, at home or anywhere at their convenience.

A. The nasopharyngeal swab is more likely to gather a higher concentration of virus than other swabbing/sampling methods.

A. There are several terms that are commonly used along with the description of sensitivity, specificity and accuracy. They are true positive (TP), true negative (TN), false negative (FN), and false positive (FP). If a disease is proven present in a patient, the given diagnostic test also indicates the presence of disease, the result of the diagnostic test is considered true positive (TP). Similarly, if a disease is proven absent in a patient, the diagnostic test suggests the disease is absent as well, the test result is true negative (TN). Both true positive and true negative suggest a consistent result between the diagnostic test and the proven condition (also called standard of truth). However, no medical test is perfect. If the diagnostic test indicates the presence of disease in a patient who actually has no such disease, the test result is false positive (FP). Similarly, if the result of the diagnosis test suggests that the disease is absent for a patient with disease for sure, the test result is false negative (FN). Both false positive and false negative indicate that the test results are opposite to the actual condition. Sensitivity, specificity and accuracy are described in terms of TP, TN, FN and FP. Sensitivity = TP/(TP + FN) = (Number of true positive assessment)/(Number of all positive assessment) Specificity = TN/(TN + FP) = (Number of true negative assessment)/(Number of all negative assessment) Accuracy = (TN + TP)/(TN+TP+FN+FP) = (Number of correct assessments)/Number of all assessments) Table 1. Terms used to define sensitivity, specificity and accuracy