As COVID-19 is a new novel virus, we are unaware of any groups of people which should not be tested specifically. All testing should be carried out by medical professionals as they are In Vitro Devices.
Are the tests accredited?
All test kits sourced from manufacturers in the USA have been CE and MHRA Approved. Furthermore, the test kits have been approved as approved In-vitro diagnostic devices.
All tests are strictly for professional use. The sale of home-use kits is illegal and prohibited under UK Law.
Do we need to use laboratory analysis to confirm the result?
Rapid Cassette Test kits do not need any confirmation from laboratory analysis. They provide an immediate qualitative response.
The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a qualitative membrane-based immunoassay for the detection of IgG and IgM antibodies to COVID-19 in whole blood, serum or plasma specimen.
This test consists of two components, an IgG component and an IgM component. In the IgG component, anti-human IgG is coated in IgG test line region. During testing, the specimen reacts with COVID-19 antigen-coated particles in the test cassette. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with the anti-human IgG in IgG test line region, if the specimen contains IgG antibodies to COVID-19. A colored line will appear in IgG test line region as a result of this.
Similarly, anti-human IgM is coated in IgM test line region and if specimen contains IgM antibodies to COVID-19, the conjugate-specimen complex reacts with anti-human IgM. A colored line appears in IgM test line region as a result. Therefore, if the specimen contains COVID-19 IgG antibodies, a colored line will appear in IgG test line region. If the specimen contains COVID-19 IgM antibodies, a colored line will appear in IgM test line region. If the specimen does not contain COVID-19 antibodies, no colored line will appear in either of the test line regions, indicating a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred
Can babies and young children be tested?
Yes, there are no issues with testing babies and young children.
Is the test specific for COVID-19?
The IgG that the test detects is specific to COVID-19, so a positive result would indicate COVID-19 infection. Although the IgM is a more generalised antibody, its presence, combined with IgG and/or the common symptoms of COVID-19, would also indicate infection with the novel SARS-CoV-2 virus. The test can be used for primary and secondary diagnosis of COVID-19.
What do the results mean?
The test strip has three different lines; one for IgG, one for IgM and one control line. There are four different valid results:
IgM + Control – The sample is positive for IgM. This means the patient is in the early stages of an infection and combined with the common symptoms, is positive for COVID-19
IgG + IgM + Control – The sample is positive for both IgG and IgM and therefore positive for COVID-19
Control only – The sample is negative
If the control line does not appear, the test is void and should be repeated, irrespective of how many test lines are visible.
MHRA/PHE does not approve the ‘quality’ of devices but provides guidance – Specification Criteria for serology/antibody point of care testing (POCT) –
Who is purchasing the tests?
The tests are being purchased by government authorities globally, healthcare institutions, frontline and critical healthcare such as Hospitals, Nursing and Care Homes, Businesses and Corporations deemed as Essential.
What are IgG and IgM?
Immunoglobulins are antibodies themselves and are part of our immune system. When we get an infection, such as COVID-19, immunoglobulins are produced, which attach to the virus and activate the rest of the immune system to attack and clear the virus. IgM is the first immunoglobulin to be produced and is a general antibody that can bind to many different types of pathogen. The presence of IgM is an indicator of early infection. IgG is a more specialised antibody that specifically binds to the SARS-CoV-2 virus. The presence of IgG is an indicator of later stage infection (usually 7 days or longer after infection).