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This rapid point-of-care antibody blood test detects two types of antibodies - IgG (past infection) and IgM (current/recent infection).
*Clinical Sensitivity based on clinical data study carried out on 1000 individuals at 14 days or more following onset of symptoms. The MHRA Target Product Profile requirements (as of 20.05.2020) for COVID-19 Antibody tests is a clinical study carried out on a sample size of a minimum of 200 individuals, 98% for both Clinical Sensitivity and Clinical Specificity on specimens collected 20 days or more following onset of symptoms. Clinical Sensitivity is the positive detection of COVID-19 IgG antibodies, these antibodies begin production at days 10-14 days following onset of symptoms and this increases incrementally, therefore this test exceeds the MHRA requirements
For optimum results, the test should be performed at 14 days or more following onset of symptoms. If a positive test result is obtained and there is a concern about a current infection, we advise performing a PCR Swab Test and seeking medical advice.
The MHRA guidance in relation to the rapid point-of-care type of COVID-19 Antibody Tests such as the one we are supplying has not changed as these tests are being used in line with their CE certification, the approved sample type i.e. capillary blood extracted through a finger-prick blood sample and their approved intended use i.e. by a healthcare professional in a professional capacity.
So Yes, this test we are supplying is MHRA approved to be used with a finger-prick blood sample and to be carried out by a healthcare professional in a professional capacity only i.e. the test should not be re-sold to a patient for them to carry out themselves as this test is not approved for home use.
In light of recent MHRA guidance (published 28.05.2020) the guidance in relation to the rapid point-of-care type of COVID-19 Antibody Tests such as this test remains unchanged.
The recent published guidance and changes are in relation to laboratory-based COVID-19 Antibody Tests that were originally granted MHRA approval to be used with a venous blood sample and to be carried out by a healthcare professional. These laboratory-based COVID-19 Antibody Tests were instead marketed and sold by companies to be carried out by the patient at home (not by a healthcare professional in a professional capacity) using a finger-prick blood sample (not venous blood) and sent to the laboratory for analysis. Therefore, these tests were being used off-label and not covered by their CE certification which invalidated the granted approval. The MHRA has therefore temporarily stopped sales of these laboratory-based tests until further validation of the sample collection kits and the sample type is carried out to support how companies which to market their intended use.