Last Updated: Tuesday 28th July 2020
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Yes, this rapid point-of-care COVID-19 Antibody Test that we are supplying has been MHRA approved to be supplied to healthcare professionals to be used in a professional capacity only. The MHRA requires all manufacturers of professional use COVID-19 Antibody Tests to contact them so that they can advise if a testing product can be placed on the UK market.
It is important to note that currently, the MHRA have not approved any home use antibody tests and therefore these tests are to be used in a professional capacity only, ensuring this test is carried out by a trained professional helps ensure that the patients’ blood sample is taken safely, the test results are interpreted correctly and the appropriate follow-up guidance is provided by the healthcare professional to the patient.
This rapid point-of-care antibody finger-prick blood test detects two types of antibodies - IgG (past infection) and IgM (current/recent infection).
*Clinical Sensitivity and Specificity 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.
In light of recent MHRA guidance (published 28.05.2020) the guidance in relation to the rapid point-of-care type COVID-19 Antibody Tests such as this test remains unchanged.
The recently 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 wish to market their intended use.
This test is classed as an "in vitro diagnostic" medical device (IVD) and all medical devices have to be CE marked, this antibody test is CE certified and marked.
Our bespoke COVID-19 page and documents are for guidance purposes only; the responsibility remains with the practitioner at all times. It is the responsibly of the practitioner to ensure clinical good practice and public health is prioritised at all times, whilst following Public Health England recommendations.