Rapid COVID-19 Antibody Diagnostic Kit (1 x 1 kit)

This rapid point-of-care antibody blood test detects two types of antibodies - IgG (past infection) and IgM (current/recent infection).

Each kit contains:
1 Test Cassette and 1 Blood Collection Kit

Benefits of antibody testing:

• Clinical Sensitivity (Accuracy for COVID-19 antibody detection)– 98.43%
• Clinical Specificity – 99.31%
• Rapid result with simple finger prick in approximately 10 minutes.
• Easy on-site testing for yourselves, your staff and your patients.
• CE certified.
• MHRA approved for sale and healthcare professional use.

Assisting with your return-to-work strategy:

• Knowing if you, your colleagues or your patients have had Coronavirus.
• Helping to ensure a safe working environment.
• Enabling you to offer additional services to your patients.

For optimum results, the test should be performed at 7 days 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.

Are rapid point-of-care type COVID-19 Antibody Tests (which we are supplying) MHRA approved to be sold?
 
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.
Please note: This in-vitro diagnostic device (IVD) is for healthcare professional use only and not regulated for home use.

Ingredients:
Each Kit contains:
1 x Test Cassette
1 x Phosphate Buffer Solution
1 x Single Use Lancet 
1 x Capillary Sampler 
1 x Alcohol Wipe 
1 x Plaster
1 x Cotton Swab