Approved COVID-19 antibody test ‘not intended for home use’, manufacturer warns

A Public Health England-approved antibody test for SARS-CoV-2 that was being sold for use at home with a finger-prick blood test, is not intended to be used in this way, the manufacturer has said.

The test, manufactured by Abbott, and found to be a “highly specific assay” by Public Health England, was launched for sale to the public by high street multiple, Superdrug, on 20 May 2020. This made Superdrug “the first high street retailer to offer a COVID-19 [SARS-CoV-2] antibody blood test” via its online doctor service.

However, Abbott has said that it has no evidence that the test can be carried out using a finger-prick blood sample.

In a statement to The Pharmaceutical Journal on 21 May 2020, a spokesperson for Abbott said its ‘ARCHITECT’ SARS-CoV-2 test “was developed for use by laboratory professionals only” and “is unable to give any guarantees or make claims for the performance of our test if it is used with finger-stick blood”. 

The Superdrug website was changed later on 20 May 2020 to say that the test was no longer available “due to the high demand of orders”.

A spokesperson for Superdrug told The Pharmaceutical Journal at the time of the launch that its laboratory was “adhering to all requirements as set by Abbott that the ‘ARCHITECT’ SARS-CoV-2 IgG (6R86) test is conducted using a serum or plasma sample (no requirement of a venous sample)”.

However, Abbott’s statement said the test “has been validated for use with a venous blood sample that is taken by a healthcare provider”.

“The test is not intended for use as a home test and it should not be conducted with a finger stick blood sample,” as the manufacturer “does not have any data to support that finger-stick blood samples can be used with our test”.

“The use of the Abbott name, our data and our materials by any companies in connection with these home tests has not been authorised by Abbott, and we regard them as misleading in that these sites imply Abbott condones the use of finger stick samples with our test. This is false and not correct,” they continued.

“We took immediate action upon learning of this and have taken steps to have companies remove our name from their website and retract any misleading information relating to our test.”

Abbott would not confirm which companies it has asked to remove information from their websites.

Responding to the statement from Abbott, a spokesperson for Superdrug said that its “accredited laboratory partner, TDL … has provided evidence of validation of the use of a capillary blood sample”.

“As a [UK Accreditation Service]-accredited laboratory, TDL has a responsibility to carry out validation [testing]. They conducted an internal study using samples provided from patients that have previously tested positive, using a polymerase chain reaction swab test, to coronavirus (SARS-CoV-2),” the spokesperson added.

“The laboratory partner that we work closely with to supply this test has provided evidence of validation of the use of a capillary blood sample. The laboratory has provided this information regarding their specificity.”

A spokesperson for Boots told the The Pharmaceutical Journal it was looking at a “range of ways” to make a COVID-19 antibody testing service available for its customers.

They added that it is only planning to start selling antibody tests “once we’re completely confident that we can provide our customers with antibody testing, which uses equipment or technology that has been approved by the appropriate bodies and the right support and advice to interpret the results”.

However, Well Pharmacy has said it is also planning to sell the finger-prick test from its online shop for £69, regardless of the comments from Abbott.