Products to diagnose coronavirus in community pharmacy should not be used as there is “little information on the accuracy of the tests”, PHE said in a statement issued yesterday (March 15).
It is uncertain how “a patient’s antibody response develops or changes during COVID-19 infection”, said PHE, which also questioned the reliability of the test results, regardless of whether they are positive or negative.
“Currently there is no published evidence about the suitability of these tests for diagnosing COVID-19 infection in a community setting,” PHE said.
While some coronavirus test kits are “very rapid” and “can work on a range of specimens including serum, plasma or finger-prick whole blood [...] others look for the body’s immune response to the virus”, according to PHE.
A National Pharmacy Association spokesperson told C+D today (March 16) that the organisation would suggest its members follow “official public health and government advice and usage of such kits goes against current guidance”.
“Given that there is presently no vaccine for coronavirus, the consequences of a positive test will require the individual to receive appropriate support,” they added.
Kits for pharmacies
Pharmadoctor – a UK-based provider of clinical services delivered in pharmacy – started selling coronavirus test kits priced at £175 for 30 last week (March 10).
The tests – which, starting this week, are being delivered to pharmacies that have ordered them – are to be used by pharmacy teams only to “quickly identify if any of the pharmacy team has become infected with coronavirus”, Pharmadoctor said.
Responding to PHE’s advice today, Pharmadoctor said “PHE has not approached either Pharmadoctor or our partner test kit manufacturer to discuss the data supporting the accuracy of the kits”.
It added that its tests – which use a “finger prick method and test for whole blood to measure the body’s immune response to COVID-19” – are showing “high sensitivity, specificity and accuracy”.
“While the [coronavirus] test kits available are new, the technology they use is not new. The technology being used in the test is well understood and its methodology proven to be effective for the detection of other virus antibodies,” Pharmadoctor said.
The company also said that “full documentation of the tests' efficacy” had been sent to the Medicines and Healthcare products Regulatory Agency (MHRA), which it said had approved the tests to be used by healthcare professionals.
Pharmadoctor said the MHRA would also authorise the use of the tests by the public once approved by an external notified body, which will assess if the test “can be used by non-health care professionals accurately”.
“We are seeking this approval in the coming days,” Pharmadoctor said.