Date of prep: December 2020
Prescribing information and
adverse events reporting
For healthcare professionals only
PharmaDoctor have been selling a COVID19 antibody test kit to pharmacists across the UK for some time now. In light of the pressure to provide testing throughout the pandemic, we decided to ask the PharmaDoctor team to find out more.
Could you tell us briefly about your involvement in COVID-19 testing?
PharmaDoctor is the exclusive marketing and distribution partner in the UK and other territories for in vitro test kits produced by Belfast-based Biopanda Reagents. Over the last couple of years, our strategic partnership with Biopanda has enabled PharmaDoctor to supply rapid diagnostic test kits to community pharmacies which are integral to our Test ‘n Treat Pharmacy Service Packages such as those for Strep A, UTI, STI and Flu.
With strong links to China, Biopanda was the first UK company to develop and produce a COVID19 antibody test kit which PharmaDoctor has made available to UK pharmacies at cost:
Why do you feel testing is so important?
Both antigen testing and antibody testing are key to support the surveillance of COVID19 and any future exit strategy which will allow people to get back to work. Antigen tests are essential for confirming if someone currently has a COVID19 infection so that they can either be treated appropriately or isolated to prevent the further spread of the disease. Antibody tests are also key to understand who has had COVID19 and equally important who has not had COVID19.
Both tests are essential to monitor the prevalence of the virus in the community and to understand the true impact of the UK epidemic.
Do you think key workers should be prioritised in terms of testing?
Absolutely. Along with testing of patients suspected of being infected with COVID19, routine testing (both antigen and antibody testing) will ensure key workers such as pharmacists and their teams can continue providing essential services safely whilst providing peace of mind to themselves and their immediate families. PharmaDoctor is also making the test available to other key workers such as care home and GP Practice staff.
What do the results of the Biopanda test show?
The tests detect both IgM and IgG antibodies to the SARS-CoV-2 virus (COVID19) in human whole blood.
Are the Biopanda tests reliable?
Yes, very reliable.
In general, IgM antibodies appear a week after infection, and IgG antibodies appear two weeks after infection.
The Biopanda test was compared with PCR. Specimens from 70 patients, whose COVID-19 disease status were confirmed using PCR, were tested using the Biopanda test. The results of the IgM and IgG components of the test are presented separately. IgG antibodies peak 28 days after infection but can be detected many days earlier.
Relative Sensitivity: 85.0%
Relative Specificity: 96.0%
Relative Sensitivity: >99.9%
Relative Specificity: 98.0%
Could they give false results?
As with any diagnostic test, there is the possibility of false-positive and negatives. This is no different to the RT-PCR test, which is the test being used by the NHS.
The BiopandaTest Kit instructions for use clearly state the possibility of false-positive and false-negative results, as well as the limitations of the test. To address this, Biopanda suggests that pharmacists should test themselves on day 3/4 and again day 6/7 following initial symptoms to limit the possibility of a false test result.
Other than using the test kit incorrectly the most likely reason for a false result will be if the test is used too early and the patient has not yet developed enough antibodies.
Do these tests have MHRA approval?
The MHRA approved the kits for sale to healthcare professionals on the 5th March 2020.
Does the test have a CE marking and is that important?
Yes, the tests are CE certified for Healthcare Professional use only.
PharmaDoctor is also working closely with Biopanda to submit a further Home Test Kit version for approval from a Notifiable Body so that they can be supplied to members of the public.
Why has Public Health England not endorsed the Biopanda test?
It is quite right that the government should evaluate all the antibody tests that are available before they endorse them. PharmaDoctor has informed PHE of our supply of the kits to UK pharmacy and offered our full support including the opportunity for PHE to evaluate the kits. Biopanda has also offered to submit their test kits and documentation for evaluation. At the time of writing neither PharmaDoctor nor Biopanda have received confirmation that our test is one of those included in the government’s current evaluation.
What is the process involved with getting Public Health England to endorse such a test?
At the time of writing, this has yet to be communicated by PHE.
Do you stand to benefit financially if Public Health England endorses the Biopanda test?
No. The test kits have already been approved for sale by the MHRA and PharmaDoctor is legally supplying the kits to UK pharmacies at cost. Any endorsement will not change PharmaDoctor’s strategy to prioritise health care workers and keep the price down at cost.
Have you offered to supply the UK government and how has that gone?
PharmaDoctor has engaged directly with PHE and is currently approaching the government through a wider group of stakeholders with a planned proposal to support wider testing and surveillance. As yet, no commitment has been made.
Are you currently selling these tests and to who?
PharmaDoctor is supplying the kits to community pharmacies and other HCPs. If a pharmacist or member of their household has suspected COVID19 symptoms, they are required to self-isolate for 14 days meaning the pharmacist is unable to work. The antibody tests PharmaDoctor is providing enable pharmacists and their families to test themselves to understand if they have had COVID19 or not. If all family tests are negative after day 3/4 and again on day 6/7, this enables pharmacists to return to work sooner whilst providing peace of mind to themselves and their families.
Over the last couple of weeks, PharmaDoctor has turned down over £10m worth of international orders for the kits (which would have generated a significant profit) so that we can prioritise the supply of the kits to UK community pharmacies at cost.
What has the feedback from pharmacists been?
Feedback from pharmacists has been incredibly positive. PharmaDoctor has already begun supplying tens of thousands of kits to UK pharmacies.
What is your overall view in terms the implementation of COVID-19 testing by the government?
With regards to the PCR antigen test, PharmaDoctor’s agrees with the Governments strategy to scale up testing at pace so that the spread and impact of the COVID19 UK epidemic can be better understood and controlled. With regards to the antibody test kits such as those being supplied by PharmaDoctor, it is correct for the government to evaluate all tests to ensure they are accurate and understand how best to deploy them in the community. It is widely believed that the use of antibody tests will play a critical role in any exit strategy which will enable people to get back to work safely as soon as possible. How best to use these tests is something that will be better understood from any evaluation. Any exit strategy using tests needs to be planned well and delivered accurately with wide-spread reporting.
Pharmacy in Practice will keep you up to date with developments in this area as they happen.
Pharmacy in Practice is a UK pharmacy publication with its roots in Scotland.