On 6th April, the Daily Mail published an article titled “Coronavirus UK: Current antibody test kits ‘only 50% accurate’”, which reported that Professor Sir John Bell, of Oxford University, said the testing kits he has examined so far ‘have not performed well’ and ‘none of them would meet the criteria for a good test’. Wondfo would like to set the record straight regarding these inaccurate claims, as well as those mentioned in a more recent New York Times article “U.K. Paid $20 Million for New Coronavirus Tests: They Didn’t Work.”, published on 16th April.
Wondfo is dedicated to providing high quality products and professional services to global clients and users. Wondfo SARS-CoV-2 Antibody Test (Lateral Flow Method) obtained the certification from National Medical Products Administration (NMPA) on February 22nd and was CE marked based on the EU IVD Medical Device Directive (98/79/EC) on March 05th in accordance with the quality standards of China and the EU.
According to information received from the UK government, Wondfo SARS-CoV-2 Antibody Test (Lateral Flow Method) was not part of the review that the Daily Mail article was based on. Wondfo’s test kits – 500,000 of which arrived in the UK in two batches on 3rd and 5th April, were sent for review on 7th April, and at the time of publication were still being evaluated.
Wondfo has not received official confirmation of the evaluation results and has received no requests for a refund by the UK government.
For clarification, as is stated clearly in the product user manual, Wondfo SARS-CoV-2 Antibody Test (Lateral Flow Method) is for professional use only. It’s not meant for home use.
Regarding antibody testing methodology,there is an incubation period after infection by the virus which causes COVID-19. During the incubation period, the virus could be detected through Polymerase Chain Reaction (PCR) testing and antigen testing. We know that the incubation period varies from person to person, and that some time after the incubation period, the immune system creates specific antibodies to the coronavirus. It is during this period that antibody tests are more sensitive and reliable, and antigen tests (which detect the presence of a live virus) will be less reliable because of the presence of antibodies to the virus, so antibody tests are used as a supplement to nucleic acid detection testing or virus culture identification methods to increase the likelihood of an accurate result.
To our knowledge, the $20 million figure mentioned in New York Times is not accurate. We did not make a deal with UK government for $20 million.
Wondfo reserves the right to ask these two media outlets to correct the inaccurate claims.
As a company, quality is our first priority. Wondfo has been transparent about the measures we are taking to ensure the accuracy of our tests and that our products meet the needs of countries as we collectively combat COVID-19.
Guangzhou Wondfo Biotech Co.,Ltd.
April 21st, 2020