THE HEALTH PRODUCTS Regulatory Authority (HPRA) and a pharmaceutical company which makes antigen tests are to investigate after a number of complaints were made about apparent false positives.
The HPRA has received a number of complaints about the Genrui SARS-CoV-2 Rapid Antigen Test, which is sold in a number of Irish shops and pharmacies, returning false positives.
A spokesperson said the HPRA “is following up with the manufacturer of the test to investigate the matter and will also liaise with other European Competent Authorities in relation to this issue”.
Genrui also confirmed to The Journal that it will investigate the reports of false positives. “We will conduct further internal investigations to understand the relevant facts,” a spokesperson for the company said.
The company will continue to work “with local agents and partners in Ireland and other countries to actively investigate related product batches complained by users and maintain active communication with users who send inquiries to properly handle the related issues”, they added.
Dr Niamh Lynch, a paediatric doctor based in Cork, said she has received hundreds of messages about false positives happening on the Genrui tests in recent days.
Received 100s of messages through my Insta about Genrui antigen tests.
— Dr Niamh Ni Loinsigh (@niamh_dr) January 1, 2022
When pcr was available there seemed to have been lots of false positives with these kits.
This could have major implications for people now with no pcr available.
Have you had any issues with them? pic.twitter.com/hmMgGz8hFp
Messages warning about the accuracy of the tests have been widely shared on social media in recent days – numerous people say they got a positive result from a Genrui antigen test but later received a negative PCR test result (which is more accurate).
The Genrui brand of antigen test is sold in several shops in Ireland including Lidl, Dunnes Stores, Supervalu, Centra and others. A number of pharmacies have already opted to stop stocking them, medical sources said.
Similar issues have been reported in other countries. Authorities in Hamburg in Germany issued a warning about the Genrui tests in December – saying that if a faint line appears to detect the presence of Covid-19, the person should do a second antigen test from a different brand.
Genrui’s tests have a CE marking, meaning they have been approved for use in the EU. The company is based in China but sells products in over 120 countries worldwide.
The company’s spokesperson said they “deeply understand product quality is crucial to fight this pandemic, therefore, we will continue to pay attention to market feedback on products”.
The HPRA spokesperson noted that rapid antigen tests, “like all diagnostics, have the potential to provide false negative and false positive results. It is widely acknowledged that rapid antigen tests are less accurate than PCR tests and should be used in line with current public health guidance”.
“Individuals who have received a positive result following use of a rapid antigen test should follow the current public health advice on the HSE website and seek advice from their doctor if necessary,” they added.
Anyone who believes they have experienced a false positive or negative result has been asked to report the occurrence to the HPRA at devicesafety@HPRA.ie.
Given the recent update on testing advice from the HSE amid difficulty booking PCR tests, the issue could have serious implications in Ireland.
Under current HSE guidance, people aged four to 39 with symptoms of Covid-19, as well as close contacts of confirmed cases, should use antigen tests rather than book a PCR test given the huge demand currently being experienced by the PCR testing system.
People with symptoms should self-isolate. If a person gets three negative antigen test results over a three-day period, they should continue to self-isolate until they have not had symptoms for 48 hours.
The HSE would not comment on the matter, telling The Journal it is an issue for the HPRA.
Isolated from her children unnecessarily
Jenny MacMahon, who lives in Dublin, received a false positive from a Genrui antigen test on New Year’s Eve. She had no symptoms bar a sore throat but assumed the antigen test was correct.
A PCR test later showed she didn’t have Covid-19 but, until she got this confirmation, Jenny had to isolate from her husband and two of her young children.
Jenny said she and her family have regularly used antigen tests in recent months as a precaution. In the past they used a different brand and never received a positive result.
On 31 December, they used Genrui antigen tests. The rest of the family were negative, but Jenny’s test came back positive. She and her husband, both aged in their 30s, had received their Covid-19 booster shots at this point.
Speaking to The Journal today, Jenny explained that she had to stay with her baby daughter as she is breastfeeding her but wore a face mask around her just in case. She and the baby isolated away from her husband and their two other children, aged five and three.
“All the tests came back negative except mine, there was a faint but very visible second line,” Jenny said.
“I have a nine-month-old baby girl who is still breastfeeding so I couldn’t be separated from her. So then basically we had to set up camp in my bedroom for three days until I got the PCR result.”
Jenny said it was very difficult to get a PCR test. Her GP surgery was closed but she finally secured an appointment after “refreshing the [HSE] page for six hours straight”.
“I got extremely lucky [to get a PCR test], I’d say I shaved three to four days off my isolation period as a result.”
While Jenny was “extremely relieved” she didn’t actually have Covid-19, the three days she spent away from two of her children were very difficult.
“My three-year-old had been outside my bedroom door crying because she wanted to see me.”
Jenny said she saw comments online about apparent false positives with this particular brand of test but took this “with a pinch of salt”.
However, when relatives and friends also started to experience false positives with Genrui tests, she believed it was more than a coincidence.
“A few friends of mine are saying the same thing happened to them or their in-laws. More and more people that I knew said it happened to them too.
“A few of them had gotten a positive antigen test and then a negative PCR, and the common denominator always seemed to be that they used a Genrui antigen test.”
Jenny said she’s glad she isolated as a precaution because she didn’t want to pass on the virus, but is frustrated that she was unnecessarily separated from her family “for nothing, because of a faulty test”.
Antigens ‘have their limitations’
The Genrui spokesperson told The Journal that Covid-19 detection methods “have their limitations” and the antigen self-testing product “can only be used as a supplement to existing detection methods but not be used alone for the diagnosis of SARS-CoV-2 infection”.
“The test result should be combined with other diagnostic information, such as PCR Test, imaging, and other medical and contact history to determine whether the user is infected.”
The spokesperson added that the accuracy of antigen test results “depends on a variety of factors, including standardised sampling, the time of result interpretation, ambient temperature, operating procedures”.
“Users are advised to strictly follow the instructions to reduce the possibility of inaccurate results.”
As with all antigen tests, the Genrui tests need to be stored and used at certain temperatures – 2-30°C when stored and 18-28°C when being used.
Genrui’s antigen self-test kits were granted authorisation for use in Germany, France, Portugal, the Czech Republic and Austria on 10 April 2021, and the product was officially issued with European Union self-test CE certification on 2 August 2021.
Pharmacies and shops
A spokesperson for the Irish Pharmacy Union told The Journal the IPU “is aware of anecdotal reports that a certain brand of antigen test may, on occasion, provide false positive results”.
“However it is essential that everyone continues to follow the public health advice,” they added.
“There are extremely high levels of Covid-19 across every community in Ireland, so if you test positive for Covid-19 on any antigen test, it is highly likely that you do have Covid-19 and you should therefore self-isolate and seek a PCR test.
“If purchasing antigen tests, people should always ensure that they are CE marked, indicating they are in compliance with official standards.”
The Journal contacted Lidl, Dunnes Stores and the Musgrave Group, which stocks Supervalu and Centra, to see if the stores planned to continue selling this brand of antigen tests.
Aoife Clarke, Head of Communications at Lidl Ireland, said all of the companies that Lidl have purchased antigen tests from are on the approved European list and contain the CE symbol.
“The CE mark indicates that a product fulfills the requirements of relevant European product directives – meaning it meets all the recognised performance and safety standards,” she said.
Dunnes Stores or Musgrave Group had not replied to a request for comment at the time of publication.
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