BELIZE CITY, Wed. Jan. 5, 2022– An invitation from the Ministry of Health & Wellness (MOHW) to bid for the procurement of Lyra COVID-19 PCR tests — a test that has been deemed faulty by the US Food Drug Administration and was recalled as a result — has been raising several eyebrows recently. In July of 2021 the US Food & Drug Administration (FDA) gave notice that all Lyra PCR testing kits were being recalled “due to a significant risk of false-negative results for patients with relatively high amounts of SARS CoV 2 virus.” The FDA gave the recall a classification of Class 1—the most serious of all, which indicates that the use of the tests may cause serious harm.
The FDA also said in their notice that “False-negative results may lead to delayed diagnosis or inappropriate treatment of SARS-CoV-2 that may cause patient harm, serious illness, and death. False-negative results can also lead to further spread of the SARS-CoV-2 virus when presumed negative patients are introduced into groups within health care, long-term care, or other similar facilities. Actions to limit exposure based on false-negative results might not be taken, such as isolating infected individuals.”
In a recent interview with the media, the Health Ministry’s Technical Advisor for Maternal and Child Health, Dr. Natalia Beer, aimed to answer some of the pressing questions regarding the presence of the recalled Lyra PCR tests in Belize. When asked whether using less sensitive tests, like Lyra, might be causing a large number of false-negative results, Dr. Beer had the following to say:
“I think, like any other country, the recommendation for the control of the outbreaks of the Covid-19 pandemic and now outbreaks in the country is to get tested. It is recommended to do the contact tracing, it is recommended to isolate, and it is recommended to provide support for these isolation and quarantine measures to be more effective. But we know that persons tested positive are given instruction to isolate and given instruction on what to do and we find them on the street. Even though we may have tests that are not the best quality, we have to get the population to do their part. And we can’t just say ‘the test is not sufficiently sensitive so why use it?’ No, we must use it. Because it is the only way we can find out who is positive and then work with them to get them off the street.”
Previously, Dr. Beer had also commented that due to the recent and rapid spread of the COVID-19 Omicron variant across the globe, the need for testing has increased worldwide. As a result, access to tests is now more difficult, and according to Beer, “we have to work with what we have.”
One possible reason for the Ministry’s lack of alarm in regards to using the recalled tests is the manner in which they were recalled. According to a biotechnology magazine, Fierce BioTech, rather than asking for all the Lyra tests to be returned, as is usually the case when an item is recalled, Quidel—the makers of Lyra—issued updated instructions for interpreting test results and re-testing samples.
So far, Quidel has received five complaints about the Lyra PCR testing kits but have reported no injuries or deaths.