The rapid development of the production of lateral flow devices (LFD) over the last two years has been transformative. In the wake of the 2020 global pandemic, regulatory bodies made rapid changes to the requirements for bringing a lateral flow device to market. In response, companies fast-tracked production to meet market demand. Despite nearing a post-COVID world, there is still a need for these devices. Regulatory bodies are returning to pre-COVID requirements to ensure the safety and accuracy of these products.
In a post- COVID world, there is absolutely still a requirement for COVID diagnostics. Many airlines still require negative test results before passengers travel. While the UK government is still advising the public to “lateral flow before you go.” The global lateral flow assay market was valued at $8,351.30 million in 2020 and is projected to reach $13,352.90 million by 20301
Perfectus Biomed Group supports companies by testing these diagnostics, generating reproducible and robust data for submission, and providing clarity on submission requirements. As such, we have collected our recommendations for how companies can best prepare to have their flow tests move through regulatory submission as quickly as possible.
Painlessly Flow Through New Regulatory Submissions
To ensure the safety and accuracy of these test kits, regulatory bodies are now returning to more stringent pre-COVID requirements. The UK government has developed selection criteria to determine devices that will proceed through the evaluation process.
Rapid lateral flow tests must conform to all the primary criteria and at least one of the secondary criteria to be considered for evaluation. Click here to find out more on the latest regulation advisements from the UKHSA. In America, lateral flow devices can be granted an emergency uses authorization (EUA) by the FDA. With the use of an EUA the FDA may authorise unapproved medical products to be used in an emergency. Click here for the revised policy from the FDA.
Below are some of the requirements Perfectus assists companies with:
- The lateral flow device shows a one-log improvement in sensitivity over current lateral flow devices (currently 1 x 102PFU/ml).
- The time required for a ‘T-line’ to be fully developed is in line with current guidelines.
- The lateral flow device has been screened using clinical samples. We have coronavirus 229E (a surrogate virus)
The following validation studies are recommended for a SARS-CoV-2 antigen test:
- Limit of detection (LoD) / analytical sensitivity
- Cross-reactivity/ analytical specificity
- Microbial interference
Speak to a Perfectus team member to find out more about the latest UK guidelines.