There are many good sources of useful and reliable information emerging to support the development of tests during the pandemic. This blog summarises some of these documents and whilst they may not be relevant for the particular country to which you intend to market your device they still contain useful information about current best practice or expectations. This is a rapidly evolving area so please see other posts focusing on FDA Updates to FDA's EUA Molecular Diagnostic Templates and EUA Policy Plus a New Antigen Template for COVID-19 Tests.
If you have more country specific information that you would like to share, we are happy to add to future posts. Please email the information to teamivd@Qservegroup.com.
- WHO Emergency Use Listing (EUL)
The WHO EUL website provides instructions for the submission of nucleic acid, serology and rapid tests. Even if you do not intend to apply for the EUL it is worth reviewing as the requirements are compatible with elements of the EU IVDD/ IVDR and provide more detail than is covered in the legislation.
Some manufacturers that may be applying for the humanitarian use for their test may not have a QMS currently certified to ISO 13485 so it is useful to read the quality management system expectations that they would expect. These minimum requirements are found in the WHO’s Instructions for Submission Requirements documents provided separately for nucleic acid and antibody tests. This is especially important for start-up companies who often overlook the importance of generating data under a quality management system. However, meeting these minimum QMS requirements is essential for ensuring data integrity when generating data to support the performance of the test using product that is representative of the product to be made in routine production. To support this, it is therefore critical that the control of the supply of key raw materials is understood and controlled, equipment and processes are validated, product is made to approved procedures and that appropriate QC is conducted for batches used to generate data to represent the final product.
- Intended Use
We talk a lot about the importance of understanding the intended use of a device to our customers because this influences the associated risk and the data needed to support the performance and ultimately the compliance. There are two documents that help you think about potential intended uses for a device. The first is from the non for profit organisation FindDx and describes Use Case Considerations.
The second is a document in the Cochrane Library that reviews the accuracy of several COVID-19 tests available that includes in Table 1 the different potential uses of the devices and considerations for their validation.
The MHRA has also published a simple guide for patients, the public and professional users on the types of tests available in the UK. This guide describes how the various available tests are used and is helpful as an aid to help manufacturers describe device intended uses.
- Data on independent testing of COVID-19 tests
FindDx has published data from evaluations performed by the University Hospital of Geneva (HUG) SARS-COV-2 MOLECULAR ASSAY EVALUATION: RESULTS and have plans to evaluate serology assays SARS-COV-2 IMMUNOASSAYS
- Performance Expectation in the UK
The UK publishes Target Product Profiles for COVID-19 tests including an Annex on assay validation.
The UK has also published guides on how to take swabs, This is particularly important to ensure that any variations in the data are due to the test and not the sampling process.
Usability testing is also very important for near patient tests and self-tests and some guidance can be found here: Regulation of IVDs for self-testing.
- COVID-19 CE marked run controls
NIBSC have CE marked run control reagents available.