Designing a robust lateral flow test specification for high-volume manufacture

Important considerations pre-development
Before you start
Producing robust test specifications
Overcoming common issues
Conclusion

Ease of use and an ability to be applied in multiple testing scenarios are the reasons why lateral flow technology has been used successfully across many industries for a long time. It also explains why lateral flow usage ramped-up during the COVID-19 pandemic.

But the increasing demand for both COVID and non-COVID formats1 following mainstream exposure of lateral flow technology during the pandemic means lateral flow manufacturing output will of course need to cope with demand.

The mass production of lateral flow tests is not always straightforward and requires experience and expertise. Therefore, in this article Mark Jones, Abingdon Health’s Technical Director, goes through the process of ensuring lateral test specifications are robust and can cope with long-term, routine high-volume manufacture.

Note: an experienced lateral flow manufacturing partner will guide you on this before discussing any project.

Before you start
At Abingdon Health, we follow a formal design control process under our quality management system. We capture critical design requirements and convert them into our Product Requirement Specifications (PRS) document. The PRS is a key document for earmarking every tiny detail of what the rapid test needs to be: for development, routine manufacture, the end-user, and the market.

There are many considerations needed, too many to fit in one article. A member of our team can run you through the process. However, below are few examples of what is considered in the PRS:

• Performance targets
• Analytical sensitivity and specificity
• End-user requirements
• The number of steps in the test running protocol
• Does the readout need to be qualitative or quantitative?
  

Producing robust lateral flow test specifications
The PRS forms the basis of the R&D and technical transfers ‘playbook’ for assay development and transfer into routine manufacture. But within the process there are several key considerations: overlooking these can have an impact on test performance and delay market entry.

Key considerations when developing a robust test are:

The sample matrix must be considered early during development. Again, an obvious statement but evaluating the real sample matrix early lays the foundation for understanding how the test is likely to perform. Working in a ‘perfect system’ is not appropriate – real-world performance is all that matters.

Quality is key – control of design and development through industry standard processes allows the test development and transfer to be structured in a way that directs areas of focus to ensure a successful test is developed.

QC (Quality Control) Panel selection and performance specifications are vital – developing appropriate, robust and reproducible incoming, in process and final release test specifications is critical. This also means ensuring that a QC panel is reflective of required performance, is reproducible and stable over time. This is essential to ensure you can manufacture the same product over and over again.

We covered this part early in the article, but this area holds significance. Selection of good quality, reproducible, scalable raw materials is an important factor in developing a robust test.

Finally, the use of quality equipment for production purposes is significant in ensuring a robust product is developed and transferrable into scale manufacturing. Whether the rapid tests are to be produced in a semi or fully automated environment (here at Abingdon Health we can do both), ensuring that the equipment is aligned with the specifications the test strip requires and the equipment appropriately qualified for use in the defined manufacturing process is essential.

Overcoming common issues

As mentioned above developing and manufacturing lateral flow tests is not always straightforward. Therefore, our specialists have created a troubleshooting guide to offer insights into producing accurate and reproducible rapid tests. The guide outlines dealing with potential manufacturing issues and identifying what caused them.

Conclusion 
Preparation, evaluation, expertise and the right materials are the foundations for designing a robust lateral flow test specification for high-volume manufacture. Careful consideration and on-going monitoring of multiple factors will enable a test strip to be manufactured time and time again.

Here at Abingdon Health, we have the required expertise in design, development, transfer and manufacture of lateral flow tests – which includes design and development of essential manufacturing and QC specifications.  This expertise is teamed with access to world class manufacturing facilities and equipment which ensures that a quality lateral flow test is the end result.

If you need assistance to overcome reoccurring issues or need to scale-up out of R&D, book a no-obligation and confidential consultation with a member of the team.

Reference
https://www.marketsandmarkets.com/Market-Reports/lateral-flow-assay-market-167205133.html