Behind the scenes

There is a lot of technology inside a Pocket Diagnostic, and making sure each test performs as it should requires precision manufacture and extensive quality control.  In this series of articles we want to take you inside the test  - to discover how it is made and how we ensure that each test you use will perform exactly as it should.   In this issue we look at ‘quality control’ during the production process.

Checking for quality

With any diagnostic tool, quality is key.  Pocket Diagnostic tests are no different.  Before any products are despatched by Forsite many checks are made by the production staff to ensure that users can have a high degree of confidence in the test result. 

Daniella Portner manages the quality control processes used on the Pocket Diagnostic tests, and points out that at every point of the production chain the products are examined carefully.  ‘Our quality control processes comply with ISO9001 requirements, and ensure that all tests are fully traceable’, says Daniella.  

Even before assembly into the plastic housings, the membranes carrying the antibodies and other reagents are tested with positive and negative controls to show they are working properly and are comparable to previous batches.  ‘We use plant material certified as infected with the appropriate pathogen for this important phase of testing’, continues Daniella.  ‘Only after passing this stage do we assemble the tests using the high-speed Kinematic autoassembler.  Further extensive QC tests are made on the assembled tests before they are packaged in foil pouches.’

Final checks are made on the packaged tests, along with the buffer and other components which go to make up a complete test.  Regular monitoring of the production environment is also carried out to ensure it remains within tolerance for humidity – one of the most important factors in ensuring long shelf life. 

The QC processes in place mean you can be fully confident in the performance of the product.  If you do have any questions about the quality or performance of Pocket Diagnostic tests, please contact us, quoting the batch number shown on the reverse of the test device.