What does Beckman Coulter do to ensure the ASR product quality?
All ASRs are tested by Beckman Coulter to meet specifications for consistent quality. During product development, specifications are strictly assessed and optimized to ensure the ASR will perform as expected. Manufacturing requires adherence to rigorous procedures that meet cGMP regulations.
ASR performance must be validated by the laboratory developing the LDT assay. Only in the final test composition and with the corresponding protocol can the performance of the LDT be evaluated and documented.
ASR manufacturers are not allowed to provide any specific protocol or performance claims. Hence, product documentation, such as the Instructions For Use or Product Datasheet, include:
- No recommended protocol or procedure, including recommended volume per test
- No specific analytical or clinical performance claims
- No literature regarding an ASR’s clinical utility and clinical performance
- No instruction for use in a particular test or application
- No instruction for validation of a specific test using the ASR
- No suggested companion products (markers, buffers, controls, etc.)