Learn how the initiative promotes consistent testing and offers real benefits for both testing services and manufacturers.
Confidence in test results is essential for safe clinical decision-making. Although manufacturers rigorously control the production process of their reagents and materials, lot-to-lot variations can still occur and directly impact analytical performance, potentially compromising the quality of diagnoses.
In this context, the Programa de Certificação Lote a Lote emerges as a strategic solution to ensure consistent results across reagent lots for POCTs (Point-of-Care Tests). It compares the performance of the new lot with the previous one before it is introduced into routine use, helping to prevent unwanted variations.
Why is certification essential?
Even with strict process control by the manufacturer, there are factors that can affect lot performance. Among them are:
- differences in reagent reactivity;
- lack of calibrators recognized as Certified Reference Materials (CRMs);
- variations in the concentrations of substances on the test strips;
- as well as logistical aspects and storage conditions.
These variables can compromise consistency between lots.
Benefits for those performing the test
Advantages for manufacturers
For manufacturers, the program technically validates lot performance, increases transparency with clients, and strengthens their competitive edge. The certification also reduces non-conformities in the field and supports healthcare services in maintaining efficiency in their analytical routines.
Shared confidence throughout the entire chain
By promoting this certification, Controllab reinforces its commitment to the safety and excellence of analytical processes, strengthening the in vitro diagnostics supply chain and ensuring greater confidence for all involved.
Want to know which manufacturers have already adopted the Batch-to-Batch Certification?
Check the table below:
To view the complete list of certified lots, please visit this link.
Want to have this advantage in your routine?
Talk to your manufacturer and request the certification. This initiative provides greater confidence in your results and contributes to more accurate and reliable diagnoses.