The growing demand for equipment and products included in quality programs has led LumiraDX LumiraDx to also participate in the Collaborating Supplier Program of Controllab It is a continuous partnership, whereby the supplier makes its systems available for Controllab to monitor the performance of each routine in the Internal Control (IC) and periodically check the accuracy of the results using the Proficiency Test (PT or external control).
“This way, we assure our clients of the quality, precision and safety when using our products ”, evaluates Camila Dias, manager of LumiraDX products, who hopes to retain existing clients and attract new ones as their priority be the quality making use of external and internal control, ” said Camila.
The Rapid Diagnostic Tests of the Lumiratek line that are part of the program are Urine Tests, Anti-HCV, Anti-HIV, Dengue NS1 and IgG/IgM, HbA1c, HBsAg, Hemoglobin (Donor Selection), Fecal occult blood , Syphilis, Syphilis/HIV and Troponin I.
Controllab verifies the analytical system of the supplier, in this case, the LumiraDX kits, the materials of the Proficiency Test (PT), a program that allows comparison between laboratories. By participating in the Controllab EA, in turn, the laboratory that is a client of LumiraDX periodically verifies the accuracy of the results for the examinations carried out with the analytical system of this supplier, evaluating its performance against the expected results in the samples of control.
In the case of IC, the supplier makes its products available so that Controllab can carry out the sequence of repeated analyzes to assess internal control. This way, the reference values for the material of the supplier become part of the inserts of the internal control programs of Controllab.
This is what enables the integration between the supplier, the customer's laboratory and Controllab. Jessica Gomes, service supervisor of Controllab, recalls that the analyzes and evaluations in the supplier's system are carried out with each new control material produced by Controllab, either for use in external control or internal control. "The dynamics of the program favors the exchange of information," emphasize the Controllab supervisor.
External and internal quality controls allow monitoring the processes against the different variables that can interfere with the analytical routine and promote the reliability of the test results.
LumiraDx is a Bristol, UK-based company that develops diagnostic-focused platforms and technologies in the Point of Care Testing (POCT, or Remote Laboratory Tests), Rapid Testing, and Self-Assessment segment.
In addition to having O&M associations for solutions in the areas of gases, electrolytes and metabolites, biochemistry, hematology, urine analysis, lipid profile, glycated hemoglobin, cardiac markers.
"Participating as a collaborating supplier allows us to seek improvements in the process and development of our products, emphasizing the importance of having quality and responsibility when serving the diagnostic market," concludes the LumiraDX product manager.
Controllab is recognized by ISO 9001, 17025, 17034 and 17043. The extensive portfolio of quality control, over 2,500 tests, provides a unique ability to meet the needs of the diagnostic industry.
For more information on how to participate in the Quality Control Programs, you can contact Controllab directly: firstname.lastname@example.org or + 55 21 3891-9900.Back