LumiraDX: more quality, safety and performance with the Collaborating Supplier Program of Controllab

English multinational, focused on the Point of Care Testing segment, highlights search for process improvements by including its remote laboratory tests in this partnership.

A demanda crescente por equipamentos e produtos inseridos em programas de qualidade levou a LumiraDX a também participar do Programa Fornecedor Colaborador da Controllab. Trata-se de uma parceria contínua, pela qual o fornecedor disponibiliza seus sistemas para que a Controllab monitore o desempenho a cada rotina no Controle Interno (CI) e verifique periodicamente a exatidão dos resultados usando o Ensaio de Proficiência (EP ou controle externo). “Desta maneira, asseguramos aos nossos clientes, a qualidade, a precisão e a segurança ao utilizar os nossos produtos”, avalia Camila Dias, gerente de produtos da LumiraDX, que espera fidelizar os clientes já existentes e atrair novos que priorizam qualidade fazendo uso de controle externo e interno.”, afirma Camila.
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: or + 55 21 3891-9900.

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PRM 0009

Accreditation Cgcre/Inmetro - Certified Reference Material Producer

Controllab has been accredited as a Certified Reference Material Producer (MRC) since 2016 by Inmetro’s General Coordination for Accreditation (CGCRE), under the PMR 0009 number. The assessment of this conformity is carried out according to the requirements established in ABNT NBR standards ISO 17034 and Inmetro, thus ensuring competence for the production of MRCs, according to the Scope of Accreditation.
Cgcre is signatory to the Mutual Recognition Arrangements of the International Laboratory Accreditation Cooperation (ILAC) and Interamerican Accreditation Cooperation (IAAC).

CAL 0214

Accreditation Cgcre/Inmetro - Calibration Laboratory

In December 2002, the Calibration Laboratory was accredited by Inmetro’s General Coordination for Accreditation (CGCRE). With this recognition, it became an integral part of the Brazilian network of accredited laboratories, under nº214. Since then, it is periodically evaluated for the maintenance and/or extension of accreditation.

Cgcre is signatory to the Mutual Recognition Arrangements of the International Laboratory Accreditation Cooperation (ILAC) and Interamerican Accreditation Cooperation (IAAC).

PEP 0003

Accreditation Cgcre/Inmetro - Proficiency Test Provider

In September 2011, Controllab was accredited by Inmetro’s General Coordination for Accreditation (CGCRE) as a proficiency test provider, under nº PEP0003. Initially as part of a pilot project by Inmetro, this accreditation was based on ILAC G13: 2007 and included several clinical and hemotherapy tests. In the periodic evaluations of this accreditation, new segments and tests are included and the evaluation is now conducted according to ABNT NBR ISO/IEC 17043.

This accreditation attests to Controllab’s technical competence to develop and conduct proficiency tests in accordance with international requirements and enables it to be recognized in other countries, in accordance with mutual recognition agreements signed by Brazil in Mercosur, the Americas and Europe.

Cgcre is signatory to the Mutual Recognition Arrangements of the International Laboratory Accreditation Cooperation (ILAC) and Interamerican Accreditation Cooperation (IAAC).