Reference Material for Covid-19 consolidates Controllab’s pioneering spirit

Reference Material for Covid-19 consolidates Controllab’s pioneering spirit

Material
In yet another unprecedented initiative, the company is recognized as a producer of Reference Material with proven commutativity for Covid-19 Since the beginning of the Covid-19 pandemic, Controllab has made its know-how available as an important ally of the diagnostics sector. The company forerunner SARS-CoV2 External Controls to ensure the analytical accuracy of testing, earning recognition as the world’s first accredited provider for all virus detection methodologies. In addition, it pioneered public performance evaluation reports that helped kit manufacturers and laboratories make decisions about their analytical systems. The company’s vanguard has been consolidated in another initiative: Controllab is the precursor of the Reference Material (RM) for Covid-19 with proven commutativity.

The importance of commutativity and RM for Covid-19

Commutativity is evidence that the RM has the same behavior as the clinical sample. That is, with the same characteristics, not undergoing significant changes during the material preparation process. Labnetwork materia Controllab 112 2 The RM for Covid-19 is intended for IgG and Total antibody identification tests for SARS-CoV2, and can be used for evaluation of Automation and RLT (Remote Laboratory Test) / POC (Point of Care) systems. The RM offer complements the quality control tools, such as the Proficiency Testing and Internal Control, regarding the verification of effectiveness, methodological validation, implementation and selection of analytical systems, in addition to the evaluation of processes. “The RM for Covid-19 with proven commutativity will infuse more confidence into analytical processes. The user has the use of the material as a very important tool to avoid false positive or negative results”, comments Vinícius Dias, manager of Chemical Tests at Controllab.

Differential that attests to competence

This pioneering spirit is Controllab’s brand, which is known for its competence, experience, trust and innovation. The company has been accredited since 2016 by Cgcre do Inmetro as a Reference Material Producer (PMR 0009) and applies the same quality throughout its production, regardless of material recognition. “This initiative is the result of an innovative environment stimulated by the company’s board of directors. Mr. Márcio Biasoli, Controllab’s founder, launched the challenge and provided the support for the research and development necessary for the recognition of the material. It is a collective achievement that fills us with pride”, adds Vinícius Dias. The RM for Covid-19 is lyophilized. This characteristic preserves the material during transportation. To apply the RM for Covid-19 in your activity, access the Material information page.

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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.
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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.

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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.

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