Reference Material for Covid-19 with proven commutativity

Reference Material for Covid-19 with proven commutativity

Material de Referência

The solution complements the quality control tools and ensures the analytical accuracy of the identification of IgG and Total antibodies to SARS-CoV2

The Reference Material (RM) for Covid-19 is an ally of the diagnostic sector, contributing to the analytical processes of IVD (InVitro Diagnostic) manufacturers and laboratories. The RM has proven commutativity, showing that it has the same behavior as the clinical sample. That is, with the same characteristics, not undergoing significant changes during the preparation process.

This property aligned with material recognition is critical to instilling more trust in analytical processes. The RM for Covid-19 is produced in accordance with internationally accepted criteria and established in the ABNT NBR ISO 17034 standard.

The RM for Covid-19 is intended for IgG and Total antibody identification assays for SARS-CoV2, and can be used for evaluation of Automation and TLR (Remote Laboratory Testing) / POC – Point of Care systems. Available in both positive and negative nominal (presentation) properties, the material is lyophilized. This feature preserves the material during transport.

The application of the RM 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 user has in the use of the material a tool of major importance to avoid false positive or negative results.

The availability of this material is a pioneering initiative by Controllab, which is known for its competence, experience, trust and innovation.

Access the material information page to apply the RM for Covid-19 in your activity.

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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).