Reference Material for Covid-19 with proven commutativity

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.

Sign up for our newsletter

Receive relevant publications about lab and solutions for
quality management.

plugins premium WordPress
X
We use cookies and other similar technologies to improve your experience, enabling a more personalized navigation, according to the characteristics and your interest. For more information see our Privacy and Security Policy.

PRM 0009

Certified Reference Material Producer

Accredited by Coordenação-Geral de Acreditação do Inmetro

Controllab has been accredited as a Certified Reference Material (CRM) Producer since 2016 by Cgcre, under number PMR 0009. The conformity assessment is carried out in accordance with the requirements established in ABNT NBR ISO 17034 and Inmetro standards, ensuring competence for the production of CRMs, as defined in the Scope of Accreditation.

This accreditation attests to Controllab’s technical competence in producing CRMs according to international requirements and enables it to be recognized in other countries, under mutual recognition agreements, thereby reducing technical barriers between Brazil and other countries across continents.

Materiais de Referência Certificados - PMR 0009 - ABNT NBR ISO 17034-Controllab
Cgcre is signatory to the Mutual Recognition Arrangements of the International Laboratory Accreditation Cooperation (ILAC) and Interamerican Accreditation Cooperation (IAAC).

CAL 0214

Calibration Laboratory

Accredited by Coordenação-Geral de Acreditação do Inmetro

In December 2002, the Calibration Laboratory was accredited by Cgcre. With this recognition, it became part of the Brazilian network of accredited laboratories, under number 214. Since then, it has been periodically evaluated for the maintenance and/or extension of its accreditation.

The Inmetro seal attests to Controllab’s technical competence, credibility, and operational capability for calibration services, in accordance with the requirements of ABNT NBR ISO/IEC 17025.

Calibração de Instrumentos - CAL 0214 - ABNT NBR ISO/IEC 17025 - Controllab
Cgcre is signatory to the Mutual Recognition Arrangements of the International Laboratory Accreditation Cooperation (ILAC) and Interamerican Accreditation Cooperation (IAAC).

PEP 0003

Proficiency Test Provider

Accredited by Coordenação-Geral de Acreditação do Inmetro

In September 2011, Controllab was accredited by 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.

PEP 0003 - ABNT NBR ISO-IEC 17043 - Controllab

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