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. 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 Coordenação-Geral de Acreditação 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.

Related news

Sign up for our newsletter

Receive relevant publications about lab and solutions for
quality management.

X
Contate-nos
Whatsapp
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.
I AGREE

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.

view certificate
access accredited scope
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.

view certificate
access accredited scope - RBC/Cgcre/Inmetro - Physical-Chemical
access accredited scope - RBC/Cgcre/Inmetro - Mass
access accredited scope - RBC/Cgcre/Inmetro - Volume and Specific Mass
access accredited scope - RBC/Cgcre/Inmetro - Pressure
access accredited scope - RBC/Cgcre/Inmetro - Temperature
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.

view certificate
access accredited scope
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).