Controllab Launches Control for Molecular RDT

Largest provider of solutions for the quality control of Covid-19 exams, expands the portfolio with the Proficiency Testing for molecular results by Rapid Diagnostic Test (RDT)/Point of Care (POC) in April

Since the beginning of the Covid-19 pandemic, Controllab has been a pioneer in meeting the quality control needs of the new analytical systems available for the SARS-CoV2 test.

In April, the provider will send the pilot round of the Proficiency Testing for molecular RDT. This initiative will allow users of RDT/Point of Care (POC) systems that use the isothermal amplification method to demonstrate the credibility of their analysis.

The Proficiency Testing (PT), also known as External Quality Control, indicates the analytical accuracy of the laboratory. The tool is efficient for assessing technical quality and to guarantee the reliability of the results.

The test items of the PT contain inactivated cell suspension. They are lyophilized and prepared from viral isolation containing the complete SARS-CoV-2 genome for virus identification.

The assessment will be made available in an individual results report with a concept and another report with a general performance profile. The round was structured according to the guidelines of ISO/IEC 17043.

Having quality control applied to each of the methodologies is essential to guarantee the reliability of the results and Controllab is committed to this cause.

“The Covid-19 scenario has been challenging for everyone in the diagnostic sector. Developing a quality control in a short period of time, in the face of scarcity of inputs, multiple questions and uncertainties, shows Controllab’s technological and scientific know-how in providing solutions for quality assurance and the reliability of the analysis reports ”, says Jéssica Gomes, company services supervisor.

Controllab‘s 43-year history is based on a commitment to offering solutions for the quality and assertiveness of laboratory results. There are more than 3,500 tests offered for different segments: clinical, blood bank, veterinary, microbiology and physical-chemical tests for medicines, food, sanitizing agents, water and effluents, fuels and others. The services provided facilitate the routine for the processes of laboratory accreditation and regulatory bodies.

To participate in the Proficiency Testing for Molecular RDT, access the registration link. More information about Controllab solutions is available on the website, by e-mail or by phones and WhatsApp +55 (21) 97901-0310 and +55 (21) 98036-1592.

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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.

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).