Controllab enriches quality control with SARS-CoV2 variants

Controllab enriches quality control with SARS-CoV2 variants

To guarantee the reliability of the laboratory reports that carry out the diagnosis of Covid-19, from April, the Proficiency Testing for Molecular Biology of SARS-CoV2 will be enriched with items of different variants of the virus and the participants will be able to report the identification

Since the discovering the new SARS-CoV2 variants, experts began to discuss the ability of analytical systems in use to continue to accurately identify the presence of the virus. This discussion is due to the presence of different mutations in the virus genome and the sensitivity and effectiveness of the various genetic targets to identify them.

As a result, manufacturers of reagent kits are adapting information and laboratories are evaluating whether the analytical systems used in the routine need adjustments. To collaborate in this scenario, Controllab, a pioneer in quality control for SARS-CoV2, will enrich the Molecular Biology Proficiency Testing of SARS-CoV2 (Nasopharynx and Oropharynx).

In April, in addition to the 2 items that make up the program, another three extra items will be sent containing variants of the virus from different regions, for the detection of SARS-CoV2. The EP consists of inactivated and lyophilized cell suspension items prepared from viral isolation containing the complete SARS-CoV2 genome (Nasopharynx and Oropharynx). In it, users already report identification of genes E, RdRp, N, N1, N2, ORF1ab, S and ORF3a.

In addition to these identifications, participants who already have kits that distinguish mutations in the routine will be able to report the variant found. This initiative will assist both kit manufacturers and laboratories, demonstrating the relevance of quality control for decisions about the systems implanted in the routine.

The round will be another opportunity for the diagnostic sector to play a leading role, highlighting the reliability of analytical routines. Organizations that apply Molecular Biology using the reverse transcription polymerase chain reaction (RT-PCR) method for the detection of SARS-CoV2 are eligible to participate in the program.

Currently, there are more than 160 participating laboratories – 25% of which are from different continents – such as Europe, Asia and the Latin American region. This region includes 7 different countries, including Brazil. The profiles of the participating laboratories prove the heterogeneity of the data, contributing to a robust interlaboratory comparison program.

“This is also an opportunity for suppliers and manufacturers of diagnostic kits to demonstrate the performance and representativeness of the results of their analytical systems to the market”, informs Jéssica Gomes, Service Management supervisor.

Suppliers and manufacturers who wish to enroll their users, as well as laboratories that have not yet adhered to the EP Molecular Biology Coronavirus (SARS-CoV2), can access the program page to participate.

To learn more, access the site, contact us by email or by phone and WhatsApp (21) 97901-0310 and (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).