Controllab launches more controls for sequencing tests

Controllab launches more controls for sequencing tests

Sequencing

Estruturada conforme os critérios da ISO/IEC 17043, a rodada piloto está prevista para novembro e contemplará Ensaio de Proficiência para mapear o genoma viral de diferentes vírus e Coronavírus (SARS-CoV2)

Os testes de sequenciamento têm se tornado mais acessíveis e populares conforme o avanço da tecnologia. No entanto, assim como os demais exames realizados em laboratório, eles precisam de monitoramento para garantir a exatidão dos resultados.

Em junho, a Controllab lançou os primeiros controles para testes de sequenciamento e agora expande a área com os controles externos específicos para sequenciamento do Coronavírus (SARS-CoV2) e sequenciamento para Genoma Viral, que contemplará diferentes vírus, incluindo respiratórios, oncogênicos e arboviroses.

Para Covid-19, devido às mutações, a vigilância genômica se tornou uma aliada no enfretamento da doença. Laudos precisos são essenciais para detectar suas variantes, estabelecer por onde ele passou, discutir programas de ação e atualizar vacinas.

O Ensaio de Proficiência (EP) ou Controle Externo da Qualidade auxilia o laboratório na implantação e acompanhamento da qualidade técnica e insumos aplicados na realização dos testes de sequenciamento.

Ao participar destes EPs, os laboratórios poderão evidenciar aos médicos e pacientes a confiabilidade dos seus laudos, assim como a eficácia dos procedimentos e das etapas envolvidas nas análises.

A rodada foi estruturada conforme os critérios da ISO/IEC 17043 e os relatórios emitidos após a avaliação facilitam o reconhecimento para os processos de acreditação e órgãos regulamentadores.

Previstas para serem enviadas sem custos em novembro, os interessados nesses controles devem assinalar a participação neste link até o dia 08 do próximo mês.

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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).