Covid-19: The Internal Control of Controllab reinforces the reliability of the exams

The importance of laboratory tests for the diagnosis of patients with Covid-19 has been widely reported, but just as important as expanding the number of tests is having those that provide adequate information.

The increasing demand for tests and more agility in the publication of results requires that the laboratories that perform the analysis commit to quality tools. This commitment extends to kit manufacturers and distributors, who must uphold their customers’ best practices as they affect the reliability of their tests.

With the dissemination of the cases, there was an expansion of the available methodologies for the detection of SARS-CoV2. Having a quality control applied to each of them is essential to guarantee the reliability of the results.

Controllab is committed to this cause and already offers internal quality control for all methodologies. The programs of the Internal control of Controllab are considered third opinion controls. The materials have an inter-laboratory assessment in different rapid diagnostic test (TLR) systems, molecular and automated tests, such as: Roche Elecsys (Cobas e601, e602, e411, e801), Abbott (Architect i1000sr and i2000sr), Euroimmun, MagLumi, among others. These multiple evaluations allow the laboratory to detect more sensitive variations, which are not perceived in the controls of the analytical system manufacturers.

Controls are lyophilized – allowing better stability during transportation – and are distributed in different compositions to meet the most varied routines. These controls are available for immediate shipment, at the request of the laboratory, or scheduled monthly.

Two tools have been highlighted in good practices for composing exam quality control: The Internal Control (IC) and the Proficiency Test (EP). Recommended worldwide for the operation of analytical laboratories, they are essential for monitoring analytical performance and, linked to a management committed to quality, help to produce reliable results.

The first EP for all SARS-CoV2 methods was made in May. The behavior obtained in the comparison between laboratories was analyzed by a group of specialists in the diagnostic sector and made available in a report.

Data analysis showed the importance of continuous use of reference material, such as internal quality control, to validate routines on a daily basis and eliminate interferences that negatively reflect the reliability of patient results.

controle qualidade 1

Internal control is performed in conjunction with routine analysis of patient samples. In complementary use with the proficiency test, calibrators and other tools, it promotes adequate monitoring and control of the analytical phase, which guarantees the quality of the results of the patients obtained daily by the laboratory.

For more information on how to participate in the programs, access know the controls or contact us by email or by phone 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 - Control Laboratory

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).