Solutions for quality control in the analysis of the Covid-19

In order to contribute to the validation of these tests, whose reliability has been the subject of discussions, quality control is a fundamental ally.

In the current pandemic scenario, the contribution and credibility of laboratory tests for Covid-19 has been widely reported. To increase the reliability of these reports, Controllab has just launched the Proficiency Test for SARS-CoV2 (Covid-19).

The importance of laboratory tests for health care is widely known. Therefore, analytical systems support the confidence that clinical staff must have in the results received.

The Proficiency Test (also known as External Control) monitors process trends (inaccuracy), commonly related to linearity, specificity, sensitivity, interference and calibration characteristics. These variables are inherent to the analysis process and keeping them under control is essential so as not to compromise the quality of the laboratory reports.

Having quality control to guarantee the reliability of laboratory tests, and of national origin, to avoid the logistical impacts caused by the pandemic, collaborates to strengthen the Brazilian health system.

The Proficiency Test follows the criteria of ABNT NBR ISO/IEC 17043 and Controllab is accredited by the General Accreditation Coordination (Cgcre / Inmetro), under the number PEP 0003, according to the scope published in Inmetro.

Laboratory quality control programs of Controllab help the laboratory obtain recognition from physicians and patients regarding the quality of the reports issued.

Controls available for SARS-CoV2 (Covid-19)

The first round of the Proficiency Test (EP) for SARS-CoV2 of Controllab was held in May and helped laboratories evaluate the analytical performance of their systems. The behavior obtained in the interlaboratory comparison was analyzed by a group of specialists in the diagnostic sector and made available in a report. The content is enriched with information to assist manufacturers of diagnostic kits and, especially, laboratories, demonstrating the relevance of quality control in periods of uncertainty and complexity. Access the document.

Controllab offers internal quality control (CQI) for all SARS-CoV2 detection methodologies. The programs of the CQI of Controllab are considered third-party controls. The materials have interlaboratory valuation in different remote laboratory test systems (TLR), molecular and automated tests, such as: Roche Elecsys (Cobas e601, e602, e411, e801), Abbott (Architect i1000sr and i2000sr), Euroimmun, MagLumi, among others . These multiple valuations allow the laboratory to detect more sensitive variations, which are not perceived in the controls of the manufacturers of the analytical system.

The controls are lyophilized – allowing better stability during transportation – and distributed in different compositions to meet the most varied routines. These controls are available for immediate dispatch, upon request from the laboratory, or scheduled monthly.

In addition to the new coronavirus, it is necessary to keep chronic diseases under control, in order not to be aggravated with Covid-19 (disease caused by the virus). The patient with Covid-19 also needs other complementary exams (such as a complete blood count, D-dimer, PCR and others) to monitor and contain the evolution of the disease. To optimize resources, it is also essential to monitor the routine of tests for differential diagnosis of respiratory diseases for coronavirus.

Due to team adjustments and other laboratory routines affected by the pandemic, maintaining quality control in all tests performed by the laboratory is essential to avoid errors in the laboratory analytical phase and repetition costs.

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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.

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.