How the SARS-CoV2 Proficiency Test assists the diagnostic industry

The information generated by the Proficiency Test contributes to the improvement of laboratories, helps kit manufacturers and benefits the whole society.

In the current Covid-19 pandemic scenario, in which constant technologies are being improved or emerging to aid diagnosis, participation in a Proficiency Test (EP), a tool also known as External Quality Control, is evidence of the laboratory’s commitment to the reliability of its reports. The release of accurate results leads to early clinical management of the patient and reliable epidemiological data. The laboratory reports for Covid-19 are references for tracking contacts of the infected individual, aiming at controlling the transmission of the disease. These data are also used by the authorities for planning and actions to deal with the pandemic. EP is one of the mechanisms for controlling the quality of results. It works like this: the laboratory receives samples with unknown results and is instructed to test them in the same way as patient samples. The results found by the laboratory are sent to the proficiency provider, such as Controllab. After receiving the data from the laboratories and applying a statistical treatment of comparison and evaluation of the results, the provider issues a report to each participant. In it, it is possible to identify the expected result compared to the reported data. It is information that, when analyzed critically by the participant, contributes to the continuous improvement of the laboratory and, consequently, to the reliability of doctors and patients. The performance of the group of participants by analytical system shows how efficiently these laboratories are applying the techniques of the system, but inconsistencies can also be verified in batches of diagnostic kits distributed by the manufacturers or even issues of improvements of this analytical system when compared by other groups similar. Committed to supporting diagnostic routines, Controllab was a pioneer in offering EP for SARS-CoV2 and was recently accredited by Cgcre of Inmetro (PEP 003) for the main methodologies for detecting the disease. This recognition enabled Controllab to be the first Proficiency Test provider in the world accredited by Covid-19 research using Molecular Biology, Automated Immunology and Rapid Diagnostic Test (POCT)* methods for antibody and antigen research. All tests offered by Controllab follow the criteria of ISO/IEC 17043 and accreditation is evidence of these actions. It endorses reliability and competence in relation to the services offered. By choosing the Proficiency Test program from an accredited provider, the laboratory meets certification and accreditation requirements. Aware of the evolution of diagnoses for Covid-19, Controllab expanded the offer of quality control for disease with the saliva matrix. In September, it released the 2nd interlaboratory report for SARS-CoV2 methods, with valuable information that will be useful to demonstrate to the market the performance of the analytical systems used. Like the first report, which was a precursor in Brazil, the behavior obtained in the interlaboratory comparison was analyzed by a group of specialists in the sector. The new document contemplates a greater diversity of kits and automated systems. It assists both kit manufacturers and laboratories, demonstrating the relevance of quality control for decisions about systems implanted in the routine, in this period of learning and uncertainty. For more information about the solutions provided by Controllab, contact us by email or by phones and WhatsApp +55 (21) 97901-0310 e +55 (21) 98036-1592. *According to the EPTIS website on 10/14/2020.

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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.
Cgcre is signatory to the Mutual Recognition Arrangements of the International Laboratory Accreditation Cooperation (ILAC) and Interamerican Accreditation Cooperation (IAAC).

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).