Covid-19: Controllab and SBPC/ML guide interpretation of report from the first interlaboratory

On June 9, the report of the first Proficiency Test (PE) carried out in Brazil for SARS-CoV2 was published, an initiative of Controllab in association with the Brazilian Society of Clinical Pathology/Laboratory Medicine – SBPC/ML

The laboratories that participated in the pioneering proficiency test contributed essential information to demonstrate to the market the performance of the analytical systems used. Controllab and SBPC/ML congratulate these laboratories for participating in the program at such a challenging time for testing routines. The presence of users in quality control programs is essential to support the diagnosis of SARS-CoV2 with reliable information and must be supported by the manufacturers of diagnostic kits to demonstrate the performance and representativeness of the results of their analytical systems. in the market.

Access here

the report of the first evaluation of a pioneering proficiency test on all SARS-CoV2 detection methods

The behavior obtained in the comparison between laboratories was analyzed by a group of specialists in the diagnostic sector and is enriched with information to help laboratories, demonstrating the relevance of quality control for decisions about the systems implemented in the routine. However, for a correct use of the information, it is necessary to observe the following points:
  1. The Proficiency Test is part of the analytical monitoring with the Internal Quality Control. The results of the report cannot be compared with the reagent validation programs, which aim to determine the sensitivity and specificity of kits and reagents available on the market. One assessment does not replace the other. They are complementary and fundamental in laboratory practice.
  2. Observe the representativeness of the systems (kits and equipment) against the market. There are systems with only 1 respondent in the comparison between laboratories.
  3. Analyze the adequacy percentage of the system adopted by the laboratory for each item, noting the number of respondents facing the market.
  4. Investigate the performance of the kits against items not evaluated by the supplier. In the report, this situation was a consequence of the low consensus of the kits available on the market.
  5. Examine the number of batches that manufacturers make available on the market and whether there is a difference in sensitivity between batches.
  6. Discuss with the quality management the conclusion commented by the group regarding the first proficiency test in Brazil for all the SARS-CoV2 detection methods.
These are some of the essential points for the laboratory to make correct use of the information and choose the kits that will make up the analytical system of the routine. Content must be analyzed in its entirety, as partial analyzes, such as only graphs or isolated extracts, can lead to erroneous information and do not reflect the reality of the analytical performance of the system. To meet the new participants, this week the second round of external controls for COVID-19 was made available and your laboratory can still participate. This is an opportunity for more laboratories to immediately strengthen their quality management systems. By signing up, they will build, together with current participants, a broader picture of important data and information for the sector. Participate, contribute and help the laboratory diagnostic market! Laboratories that want to participate can register here.

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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).