Covid-19: Controllab solutions for kit validation

The new Coronavirus pandemic challenged laboratories to introduce new routines for Covid-19 testing in a short period of time. Even with little knowledge about the disease and with the recent arrival of diagnostic kits on the market, validation protocols are necessary for this stage.

In addition to meeting regulatory requirements, the entire laboratory must perform the verification and validation of its analytical system before inserting it into its routine. These practices must also be carried out periodically in order to: measure the present errors and determine with certainty whether they affect the results or not; identify significant changes in its processes and obtain objective evidence that the system or method adequately produces a result that meets predetermined requirements.

Those responsible must manage the tests, analyze the results obtained, prepare the report and decide whether the performance of the system or method has been approved. In support of these routines, Controllab provides services that optimize time and add more confidence to the evaluation of the analytical quality cycle.

For laboratories that search for Covid-19 antibodies through automation serology tests and/or Rapid Diagnostic Test (TLR), the Performance Panel and batch-to-batch Validation are available.

These are solutions that help laboratories, suppliers and manufacturers of diagnostic kits. See the functions:

Performance Panel: used to evaluate and validate new test methods and equipment, the service demonstrates the reliability of the systems. Composed of positive and negative items, with varied concentrations and heterologous items obtained from different donors from the regions of Brazil, this panel is previously assessed by different analysis methodologies. The use of little relative control materials allows to obtain valuable information regarding the analytical capacity of the laboratory and the variations between reagent batches.

Batch-to-batch Validation/Shipment: Verifies the proximity of the results obtained with the new lot and the current lot to detect any significant deviation in reagent performance, and then defines whether the reagent lot needs to be replaced.

To know the services and get more information, contact Controllab by e-mail contato@controllab.com or by phone and WhatsApp (21) 97901-0310 and (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.

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.