quali

Among so many doubts about the disease, ensuring the quality of the reports of SARS-CoV2 exams is fundamental for combating Covid-19

More than a year after the notification of the first cases, the disease continues to provoke innumerable questions and, in this scenario, the diagnostic laboratories have a fundamental role in helping the answers.

To facilitate the management of the analytical phase processes and to insert the required reliability into the routine, Controllab offers complete solutions for the quality control of exams related to Covid-19, from validation to routine monitoring. See some of the solutions available:

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 in the regions of Brazil, this panel is previously valued by different analysis methodologies.

Batch-to-batch validation/Shipping: Checks the proximity of results obtained with the new batch and the current batch to detect any significant deviations in the performance of the reagent and, then, define whether there is a need for a replacement of the reagent batch.

Linearity: analyzes the ability of the method to generate results linearly proportional to the concentration of the analyte.

Proficiency Testing (PT): also known as External Quality Control (EQC), is an effective quality control tool for determining the analytical performance of the laboratory.

Internal Control (IC):  is responsible for the continuous monitoring of the reproducibility of the laboratory analytical phase.

Exam


Methodology


Samples


Tests


Performance Panel


Batch-to-batch Validation
/ Shipping


Linearity


Proficiency Test


Internal Control


SARS-Cov2

(Nasopharynx, Oropharynx)
Molecular Biology by the polymerase chain reaction method with reverse transcription (RT-PCR)
Inactivated cell suspension items, lyophilized and prepared from viral isolation containing the complete SARS-CoV2 genomeIdentification of genes E, RdRp, N, N1, N2, ORF1ab, S and ORF3a

available




available


available


SARS-Cov2 (Saliva)Molecular Biology RT-PCR and RT-LAMPinactivated cell suspension items, lyophilized and prepared from viral isolation containing the complete SARS-CoV2 genome or lyophilized human salivaIdentification of genes E, RdRp, N, N1, N2, ORF1ab, S and ORF3a




available


available


SARS-Cov2Automation Immunology by enzyme immunoassay, immunofluorescence, electrochemiluminescence, microparticles by chemiluminescenceItems for lyophilized human serum from a single or more donorsIIgG, IgM, IgA, Total and Avidity of IgG



available


available


available


SARS-Cov2Immunology RDT
by immunochromatography and immunofluorescence
Items for lyophilized human serum from a single or more donorsIgG, IgM and Total


available



available


available


SARS-Cov2

Nasopharynx, Oropharynx and Saliva)
AntigenInactivated cell suspension items, lyophilized and prepared from viral isolation containing the complete SARS-CoV2 genomeIdentification




available


available


SARS-Cov2Molecular RDT for isothermal amplificationInactivated cell suspension items, lyophilized and prepared from viral isolation containing the complete SARS-CoV2 genomeIdentification

available from April / 21


SARS-Cov2 (FoodsMolecular Biology by the polymerase chain reaction method with reverse transcription (RT-PCR)Inactivated cell suspension items, lyophilized and prepared from viral isolation containing the complete SARS-CoV2 genomeIdentification




available



Neutralizing Antibody ResearchAutomationItems for lyophilized human serum from a single donorIdentification, Value and Inhibition Rate %




available



Neutralizing Antibody ResearchRDTItems for lyophilized human serum from a single donorIdentification, Value and Inhibition Rate %




available from April / 21


In addition to these tools, Controllab provides Instrument Calibration, which is essential to reduce costs and rework, increase productivity and avoid errors in analytical processes.

Insert Controllab solutions into your routine and show your audience the reliability of your analyzes. To learn more, access the website, contact us by email contato@controllab.com 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.

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.