From evidence to practice: Controllab studies inspire advances in laboratory quality

From evidence to practice: Controllab studies inspire advances in laboratory quality

From evidence to practice: Controllab studies inspire advances in laboratory quality

Scientific contributions highlight Brazil’s leadership and its commitment to excellence and safety in laboratory results.

Brazil’s participation in major national and international congresses throughout this year once again highlighted Controllab’s presence as a scientific reference in laboratory quality. At the 57th Brazilian Congress of Clinical Pathology/Laboratory Medicine (CBPC/ML), the 26th IFCC-EFLM EuroMedLab Congress of Clinical Chemistry and Laboratory Medicine, and the ISQua’s 41st International Conference, the company presented studies that reveal consistent data applicable to the continuous improvement of laboratory services.

The research covered topics ranging from molecular diagnostics to monitoring patient safety culture, demonstrating the role of Proficiency Testing programs and Laboratory Indicators (Metricare) in harmonizing practices and driving increasingly reliable results.

Evidence that transforms practice

1. Accuracy in reading ANA patterns by HEp-2 immunofluorescence

The study evaluated laboratories’ ability to identify autoantibody patterns in ANA (Antinuclear Antibody) tests, based on national (BCA) and international (ICAP) consensus. Results showed good recognition of basic patterns (such as AC-0, with 95.2% accuracy), but difficulties with more complex nuclear patterns (AC-1, AC-2, and AC-29). The study reinforces the importance of continuous education to standardize laboratory practices, essential for diagnostic harmonization in autoimmune diseases.

🔗 Read the published abstract

2. Anti-HIV and Anti-HCV by POCT: 14 years of performance monitoring

Two studies presented a 14-year performance overview of rapid tests for detecting antibodies to the human immunodeficiency virus (HIV) and the hepatitis C virus (HCV) in Brazil. Both showed high accuracy of the kits available on the market — with success rates above 98% in most cases — and a significant increase in the number of healthcare facilities participating. The results reflect the contribution of pre-market evaluation and post-market monitoring actions for rapid tests, ensuring ongoing quality and reliability of these assays over time.

🔗 Read the abstract on HIV
🔗 Read the abstract on HCV

3. Syphilis: increasing quality in the use of rapid tests

Another highlight among rapid tests was the study of the syphilis program, which showed significant growth in participant facilities — from 9 in 2010 to 113 in 2024 — and robust performance of the evaluated kits, with sensitivity and specificity above 98%. The data confirm the reliability of rapid tests and show how participation in the Proficiency Testing program ensures safety when releasing results.

🔗 Read the published abstract

4. HPV: commercial kits outperform laboratory-developed tests

Two studies on HPV (Human Papillomavirus) compared the performance of molecular tests for detecting high-risk and low-risk oncogenic HPV. One study demonstrated that commercial kits (IVD) outperformed laboratory-developed tests (LDTs), especially in detecting high-risk HPV. In the other, although both test types (high and low risk) showed good results, there is room for improving accuracy in low-risk HPV detection. These findings support more assertive decisions when choosing tests for cervical cancer screening.

🔗 Read the abstract on high-risk HPV
🔗 Read the abstract on high- and low-risk HPV

5. Laboratory indicators: stability and challenges in pre-analytical processes

The analysis of seven indicators harmonized by the IFCC showed stability in sigma metrics between 2018 and 2023, with highlight to sustained high performance in indicators such as “sample not received due to transport error” (>7.0σ). However, indicators such as “sample recollection” and “incorrect patient identification” showed statistically significant deterioration, revealing critical areas for continuous improvement actions.

🔗 Read the published abstract

6. Patient safety: perception still varies among professional categories

A survey with more than 1,400 Brazilian clinical laboratory professionals revealed that managers perceive patient safety culture more positively than technicians, analysts, and administrative staff. This difference — mainly in aspects such as open communication, non-punitive response to errors, and leadership support — reinforces the need to engage all professional categories to ensure that the safety culture becomes fully established in institutions.

🔗 Read the published abstract

Technical leadership and commitment to quality

Controllab’s presence, with the presentation of scientific studies at these events, demonstrates the role of Proficiency Testing programs and Metricare (Laboratory Indicators) in generating data that guide the improvement of laboratory quality in Brazil and other countries.

With programs accredited by ABNT NBR ISO/IEC 17043 and grounded in robust evidence, the studies strengthen the importance of continuous performance evaluation, harmonization of practices, and technical qualification of laboratory teams.

These contributions encourage healthcare institutions of all sizes to promote analytical excellence and patient safety, reinforcing Controllab’s commitment to applied science and the continuous development of laboratory medicine.

Sign up for our newsletter

Receive relevant publications about lab and solutions for
quality management.

plugins premium WordPress
X
We use cookies and other similar technologies to improve your experience, enabling a more personalized navigation, according to the characteristics and your interest. For more information see our Privacy and Security Policy.

PRM 0009

Certified Reference Material Producer

Accredited by Coordenação-Geral de Acreditação do Inmetro

Controllab has been accredited as a Certified Reference Material (CRM) Producer since 2016 by Cgcre, under number PMR 0009. The conformity assessment is carried out in accordance with the requirements established in ABNT NBR ISO 17034 and Inmetro standards, ensuring competence for the production of CRMs, as defined in the Scope of Accreditation.

This accreditation attests to Controllab’s technical competence in producing CRMs according to international requirements and enables it to be recognized in other countries, under mutual recognition agreements, thereby reducing technical barriers between Brazil and other countries across continents.

Materiais de Referência Certificados - PMR 0009 - ABNT NBR ISO 17034-Controllab
Cgcre is signatory to the Mutual Recognition Arrangements of the International Laboratory Accreditation Cooperation (ILAC) and Interamerican Accreditation Cooperation (IAAC).

CAL 0214

Calibration Laboratory

Accredited by Coordenação-Geral de Acreditação do Inmetro

In December 2002, the Calibration Laboratory was accredited by Cgcre. With this recognition, it became part of the Brazilian network of accredited laboratories, under number 214. Since then, it has been periodically evaluated for the maintenance and/or extension of its accreditation.

The Inmetro seal attests to Controllab’s technical competence, credibility, and operational capability for calibration services, in accordance with the requirements of ABNT NBR ISO/IEC 17025.

Calibração de Instrumentos - CAL 0214 - ABNT NBR ISO/IEC 17025 - Controllab
Cgcre is signatory to the Mutual Recognition Arrangements of the International Laboratory Accreditation Cooperation (ILAC) and Interamerican Accreditation Cooperation (IAAC).

PEP 0003

Proficiency Test Provider

Accredited by Coordenação-Geral de Acreditação do Inmetro

In September 2011, Controllab was accredited by 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.

PEP 0003 - ABNT NBR ISO-IEC 17043 - Controllab

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