Application of WHO International Biological Reference Standards to evaluate commercial serological tests for chronic Chagas disease.

BACKGROUND Chagas disease, resulting from Trypanosoma cruzi infections, continues to be a health concern mainly in Latin American countries where the parasite is endemic. The laboratory diagnosis of a chronic infection is determined through serological assays for antibodies against T. cruzi and several tests are available that differ in key components, formats and methodologies.

Preanalytical Nonconformity Management Regarding Primary Tube Mixing in Brazil.

Background: The multifaceted clinical laboratory process is divided in three essential phases: the preanalytical, analytical and postanalytical phase. Problems emerging from the preanalytical phase are responsible for more than 60% of laboratory errors. This report is aimed at highlighting and discussing nonconformity (e.

Implementation of the External Quality Assessment Program in Brazil.

The External Quality Assessment (EQA) in Brazil is performed by the National Health Ministry for diseases that are under supervision of Public Health Department. In addition to the government program, the Brazilian Society of Clinical Analysis and the Brazilian Society of Medical Pathology are allowed to provide their programs under the Supervision of National Agency for Sanitary Surveillance (ANVISA) that regulates laboratories to perform EQA programs.

Quality Control in Screening for Infectious Diseases at Blood Banks. Rationale and Methodology.

Quality control procedures are indispensable to ensure the reliability of the results provided by laboratories responsible for serological screening in blood banks. International recommendations on systems of quality management classify as a top component the inclusion of two types of control: (a) internal quality control (IQC) and (b) external quality control (EQC). In EQC it is essential to have, at least, a monthly frequency of laboratory assessment.