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.
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:
- 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.
- Observe the representativeness of the systems (kits and equipment) against the market. There are systems with only 1 respondent in the comparison between laboratories.
- Analyze the adequacy percentage of the system adopted by the laboratory for each item, noting the number of respondents facing the market.
- 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.
- Examine the number of batches that manufacturers make available on the market and whether there is a difference in sensitivity between batches.
- 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.