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EQA/IQC
Description
In laboratory quality management, external quality assessment is increasingly valued by clinical laboratories and laboratory users.
External quality assessment (EQA) is a process in which multiple laboratories analyze the same specimen, and an external independent organization collects and feedbacks the laboratory's reported results to evaluate the laboratory's operation.
External quality assessment is also called proficiency testing. According to ISO/IEC 17043: 2010, proficiency testing (PT) is defined as "the use of inter-laboratory comparisons to evaluate the ability of participants according to pre-established criteria." It is an inter-laboratory comparison conducted to determine a laboratory's ability to perform a specific calibration/test and to monitor its continued ability. Inter-laboratory comparison is defined as "the organization, implementation and evaluation of measurements or tests of the same or similar items by two or more laboratories under pre-defined conditions."
Introduction
Tumor Gene EQA Control In the EQA related to tumor NGS testing, the test results and bioinformatics analysis process are evaluated respectively in combination with clinically important genes and NGS quality control. Participating laboratories can select appropriate EQA plans based on their own product performance (genes tested, number of genes, sensitivity, etc.). | Hereditary Genetic EQA Control Genetic disease NGS external quality assessment is a standardized quality control process in the medical testing field used to evaluate the accuracy, reliability and consistency of the application of NGS in genetic disease gene testing by different laboratories. | |
Pathogen EQA Control In order to meet clinical needs, more and more clinical laboratories have carried out this project in the past two years. With the increase of certified reagents and laboratory self-built projects (LDT), more and more multiple respiratory pathogen nucleic acid detection reagents are used in clinical practice. Because of its characteristics of numerous methodologies, different detection targets, different operating procedures, and different capabilities of testing personnel in various laboratories, the above factors will have an adverse impact on the quality of testing, thus causing problems with laboratory test results...... | Prenatal EQA Control At present, there are differences in the quality of maternal serum prenatal screening in early pregnancy in my country. Carrying out inter-laboratory quality evaluation and internal quality control will help laboratories find problems, improve the detection level, and ensure the consistency of test results. | |
PGx EQA Control External quality control itself is not directly aimed at drug use guidance, but is used to evaluate and monitor the quality of laboratory testing to ensure the accuracy and reliability of test results, thereby providing a reliable basis for clinical drug use, etc. |
Purpose of external quality assessment
① Determine the laboratory's ability to perform measurements and to continuously monitor laboratory quality;
② Identify laboratory problems and develop appropriate remedial measures. These measures may involve, for example, the behavior of individual personnel or the calibration of instruments;
③ Determine the validity and comparability of new measurement methods and monitor these methods accordingly;
④ Increase the confidence of laboratory users;
⑤ Identify differences between laboratories;
⑥ Determine the performance characteristics of a certain detection method.
