PGx EQA Control

Definition

Medication guidance refers to the use of technologies such as genetic testing to select appropriate medications and dosages for patients, achieving personalized, precise medication use.

Internal Quality Control:

Quality control materials are substances with known, precise properties used to verify and validate the accuracy and reliability of testing instruments, reagents, methods, and the entire operational process.

External Quality Assessment (EQA) refers to the process by which a third-party organization (such as a clinical testing center) organizes multiple laboratories to test the same samples and then compares the results to assess the compliance and comparability of the laboratories' testing capabilities.

Internal Quality Control materials are quality control materials specifically used in "external quality assessment" activities.

In summary, the definition of "external quality control materials for medication guidance" is:A standard material used to evaluate and ensure the accuracy, consistency, and comparability of test results from different laboratories for "genetic testing related to medication guidance."

PGx EQA Control Function

Its core role lies in quality assurance and standardization:

*Evaluating laboratory testing capabilities: By having multiple laboratories test the same quality control material, we can objectively determine which laboratory's test results are accurate and which may have systematic errors or operational errors.

*Ensuring the accuracy and reliability of results: This ensures that genetic testing results are accurate and correct. This is the foundation of precision medicine. If the genotype is incorrectly determined, medication guidance becomes meaningless.

*Enabling interlaboratory recognition: Only when all laboratories meet unified standards can test reports issued by one hospital be trusted and accepted by another, avoiding duplicate testing for patients.

*Detecting and correcting problems: If a laboratory's test results deviate from the recognized value, the laboratory can be prompted to identify the cause (possibly due to issues with the instrument, reagents, personnel operation, or data analysis) and implement improvements.

*Monitoring the stability of testing processes: Regular participation in external quality assessments continuously monitors the long-term stability of laboratory testing quality.

Disease-Related

Medication guidance external quality control products are not directly related to a specific disease, but are highly relevant to therapeutic areas where genomic information is needed to guide drug selection. These areas typically include:

1. Cardiovascular disease: 

For example, testing the CYP2C19 genotype guides the use of clopidogrel (an antiplatelet drug); testing VKORC1 and CYP2C9 genotypes guides the dosage of warfarin (an anticoagulant).

2.Oncology: This is the most widely used area. For example:

*Detecting EGFR gene mutations guides the use of targeted drugs such as gefitinib and erlotinib.

*Detecting ALK and ROS1 gene fusions guides the use of drugs such as crizotinib.

*Detecting HER2 gene amplification guides the use of trastuzumab.

*Detecting PD-L1 expression levels (although not a gene, it is also a biomarker for medication guidance) and MSI-H/dMMR status guides the use of immune checkpoint inhibitors.

3.Neuropsychiatric disorders: For example, testing for the HLA-B*1502 allele can help prevent severe skin reactions to carbamazepine (an antiepileptic drug) in certain populations.

4.Gastroenterology: Testing for the DPYD genotype guides the use of fluorouracil-based chemotherapy to avoid severe toxicity.

5.Infectious diseases: Testing for the HCV genotype guides the selection of interferon combination therapy; testing for HIV resistance gene mutations guides the selection of highly active antiretroviral therapy regimens.

Application Scenarios

Its application scenarios are very clear and primarily exist within the quality management system of medical laboratories:

1.External quality control activities by third-party clinical testing centers/National Health Commission clinical testing centers:

This is the most core application scenario. The agency regularly distributes the same batch of quality control materials (usually simulated samples or processed real samples) to all laboratories conducting relevant testing projects. The laboratories complete the testing and report the results within a specified timeframe. The agency collects all data, conducts statistical analysis, and issues an evaluation report to each laboratory, informing them whether the test passed the assessment.

2.Internal quality supervision in large hospital laboratory/pathology departments or independent laboratories:

Even outside of official quality control assessment periods, laboratories can purchase commercial external quality control materials for:

*Validation of new testing projects before launch.

*Evaluating the performance of new batches of reagents or new instruments.

*Periodically assessing the competency of testing personnel.

*Supplementing routine internal quality control to ensure optimal testing system performance.

3.Applications by Reagent and Equipment Manufacturers:

When developing new test kits or instruments, manufacturers use external quality control products to verify the accuracy, sensitivity, and specificity of their products and compare them with existing products on the market.