Tumor Gene EQA Control

Definition

Oncology genes: These refer to specific genes associated with cancer development, progression, treatment, and prognosis (such as EGFR, KRAS, BRAF, ALK, and PD-L1). Detecting mutations, fusions, and amplifications in these genes is the foundation of modern precision medicine.

Internal quality control: "Internal" refers to the process between different laboratories; "quality control" is short for "quality control material," and is a sample with known accurate results.

General definition: An external quality control sample for tumor genomics is a standard material with a known specific tumor genotype (i.e., the presence or absence of a specific gene mutation). It is distributed to different laboratories for testing to evaluate and compare the accuracy and consistency of their test results.

Simply put, it's a "standard test question." Authoritative organizations (such as the National Health Commission's Clinical Laboratory Center) simultaneously distribute this test (quality control product) to laboratories in hundreds of hospitals nationwide, asking them to perform the test using their own equipment and reagents and submit their results. The authority then compares the results with the standard to determine which laboratories are performing accurately and which are not.

The Role of Tumor Genetic External Quality Control Products

Their core role is to ensure the quality of tumor genetic testing, specifically by:

*Evaluating Laboratory Testing Capabilities: This is their most important role. Testing quality control products allows an objective assessment of a laboratory's ability to accurately detect specific genetic variants.

*Ensuring Accuracy and Reliability: This ensures that patients receive reliable genetic testing reports. Inaccurate test results can lead to misdiagnosis, incorrect medication use (e.g., misusing a targeted drug when appropriate, or misusing a drug when inappropriate), and delayed treatment.

*Enabling Interlaboratory Recognition: If all laboratories pass the same set of quality control product assessments, reports issued by different hospitals and testing institutions will be comparable and reliable, facilitating patient referrals and expert consultations. Identifying Problems and Continuously Improving: If a laboratory's test results differ from the standard, it may indicate a problem with its testing process (such as DNA extraction, library construction, sequencing, and data analysis). The laboratory can then identify the cause, make corrections, and improve its testing capabilities.

*Certification and Supervision: National health regulatory authorities or industry associations typically consider external quality assessment (using quality control products) as a necessary component of laboratory certification (such as PCR laboratory acceptance) and routine oversight.

Disease-Related

Tumor gene external quality control products are primarily associated with various cancers (malignant tumors), particularly those with identified driver genes and treatable with targeted drugs or immunotherapies. For example:

*Lung Cancer: One of the most relevant diseases. This involves testing for genes such as EGFR, ALK, ROS1, BRAF V600E, MET, RET, KRAS, NTRK, and PD-L1.

*Colorectal Cancer: This involves testing for genes such as KRAS, NRAS, and BRAF V600E.

*Breast/ovarian cancer: This involves testing for genes such as BRCA1/2, HER2, and PIK3CA.

*Gastric cancer: This involves testing for genes such as HER2 and PD-L1.

*Melanoma: This involves testing for genes such as BRAF V600E and C-KIT.

*Leukemia/lymphoma: This involves testing for multiple gene fusions, mutations, and expression levels.

*Pan-cancer: This involves testing for biomarkers such as MSI-H/dMMR, TMB (tumor mutation burden), and NTRK fusions.

In short, whenever a cancer requires genetic testing to guide treatment, determine prognosis, or assess genetic risk, the corresponding tumor genetic external quality control products are required to ensure test quality.

Application Scenarios

The application scenarios are very clear and primarily exist within the quality control system of clinical testing laboratories:

1.External Quality Assessment (EQA)/Proficiency Testing (PT)

This is the most core application scenario. Conducted regularly (usually 2-4 times per year) by the National Clinical Laboratory Center, provincial clinical laboratory centers, or international professional organizations (such as CAP and EMQN).

The agency mails quality control materials to participating laboratories. -> The laboratories complete the tests and report the results within the specified timeframe, just as they would for patient samples. -> The organization collects all results for statistical analysis and issues an evaluation report. -> The laboratories evaluate their performance based on the report.

2. Internal Laboratory Quality Control

Laboratories may also purchase commercial quality control materials and run them alongside patient samples during routine testing as part of their internal quality control efforts to ensure daily testing stability.

3. Validation of New Test Methods/Reagents

When a laboratory introduces a new testing technology (such as switching from a PCR platform to an NGS platform) or a new test kit, it must verify the accuracy and reliability of the new method using quality control materials with known results. Only after these materials pass the validation test can they be used clinically.

4. Personnel Training and Assessment

Used to train new technicians and assess their operational procedures and result interpretation abilities.