WS/T 459-2018Common used serum tumor marker tests - Clinical practice and quality management (English PDF)

4.1 Alpha-fetoprotein (AFP)

A 591 amino acid glycoprotein synthesized by the liver and yolk sac in the early stage of fetal development. It is located in albumin and alpha1 during electrophoresis.

Between globulins. AFP is high in the neonatal period and drops to 10 µg/L to 20 µg/L by the age of 1 year, and the AFP content in adult serum is very low.

When hepatocytes undergo malignant transformation, AFP content is significantly increased, which is an important indicator for clinical diagnosis of primary liver cancer.

4.1.1 Reference interval

The reference interval for serum AFP detection may vary depending on the method, instrument, and reagent. Therefore, each laboratory should follow the reagent instructions.

Establish your own reference intervals with clinical practice.

4.1.2 Screening

Serum AFP combined with liver ultrasound can be used as a screening for high-risk populations of primary liver cancer. High-risk population with hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection, long-term alcoholics, and family history of primary liver cancer, screening age male >= 40 years old, women >= 50 years old, should be checked every 6 months.

4.1.3 Auxiliary diagnosis

4.1.3.1 Serum AFP is the most commonly used tumor marker for clinical diagnosis of primary liver cancer (referred to as liver cancer). For serum AFP >= 400µg/L for more than 1 month, or >=200µg/L for 2 months, excluding pregnancy, active liver disease and germline embryogenic tumors After that, liver cancer should be highly suspected, and B-ultrasound examination should be performed. If necessary, CT/MRI and biopsy should be performed to confirm the diagnosis. Serum AFP for liver cancer the positive rate of diagnosis is generally about 70%, and about 30% of liver cancer patients have negative AFP detection. Therefore, AFP cannot be used to diagnose liver cancer.

4.1.3.2 Elevated serum AFP can also be found in germline embryogenic tumors, such as testicular non-seminoma, yolk sac tumor, malignant teratoma Wait. Also seen in other malignant tumors, such as gastric cancer, colorectal cancer.

4.1.3.3 AFP in serum of patients with acute or chronic hepatitis and cirrhosis may increase in different degrees, mostly between 20 and.200 µg/L.

It gradually declined in 2 months as the condition improved.

4.1.3.4 After 3 months of pregnancy, serum AFP is elevated, mainly from the fetus. Abnormally elevated AFP in maternal serum can be seen in Fetal neural tube defects, spina bifida, no brain and so on. AFP can enter amniotic fluid from an open neural tube resulting in an abnormal increase in amniotic fluid content.

Abnormally decreased AFP in maternal serum, suggesting that the fetus has a risk of Down's syndrome. Therefore, monitoring of AFP concentration in maternal serum and amniotic fluid it can be used for prenatal diagnosis of fetal neural tube defects and Down's syndrome.

4.1.4 Prognosis assessment

Serum AFP is an important marker for judging the prognosis of primary liver cancer. High concentration of serum AFP suggests a poor prognosis.

4.1.5 Efficacy and recurrence monitoring

4.1.5.1 Serum AFP measurement helps to monitor the response of liver cancer patients to treatment. After liver cancer surgery, serum AFP concentration drops to the reference area in the meantime, the operation is effective; if the serum AFP is only partially reduced, it means that the operation is not complete or there is a metastatic lesion.

4.1.5.2 Serum AFP can be used for follow-up and recurrence monitoring after liver cancer surgery or liver transplantation in liver cancer patients. Within 2 years after surgery, it should be tested every 3 months and every 6 months within 3 to 5 years.

4.2 Carcinoembryonic antigen (CEA)

A complex acid glycoprotein, which is mainly found in adult cancer tissues and fetal gastrointestinal tissues, is a broad spectrum of swelling Tumor marker.

4.2.1 Reference interval

The reference interval for serum CEA detection may vary depending on the method, instrument, and reagent, so each laboratory should follow the reagent instructions and Clinical practice establishes its own reference interval.

4.2.2 Screening

Serum CEA is generally not used for tumor screening in asymptomatic populations.

4.2.3 Auxiliary diagnosis

4.2.3.1 Serum CEA is a broad spectrum of tumor markers. Clinically useful for colon cancer, rectal cancer, lung cancer, breast cancer, food Auxiliary diagnosis of common tumors such as cancer, pancreatic cancer, gastric cancer, and metastatic liver cancer. Other malignant tumors such as medullary thyroid carcinoma, cholangiocarcinoma, and secretion There are also varying degrees of positive rates in urinary malignancies.

4.2.3.2 Pregnancy, colitis, colon polyps, intestinal diverticulitis, pancreatitis, cirrhosis, hepatitis, benign lung diseases and cardiovascular diseases Disease, etc., serum CEA can also be increased to varying degrees, but the percentage of positive is lower.

4.2.4 Prognosis assessment

Serum CEA level is one of the factors to judge the prognosis of the tumor. Serum CEA continues to increase, indicating a poor prognosis.

4.2.5 Efficacy and recurrence monitoring

4.2.5.1 Patients with elevated CEA before treatment, if the surgery, chemotherapy, targeted therapy or immunotherapy are effective, the serum CEA concentration drops to Within the reference interval; if the serum CEA only partially decreased or did not decrease after treatment, the treatment effect was not good.

4.2.5.2 Serum CEA can be used for follow-up and recurrence monitoring after tumor treatment, generally within 2 years after treatment, should be tested every 3 months.

It is tested every 6 months within 3 to 5 years.

4.3 Neuron specific enolase (NSE)

Enolase can be divided into five kinds of dimerizations of alphaalpha, betabeta, gammagamma, alphabeta and alphagamma according to the different components of alpha, beta and gamma.

Body isozyme. The gamma subunit is mainly found in nerve tissue, and is unique to gammagamma isozyme neurons and neuroendocrine cells, so it is named as a neuron.

Specific enolase. NSE is an acidic protease involved in the glycolysis process. Tumor tissue glycolysis, cell proliferation as the cycle speeds up, the release of NSE from the cells increases into the bloodstream. Tumors derived from neuroendocrine tissues such as neuroblastoma and small cell lung Cancer (SCLC), elevated serum NSE.

4.3.1 Reference interval

The reference interval for serum NSE detection may vary depending on the method, instrument, and reagent. Each laboratory should follow the reagent instructions and the clinical practice establishes its own reference interval.

4.3.2 Screening

Serum NSE is generally not used for screening for lung cancer.

4.3.3 Auxiliary diagnosis

4.3.3.1 Serum NSE is one of the preferred markers for small cell lung cancer (SCLC). The level of NSE in patients with small cell lung cancer is significantly higher than that in lung adenocarcinoma.

Non-small cell lung cancer (NSCLC) such as lung squamous cell carcinoma and large cell lung cancer has auxiliary diagnostic value. And can be used for small cell lung cancer and non-small cells Differential diagnosis of lung cancer.

4.3.3.2 Serum NSE is also a tumor marker for neuroblastoma, patients are significantly elevated, and patients with Wilms tumor (Wilms tumor) it is less elevated and, therefore, can be used for the differential diagnosis of neuroblastoma and Wilms tumor.

4.3.3.3 elevated serum NSE is also common in neuroendocrine cell tumors, such as pheochromocytoma, medullary thyroid carcinoma, melanoma, pancreas Islet cell tumor, retinoblastoma, etc.

4.3.3.4 Serum NSE is also elevated in certain neurological and pulmonary diseases such as meningitis, pneumonia, etc., but the percentage of positive Lower.

4.3.4 Prognosis assessment

Serum NSE is an important prognostic indicator for small cell lung cancer and neuroblastoma. Serum NSE continues to rise, suggesting a poor prognosis.

4.3.5 Efficacy and recurrence monitoring

4.3.5.1 Serum NSE levels may reflect the response of small cell lung cancer chemotherapy, and the temporary NSE may occur from 24h to 72h after chemotherapy.

Elevated (the phenomenon of tumor dissipation). Serum NSE levels in patients with good response to chemotherapy will decrease rapidly after the end of the first course of treatment. patient A sustained or temporary decrease in NSE levels suggests a poor treatment outcome.

4.3.5.2 Serum NSE can be used for follow-up and recurrence monitoring of small cell lung cancer. Generally, it should be tested every 3 months within 2 years after treatment.

It is tested every 6 months within 3 to 5 years.

4.4 Squamous cell carcinoma antigen (SCC or SCCA)

A subunit of tumor-associated antigen TA-4 isolated from cervical squamous cell carcinoma, present in the cervix, lung, esophagus, in the cytoplasm of squamous cell carcinoma such as the head and neck, it is a tumor marker for detecting squamous cell carcinoma with high specificity but low sensitivity.

4.4.1 Reference interval

The reference interval for serum SCC detection may vary depending on the method, instrument, and reagent. Each laboratory should be based on the reagent instructions and clinical Practice to establish your own reference interval.

4.4.2 Screening

Serum SCC is generally not used for screening for cervical squamous cell carcinoma and lung squamous cell carcinoma.

4.4.3 Auxiliary diagnosis

4.4.3.1 Serum SCC is a tumor marker mainly used for the diagnosis of squamous cell carcinoma, in cervical squamous cell carcinoma, lung squamous There is an increase in the serum of patients with cell carcinoma, and the concentration increases as the condition worsens.

4.4.3.2 Serum SCC also has different degrees in other malignant tumors, such as head and neck epithelial cell carcinoma, esophageal cancer, nasopharyngeal carcinoma, and skin cancer.

Positive rate.

4.4.3.3 Serum SCC in certain benign diseases such as hepatitis, cirrhosis, pneumonia, tuberculosis, psoriasis, eczema, renal failure, etc.

There may also be different degrees of elevation, but the percentage of positives is lower.

4.4.4 Prognosis assessment

It is generally believed that elevated serum SCC is a risk factor for poor prognosis of cervical squamous cell carcinoma and lung squamous cell carcinoma, but SCC is not currently recommended.

It is routinely applied to the prognosis of cervical squamous cell carcinoma and lung squamous cell carcinoma.

4.4.5 Efficacy and recurrence monitoring

4.4.5.1 Elevated serum SCC is associated with lymph node metastasis of cervical squamous cell carcinoma and can be used for personalized treatment of cervical squamous cell carcinoma.

Formulated, but not currently used as a regular application.

4.4.5.2 Serum SCC concentration and stage of cervical squamous cell carcinoma, tumor size, residual tumor after surgery, tumor recurrence and progression it is related, so it can be used for evaluation, follow-up and recurrence monitoring of cervical cancer.

4.4.5.3 Serum SCC has a certain value in monitoring the efficacy of lung squamous cell carcinoma.

4.5 Cytokeratin 19 fragment (cytokeratin fragment 19; CYFRA 21-1)

Cytokeratin is a structural protein of epithelial cells throughout human epithelial cells, and 20 different cytokeratins have been discovered.

A soluble fragment of cytokeratin 19 (CK19) was detected by means of two monoclonal antibodies, KS19.1 and BM19.21.

CYFRA21-1, which is found in tumor cells of epithelial origin such as lung cancer and esophageal cancer, is a sensitive marker for detecting non-small cell lung cancer (NSCLC).

Volunteer.

4.5.1 Reference interval

The reference interval for detection of serum CYFRA 21-1 may vary depending on the method, instrument, and reagent. Each laboratory should follow the reagent instructions.

The book establishes its own reference interval with its own clinical practice.

4.5.2 Screening

Serum CYFRA 21-1 is generally not used for screening for lung cancer.

4.5.3 Auxiliary diagnosis

4.5.3.1 Serum CYFRA21-1 is one of the preferred markers for non-small cell lung cancer, especially squamous cell carcinoma, with diagnostic value.

4.5.3.2 Serum CYFRA21-1 is also found in other malignant tumors such as bladder cancer, esophageal cancer, nasopharyngeal carcinoma, ovarian cancer and cervical cancer.

Different degrees of positive rate.

4.5.3.3 Serum CYFRA21-1 may also have a certain course in certain benign diseases such as hepatitis, cirrhosis, pancreatitis, pneumonia, tuberculosis, etc.

The degree is increased, but the percentage of positive is lower. Renal failure can lead to an increase in serum CYFRA21-1.

4.5.4 Prognosis assessment

Serum CYFRA21-1 is an important prognostic indicator for non-small cell lung cancer. Serum CYFRA21-1 continues to rise, suggesting a poor prognosis.

4.5.5 Efficacy and recurrence monitoring

4.5.5.1 Serum CYFRA21-1 can be used for the monitoring of the efficacy of non-small cell lung cancer. The continuous increase of CYFRA21-1 concentration indicates disease progression.

4.5.5.2 Serum CYFRA21-1 can be used for follow-up and recurrence monitoring of non-small cell lung cancer. Generally within 2 years after treatment, every 3 months Test once, every 6 months within 3 to 5 years.

4.6 Pro-gastrin releasing peptide (ProGRP)

Gastrin-releasing peptide (GRP) is widely distributed in mammalian gastrointestinal, pulmonary and neuronal cells. Small cell lung cancer (SCLC) has intraneural Secretory characteristics, cancer cells can synthesize and release GRP, but because of its instability in serum, it is easily degraded, and it is difficult to determine its serum concentration. ProGRP it is a precursor structure of gastrin-releasing peptide and is relatively stable in blood. ProGRP is known to have three molecular structures with a common carboxy terminal.

The sequence region is the gastrin-releasing peptide precursor fragment 31-98 (ProGRP-31-98), which is stably expressed in the blood and is a small cell lung cancer test.

Good marker.

4.6.1 Reference interval

The reference interval for serum ProGRP detection may vary depending on the method, instrument, and reagents. Each laboratory should follow the reagent instructions and Establish your own reference interval for your own clinical practice.

4.6.2 Screening

Serum ProGRP is generally not used for screening for lung cancer.

4.6.3 Auxiliary diagnosis

4.6.3.1 Serum ProGRP is one of the preferred markers of small cell lung cancer (SCLC) and has diagnostic value. And can be used for small cells Differential diagnosis of lung cancer and non-small cell lung cancer. ProGRP and NSE can increase the positive rate of small cell lung cancer detection when used in combination.

4.6.3.2 Serum ProGRP elevation can also be seen in certain neuroendocrine cell tumors, such as medullary thyroid carcinoma.

4.6.3.3 Serum ProGRP may also be elevated to varying degrees in certain benign diseases such as urinary system diseases and respiratory diseases, but the percentage of positive is lower. Renal failure can lead to elevated serum ProGRP.

4.6.4 Prognosis assessment

Serum ProGRP is an important prognostic indicator for small cell lung cancer. Serum ProGRP continues to rise, suggesting a poor prognosis.

4.6.5 Efficacy and recurrence monitoring

4.6.5.1 Serum ProGRP can be used for the monitoring of the efficacy of small cell lung cancer. The ProGRP concentration is significantly reduced after treatment, suggesting that the treatment is effective;

If the serum ProGRP continues to rise, the efficacy is poor.

4.6.5.2 Serum ProGRP can be used for follow-up and recurrence monitoring of small cell lung cancer. Generally, within 2 years after treatment, it should be tested every 3 months.

Once, every 6 months in 3 to 5 years.

4.7 Carbohydrate antigen 125 (CA 125)

A macromolecular glycoprotein, a monoclonal antibody OC125 prepared by using ovarian serous cystadenocarcinoma cell line (OVCA433) as an antigen it is found in epithelial ovarian cancer tissues and is a tumor marker commonly used in clinical detection of ovarian cancer.

4.7.1 Reference interval

The reference interval for serum CA125 detection may vary depending on the method, instrument, and reagent. Each laboratory should follow the reagent instructions and Bed practice establishes its own reference interval.

4.7.2 Screening and early detection

4.7.2.1 Serum CA125 is generally not used for ovarian cancer screening in asymptomatic women.

4.7.2.2 For high-risk groups with special genetic mutations or family history of ovarian cancer, serum CA125 combined with vaginal ultrasound may be considered.

The ovarian cancer was detected early.

4.7.3 Auxiliary diagnosis

4.7.3.1 Serum CA125 is mainly used for the auxiliary diagnosis of ovarian cancer, especially epithelial ovarian cancer. Can also be used as good and bad for postmenopausal women Differential diagnosis of pelvic tumors.

4.7.3.2 Serum CA125 also has a certain positive rate in other malignant tumors such as lung cancer, pancreatic cancer, colon cancer and other gynecological tumors.

4.7.3.3 Serum CA125 in certain benign diseases such as endometriosis, chronic pelvic inflammatory disease, peritonitis, ovarian cysts, pancreatitis, Hepatitis, cirrhosis and other diseases can also be increased to varying degrees, but the percentage of positive is lower.

4.7.4 Prognosis assessment

Serum CA125 is one of the factors in determining the prognosis of ovarian cancer. No matter before or after surgery, serum CA125 continues to rise, suggesting that the prognosis is not good.

4.7.5 Efficacy and recurrence monitoring

4.7.5.1 Continuous detection of serum CA125 can be used for the monitoring of the efficacy of chemotherapy for ovarian cancer, usually within 2 weeks before chemotherapy, during chemotherapy Detected once every 2 to 4 weeks. A persistent increase in CA125 during monitoring suggests a disease progression or poor response.

4.7.5.2 Patients with elevated serum CA125 before treatment can be followed up for monitoring after treatment with CA125. Generally within 2 years after treatment, it should be Test once every 2 to 4 months, every 3 to 6 months within 3 to 5 years.

4.8 Carbohydrate antigen 15-3 (carbohydrate antigen 15-3; CA 15-3)

A macromolecular glycoprotein, identified by a double antibody sandwich method with a pair of monoclonal antibodies (MAb115-D8 and MAbDF-3), for the mammary gland the auxiliary diagnosis of cancer has certain value.

4.8.1 Reference interval

The reference interval for serum CA15-3 detection may vary depending on the method, instrument, and reagent. Each laboratory should follow the reagent instructions and Bed practice establishes its own reference interval.

4.8.2 Screening

Serum CA15-3 is generally not used for breast cancer screening in asymptomatic populations.

4.8.3 Auxiliary diagnosis

4.8.3.1 Serum CA15-3 is an indicator mainly used for the diagnosis of breast cancer, but the early positive rate in breast cancer is low, and breast cancer is late.

The positive rate of metastatic and metastatic breast cancer is 70% to 80%. Combined detection of CA15-3 and CEA can improve the sensitivity of breast cancer diagnosis.

4.8.3.2 serum CA15-3 in other malignant tumors, such as lung cancer, ovarian cancer, liver cancer, cervical cancer, colon cancer, etc., also have varying degrees of Positive rate.

4.8.3.3 Serum CA15-3 may be elevated in the liver, gastrointestinal tract, lung, breast, ovary and other benign diseases, but positive the percentage is lower.

4.8.4 Prognosis assessment

Serum CA15-3 is generally not used for prognosis of breast cancer.

4.8.5 Efficacy and recurrence monitoring

4.8.5.1 Serum CA15-3, together with imaging examination and clinical physical examination, can be used for treatment response monitoring in breast cancer patients, CA15-3 A sustained increase in concentration suggests a progression of the disease.

4.8.5.2 Serum CA15-3 is not routinely used for the monitoring of recurrence and metastasis of breast cancer. However, patients with elevated serum CA15-3 before surgery may have postoperative Follow-up and monitoring were performed with CA15-3.

4.9 Carbohydrate antigen 19-9 (carbohydrate antigen 19-9; CA 19-9)

A macromolecular glycoprotein, a tumor marker of Lewis blood group antigen, which is isolated from the surface of colon cancer cell line SW1116 the monosialo ganglioside is used as an antigen to prepare the corresponding monoclonal antibody 1116-NS-19-9, which is recognized by this monoclonal antibody.

The tumor-associated antigen is CA19-9, which is a tumor marker commonly used in clinical detection of pancreatic cancer.

4.9.1 Reference interval

The refe...