Organize: Chemiluminescence projects and clinical significance!

Chemiluminescence immunoassay technology was developed in the 1990s. By controlling and measuring the luminescence of labeled chemiluminescent substances, corresponding biomarkers are detected. Due to its high sensitivity, fast detection, stable reagents without biological toxicity, and easy automation, it has become one of the most promising luminescent technologies in immunoassay technology, and has significant clinical significance in the diagnosis of many diseases.

01 Thyroid function

1. Clinical significance of total triiodothyronine (Tot T3)：

Tot T3 is one of the preferred indicators for diagnosing hyperthyroidism and diagnosing thyroid dysfunction.

Increase: Grave's disease is mostly caused by hyperthyroidism (idiopathic T3 type hyperthyroidism, transient neonatal hyperthyroidism, subacute thyroiditis, TBG, albumin increase, endemic iodine deficiency goiter, taking exogenous T3, etc.).

Reduction: Primary hypothyroidism (such as cretinism, Hashimoto thyroiditis, congenital thyroid abnormalities, neonatal hypothyroidism, idiopathic mucinous edema, etc.); Secondary hypothyroidism (such as pituitary dysfunction, TSH deficiency alone, etc.); Hypothalamic dysfunction and severe consumptive diseases; Congenital TBG reduction; Over 65 years old.

Reference range 1.34~2.73nmol/L （0.87–1.78 ng/mL）

2. Clinical significance of total thyroxine (Tot T4):

Elevated: hyperthyroidism; Pregnancy, newborn; Taking estrogen and contraceptive pills; HyperTBG anemia; Acute hepatitis; When taking iodine; Subacute thyroiditis; TSH secretory tumor; Overuse of thyroid hormone.

Reduce: hypothyroidism; TSH should not be symptomatic; Abnormal thyroid formation; Application of maternal anti thyroid preparations; TBG deficiency; Some severe liver diseases, fasting, high fever, and nephrotic syndrome.

Reference range 78.38~157.4nmol/L (6.09~12.23 ug/dL

3. Clinical significance of free triiodothyronine (FT3):

Hyperthyroidism increases and hypothyroidism decreases, consistent with pathophysiology and unaffected by TBG, making it the best indicator for diagnosing gestational hyperthyroidism.

Reference range 3.8～6.0pmol/L  （2.5～3.9 pg/mL）

4. Clinical significance of free thyroxine (FRT4):

Hyperthyroidism, T4 poisoning, malignant tumors, etc. increase while hypothyroidism decreases, consistent with pathological physiology and not affected by TBG, making it the best indicator for diagnosing hypothyroidism.

Reference range 7.86～14.41 pmol/L  （0.61～1.12 pg/mL）

5. Clinical significance of thyrotropin (hTSH):

Assessing the state of the thyroid gland and identifying subclinical or potential hypothyroidism or hyperthyroidism is the most sensitive diagnostic indicator for screening subclinical thyroid dysfunction, as well as the best indicator for prenatal diagnosis of congenital hypothyroidism. It can also assess the efficacy of treatment for primary thyroid dysfunction and guide medication.

Elevated: Indicates hypothyroidism. Such as primary hypothyroidism, ectopic TSH secretion syndrome (ectopic TSH tumor), pituitary TSH tumor, subacute thyroiditis recovery period, hypothalamic hyperthyroidism, endemic or simple goiter.

Reduced: Indicates hyperthyroidism. Such as tertiary (hypothalamic) hypothyroidism, hyperthyroidism, secondary hypothyroidism, and clinical application of high-dose glucocorticoids.

Reference range 0.34～5.60  uIU/ml （mIU/L）

6. Clinical significance of thyroid globulin (Tg):

Helps to monitor in situ and metastatic thyroid tissue in patients who have undergone thyroidectomy (with or without radiation), as well as those who lack serum thyroglobulin autoantibodies.

Elevated levels of circulating Tg can occur in Hashimoto's disease, Graves' disease, thyroid adenoma, subacute thyroiditis, thyroid cancer, and other conditions.

Reference range<0.1~36.8; Ug/L (ng/mL) (generated using ThgAb negative samples)

7. Clinical significance of anti anti-thyroid autoantibodies (Thg Ab):

ThgAb usually exists in patients with autoimmune thyroid diseases, which is helpful to diagnose certain thyroid disorders, such as Hashimoto disease, nontoxic goiter and Graves disease. ThgAb can be detected in approximately 10% of healthy individuals. Thyroglobulin autoantibodies may interfere with the determination of serum thyroglobulin.

Elevated: Hashimoto's thyroiditis, autoimmune thyroid disease, primary hypothyroidism, hyperthyroidism patients, etc; Certain liver diseases, various collagen related diseases, and myasthenia gravis; Normal women increase with age, with approximately 18% of women over 40 years old.

Reference range ＜4  IU/ml

8. Clinical significance of thyroid hormone uptake rate (TU):

TU can indirectly measure the unsaturated binding capacity of certain serum proteins (mainly TBG), and combined with T4 can indirectly indicate the functional status of the thyroid gland. By calculating the free thyroxine index (FTI), the relative amount of free T4 in the sample can be indirectly measured, and combined with total thyroxine measurement for clinical diagnosis.

Reference range  TU   32.0～48.4 %   (0.32～0.48)

FTI     5.93～13.13  ug/dL (76.32～168.98 nmol/L)

9. Clinical significance of anti Thyroid peroxidase antibody (TPO Ab):

TPO Ab is the most sensitive test method for detecting autoimmune thyroid diseases, which helps to diagnose thyroid autoimmune disorders and risk stratification, and helps to distinguish thyroid autoimmune disorders from non autoimmune goiter or hypothyroidism. Risk assessment of hypothyroidism in patients with Down syndrome, as well as thyroid dysfunction in pregnant women and postpartum thyroiditis, treated with interferon, interleukin-2, and lithium.

Elevated: Hashimoto's thyroiditis (detection rate of about 90%), Graves' disease (detection rate of about 60-80%), etc.

Reference range ＜9  U/ml

02  hormone

1. Chorionic gonadotropin（ β- Clinical significance of HCG:

The best indicator for early pregnancy diagnosis. It can also be used for the diagnosis of choriocarcinoma, ectopic pregnancy, and hydatidiform mole, to determine threatened or incomplete miscarriage; Observation of the therapeutic effects of malignant mole, choriocarcinoma, and anti early pregnancy drugs; Early screening for Down syndrome; The increase is also seen in brain tumor and testicular tumors without spermatogonium.

Reference range  

male＜0.5～2.67  mIU/ml（IU/L）

Non pregnant women＜0.5～2.90

Pregnant women 0.2-1 gestational weeks     5～50      

1-2 gestational weeks    50～500

2-3 weeks of pregnancy   100～5,000

3-4 gestational weeks   500～10,000

4-5 gestational weeks  1,000～50,000

5-6 gestational weeks 10,000～100,000

6-8 gestational weeks 15,000～200,000

8-12 gestational weeks10,000～100,000

2. Clinical significance of follicle stimulating hormone (FSH):

Measuring FSH levels can determine the function of the hypothalamic pituitary gonadal axis; Combining LH can accurately determine the ovulation period.

Elevated: Diagnosis and differential diagnosis of ovarian amenorrhea, pituitary hypothalamus, and pituitary amenorrhea; It can be seen in primary hypogonadism, testicular or ovarian dysplasia (such as Klinefelter's syndrome, congenital testis syndrome, Turner syndrome and testicular spermatogonium tumor), premature ovarian failure, primary testicular dysfunction, testicular spermatogonium cancer, male infertility, true precocious puberty, chronic renal failure, pituitary FSH tumor, ectopic hormone secretion syndrome, chronic alcoholism, etc. after treatment with adrenal cortical hormone.

Reduction: seen in pituitary dysfunction (such as Schihan's syndrome) and various hypothalamic pituitary diseases, pseudoprecocious puberty, delayed puberty, oral contraceptives, anorexia, prostate cancer, sickle cell anemia, etc.

Reference range  

male  

1.27～19.26  

female

Follicular phase 3.85-8.78   

Ovulation period 4.54 ~ 22.51 

Luteal phase 1.79-5.12   

Menopause 16.74 ~ 113.59    mIU/ml      

3. Clinical significance of luteinizing hormone (LH) :

The source is the same as FSH, reflecting the functional status of pituitary-gonadal axis. Predict ovulation; Diagnosis of polycystic ovarian syndrome, premature ovarian failure, Turner's syndrome, true ovarian insufficiency, menstrual disorders, differential male sexual dysfunction, differential precocious puberty in adolescent children, endometriosis and pituitary adenoma postoperative observation.

Reference range  

Male   1.24 ~ 8.62   

Female   Follicular stage   2.12 ~ 10.89   

Ovulation period 19.18 ~ 103.03     

Luteal phase 1.2-12.86     

Menopause 10.87-58.64    mIU/ml

4. Clinical significance of pituitary prolactin (PRL) :

Determination of PRL level is an important index to evaluate hypothalamic-pituitary function. Metocloprl test, chlorpromazine PRL test, levodopa inhibition PRL test, bromocryptotine inhibition PRL test can be conducted to judge pituitary function and the differential diagnosis of prolactoma. It is of great significance to diagnose and differentiate the cause of abnormal menstruation and infertility.

Increase: PRL> 30ng/ml, indicating increased PRL; Below 100ng/ml, the nature is uncertain, can be caused by a variety of reasons (such as some drugs such as chlorpromazine, antihistamines, methyldopamine, hemoequal), can also be early mild prolactinoma; PRL> 100ng/ml about 50% pituitary prolactin secretory tumor, PRL> 200ng/ml should be highly suggestive of pituitary prolactin secretory tumor.

Adolescent hypothalamic syndrome, amenorrhea and galactorrhea syndrome, pituitary tumor, pituitary hyperplasia; Male breast development, renal failure patients, primary hypothyroidism patients, other trauma, surgery, shingles, breast pumping, renal failure, sexual intercourse can increase.

Decreased: hypopituitarism; Schiehan's syndrome; Polycystic ovarian syndrome; Dysfunctional uterine bleeding.

Reference range   Male   2.64 ~ 13.13 

Female   < 50 years old 3.34 ~ 26.72

> 50 years old   2.74 ~ 19.64  ng/ml (ug/L)

5. Clinical significance of Progesterone (Prog) :

Progesterone content is closely related to the corpus luteum of ovary and the placenta of pregnancy. It is clinically used to determine ovulation, detect the function of corpus luteum and observe the progress of pregnancy.

Increase: luteal phase of normal menstrual cycle, multiple pregnancies, moles, mild pregnancy-induced hypertension, diabetic pregnant women, preeclampsia, granulosa membrane cell tumor of ovary, lipoid tumor of ovary, congenital adrenal hyperplasia, congenital 17A-hydroxylase deficiency, essential hypertension, etc.

Decreased: luteal insufficiency, polycystic ovary syndrome, anovulatory dysfunctions uterine bleeding, severe pregnancy hypertension syndrome, placental dysfunction of pregnancy, intrauterine growth retardation, stillbirth, ectopic pregnancy, primary or secondary amenorrhea.

Reference range  

Male   0.14 ~ 2.06

Female   Follicular stage   0.31 ~ 1.52   

Ovulation period   3.3 ~ 25.6     

Luteal phase   5.16 ~ 18.56   

Menopause   < 0.08

Pregnant women   < 3 weeks 4.73-50.74

> 3 - < 6 weeks 19.41 ~ 45.3 ng/ml

6. Clinical significance of estradiol (E2) :

It can be used as one of the indicators to monitor follicle development and maturation during ovulation induced by assisted pregnancy technique, and can be used to guide drug administration and determine the time of ovulation collection.

Increase: normal pregnancy, multiple pregnancy, diabetic pregnant women; Liver cirrhosis, ovarian cancer, endometrial cancer, breast cancer; Central precocious puberty; Obesity, certain medications (e.g., chlorophenolamine, chorionic gonadotropin), smoking men, testicular tumors, systemic lupus erythematosus in men.

Decreased: hypothalamic disease, anterior hypopituitary dysfunction, Turner syndrome; Hypertensive syndrome of pregnancy, women who smoke during pregnancy, abnormal pregnancy; Ovarian cyst, premature ovarian failure, after oophorectomy; Patients with mole; Pituitary-ovarian infertility; Menstrual disorders, pituitary ovarian amenorrhea, menopausal syndrome; Hypercortisolism; Schiehan's syndrome; Anencephaly; Mild diabetes; Certain medications (such as luteal release hormone agonists to suppress ovarian function for endometriosis, oral contraceptives and androgens).

Reference range   Male < 20 ~ 47 pg/mL (< 73 ~ 172 pmol/L)

Female   Follicular stage   27 ~ 122  (  99 ~ 448 )

Preovulation   95 ~ 433  (349 ~ 1590)

Middle luteal stage 49 ~ 291  (180 ~ 1068)

Postmenopausal < 20 ~ 40 (< 73 ~ 147)

7. Clinical significance of unbound estriol (uE3) :

To monitor placental function and judge fetal development. For the diagnosis of intrauterine fetal growth retardation; Judgment of expired pregnancy; Gestational hypertension syndrome, preeclampsia observation; Stillborn, brainless child judgment; Recessive genetic disease; Increased uE3 in adrenal syndrome. Early β-hCG and late uE3 were monitored when pregnancy was abnormal.

Reference range  

Pregnant women   26 ~ 28 gestational weeks   > 4.1

29 ~ 32 gestation weeks   7.40 to 8.50

33 ~ 36 weeks of gestation   9.30 to 13.7

37 ~ 38 gestation weeks   16.7 to 23.7

39 ~ 40 gestation weeks   17.7 to 25.4

> 40 gestation weeks   19.3 ~ 30.0    ng/ml

8, Clinical significance of Testosterone(T) :

Testosterone is closely related to all changes in male sexual characteristics caused by male sexual development. The content of testosterone has circadian rhythm changes in a day. Generally, it is appropriate to take blood from 6 to 9 in the morning on an empty stomach.

Increase: common in testicular stromal cell tumor, adrenal tumor, congenital adrenal hyperplasia or pendulous brain - pituitary - testicular axis abnormalities, true male precocious puberty; In females, polycystic ovarian syndrome (PCOS), hirsutism, hypercortisolism, interstitial alveolar hyperplasia, and ovaloma are found.

Decreased: common in primary testicular dysfunction, including congenital absence of testis, testicular atrophy; Hypopituitarism, hyperprolactin, kidney failure, cirrhosis or Kleinfelter syndrome.

Reference range   Male   1.75 ~ 7.81  Female < 0.1 ~ 0.75 ng/ml

9, dehydroepiandrosterone sulfate   (DHEA-S) Clinical significance:

DHEA-S can be metabolized as "activated" androgens, and the level of DHEA-S decreases with the increase of age. The level of DHEA-S is only 10-20% of that at the peak when > 70 years old, which is an indicator of adrenal cortex function. It can be used for the differential diagnosis of Cushing syndrome, adrenal diseases (such as congenital adrenal hyperplasia and adrenal tumors), female patients with hypertrichosis, masculine adrenal cysts, and polycystic ovarian syndrome.

03   Tumor

1. Clinical significance of alpha-fetoprotein (AFP) :

AFP is the most sensitive and specific tumor marker for primary liver cancer, which has the value of evaluating the efficacy and follow-up of the disease.

Increased: primary liver cancer (diagnostic threshold: AFP > 400ng/ml; more than two dynamic measurements are preferred), non-spermatogonial testicular cancer, telangiectasia ataxia, hereditary hypertyrosinemia, neonatal hyperbilirubinemia, acute and chronic viral hepatitis, cirrhosis, and other malignant diseases.

Reference range   0 ~ 9  ng/ml

2. Clinical significance of Carcinoembryonic antigen (CEA2) :

Colon cancer, rectal cancer, gastric cancer, pancreatic cancer, lung cancer, breast cancer, bladder cancer and malignant hydrothorax increase, especially colorectal cancer has the value of evaluating the curative effect, the diagnosis of gastric cancer with gastric fluid measurement is good, inflammation, smoking can cause a slight increase in the blood CEA.

Reference range   0 ~ 5  ng/ml

3. Clinical significance of prostate Specific antigen (second generation PSA) :

PSA is present in normal benign prostatic hyperplasia and malignant prostatic tissue, as well as in prostatic fluid and seminal plasma. Psa is organ (prostate) specific, but not tumor specific. Mainly used in prostate cancer detection, prognosis, surgical control and postoperative monitoring, such as PSA combined with digital rectal examination (DRE) can improve the detection rate of prostate cancer; Continuous PSA testing is beneficial for detection of residual tumors and cancer recurrence after radical prostate cancer surgery, and for post-treatment prosecution.

Increase: Prostate cancer significantly increased, diagnostic specificity of 90%-97%. Serum PSA concentrations in other tissues such as benign prostatic hypertrophy, prostatic inflammation, and other adjacent tissues may also be elevated.

Reference range   < 4.0 ng/ml

4. Clinical significance of free prostate antigen (f PSA) :

Free PSA is used in conjunction with total PSA to detect prostate cancer. Percentage free PSA values (free PSA/ total PSA) help to distinguish prostate cancer from benign prostate disease and can be used in risk assessment to determine an individual patient's likelihood of developing cancer. The lower the percentage of free PSA in patients with elevated PSA levels, the higher the likelihood of cancer.

Reference range

In men, the percentage of free PSA ≤25% is recommended for biopsy.

5. Clinical significance of carbohydrate antigen CA-125 (OV) :

Markers of epithelial ovarian cancer and endometrial cancer.

Increased: in ovarian cancer (60% ~ 97%, often used for diagnosis), cervical cancer, endometrial cancer, fallopian tube cancer, endometriosis, pelvic inflammatory ovarian cyst, pancreatic cancer, cirrhosis, hepatitis, acute and chronic pancreatitis, cholecystitis, etc. CA-125 elevation is also possible during the first 3 months of first trimester.

Reference range   < 35 U/ml

6. Clinical significance of carbohydrate antigen CA15-3 (BR) :

It is present in many adenocarcinomas and is an important antigen for detecting breast cancer.

Increased: in breast cancer (Ⅰ, Ⅱ stage 10% ~ 20%; Stage IV 70%), liver cancer, pancreatic cancer, bile duct cancer, lung cancer, colon cancer, papillary cancer, ovarian cancer, cervical cancer, etc. Liver, gastrointestinal, lung, breast, ovary and other non-malignant diseases, the positive rate is generally less than 10%.

Reference range   < 31.3 U/ml

7. Clinical significance of carbohydrate antigen CA19-9 (GI) :

The marker with the highest reported sensitivity to pancreatic cancer.

Increased: in pancreatic cancer (80% ~ 90%), liver cancer, bile duct cancer, bile duct ampulla cancer, esophageal cancer, colon cancer and gastric cancer. In addition, acute pancreatitis, cholecystitis, cholestatic cholangitis, gallstones (CA19-9 decreased to normal level with the improvement of the disease and the resolution of jaundice), cirrhosis, hepatitis, etc., also increased.

Reference range   < 35 U/ml

04   Anemia and bone markers

1. Clinical significance of ferritin (SF), a marker of anemia :

The concentration of ferritin, which is proportional to the total iron content in the body and is not affected by diurnal changes, is a sensitive method to detect early iron deficiency.

Increased: Chronic inflammation, acute and chronic liver disease, chronic kidney failure, and certain types of cancer (such as leukemia, lung cancer, and breast cancer). It is also a risk factor for coronary heart disease, transient increase of ferritin after drinking alcohol.

Reference range  

Male   23.9 ~ 336.2 Female     11 to 306.8 ng/ml

2. Clinical significance of Vitamin B12 (VB12)   :

Increased: acute leukemia, lymphoma and other malignant tumors.

Reduced: cirrhosis, sickle cell anemia, chronic myeloid leukemia, chronic myeloid leukemia, cirrhosis, alcoholism, pregnancy.

Reference range   180 ~ 914  pg/ml

3. Clinical significance of folic acid (Fol2/RBC2)   :

Serum folic acid (Fol2) levels reflect recent folic acid intake. Erythrocyte (RBC2) folic acid reflects folic acid storage status over time.

Increase: pernicious anemia, aplastic anemia.

Reduced: folate deficiency, acute lymphoblastic leukemia, acute myelogenous leukemia, chronic myelogenous leukemia, cirrhosis, alcoholism, pregnancy.

Reference range  

Fol2＞5.21     RBC2 ＞237     ng/ml        

Fol2＞11.8     RBC2 ＞537     nmol/L

4. Clinical significance of bone alkaline phosphatase (Ostase) :

The BAP(bone alkaline phosphatase), which reflects the activity of osteoblasts, is useful for the assessment of Paget's disease, chondrosis, primary hyperparathyroidism, renal insufficiency, osteoporosis, and skeletal virus metastasis.

Reference range   Male   < 20.1

Premenopausal women   < 14.3

Postmenopausal women   < 22.4ug /L

5. Clinical significance of parathyroid hormone (I-PTH) :

The determination of PTH can obtain the activity of parathyroid glands and the status of bone metabolism, which is helpful to make the differential diagnosis of hyperparathyroidism, parathyroidism decline or malignant hypercalcemia, and is an important indicator to evaluate the severity and prognosis of patients with chronic renal failure.

Periodic calcium serum levels, phosphorus, and PTH measurements were used to monitor the occurrence of renal bone disease in patients with chronic kidney disease. It could also be used in surgery to help clinicians make treatment decisions with other clinical data.

Increase: commonly seen in primary hyperparathyroidism, chronic renal failure and uremia caused by secondary hyperparathyroidism, hyperparathyroidism bone disease, ectopic PTH secretion (pseudohyperparathyroidism, such as liver, kidney, breast, lung cancer, etc.) caused by high blood calcium patients.

Decreased: In patients with hypercalcemia due to malignant disease or other causes, the concentration of PTH in the blood circulation is usually low, below or toward the lower end of the reference range for an apparently healthy individual.

Reference range   15 ~ 88  pg/ml     (1.6-9.3 pmol/L)

6. Clinical significance of human Growth Hormone (hGH2)  

It is used to diagnose and treat disorders of anterior pituitary gland.

Elevation: Acromegaly and gigantism.

Reduced: Pituitary dwarfism.

Reference range   Male   0.003 ~ 0.971 

Female   0.010 ~ 3.607 ng/ml (ug/L)

7. Clinical significance of endogenous factor antibody (IF Ab) :

The diagnosis of pernicious anemia is highly specific and can rule out the need for further detection such as the Schillings test. The presence of pernciparous anemia and endogenous factor antibodies has been associated with a number of autoimmune diseases, such as Hashimoto thyroiditis, insulin-dependent diabetes, Graves' disease, rheumatoid arthritis, myasthenia gravis, parathyroid decline, and Lan-Y syndrome.

Reference range negative < 1.20 Suspicious ≥1.20 ~ < 1.53 Positive ≥ 1.53au /ml

8. Clinical significance of erythropoietin (EPO) :

Used to help diagnose anemia and polycythemia; Predicting response to recombinant erythropoietin therapy in patients with anemia. EPO is not associated with primary polycythemia or polycythemia vera, caused by an increase of primitive red blood cells in abnormal bone marrow stem cells.

Increased tissue hypoxia, such as living at altitude, chronic obstructive pulmonary disease, cyanosis heart disease, sleep apnea, hyperoxy-affinity hemoglobin disease, smoking, or local renal hypoxia. It's caused by the production of tumor cells. It occurs in patients with kidney cancer, polycystic kidney disease, Wilm's tumor, hepatoma, liver cancer, hemangioblastoma, adrenal tumor, and leiomyoma.

Reduced: Associated with some forms of anaemia, including renal failure anaemia, advanced renal disease, preterm anaemia, hypothyroidism anaemia and malnutrition anaemia.

Reference range   2.59 ~ 18.50  mIU/ml

05   Diabetes

1. Clinical significance of glycosylated hemoglobin

(1) Contribute to the understanding of chronic complications of diabetes.

(2) To guide the adjustment of blood sugar.

(3) It has certain significance for judging the different stages of diabetes.

(4) The difference between stress hyperglycemia and gestational diabetes mellitus (GDM).

(5) Reflect the true blood sugar level

(6) Prevention of diabetes complications.

(7) Preventing the development of gestational diabetes mellitus.

2. Fructosamine

Fructosamine is a fast and inexpensive assay (chemical method), which is a good indicator to evaluate the control of diabetes mellitus. It is of practical significance to know the mean blood glucose level of brittle diabetes mellitus and gestational diabetes mellitus.

3. Urinary microalbumin

The increase of urinary microalbumin is more common in diabetic nephropathy, hypertension and preeclampsia of pregnancy, which is an early sensitive indicator of kidney injury. Urinary microalbumin is a sign of early kidney damage in diabetic nephropathy and hypertensive nephropathy.

4. Insulin, C-peptide

Increased: insulinoma, Type 2 diabetes mellitus (NIDDM), autoimmune insulin syndrome (autoimmune insulin receptor antibody and insulin antibody syndrome), cirrhosis, hyperthyroidism, acromegaly. Hypoglycemia caused by dystrophic myotonia and pancreatic hyperplasia; Some amino acids, glucagon, testosterone, growth hormone and oral contraceptives can increase blood insulin.

Reduced: In type I diabetes mellitus, some type II diabetes mellitus, hypopituitarism, adrenocortical hypofunction, secondary pancreatic injury, and chronic pancreatitis; Catecholamines, beta-blockers and diuretics can reduce insulin levels.

Reference range   1.9 ~ 23 uIU/mL (13 ~ 161 pmol/L)

06   Inflammation

1. Clinical significance of interleukin-6 (IL-6) :

IL-6 plays an important role in mediating inflammation and immune responses caused by infection and injury. Elevated IL-6 levels are associated with a number of diseases, including autoimmune diseases, glomerular membrane cell proliferative glomerulonephritis, psoriasis and plasmacytoma, and malignant diseases such as myeloma.

Reference range   < 50 1.9-4.0

> 50  4.1-6.5pg /ml

2. Clinical significance of immunoglobulin:

Physiological changes: the fetus can obtain IgG from the mother before birth. During 22-28 weeks of pregnancy, the concentration of fetal blood IgG is equal to the concentration of maternal blood IgG. After birth, the concentration of fetal blood IgG is gradually reduced, and the concentration of fetal blood IgG is reduced to the lowest level in the 3rd and 4th month.

Pathological changes:

(1) Increased IgG: Increased IgG is a sign of reimmunization. Common in a variety of chronic infections, chronic liver disease, collagen vascular disease, lymphoma and autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis; Increased simple IgG is mainly seen in immunoproliferative diseases, such as IgG secretory multiple myeloma.

(2) Decreased IgG: It can be seen in various congenital and acquired humoral immunodeficiency diseases, combined immunodeficiency diseases, severe chain diseases, light chain diseases, nephrotic syndromes, viral infections, and patients taking immunosuppressants. It can also be seen in metabolic diseases such as hyperthyroidism and muscular dystrophy.

Normal reference value: 7.0-16.6g/L.

3. Clinical significance of IgA detection:

Physiological changes: IgA levels in children are lower than in adults and increase with age until they reach the human level by the age of 16.

4. Clinical significance of IgM detection:

Physiological changes: from 20 weeks of gestation, the fetus itself can synthesize IgM in the amount, fetal and neonatal IgM concentration is 10% of the adult level, and increases with the increase of age, 8-16 years before reaching the human level.

Pathological changes:

(1)IgM increase: seen in early viral hepatitis, cirrhosis, rheumatoid arthritis, systemic lupus erythematosus, etc. Because IgM is the Ig that should be used for primary immunization, an increase in IgM alone is often suggestive of a primary infection caused by a pathogen. Intrauterine infection may cause a sharp increase in IgM concentration. If IgM in umbilical cord blood is higher than 0.2g/L, it indicates intrauterine infection. In addition, in primary macroglobulinemia, IgM showed significantly increased monoclonal activity.

(2)IgM decrease: it can be seen in IgG heavy chain disease, IgA multiple myeloma, congenital immunodeficiency disease, lymphoid system tumor, nephrotic syndrome and metabolic diseases (such as hyperthyroidism and muscular dystrophy) after immunosuppressive therapy.

Normal reference value: 0.5-2.6g/L.

5, procalcitonin (PCT)

The clinical significance of procalcitonin ① Differential diagnosis of bacterial infection and viral infection ② to help the early diagnosis of SIRS/ sepsis, to evaluate the severity and prognosis of the disease ③ to evaluate the therapeutic effect of antibiotics, to guide the clinical use of antibiotics ④ to monitor the complications of bacterial infection in patients with surgery and severe trauma ⑤ differential diagnosis of pancreatitis

6, C-reactive protein (CRP) Clinical significance of C-reactive protein

(1) Distinguish bacterial infection from viral infection

(2) Monitor the changes of susceptible disease and postoperative infection, and observe the efficacy of antibiotics

(3) To predict the risk of cardiovascular disease (4) for disease follow-up and monitoring efficacy

07   Down's prenatal screening

Clinical significance of prenatal screening uE3+βHCG + AFP for Down's disease:  

(uE3), human chorionic gonadotrophin (βHCG) and alpha-fetoprotein (AFP) were collected from pregnant women at 15-18 weeks. The concentrations were measured by the Access detection system and seamlessly connected to the TCSoft screening system using the Chinese population database. The combined risk rates of trisomy 21, trisomy 18 and NTD of fetuses were reported based on maternal weight, age and exact gestational age.

08   Heart markers

Detection of cardiac enzyme markers

1. Lactate dehydrogenase and its isoenzymes

(1) Lactate dehydrogenase

Scope of reference:

Rate Method 109-145U/L (37℃)

Colorimetric method 190-437 gold units

Clinical significance: LDH of patients with myocardial infarction began to increase at 8-12h after the occurrence of chest pain, and reached a peak at 24-48h. The increased enzyme activity could be maintained for about 7d or longer, which can be used as an auxiliary diagnostic indicator in the later stage of acute myocardial infarction. Elevated levels are usually 3-4 times normal and can be as high as 10 times normal. Moderately elevated LDH is seen in myocarditis.

(2) lactate dehydrogenase isoenzyme

Reference range: The sequence of LDH isozyme activity in normal serum was LDH2> LDH1> LDH3> LDH4> LDH5.

LDH1  （28.4 ± 5.3）%

LDH2  （41.0 ± 5.0）%

LDH3  （19.0 ± 4.0）%

LDH4  （6.6 ± 3.5）%

LDH5  （4.6 ± 3.0）%

Clinical significance: LDH1 usually begins to increase at 6h after AMI, and total LDH increases with a slight lag. Since more LDH1 is released than LDH2 during AMI, LDH1 / LDH2> 1.0, the LDH1 /LDH2 ratio peaked at about 24-36h after onset, then began to decline, and returned to normal at 4-7d after onset.

LDH1> LDH2 can also be found in myocarditis, pulmonary embolism, giant cell anemia, and hemolytic anemia, but in vitro hemolysis usually does not cause LDH1>. LDH2.

2. Creatine kinase and its isoenzymes

(1) Serum creatine kinase

Clinical significance:

CK assay is mainly used to diagnose myocardial infarction in clinic. It increases sharply 3 -- 6h after acute myocardial infarction and can be as high as 10 -- 12 times the upper limit of normal, peaking at 20 -- 30h. CK is more specific than AST and LDH in the diagnosis of myocardial infarction, but the duration of this enzyme increase is shorter, and it will return to normal after 2-4d.

Viral myocarditis, CK activity can also be significantly increased.

Both cardiac surgery and non-cardiac surgery will lead to increased CK activity, and the extent of increase is closely related to the extent of muscle injury and the length of operation time.

In acute brain trauma, meningitis, malignant tumor, pulmonary infarction, hypothyroidism, CK cocoa increased.

(2) creatine kinase isoenzyme

Reference range

CK-MB: less than 10U/L (37℃)

Total activity of CK-MB/CK: less than 5%

Clinical significance:

CK-MB in plasma mainly comes from myocardium, and its elevation is often considered as a specific indicator of myocardial damage, which is valuable for the early diagnosis of myocardial infarction. Serum CK-MB began to increase at 2-4h after the onset of acute myocardial infarction (> 15u/L), reached a peak at 12-24h, and returned to normal level after 3 days without complications. The positive rate of AMI diagnosed by CK-MB was 50% 3 hours after the onset of chest pain, and 80% after 6 hours.

3. Aspartate aminotransferase and its isoenzymes

(1) aspartate aminotransferase

Scope of reference:

Rate method: 8-40U/L (reaction temperature is 37℃)

Colorimetric method: 8-28 Karman units (reaction temperature 37℃)

Clinical significance: Serum AST activity increased during myocardial infarction and was significantly increased within 6-12h after the onset of myocardial infarction. The degree of increase could reflect the degree of damage, and reached a peak at 48h and returned to normal at about 3-5 days. Myocarditis, pleurisy, nephritis and pneumonia may also cause a slight increase in serum AST. AST combined with CK-MB and LDH is helpful to determine the course of acute myocardial infarction.

(2) aspartate aminotransferase isoenzyme

AST has two isoenzymes that are controlled by different genes and are found in the cytoplasm (c-AST) and mitochondria (m-AST).

Reference range: m-AST ≤15U/L (37℃)

Clinical significance:

Generally, m-AST is released into the blood after cell necrosis and mitochondrial destruction. When the cell is no longer damaged or repaired, the serum m-AST value quickly drops to the normal level. Therefore, the determination of m-AST is beneficial to determine the severity of cell necrosis and predict the prognosis of patients.

The dynamic activity of m-AST was closely related to the course of the disease. It increased significantly at 12h after myocardial infarction (later than CK), reached a peak at 24h and continued to 48h.

The sensitivity (100%) and specificity (93.5%) of m-AST in the diagnosis of myocardial infarction are not lower than that of CK-MB (92.8% and 93.5%, respectively), and the peak time is longer, so M-AST can be used as a new enzyme index in the diagnosis of myocardial infarction.

Prognosis before cardiac surgery: when preoperative m-AST value was above 20U/L, postoperative mortality increased. When the mAST value is below 20U/L, the postoperative prognosis is good.

Cardiac protein marker detection

1. Serum myoglobin

Scope of reference:

Healthy adult Mb < 70ug/L It is recommended that each laboratory establish a local normal reference range according to its own conditions.

Clinical significance:

Increased serum Mb can be seen in the early stage of acute myocardial infarction, acute muscle injury, muscular dystrophy, muscular atrophy, polymyositis, acute or chronic renal failure, severe congestive heart failure and long-term shock.

Elevated myoglobin in both blood and urine can be seen in acute myocardial infarction, angina pectoris, cardiogenic shock, cardiomyopathy, and muscle diseases (progressive muscular dystrophy, polymyositis, and myasthenia gravis).

2. Determination of troponin I

Scope of reference:

cTnI < 0.8ug/L

It is recommended that laboratories establish local normal reference range and diagnostic criteria according to their own conditions.

Clinical significance:

cTnI is a specific indicator of myocardial injury. Serum cTnI level increased at 4-8h after AMI occurrence, reached a peak at 12-14h, and returned to normal at 6-10d. That is, appear earlier, and CK-MB equivalent or earlier; It disappears slowly, lasts longer than LD1, and has the advantages of CK-MB and LD1. The diagnostic specificity of cTnI is better than that of CK-MB and Mb, which can be used to evaluate unstable angina pectoris. Increased cTnI level predicts a higher risk of short-term death. Continuous monitoring of cTnI can help to determine thrombolysis and myocardial reperfusion. In AMI, the sensitivity of all biochemical markers is time-dependent. For patients with chest pain within 4 hours of onset, the Mb level should first be measured; Both Mb and cTnI should be evaluated for blood samples obtained after 3 hours. All positive results can be confirmed as AMI, and all negative results can rule out myocardial injury.

Reference range  

Adult 1-2 ng/ml (1.3-2.6 nmol/L)

Poisoning level   > 2 ng/ml (2.6 nmol/L)

Children 1.1-1.7ng /ml (1.4-2.2nmol /L)

09   Renal function

1, the normal reference value of serum urea nitrogen (BUN) is 3.2~7.1mmol/L.

Increased urea nitrogen is seen in renal diseases (such as acute and chronic nephritis, toxic nephritis, severe pyelonephritis, congenital polycystic kidney, kidney tumor, etc.), prerenal factors (such as dehydration, blood loss, shock, severe burn, severe infection, diabetic acidosis, upper gastrointestinal bleeding, etc.) and postrenal obstruction and other causes (such as prostatic hypertrophy, tumor compression, double ureteral calculi, etc.).

2. The normal reference value of serum creatinine (Cr) is 53-106umol /L.

Increased serum creatinine is an indicator of impaired glomerular filtration function. It can be seen in primary and secondary renal injury (acute and chronic glomerulonephritis, nephrosclerosis, polycystic kidney disease, rejection after renal transplantation, etc.). Increases are also seen after severe dehydration, blood loss, shock, heart failure, and strenuous physical activity.

3. The normal reference value of serum uric acid (UA) is 150-416umol /L.

Increased serum uric acid is seen in acute and chronic nephritis, pyelonephritis, renal tuberculosis, hydronephrosis, toxic nephropathy (such as chloroform, carbon tetrachloride, lead, etc.) and gout.

10   TORCH

1. Toxoplasmosis (TOXO) : Toxo infection in pregnant women can lead to miscarriage, stillbirth, premature delivery, intrauterine fetal growth delay, mental retardation, or increased pregnancy complications.

2. Rubella virus (RUB) : Infection in pregnant women can lead to congenital rubella syndrome in fetuses, resulting in congenital cataracts, heart disease, deafness and permanent developmental abnormalities.

3. Cytomegalovirus (CMV) : The fetus is infected with central nervous system and liver damage as obvious symptoms, such as hydrocephalus, encephalomalacia, motor neurological disorders, hearing loss, chronic hepatitis, etc.

4. Herpes simplex virus (HSV) : It can cause local blistering lesions of the skin or mucous membranes, such as fetal infection manifested as skin herpes, blindness, deafness, hydrocephalus, intracranial calcification and other symptoms.

11 Liver fibrosis four items  

1. Serum hyaluronic acid (HA) is mainly taken up and decomposed by hepatic endothelial cells, and a few small molecules are also filtered by glomerulus. When liver and kidney function were impaired, serum HA increased, and showed an increasing trend with the aggravation of the lesion. Serum HA detection can reflect the development and outcome of hepatic fibrosis to a certain extent.

2. Laminin (LN) is also known as laminin. It is a structural glycoprotein, which exists in the transparent layer of basement membrane. It has important relationship with hepatic fibrosis and is the main basis of portal hypertension. Serum LN level is usually parallel with type IV collagen and hyaluronic acid, which is of great value in the diagnosis of hepatic fibrosis.

3. Type III procollagen (pcⅢ) is the precursor of type III procollagen. Serum PCⅢ content is closely related to the degree of liver fibrosis, which reflects the synthesis of liver fibers.

4. Type Ⅳ collagen (ⅳ-C), serum ⅳ-C is considered to be a good reflection of collagen synthesis, and is positively correlated with the degree of fibrosis.

12   Infectious diseases

Four tests for infectious diseases, hepatitis B, hepatitis C, syphilis, AIDS,

Second liver two half (second liver virus indicators have 5, commonly known as "second liver two half")

Hepatitis B Surface Antigen (HBsAg), Hepatitis B Surface Antibody (HBsAb), Hepatitis Be Antigen (HBeAg), Hepatitis Be Antibody (HBeAb), Hepatitis B Core Antibody (HBcAb)

Clinical significance of Hepatitis B penta: Generally speaking, hepatitis B penta serum markers, if the virus antigen marker (HBsAg/HBeAg) positive, indicating the existence of hepatitis B virus infection; Antigen, antibody were negative, no virus infection; Antigen negative, one or more antibodies positive, indicating previous infection or recovery period, the virus has been cleared. When analyzing the clinical significance of "Five items of Hepatitis B", we should not analyze one of them in isolation and unilaterally. Instead, we should refer to several other indicators, and sometimes refer to HBVDNA, DNA-P, Pre-S1, S2, etc. At the same time, we should combine clinical and other comprehensive analysis, so as to make a correct judgment and accurate evaluation.

Hepatitis C

Of the four infectious diseases, one is responsible for monitoring hepatitis C virus: Hepatitis C antibody (HCV-Ab).

Negative (-) indicates no HCV infection;

Positive   (+) indicates hepatitis C virus infection;

syphilis

Among the four infectious diseases, the indicator responsible for monitoring syphilis is Treponema pallidum antibody TPPA.

AIDS

HIV is a virus that attacks the body's immune system and can be transmitted through blood, mother-to-child transmission and sexual transmission, so it is very important for couples of childbearing age to do a good job of HIV prevention.

Negative (-)   Indicating no HIV infection;

(+  )     Suggestive of HIV infection

> Knowledge Base for In Vitro Diagnosis IVD

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