Clinical biochemistry is the study of biochemical changes in pathological conditions on the basis of normal human biochemistry. By analyzing the changes of relevant metabolites, characteristic markers are found and corresponding detection methods are established to provide biochemical information and decision basis for disease prevention, diagnosis, treatment and prognosis.

Biochemical diagnosis refers to the in vitro diagnosis method that USES Lamber-Beer law to measure various inorganic elements, protein and non-protein nitrogen, enzymes, sugars, lipids and other biochemical indicators in vitro through a variety of biochemical reactions. The commonly used examination items such as liver function, renal function, blood glucose and blood lipid belong to biochemical diagnosis. Clinical biochemical diagnostic reagents are combined with biochemical analyzer to diagnose clinical biochemical indicators related to human body by applying chemical, enzymology, immunology and other related technical principles. Specific optical signals are given through the specific reaction between the reagent and the relevant substance to be measured, which is recorded by biochemical analyzer and compared with the calibrated substance to give the level of the relevant substance to be measured. Biochemical diagnosis is one of the most commonly used in vitro diagnostic methods, and is also the earliest and most mature field of IVD subdivision at home and abroad.

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Classification of biochemical diagnostic reagents
    Biochemical diagnosis is the earliest automated detection method and one of the most commonly used in vitro diagnosis methods. Common clinical biochemical reagents can be          classified in the following ways:

    Classified by clinical nature
    1. Liver function test Items:
    Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) and gamma glutamine transferase (gamma GT), cholinesterase (CHE), total bilirubin (TBIL), direct bilirubin (DBIL), total bile acid (associates), glutamate dehydrogenase (GLDH), adenosine deaminase (ADA), 5 '- nucleotidase (5' -nt) and alpha L - fucus glycosidase (AFU) and prealbumin (PA), etc.
    2. Renal function test items:
    Urea, UA, CREA, cystatin C, 1-mg, 2-mg, RBP, UTP, UTRF, MALB, etc.
    3. Glucose metabolism Test Items:
    Glucose (Glu), glycosylated hemoglobin (HbA1c), glycosylated albumin (GA), fructoamines (FMN) and so on.
    4. Blood lipid testing Items:
    Cholesterol (TC), triglyceride (TG), high-density lipoprotein cholesterol (HDL - C), low density lipoprotein cholesterol (LDL - C), apolipoprotein A1 (ApoA Ⅰ), apolipoprotein B     (ApoB), lipoprotein (a) (Lp (a)), apolipoprotein E (APOE), etc.

    5. Cardiovascular disease testing items:
    Creatine kinase (CK), creatine kinase isoenzyme (CKMB), myoglobin (Mb), troponin (cTnI), homocysteine (Hcy), etc.
    6. Pancreatic disease detection Items:
    Alpha-amylase (AMY), pancreatic amylase (PAMY), lipase (LPS), etc.
    7. Trace elements:
    Calcium (Ca), chlorine (Cl), magnesium (Mg), inorganic phosphorus (P), carbon dioxide (CO2), zinc (Zn), iron (Fe), etc.
    8. Immunization Test Items:
    Immunoglobulin G (IgG), immunoglobulin A (IgA), immunoglobulin M (IgM), complement C3 (C3), complement C4 (C4), immunoglobulin D (IgD), C-reactive protein (CRP), hypersensitive C-    reactive protein (HS-CRP), immunoglobulin E (IgE), etc.
    9. Other test items:
    Lactic acid (LA), carbamazepine (CRA), ethanol (ALC), etc.