Selling unit: per 100ml
Common name: Total bile acid (TBA) assay kit (enzyme cycle method)
English name: TBA Reagent Kit (Enzymatic Cycling Method)
3:1,4:1 can be used
This kit is used for the determination of total bile acids (TBA) in human serum.
TBA is catabolized by the liver, and the rise of bile acid concentration in blood is related to hepatobiliary diseases, which is specific and can reflect the pathological process of hepatobiliary diseases acutely. Increased bile acids are seen in: a. hepatocellular damage, such as acute hepatitis, chronic active hepatitis, cirrhosis, hepatocellular carcinoma, ethanol liver and toxic liver disease; b. biliary obstruction, such as intrahepatic and extrahepatic bile duct obstruction; c. portal shunt, secondary bile acids in the intestine enter the body circulation directly through the shunted portal system; d. serum bile acids may increase transiently after eating, which is a physiological phenomenon. Changes in TBA are more sensitive than ALT in acute hepatitis and chronic active hepatitis. The difference in results is especially pronounced in cirrhosis: the positive rate of TBA is as high as 95%, while the positive rate of ALT is only 20%. Therefore, the TBA assay is of great value for monitoring chronic liver disease. The method is simple and it is a useful diagnostic index of liver function.
The bile acids in the samples were specifically oxidized by 3α-hydroxysteroid dehydrogenase and Thio-NAD+ to generate 3-ketosteroids and Thio-NADH. In addition, the generated 3-ketosteroids generated bile acids and NAD+ in the presence of 3α-hydroxysteroid dehydrogenase and NADH, and the cycle was repeated so as to amplify the trace amount of bile acids. The rate of change of the absorbance of the generated Thio-NADH was measured to obtain the bile acid value.
Reagent components included in the product.
*Components are not interchangeable in kits with different lot numbers.
*Reagent components not included in the product, but necessary for the test: outsourced normal and abnormal QCs and calibrators.
Storage Conditions And Expiration Date
The kit is stored at 2-8°C away from light and is valid for one year.
Reagents that have been opened are careful not to be contaminated, and reagents are stable in the instrument compartment (2-8°C) for one month.
The reagents must not be frozen.
Hitachi 7180/7600; Olympus AU680/2700; Toshiba TBA120; Myriad BS2000M/480; Siemens ADVIA1800/2400 automatic biochemical analyzer.
Patients are fasted or randomized before blood collection, venous blood is drawn, and serum is promptly separated. Specimens with severe hemolysis or hemostasis cannot be measured.
Serum samples can be stored at room temperature for up to 7 days.
- Reagent preparation: liquid reagents are ready to use out of the bottle.
- Test conditions: (the following parameters are set in accordance with Toshiba TBA120, and different on-board parameters can be requested according to different testing instruments)
Reagents and sample volumes can be increased or decreased in proportion to the requirements of different biochemical analyzers.
- Calibration procedure.
Randox Laboratories Ltd UK is recommended to use the calibration serum produced by Randox Laboratories Ltd. The method of choice for Randox calibration serum is the fifth generation circular enzyme method.
- QC control procedures.
It is recommended to use quality control sera produced by Randox Laboratories Ltd UK, Landau Laboratory Diagnostics Ltd. It is recommended that each laboratory establish its own QC system and select appropriate QCs for quality control. The QC values should be within the specified range. If outside the specified range, it is necessary to take appropriate measures or contact the manufacturer.
TBA content in the sample (μmol/L) =(ΔAsample – ΔAblank ) × Cstandard / (ΔAstandard – ΔAblank )
The blood samples of 150 normal people were selected by clinical trials, measured by automatic biochemical analyzer, and the values obtained were processed statistically and reference ranges were calculated. It is recommended that each laboratory establish its own reference range of normal values.
Interpretation Of Test Results
Serum TBA measurement is only one of the indicators used by clinicians to diagnose patients. Clinicians must also make a comprehensive judgment based on the patient’s physical symptoms, medical history, and other diagnostic items and diagnostic tools.
Limitations Of The Test Method
Ascorbic acid ≤ 30 mg/dL, bilirubin ≤ 20 mg/dL, hemoglobin ≤ 500 mg/dL, and celiac disease ≤ 500 mg/dL did not interfere with the determination.
Product Performance Index
Appearance: The appearance of the kit should be neat and clean, with clear identification of text symbols and intact reagent bottles; R1 is a light yellow clarified liquid and R2 is a colorless clarified liquid, both without precipitation, suspension and flocculent.
Absorbance of reagent blank: wavelength 404 nm, optical diameter 1.0 cm, temperature 37°C, A0 ≤ 0.80.
Absorbance change rate of reagent blank: △A/min ≤ 0.04 at wavelength 404 nm and optical diameter 1.0 cm.
Analytical sensitivity: the kit tests 10 μmol/L of the test substance, the absorbance change rate ΔA/min ≥ 0.005.
Linearity range: test serum samples, reagent linearity in the interval of 1-200 μmol /L, linear correlation coefficient|r| should not be less than 0.990; in the interval of 1-10 μmol/L, the absolute deviation of linearity should not exceed 1 μmol/L; in the interval of (10-200 μmol/L, the relative deviation of linearity should not exceed ±10%.
Precision: repeatability CV ≤ 5%; relative extreme difference between batches ≤ 10%.
Accuracy: Relative deviation ≤ 10%.
- This product is for in vitro diagnosis only.
- Avoid contamination when using the reagent, the container used must be clean, and please take necessary precautions, do not swallow, and avoid contact with skin and mucous membrane.
- Do not mix R1 and R2 into a single reagent.
- When changing the reagent lot number, please recalibrate.
- There may be differences in the use of reagents from different manufacturers for the same sample.
- All cassette reaction waste should be treated as an infectious agent and operators need to take the necessary protective measures.
- The reagent contains sodium azide (toxic), so if you accidentally get it in your eyes or mouth or on your skin, please rinse it thoroughly with water immediately and seek medical attention if necessary. Sodium azide can react strongly with copper, lead and other metals to form azide metal, so please dilute the waste solution and flush the drainage pipe when disposing to avoid residue in the drainage pipe.
- test tubes and other instruments that have come into contact with the test sample should be disposed of in accordance with medical waste disposal methods.
- Samuel J. Levin and Morton K. Schwartz.Serum Bile Acids in Patients with Liver Disease.ClinChem 1965; 12: 547.
- Linnet K. Kelbaek H. The patterns of glycine and taurine conjugates of bile acids in serum in hepatobiliary disease. Scand J Gastroenterol 1982; 17: 919 .