Selling unit: per 100ml
Product Name
- Common name: α-hydroxybutyrate dehydrogenase (HBDH) assay kit (rate method)
- English name: HBDH Reagent Kit (Kinetic Method)
Reagent Ratio
3:1,4:1,5:1 are available
Intended Use
This kit is used to determine the viability of HBDH in human serum or plasma.
HBDH is actually lactate dehydrogenase type I isoenzyme, which is very useful for the diagnosis of myocardial infarction. HBDH activity is increased when the following pathological conditions are present: myocardial infarction, hepatitis, and myotonic dystrophy. In addition, it is also seen to be increased in rheumatic heart disease, acute viral myocarditis, pernicious anemia, hemolytic anemia, renal infarction, myocardial injury, and cardiomyopathy. The normal α-HBDH/LDH is 0.67, with a ratio >0.8 in patients with acute myocardial infarction and <0.6 in patients with liver disease.
Test Principle
HBDH catalyzed the conversion of α-butyric acid to α-hydroxybutyric acid and the oxidation of NADH to NAD+. The rate of decrease of NADH absorbance at 340 nm was proportional to the HBDH activity in a certain range.
Main components.
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 taken care not to be contaminated and the reagents are stabilized in the instrument compartment (2-8°C) for one month.
The reagents must not be frozen.
Applicable Instruments
Hitachi 7180/7600; Olympus AU680/2700; Toshiba TBA120; Myriad BS2000M/480; Siemens ADVIA 1800/2400 series automatic biochemical analyzers.
Sample Request
Blood was collected on an empty stomach and the serum was separated as soon as possible to avoid hemolysis. The specimen can be stored at 2-8℃ for 3 days. If the specimen cannot be measured in time, it should be stored at -20℃ and can be stable for half a year, avoid repeated freezing and thawing.
Test Method
- Reagent preparation: liquid reagents are ready to use out of the bottle.
- test conditions: (different test instruments can be requested according to the different parameters on the machine)
Operation steps.
*Reagents and sample volumes can be increased or decreased in proportion to the requirements of different biochemical analyzers.
- Calibration procedure.
Randox calibration sera are recommended. 2-carboxybutyric acid <10 mmol/L at 37°C is the method of choice for Randox calibration sera.
- QC control procedures.
It is recommended that each laboratory establish its own quality control system and select appropriate quality control products for quality control. The measured values of QC products should be within the specified range. If outside the specified range, it is necessary to take appropriate measures or contact the manufacturer.
- Calculation.
Sample concentration = (sample ΔA /min) / (standard ΔA /min) × standard concentration
Positive Judgment Value Or Reference Interval.
72 to 182 U/L
It is recommended that each laboratory establish its own reference range of normal values.
Interpretation Of Test Results.
The determination of HBDH in serum or plasma is only one of the indicators used by the clinician to make a diagnosis of the patient. The clinician must also make a comprehensive judgment based on the patient’s physical symptoms, medical history, and other diagnostic items and tools.
Limitations Of The Test Method.
Ascorbic acid ≤ 30 mg/dL, bilirubin ≤ 40 mg/dL and celiac disease ≤ 200 mg/dL did not interfere with the determination.
Product Performance Index
Absorbance of reagent blank: wavelength 340 nm, optical diameter 1.0 cm, temperature 37°C, A0 ≥ 1.1.
Absorbance change rate of reagent blank: △A/min ≤ 0.002 at wavelength 340 nm and optical diameter 1.0 mm.
Analytical sensitivity: The kit tests 100 U/L of the test substance with absorbance change rate ΔA/min ≥ 0.003.
Linearity interval: For testing serum samples, the linear correlation coefficient|r| should be not less than 0.990 in the interval of 5~1000 U/L. In the interval of 5~100 U/L, the absolute deviation of linearity should not exceed 10 U/L; in the interval of (100~1000 U/L, the relative deviation of linearity should not exceed ±10%.
Precision: repeatability CV ≤ 5%; relative extreme difference between batches ≤ 10%.
Accuracy: Relative deviation ≤ 10%.
Caution
- 1. This product is for in vitro diagnosis only.
- 2. 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.
- 3. Please dispose of the measured samples and waste liquids in accordance with the relevant national and local laws and regulations.
- 4. When changing the reagent lot number, please recalibrate.
Reference
- Clin. Chem. andClin. Biochem. 8, 658, (1970)
- Clin. Chem. and Clin. Biochem. 10, 182, (1972)
- Elliott, B.A. et al. Clin. SCI 24, 349, (1963)
