Selling unit: per 100ml
Common name: Alanine Aminotransferase (ALT) Assay Kit (IFCC Rate Method)
English Name.ALT Reagent Kit (IFCC Kinetic Method)
3:1, 4:1, 5:1, common ratio 3:1, other ratios need to be customized
It is used to determine the viability of ALT in human serum or plasma. It is clinically useful for the differential diagnosis of hepatobiliary diseases and is important for acute viral hepatitis, acute disorders of liver perfusion, acute toxic hepatic necrosis, obstructive jaundice and other diseases.
L-alanine + α-ketoglutarate ──→ pyruvate + L-glutamic acid
Pyruvate + NADH + H+ ───→ L-lactic acid + H2 O + NAD+
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.
Hitachi 7180/7600; Olympus AU680/2700; Toshiba TBA120; Myriad BS2000M/480; Siemens ADVIA 1800/2400 series automatic biochemical analyzers.
The most appropriate sample is fresh, non-haemolyzed serum or plasma. Plasma should be anticoagulated with heparin or EDTA; do not use citrate, oxalate or fluoride. ALT in samples is stable at room temperature (20-25°C) for 24h, 2-8°C for 7 days, and -20°C for one month when stored.
- 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)
*Reagents and sample volumes can be increased or decreased in proportion to the requirements of different biochemical analyzers as appropriate.
- Calibration procedure.
Randox calibration sera are recommended. the method of choice for Randox calibration sera is the IFCC/SFBC method, Tris buffer without pyridoxal phosphate, 37°C.
- 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.
Sample concentration = (sample ΔA /min) / (standard ΔA /min) × standard concentration
Positive Judgment Value Or Reference Interval
It is recommended that each laboratory establish its own reference range of normal values.
Interpretation Of Test Results
The measurement of ALT in serum 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 diagnostic tools.
Limitations Of The Test Method
Ascorbic acid ≤ 30 mg/dL, bilirubin ≤ 40 mg/dL and hemoglobin ≤ 400 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 ≥ 1.0.
Absorbance change rate of reagent blank: △A/min ≤ 0.004 at wavelength 340 nm and optical diameter 1.0 cm.
Analytical sensitivity: The kit tests 130 U/L of the test substance with absorbance change rate ΔA/min ≥ 0.015.
Linearity range: test serum samples, reagent linearity in the interval of 5 to 1200 U/L, linear correlation coefficient|r| should not be less than 0.990; in the interval of 5 to 40 U/L, the absolute deviation of linearity should not exceed 4 U/L; in the interval of (40 to 1200 U/L, the relative deviation of linearity should not exceed ±10%.
Precision: Repeatability CV ≤ 4%; relative extreme difference between batches ≤ 5%.
Accuracy: Relative deviation ≤ 10%.
- 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. Do not mix R1 and R2 into a single reagent.
- Clin. Chem. Acta 105 (1980) S. 147-172.
- Synopsis der Leberkrankheiten: H. Wallhöfer, E. Schmid u. F. W. Schmidt, G. ThiemeVerlag, Stuttgart (1974).
- Thefeld W. et al, Dt. Med. Wschr. 99 (1974), 343.