Selling unit: per 100ml
Common name: Direct bilirubin (D- BIL) assay kit (chemical oxidation method)
English name: D-BIL Reagent Kit (Chemical Oxidation Method)
This kit is used for the in vitro quantitative determination of D-BIL concentration in human serum and plasma.
Bilirubin is a degradation product of hemoglobin, and the determination of D-BIL is mainly to detect water-soluble conjugated bilirubin. increased D-BIL is clinically seen in hepatocellular damage, and has important clinical significance for intra- and extra-hepatic biliary obstruction, hepatitis, acute jaundice and liver atrophy.
At pH values close to 3, D-BIL is oxidized to bilirubin in the presence of oxidizing agents and surfactants. At this time, the characteristic yellow color of bilirubin is reduced, and the concentration of D-BIL in the sample can be found by measuring the difference in absorbance at 450 (450-470) nm before and after the action of the oxidant.
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.
Serum or EDTA anticoagulated plasma, measured within 2h after sample collection, sealed and stored away from light, samples can be stored at 2 to 8˚C for 12h and -20˚C for 3 months.
- 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.
The Randox calibration serum is recommended and the method of choice for the Randox calibration serum is choline oxide (vanadate method).
- 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.
D-BIL content in samples (μmol/L) = (ΔAsample – ΔAblank ) × Cstandard / (ΔAstandard – ΔAblank )
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 D-BIL in human serum and plasma 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
Hemoglobin ≤ 150 mg/dL and ascorbic acid ≤ 20 mg/dL did not interfere with the determination.
Product Performance Index
Absorbance of reagent blank: wavelength 450 nm, optical diameter 1.0 cm, temperature 37°C, A0 ≤ 0.2.
Analytical sensitivity: The kit tests 30 μmol/L of the test substance with absorbance change value ΔA ≥ 0.003.
Linearity interval: for the tested serum samples, the linearity of the reagents should be within the interval of 1.0~450.0 μmol/L, and the linear correlation coefficient|r| should be not less than 0.990; within the interval of 1.0~30.0 μmol/L, the absolute deviation of linearity should not exceed 5 μmol/L; within the interval of (30.0- 450.0 μmol/L, the relative deviation of linearity should not exceed ± 10%.
Precision: Repeatability CV ≤ 6%; relative extreme difference between batches ≤ 6%.
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.
- 5. When changing the reagent lot number, please recalibrate.
- Tokuta, K. and Tanimoto, K. Jpn. J. Clin. Chem., 22 (2), 116-112 (1993).
- Akiyama, K. And Makino, I. Rinshoh-i. 19 (suppl), 242-244 (1993).