Selling unit: per 100ml
Product Name
Common name: β2-Microglobulin (β2-MG) assay kit (latex-enhanced immunoturbidimetric method)
English name: β2-MG Reagent Kit (Immuno- turbidimetric Method)
Reagent Ratio
3:1, 4:1, 5:1, common ratio 4:1, other ratios need to be customized
Intended Use
This kit is used to determine the amount of β2-MG in human serum or urine.
β2-Microglobulin (β2-MG) is a low molecular weight protein with a molecular weight of approximately 11,800. BMG is found in human blood, urine, and cerebrospinal fluid. detection of β2-MG in serum is useful for the diagnosis of renal dysfunction and malignancy, and for the assessment of disease treatment and prognosis. It is also useful for the diagnosis of malignant tumors and for the treatment and prognosis of diseases. In acute nephritis, chronic nephritis and chronic renal insufficiency, serum β2-MG increases due to the decrease of glomerular filtration rate and renal blood flow; it is earlier and more significant than the increase of serum creatinine concentration; renal injury caused by hypertension and diabetes mellitus all have the increase of serum β2-MG, which has early diagnostic significance.
The concentration of β2-MG in urine is mainly related to the development and function of renal tubules. When renal tubular reabsorption is impaired, the concentration of β2-MG in urine increases significantly, which is called renal tubular proteinuria and is mainly seen in the following diseases: pyelonephritis, antibiotic toxic nephropathy, renal tubular damage caused by heavy metal poisoning, etc.
Test Principle
The antibody of the β2-MG determination kit in the sample is encapsulated on latex particles, which can produce agglutination reaction with the β2-MG in the specimen and form an antigen-antibody complex, whose turbidity level is proportional to the concentration of β2-MG in the presence of a certain amount of antibody. The content of β2-MG can be calculated by measuring the absorbance value at a specific wavelength and referring to the multi-point calibration standard curve.
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 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.
Applicable Instruments
Hitachi 7180/7600; Olympus AU680/2700; Toshiba TBA120; Myriad BS2000M/480; Siemens ADVIA 1800/2400 series automatic biochemical analyzers.
Sample Request
Serum, blood should be separated promptly after collection to avoid hemolysis, 2 to 8°C stable for 7 days, samples of hemolysis and lipemia cannot be used.
The supernatant was taken from the urine after centrifugation. Since β2-MG in urine is not stable at pH less than 5.5, it was measured after adjusting to pH 7-8 with K2 HPO4 . It was stabilized at 2 to 8°C for 2 days.
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.
The use of matching calibrators is recommended.
- 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.
5 points are calibrated and the corresponding values are entered. With △A as the vertical coordinate and concentration as the horizontal coordinate, plot the standard curve, and correct this standard curve with suitable mathematical models such as Logit-Log4P, Spline, etc., and save this standard curve for calculating the results. The reagents of different batches must be re-calibrated.
Positive Judgment Value Or Reference Interval
Serum 1.0~3.0 mg/L
Urine 0.1-0.3mg/L
It is recommended that each laboratory establish its own reference range of normal values.
Interpretation Of Test Results
The determination of β2-MG 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 diagnostic tools.
Limitations Of The Test Method
Bilirubin ≤ 40 mg/dL, hemoglobin ≤ 500 mg/dL and celiac ≤ 500 mg/dL did not interfere with the determination.
Product Performance Index
Absorbance of reagent blank: wavelength 572 nm, optical diameter 1.0 cm, temperature 37°C, A0 ≤ 1.0.
Analytical sensitivity: the kit tests 2.0 mg/L of the analyte, the absorbance change value ΔA ≥ 0.02.
Linearity range: test serum samples, reagent linearity in the interval of 0.2~18.0 mg/L, linear correlation coefficient|r| should not be less than 0.975; in the interval of 0.2~3.0 mg/L, the absolute deviation of linearity should not exceed 0.3 mg/L; in the interval of (3.0~18.0 mg/L, the relative deviation of linearity should not exceed ±10%.
Precision: repeatability CV ≤ 8%; relative extreme difference between batches ≤ 10%.
Accuracy: Relative deviation ≤ 10%.
Caution
- 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.
- Please dispose of the measured samples and waste liquids in accordance with the relevant national and local laws and regulations.
- Do not mix R1 and R2 into a single reagent.
- When changing the reagent lot number, please recalibrate.
- The latex reagent (R2) itself has a certain turbidity, and its particle diameter is 100 nm-200 nm, the trace has strong Brownian motion in the solution, so the reagent does not need to be shaken well before use.
Reference
- Serum cystatin C, determined by a rapid, automated particle-enhanced turbidimetric method, is a better marker than serum creatinime for glomerular Clin. chem, Oct (1994); 40:1921-1926. ultrarapid.
