Selling unit: per 100ml
Common name: Prealbumin (PA) assay kit (immunoturbidimetric method)
English name: PA Reagent Kit (Immunoturbidimetric Method)
3:1, 4:1, 5:1, common ratio 3:1, other ratios need to be customized
This kit is used to determine the amount of PA in human serum.
PA is a serum protein synthesized by hepatocytes, whose main physiological function is to transport thyroxine and vitamin A. It has thymic hormone activity and can increase the immunity of the body by promoting the maturation of lymphocytes.PA has an important diagnostic value for clinical liver substantial damage. It is significantly lower in patients with hepatocellular carcinoma, cirrhosis, chronic active hepatitis, and obstructive jaundice, and is an indicator of early liver damage. In addition, PA can also be reduced in patients with malnutrition and acute infections. clinical diagnostic methods for PA assay kits are mainly two levels, immunoturbidimetric assay, immunoturbidimetric assay, etc.
The PA in the serum binds to the anti-human PA antibody in the reagent to produce an antigen-antibody complex, which forms a certain turbidity, the level of which is proportional to the PA content in the serum. The absorbance of this turbidity at 340 nm is measured and the PA content in the serum can be found against the standard curve.
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 series automatic biochemical analyzers, and Celsius specific protein analyzer HD-III.
Blood was collected on an empty stomach and specimens were separated as soon as possible. Serum specimens were stored at 4°C for one week and frozen at -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.
Multi-point non-linear calibration method using Landau calibrators. Calibrations are traceable to the international reference material: ERM-DA470k.
- 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.
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 by non-linear method Logit-Log4P, Spline and other modes, and save this standard curve for calculating the results. The reagents of different batches must be re-calibrated.
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 determination of prealbumin (PA) 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
Bilirubin ≤ 40 mg/dL, hemoglobin ≤ 200 mg/dL, ascorbic acid ≤ 30 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 ≤ 0.30.
Analytical sensitivity: The kit tests 50 mg/L of the test substance with absorbance change ΔA ≥ 0.002.
Linearity interval: test serum samples, reagent linearity in the interval of 50 to 1000 mg/L, the linear correlation coefficient |r| should not be less than 0.990; in the interval of 50 to 100 mg/L, the absolute deviation of linearity should not exceed 10 mg/L; in the interval of (100 to 1000 mg/L, the relative deviation of linearity should not exceed ±10%.
Precision: repeatability CV ≤ 6%; relative extreme difference between batches ≤ 8%.
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.
- Gitlin D, Edelhoch HJ. Immunol. 1951; 66: 76-78.
- Burtis CA, Ashwood ER. Tietz Fund. Of Clin. Chem. 5th.ed. 30-54 and 324-351 and 1014.
- Tietz NM, ed. Clinical Guide to Laboratory Testing, 3th. ed. Philadelphia, Pa: WB Saunders. 1995: 608.