Selling unit: per 100ml
Common name: Alkaline phosphatase (ALP) assay kit (IFCC rate method)
English name: ALP Reagent Kit (IFCC Kinetic Method)
3:1, 4:1, 5:1, common ratio 3:1, other ratios need to be customized
Used to determine the viability of ALP in human serum or plasma.
Increased ALP is commonly seen in bone or liver disease, including bile ducts. increased ALP (usually with normal γ-glutamyl transferase levels) is most often seen in osteochondrosis, rickets, bone-related primary hyperparathyroidism, metaplastic osteitis, secondary bone cancer, and certain osteogenic sarcoma conditions. increased ALP (usually with increased γ-glutamyl transferase levels) is most often seen in biliary depression, hepatitis, cirrhosis, and malignancy. Decreased ALP can be seen in bone arrest, hypophosphatasia, etc.
p-Nitrophenol phosphate + H2 0 ──→ p-Nitrophenol + phosphate
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 plasma. 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 to stabilize.
- 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 Randox calibration sera of choice are IFCC modified AMP, 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.
Adult serum/plasma: 40 ~ 150 U/L
It is recommended that each laboratory establish its own reference range of normal values.
Interpretation Of Test Results.
The determination of ALP in serum or 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 tools.
Limitations Of The Test Method.
Ascorbic acid ≤ 30 mg/dL, bilirubin ≤ 40 mg/dL, hemoglobin ≤ 500 mg/dL, and celiac disease ≤ 500 mg/dL did not interfere with the determination.
Product Performance Index
Absorbance of reagent blank: wavelength 404 nm, optical diameter 1.0 cm, temperature 37°C, A0 ≤ 1.0.
Absorbance change rate of reagent blank: △A/min ≤ 0.005 at wavelength 404 nm and optical diameter 1.0 cm.
Analytical sensitivity: The kit tests 120 U/L of the test substance with absorbance change rate ΔA/min ≥ 0.01.
Linearity range: test serum samples, reagent linearity in the interval of 5 to 1000 U/L, linear correlation coefficient|r| should not be less than 0.990; in the interval of 5 to 100 U/L, the absolute deviation of linearity should not exceed 10 U/L; in the interval of (100 to 1000 U/L, the relative deviation of linearity should not exceed ±10%.
Precision: Repeatability CV ≤ 5%; 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. When changing the reagent lot number, please recalibrate.
- Thomas L. Clinical Laboratory Diagnostics. 1st ed. Frankfurt: TH-Books Verlagsgesellschaft; (1998). p36-46.
- Moss DW, Henderson AR. clinical enzymology. in: Burtis CA, Ashwood ER, editors. tietz Textbook of Clinical Chemistry. 3rded. Philadelphia: W.B Saunders Company; (1999). Philadelphia: W.B Saunders Company; (1999). p. 617-721.