Selling unit: per 100ml
Common name: Triglyceride (TG) assay kit (GPO-PAP enzyme method)
English name: TG Reagent Kit (GPO-PAP Method)
Single, 3:1, 4:1 (common ratio), other ratios need to be customized
This kit is used to determine the amount of TG in human serum.
Measurement of TG is important for the diagnosis and management of hyperlipidemia. elevated TG concentrations can be caused by primary hyper-TGemia or by secondary diseases such as diabetes, nephrotic syndrome, renal failure, hypothyroidism and alcoholism.
A lipoprotein esterase, glycerol kinase, and glycerol phosphate oxidase coupled Trinder reaction was used. Lipoprotein esterase (LPL) first catalyzes the hydrolysis of triglycerides (TG) to produce glycerol and fatty acids, and subsequently, glycerol kinase catalyzes the phosphorylation of glycerol to produce glycerol-3-phosphate (G-3-P). Glycerol-3-phosphate was oxidized to dihydroxyacetone phosphate and hydrogen peroxide catalyzed by glycerol phosphate oxidase (GPO), which was combined with 4-aminoantipyrine (4-AAP) and 2-hydroxy-3-m-toluidine propionate sodium (TOOS) to form a red quinoneimine compound by the action of oxidase (POD), causing an increase in absorbance at 548 (530 to 560) nm This change was proportional to the concentration of TG in the sample.
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 automatic biochemical analyzer.
Patients should fast before blood collection, except for bedridden patients, who should sit still for at least 5 minutes before blood collection, and take blood from the forearm vein, with the use of a tourniquet for no more than 1 min.
After blood collection, the blood was left to coagulate for 30-45 min at room temperature to avoid hemolysis, and then centrifuged for 10 min at 1500 r/min~3000 r/min (centrifugal force 1100g~1300g) and the serum was promptly aspirated and placed in a closed tube. The separated serum can be stored at 2℃～8℃ for 1 week. -It can be stored for a longer time below 20°C. When used, thaw and bring the temperature to room temperature and mix thoroughly. Do not freeze and thaw repeatedly.
- Reagent preparation: liquid reagents are ready to use out of the bottle.
- Test conditions: (the following parameters are set in accordance with Toshiba TBA120, and different on-board parameters can be requested according to different testing instruments)
Single reagent operation procedure.
Dual reagent operation procedure.
Reagents and sample volumes can be increased or decreased in proportion to the requirements of different biochemical analyzers.
- Calibration procedure.
Randox Laboratories Ltd UK is recommended to use the calibration serum produced by Randox Laboratories Ltd. The Randox calibration serum is selected for the lipase/GPO-PAP free glycerol correction.
- QC control procedures.
It is recommended to use quality control sera produced by Randox Laboratories Ltd UK, Landau Laboratory Diagnostics Ltd. It is recommended that each laboratory establish its own QC system and select appropriate QCs for quality control. The QC values should be within the specified range. If outside the specified range, it is necessary to take appropriate measures or contact the manufacturer.
TG content in the sample (mmol/L) =(ΔAsample – ΔAblank ) × Cstandard / (ΔAstandard – ΔAblank )
The blood samples of 150 normal people were selected through clinical trials, measured by automatic biochemical analyzer, and the values obtained were processed statistically and the reference range was calculated. It is recommended that each laboratory should establish its own normal reference range according to the regional and population conditions.
Interpretation Of Test Results
The TG measurement in serum 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
Ascorbic acid ≤ 10 mg/dL, bilirubin ≤ 40 mg/dL and hemoglobin ≤ 200 mg/dL did not interfere with the determination.
Product Performance Index
Appearance: The appearance of the kit should be neat and tidy, the text symbols are clearly marked, and the reagent bottle is intact; R1 is colorless or light yellow clarified liquid, R2 is colorless or light yellow clarified liquid, both without precipitation, suspension and flocculent.
Absorbance of reagent blank: wavelength 548 nm, optical diameter 1.0 cm, temperature 37°C, A0 ≤ 0.2.
Analytical sensitivity: the kit tests 1.0 mmol/L of the test substance, the absorbance change value ΔA ≥ 0.05.
Linearity range: test serum samples, reagent linearity in the range of 0.2 to 10.0 mmol/L, linear correlation coefficient |r| should not be less than 0.990; in the interval of 0.2 to 2.0 mmol/L, the absolute deviation of linearity should not exceed 0.2 mmol/L; in the interval of (2.0 to 10.0 mmol/L, the relative deviation of linearity should not exceed ±10%.
Precision: repeatability CV≤ 5.0%; relative extreme difference between batches≤ 10.0%.
Accuracy: Relative deviation ≤ 10.0%.
- 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.
- Do not mix R1 and R2 into a single reagent.
- When changing the reagent lot number, please recalibrate.
- There may be differences in the use of reagents from different manufacturers for the same sample.
- All sample cassette reaction waste should be treated as an infectious source and the operator needs to take the necessary protective measures.
- The reagent contains the preservative sodium azide (toxic), so please rinse thoroughly with water immediately if you accidentally get it in your eyes or mouth or on your skin, and seek medical attention if necessary. Sodium azide can react strongly with copper, lead and other metals to form azide metal, so please dilute the waste solution and flush the drainage pipe when disposing to avoid residue in the drainage pipe.
- test tubes and other instruments that have come into contact with the test sample should be disposed of in accordance with medical waste disposal methods.
- SCHETTLER G., NUSSEL E., ARBEITSMED. sozialmed. praventivmed (1975); 10: 25
Company name: Jiangsu Aisai’s Biotechnology Co.
Instruction approval date and modification date: July 1, 2022