Selling unit: per 100ml
- Common name: Total protein (TP) determination kit (bicuculline method)
- English name: TP Reagent Kit (Biuret Reaction Method)
This kit is used to determine the content of human serum TP.
Total protein is the sum of albumin and globulin. Its clinical significance is determined by the changes in albumin and globulin, and the quantitative determination of TP is useful in the diagnosis of many diseases that cause changes in plasma protein levels. high TP concentrations are often caused by an increase in one or more immunoglobulins and can be caused by dehydration, multiple myeloma, and chronic diseases such as liver cirrhosis, systemic lupus erythematosus, and sarcoma, while a decrease in TP concentration can The decrease in TP concentration can be caused by water intoxication, excessive protein loss such as burns, nephrotic syndrome, malabsorption, intestinal diseases or liver diseases.
Biuret method: In alkaline solution, peptide bonds in protein molecules react with bivalent copper ions to form colored complexes, resulting in an increase in absorbance at 548 (530-560) nm, which is proportional to the concentration of total protein 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 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 automatic biochemistry analyzer.
For serum, blood should be collected from a vein in a supine position in a quiet state with a tourniquet compressing the vein for no more than 3 minutes. There is interference when the serum is lipidated, hemolyzed, or severely jaundiced. Confined serum samples are stable for 1 week at room temperature (18-25°C), 1 month under refrigerated (2-4°C) conditions, and longer under frozen (-20°C) conditions, and frozen samples must be fully mixed after room temperature thawing before determination.
- Reagent preparation: liquid reagents are ready to use out of the bottle.
- Test conditions: (The following parameters are set in accordance with Toshiba TBA120FR, and different on-board parameters can be requested according to different testing instruments)
*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 sera produced by Randox Laboratories Ltd. The method of choice for Randox calibration sera is the bicuculline endpoint method.
- 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.
TP concentration (g/L) =(ΔAsample – ΔAblank ) × Cstandard / (ΔAstandard – ΔAblank )
The reference interval is derived from the National Clinical Laboratory Practice, 4th edition, and is validated by clinical trials with 150 blood samples from a selected group of normal adults. Each laboratory should establish its own normal reference range based on the region and the population.
Interpretation Of Test Results
TP 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 ≤ 30 mg/dl, bilirubin ≤ 40 mg/dL, hemoglobin ≤ 200 mg/dL and celiac disease ≤ 500 mg/dL did not interfere with the determination.
Product Performance Index
Appearance: The appearance of the reagent kit should be neat, with clear identification of words and symbols, and the reagent bottle is intact; the reagent is a blue clarified liquid, 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 absorbance change value ΔA≥ 0.005 when the kit tests 45 g/L of the analyte.
Linearity interval: For testing serum samples, the linear correlation coefficient|r| should be not less than 0.999 in the interval of 0.5~150.0 g/L. In the interval of 0.5~85.0 g/L, the absolute deviation of linearity should not exceed 8.5 g/L; in the interval of (85.0~150 g/L, the relative deviation of linearity should not exceed ±10%.
Precision: repeatability CV≤1%; relative extreme difference between batches≤ 10.0%.
Accuracy: Relative deviation ≤ 2%.
- 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 cassette reaction waste should be treated as an infectious agent and operators need 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.
- 9. High lipid serum can cause false positive elevation of the results. In this case, a sample blank tube, i.e. 250 μl of 9% saline with 5 μl of sample mixed, should be used to read the absorbance of the sample blank tube at 548 nm relative to the 0.9% saline, and the actual sample absorbance should be simply subtracted from the absorbance of the sample blank tube.
- Thomas L. Clinical Laboratory Diagnostics. 1sted. Frankfurt: TH-Books Verlagsgesellschaft; 1998. p. 644-7.
- Johnson Am, Rohlfs EM, Silverman LM. proteins. in: Burtis CA, Ashwood ER, editors. tietz Textbook of Clinical Chemistry. 3rded. Philadelphia: W.B Saunders Company; 1999. p. 477-540