Selling unit: per 100ml
Common name: HDL-C assay kit (direct assay)
English name: HDL-C Reagent Kit (Direct Method)
This kit is used to determine the HDL-C content in human serum.
Abnormal (decreased) clinical manifestations are commonly seen in heart and cerebrovascular diseases, hepatitis, and cirrhosis, and the increase or decrease of its blood concentration is used as an important indicator of atherosclerosis; the level of HDL-C in serum is negatively correlated with the incidence of coronary heart disease, and the importance of HDL-C as an indicator of coronary heart disease detection has been recognized; when HDL-C is below 0.7 mmol/L is a risk factor for coronary heart disease.
Cholesterol esterase (CHE) and cholesterol oxidase (COD) are used in combination with dextran sulfate complexes to reduce the enzymatic reactivity to LDL, VLDL, and celiac particles and to selectively interact only with HDL-cholesterol. Based on this principle, LDL, VLDL, and celiac particles were combined with dextran sulfate complexes in the first step of the reaction, and HDL-cholesterol was measured directly in the second step without separating other lipoproteins using CHE, COD, and special surfactants. The absorbance of quinone dye at 548 (530-560) nm correlates with the HDL-cholesterol content.
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 fast before blood collection, except for bedridden patients, sit still for at least 5 min before blood collection, and take venous blood, the use of tourniquet does not exceed 1 min to avoid hemolysis.
After blood collection, the blood is left at room temperature for 30-40 min to coagulate on its own, and the serum is separated by centrifugation within 1h-2h. The samples should be stored at room temperature for no more than 4h, below 4℃ for 4h-48h, and below -70℃ if longer storage is needed. 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)
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 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.
HDL-C content in the sample (mmol/L) =(ΔAsample – ΔAblank ) × Cstandard / (ΔAstandard – ΔAblank )
Less than 35 mg/dl (0.91 mmol/l) is considered as low HDL-C blood.
The reference interval is derived from the National Clinical Laboratory Practice, 3rd edition, and is validated by clinical trials of 150 selected normal population blood samples. Each laboratory should establish its own normal reference range according to the region and the population.
Interpretation Of Test Results
HDL-C 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 ≤ 20 mg/dL, hemoglobin ≤ 500 mg/dL, and celiac disease ≤ 500 mg/dL did not interfere with the determination.
Product Performance Index
Appearance: The appearance of the kit should be neat and clean, with clear identification of text symbols and intact reagent bottles; R1 is a colorless or light yellow clarified liquid, R2 is a 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 ≤ 0.1.
Analytical sensitivity: the kit tests 1.0 mmol/L of the test substance, the absorbance change value ΔA ≥ 0.06.
Linearity range: test serum samples, reagent linearity in the range of 0.5 to 2.5 mmol/L, the linear correlation coefficient |r| should not be less than 0.990; in the range of 0.5 to 1.0 mmol/L, the absolute deviation of linearity should not exceed 0.1 mmol/L; in the range of (1.0 to 2.5 mmol/L, the relative deviation of linearity should not exceed ±10%.
Precision: repeatability CV ≤ 4%; relative extreme difference between batches ≤ 4%.
Accuracy: Relative deviation ≤ 5%.
- 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.
- For samples with lipid blood visible to the naked eye and triglyceride levels exceeding 250 mg/dL, the results need to be diluted with saline before determination and multiplied by the dilution factor.
- Friedewald, W.T. et al., Clin. Chem. 18 (1972) 499
- Study Group, European Atherosclerosis Society, European Heart Journal, 8, (1987), 77 – 88
- Rifal, N., Warnick, G. R, Laboratory Measurement of Lipids, Lipoproteins and Apolipoproteins. AACC Press. Washington DC, USA (1994)