Homocysteine Assay kit (Cystathionine Assay)
- Completely made of self-supplied raw materials;
- Features high-specificity, high-sensitivity, and excellent anti-interference properties;
- Maintains superior stability, stable for 18 months if tightly sealed and stored at <4°C and for 30 days after opening;
- Displays high intra- and inter-assay precision, with the intra-assay CV ≤3% and the inter-assay CV ≤5%.
Homocysteine Kit (Enzymatic Cycling Method)
Sample Requirements
- Serum, heparin or EDTA plasma, and urine are suitable for samples. Whole blood, hemolysis is not recommended for use as a sample. Freshly drawn serum is the preferred specimen.
- Stability: Serum/plasma: 5 days at 2–8℃;
Calibrator Preparation
Liquid calibrator and Control can be used when opened.
Control Preparation
Liquid calibrator and Control can be used when opened.
Method
- Reagent preparation：Liquid reagent can be used when opened.
Calibration
It is recommended to use the Calibrator from Hzymes and distilled/deionized water for two-point calibration.
Calibration frequency: After reagent lot changed; As required following quality control procedures; The value of control change significantly; the biochemical analyzer has undergone extensive maintenance.
Quality control
At least two levels of control material should be analyzed with each batch of samples.Each laboratory should establish its own internal quality control scheme and procedures for corrective action if controls do not recover within the acceptable tolerances.
Reference Intervals
[3] Each laboratory should establish its own reference intervals based upon its patient population. The reference intervals measured at 37 °C listed below were taken from literature.
Serum / Plasma: 4.0～15.4μmol／L
Interferences/Specificity
The following substances were tested for interference with this methodology. Criterion: Recovery within ±10 % of initial value.
Storage and stability
Up to expiration date indicated on the label, when stored unopened at 2-8℃ and protected from light. Once opened, the reagents are stable for 28 days when refrigerated on the analyzer or refrigerator. Contamination of the reagents must be avoided. Do not freeze the reagents.
Reagent Blank Absorbance
The absorbance of reagent blank at 340nm should be≥0.8A. Materials
Sensitivity
Assay the sample with concentration: 10.0μmol/L, the change rate of absorbance（ ∆A/min）is ≥0.01
Precision
Within-run : CV≤5%
Between-run: CV≤10%
Linearity range
Conventional Units: 2.0~50 μmol/L If the value of sample exceeds 50 μmol/L,the sample should be diluted with 9 g/L NaCl solution (e.g. 1+ 9) and rerun; the result should be multiplied by 10.
Warnings and Precautions
1.For in vitro diagnostic use.
2.Take the necessary precautions for the use of laboratory reagents.
3.Preservative contained. Do not swallow. Avoid contact with skin and mucous membranes.
4.Disposal of all waste material should be in accordance with local guidelines.
5.Material safety data sheet is available on request for professional users.
References
[1] Eikelboom JW,et.al. HCY and cardiovascular disease:a critical review of the epidemiologic edidence. Ann Intern Med; 1999,131:363-75.
[2] Scott JM,Weir DG. Homocysteine and cardiovascular disease.QJ Med; 1996,89:561-3.
[3] Nygard O, Nordrehaug je, refsum h,et.al. Plasma homocysteine levels and mortality in patients with coronary artery disease: N EngI J Med; 1997,337(4):230-6.
In vitro test for the quantitative determination of HCY concentration in serum or plasma on photometric systems. Homocysteine (Hcy) is a thiol-containing amino acid produced by the intracellular demethylation of methionine. Total homocysteine (tHcy) represents the sum of all forms of Hcy including forms of oxidized, protein bound and free. Elevated level of tHcy has emerged as an important risk factor in the assessment of cardiovascular disease. Excess Hcy in the blood stream may cause injures to arterial vessels due to its irritant nature, and result in inflammation and plaque formation, which may eventually cause blockage of blood flow to the heart
Anti-interference Performance:
Hemoglobin ≤500 mg/dL Triglyceride ≤1250 mg/dL
Vitamin C ≤20 mg/dL Bilirubin ≤50 mg/dL
The Certificate Of Analysis (COA) & Material Safety Data Sheet (MSDS) Is A Signed Document That Includes The Storage Temperature,
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