Growth Stimulation Expressed Gene 2 (ST2) Test Kit (CLIA),WB/S/P,Double Antibody Sandwich Method
A CLIA test kit for the quantitative determination of Growth Stimulation Expressed Gene 2 (ST2) in human whole blood, serum or plasma with the use of Automatic Chemiluminescence Immunoassay Analyzer.
Features:
Extraordinary Sensitivity
High Accuracy
Good Specificity
Wide Dynamic Range
Extensive Range of Applications
【INTENDED USE】
The Growth Stimulation Expressed Gene 2 (ST2) Test Kit (CLIA) is intended for quantitative determination of Growth Stimulation Expressed Gene 2 (ST2) in human whole blood, serum and plasma, as an aid in diagnosis of heart failure.
For professional in vitro diagnostic use only.
【SUMMARY】
Growth Stimulation expressed gene 2 (ST2) is a member of the interleukin-1 receptor/Toll-like receptor superfamily. There are two main subtypes of ST2: Transmembrane ST2 (ST2L), with a transmembrane structure, containing transmembrane fragments and the intracellular domain of Toll/IL-1TR receptor; Soluble ST2 (sST2), without Transmembrane structure, can be secreted to the outside of the cell. ST2 is not an "orphan receptor", its specific ligand is interleukin-33 (IL-33).
In 2013, ACCF/AHA guidelines have included sST2 as a marker of myocardial fibrosis, which can predict the hospitalization and death rates of HF patients. In patients with acute dyspnea, serum sST2 concentration can strongly predict the mortality within 1 year in patients with acute heart failure and those without heart failure. In the study of patients with acute heart failure, sST2 once again became the first choice for predictin 1-month and 1-year mortality; and showed a higher predictive value than
other biomarkers, such as NT-proBNP, BNP, CRP or muscle calcium protein.
sST2 reflects a meaningful pathophysiological process in heart disease, and is not affected by age and renal function. It is: 1) Strong prognosis for short-term and long-term results; 2) Predicting the risk of major adverse cardiovascular events, mainly HF-related events; 3) Demonstrating the added value of clinical and other biomarkers, which is of medium importance Clinical significance. When ST2>35 ng/mL in patients with acute decompensated heart failure, the risk of death and rehospitalization
due to heart failure is significantly increased.
【PRINCIPLE】
This product uses double antibody sandwich method. The first step is to mix the sample with an alkaline phosphatase-labeled ST2 antibody and magnetic particles coated with ST2 antibody. After incubation, the ST2 in the sample forms an immune complex with corresponding antibodies. In the second step, magnetic separation and cleaning were performed to remove free enzyme-labeled antibodies. The third step is to add chemiluminescent substrate solution to the immune complex.
Luminescence signal generated by the enzyme reaction was detected by Automatic Chemiluminescence Immunoassay Analyzer. The detected luminescence intensity was related to the concentration of ST2 in the sample and the concentration of ST2 in the sample could be calculated by Automatic Chemiluminescence Immunoassay Analyzer.
【REAGENTS】
The reagent strip includes ST2 antibody coated with magnetic particles, alkaline phosphatase labeled ST2 antibody, wash buffer and substrate solution.
【STORAGE AND STABILITY】
1. Unopened test kits should be stored at 2-8 °C. When stored and handled as required, all unopened reagents are stable through the expiration date printed on the label.
2. Do not freeze. Do not turn the reagent strips over.
3. Store the test kit upright. Do not expose reagents to strong light during storage. Care should be taken to protect the components of the test from contamination.
4. Remaining reagents in the kit should be stored at 2-8°C immediately.
5. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipment,
containers or reagents may lead to false results.
6. Calibrator and Control Materials:
Unopened:
Stable until the expiration date when stored at 2-8 °C.
Opened:
Undissolved: Stable for 1 week at 2-8 °C, avoid deliquescence
Dissolved: Stable for 5 days at 2-8 °C.
【PERFORMANCE CHARACTERISTICS】
1.Method comparison
lt was compared with commercial CLIA test kit, 58 specimens were tested and the correlation coefficient (R2 ) is 0.9967.
2.Accuracy The test deviation is≤±15%.
3.Assay Range and Detection Limit
Assay Range: 0.5-200 ng/mL
Blank limit: 0.5 ng/mL
4.Linearity range 0.5-200 ng/mL, R≥0.990
5.Precision
Intra-lot precision
Within-run precision has been determined by using 10 replicates of 2 specimens containing 20 ng/mL, 100 ng/mL of ST2. The C.V. is ≤8%. Inter-lot precision Between-run precision has been determined by using 10 replicates for each of three lots using 2 specimens containing 20 ng/mL, 100 ng/mL of ST2. The C.V. is ≤15%.
6.Interfering Substances
The following potentially interfering substances were added to 21.87 ng/mL
and 109.78 ng/mL of ST2 specimens.
Triglyceride: 30 mg/mL
Bilirubin: 0.2 mg/mL
Biotin: 50 ng/mL
Albumin: 2 mg/mL
Hemoglobin 5 mg/mL
None of the substances at the concentration tested interfered in the assay
