A CLIA test kit for quantitative determination of Insulin (INS) in human serum or plasma with the use of Automatic Chemiluminescence Immunoassay Analyzer.
| Product Name: |
Insulin (INS) Test Kit (CLIA), Chemiluminescence Immunoassay Test,Strip,Double Antibody Sandwich Method |
| Principle: |
Double Antibody Sandwich Method |
| Pack: |
40T |
| Format: |
Strip |
| Storage Temperature: |
2-8℃ |
| Cat No.: |
CI-INS |
| Specimen: |
S/P |
| Shelf Life: |
2 Years |
| Certificate: |
CE |
| Cut-Off: |
2-300 MIU/L
|
【INTENDED USE】
The Insulin (INS) Test Kit (CLIA) is intended for quantitative determination of Insulin (INS) in human serum or plasma, as an aid to evaluate islet function.
For professional in vitro diagnostic use only.
【SUMMARY】
Insulin is a polypeptide hormone with a molecular weight of 6KD. It is composed of two different peptide chains, A chain and B chain. A and B chains are connected by two disulfide bonds. Insulin is secreted by the precursor of insulin in pancreatic β cells, namely proinsulin (molecular weight 9KD).1 The insulin molecule is composed of two polypeptide chains, the α-chain contains 21 amino acids and the β-chain contains 30 amino acids. Islet B cells synthesize the single-chain form of preproinsulin, which is then immediately decomposed into proinsulin. Under the action of specific proteases, proinsulin is broken down into insulin and C-peptide into the blood circulation. About half of the insulin remains in the liver, but actually does not include C-peptide. Insulin in the circulation has a half-life of 3-5 minutes and is preferentially degraded in the liver; while the inactivation or excretion of proinsulin and C-peptide occurs in the kidneys.
Diabetes can be divided into two main types according to whether insulin is secreted. One is called insulin-dependent diabetes mellitus (IDDM) or type I diabetes, which is an absolute lack of insulin levels caused by autoimmune reactions that destroy the function of the pancreatic beta cells to secrete insulin. The secretion of insulin slowly decreases until all β cells are destroyed. At this time, the patient needs to be injected with insulin to maintain life.
Insulin testing has been widely used to provide auxiliary information for diagnosis. It can not only assist in the diagnosis of diabetes, but also can distinguish insulinoma and artificial hypoglycemia by judging fasting hypoglycemia. In addition, the increased risk of coronary artery disease in patients with hyperinsulinemia and normal glucose tolerance can also be found through the insulin program.
【PRINCIPLE】
This product uses the double antibody sandwich method. In the first step, the sample, the INS antibody labeled with alkaline phosphatase and the magnetic particles coated with the INS antibody are mixed. After incubation, the INS in the sample forms an immune complex with the corresponding antibody. In the second step, magnetic separation and cleaning are performed to remove free enzyme-labeled antibodies. The third step is to add the chemiluminescent substrate solution to the immune complex.
Luminescence signal generated by the enzyme reaction is detected by Automatic Chemiluminescence Immunoassay Analyzer and the detected luminescence intensity is related to the concentration of INS in the sample.
Automatic Chemiluminescence Immunoassay Analyzer can calculate the concentration of INS in the sample.
【REAGENTS】
The reagent strip includes INS antibody coated with magnetic particles, alkaline phosphatase labeled INS antibody, wash buffer and substrate solution
【PERFORMANCE CHARACTERISTICS】
1. Method comparison
lt was compared with commercial CLIA test kit, 54 specimens were tested
and the correlation coefficient (R2 ) is 0.9635.
2. Accuracy
The test deviation is≤±15%.
3. Assay Range and Detection Limit
Assay Range: 2-300 mIU/L
Minimum Detection Limit:2 mIU/L
4. Linearity range
2-300 mIU/L , R≥0.990
5. Precision
Intra-lot precision
Within-run precision has been determined by using 10 replicates of 2
specimens containing 10 mIU/L, 100 mIU/L of INS. 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 10 mIU/L, 100 mIU/L of
INS. The C.V. is ≤15%.
6. Cross-reactivity
Cross-reactivity studies were carried out with following analytes.
100ng/mL C peptide and 10ng/mL Proinsulin positive specimens. The
results showed no cross-reactivity.
7. Interfering Substances
The following potentially interfering substances were added to 10.47 mIU/L
and 91.54 mIU/L of INS specimens.
