Description：Immunoassay for qualitative screening of antibodies to Glargine in serum and plasma.
Insulin glargine is produced by recombinant DNA technology.
It is an analogue of human insulin made by replacing the asparagine residue at position A21 of the A-chain with glycine and adding two arginine to the C-terminus （positions B31 and 32） of the B-chain.
The resulting protein is soluble at pH 4 and forms micro-precipitates at physiological pH 7.4.
Small amounts of insulin glargine are slowly released from micro-precipitates giving the drug a long duration of action （up to 24 hours） and no pronounced peak concentration.
Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well.
About the kit：
- Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity.
- Recovery rates are between 85 - 115％
- Ready to use with a standard protocol with break-apart pre-coated wells
- Validated as per US FDA guidelines for Bioassays
- Optimized for matrix effects to ensure higher sensitivity.
- Shelf life： 1 year
The method employs the qualitative sandwich enzyme immunoassay technique.
A commercially available Glargine is pre-coated onto microwells.
Samples and Controls are pipetted into microwells and antibodies to human Glargine present in the sample and controls are bound by Glargine.
Then, a HRP （horseradish peroxidase） conjugated Glargine is pipette and incubated simultaneously with samples.
After washing microwells in order to remove any non specific binding, the ready to use substrate solution （TMB） is added to microwells and color develops proportionally to the amount of antibodies to Glargine in the sample.
Color development is then stopped by addition of stop solution.
