Lispro NL-ELISA Kit

Sample

plasma, serum

Species Reactivity

Human

Detection Method

dELISA

Intended Use

The Lispro NL-ELISA provides a method for the quantitative determination of insulin lispro in plasma or serum samples.

Storage

Store between 2-8°C

Performance Characteristics

High dose hook effect
Samples with a concentration up to 10 000 mU/L (20X Cal 6) can be measured without giving falsely low results.

Precision

1. Human serum
Human serum controls spiked with lispro were analyzed in 4 replicates on at least 12 different occasions by 2 different technicians on 4 days.

*Within assay variation
**Total assay variation
2. Human EDTA Plasma
Human EDTA plasma, human P-800 plasma and porcine EDTA plasma were spiked with EDQM Lispro and analyzed in 4 replicates on 6 occasions by 2 different technicians on 2 days.

*Within assay variation
**Total assay variation
3. Human P-800 Plasma

*Within assay variation
**Total assay variation
4. Porcine EDTA Plasma

*Within assay variation
**Total assay variation

Detection Limit

Capability of Detection is 0.36 mU/L as determined by the methodology described.
Lower Limit of Quantification, LLOQ, is 1.0 mU/L as determined according to EMA/FDA guidelines.
The Upper Limit of Quantification, ULOQ, is 500 mU/L as determined according to EMA/FDA guidelines.

Sensitivity

Selectivity has been validated according to FDA/EMA guidelines. At least 10 blank samples from different individuals of each tested matrix (human serum, human EDTA plasma, human P-800 plasma and porcine EDTA-plasma) showed no positive signal in the assay in the absence of lispro. Auto-insulin antibodies, HAMA, rheumatoid factor (RF), grossly lipemic, icteric or hemolyzed samples do not interfere in the assay.

General Description

The Lispro NL-ELISA is a ligand binding assay able to measure insulin lispro specifically, without cross-reaction to native insulin, native proinsulin, or any of the tested insulin analogues. Also, no interference from insulin autoantibodies (IgG antibodies), which can be present in samples from diabetic patients, has been observed. The Lispro NL-ELISA is designed to fit the needs of the pharmaceutical industry, by meeting the requirements specified in the EMA/FDA guidelines.

Standard Curve

These values were obtained using BMG Labtech Clariostar with 1 s integration time, 2500 gain and 11.5 mm focal height.

*Concentration stated on vial label.
**The RLU is affected by reader model and gain settings. Different readers can give different RLU values. Absolute RLU values do not affect calculated results.
A typical calibrator curve is shown here. Do not use this curve to determine actual assay results.