Pancreatic Elastase ELISA Kit

Sample

stool

Species Reactivity

Human

Detection Method

sELISA

Intended Use

This assay is an enzyme immunoassay intended for the quantitative determination of human pancreatic elastase in stool.

Contents of Kit

Storage

2-8°C

Performance Characteristics

Accuracy – Trueness
The trueness states the closeness of the agreement between the result of a measurement and the true value of the measurand. Therefore, pancreatic elastase spikes with known concentrations were added to 3 different stool samples.

Precision

Repeatability (Intra-Assay); n = 42
The repeatability was assessed with 2 stool samples under constant parameters (same operator, instrument, day and kit lot).

Reproducibility (Inter-Assay); n = 20
The reproducibility was assessed with 2 stool samples under varying parameters (different operators, instruments, days and kit lots).

Sensitivity

The following values have been estimated based on the concentrations of the standard without considering possibly used sample dilution factors.
Limit of blank, LoB 0.906 ng/ml
Limit of detection, LoD 1.884 ng/ml
Limit of quantitation, LoQ 2.055 ng/ml
The evaluation was performed according to the CLSI guideline EP-17-A2. The specified accuracy goal for the LoQ was 20 % CV.

General Description

Pancreatic elastase is an anionic endoprotease of the serine protease family with a molecular weight of 26 kDa. Together with other digestive enzymes it is synthesised as an inactive pro-enzyme in the acinar cells of the pancreas and is secreted into the duodenum. After its activation, pancreas elastase cleaves peptides after neutral amino acids.
Pancreas elastase is mainly bound to bile salts during intestinal passage and is not degraded. In human faeces it is 5–6 fold more concentrated than in pancreatic juice. The stool concentration reflects the secretory capacity of the pancreas.

General Notes

Pancreatic elastase is an anionic endoprotease of the serine protease family with a molecular weight of 26 kDa. Together with other digestive enzymes it is synthesised as an inactive pro-enzyme in the acinar cells of the pancreas and is secreted into the duodenum. After its activation, pancreas elastase cleaves peptides after neutral amino acids.
Pancreas elastase is mainly bound to bile salts during intestinal passage and is not degraded. In human faeces it is 5–6 fold more concentrated than in pancreatic juice. The stool concentration reflects the secretory capacity of the pancreas.