Measuring Range

The M30-Apoptosense^® assay has a working range of 100-1,000 U/L.

Detection Limit

The minimal detectable concentration in M30-Apoptosense^® ELISA is 12 U/L, defined as the concentration which corresponds to the absorbance that is two standard deviations from the absorbance of the diluent.

Precision

Five separate assays with quadruplicate samples were performed at five different times.
The results were:
Intra-assay CV (%) 0.7-5.8
Inter-assay CV (%) 2.8-4.8

Limitations

The M30-Apoptosense^® ELISA has no "high dose hook effect" (giving falsely low results) up to 42,000 U/L. This is high above obtainable concentrations in sample material presented here. Since the working range for the assay is 100-1,000 U/L, samples expected to have concentrations above this value should be suitably diluted before assay (see Instructions for Use for further information).

Specificity

The combination of monoclonal antibodies used in the M30-Apoptosense^® ELISA procedure are specific for the M30 neo-epitope in Cytokeratin 18, with no detected cross reactivity to other apoptosis associated proteins that may be present in sample material described here.

Recovery

Various quantities of reactive components were added to human serum specimen as well as tissue culture media and assayed two times. The recovery, defined as obtained against expected , was 89-104%.