Assay Performance; Performance Characteristics; Traceability Of Standard; Internal Quality Control - peviva M30 Apoptosense ELISA Gebrauchsanweisung

Instructions for Use

Assay Performance

Performance Characteristics

Measuring range: The measuring range is 0–1 000 U/L.
High Dose Effect: No High Dose effect occurs until 195 000 U/L.
Reproducibility: Within assay (WA % CV) variation is ≤ 10 %, between assay (BA
% CV) variation is ≤ 10 % and total variation is ≤ 10 % for samples over 200 U/L.
Sensitivity: The minimum detectable concentration of K18Asp396 neo-epitope
in the M30 Apoptosense ELISA is 20 U/L, defined as the concentration of ccK18
that corresponds to the absorbance being two standard deviations from the ab-
sorbance of the Standard A (0 U/L).
Lower Limit of Quantification: The lowest concentration at which an analyte
in the sample matrix can be measured with acceptable level of accuracy and
precision is 40 U/L.
Spiking Recovery: Recovery of high standard when spiked into human blood
samples: 109 % (average) and 98 – 120 % (range).
Linearity/Dilution: Recovery of human sera when diluted in M30 Standard A
(0 U/L): 107 % (average) and 99 – 122 % (range).
Reference range: In serum from 200 Swedish blood donors, the median was
94 U/L and the 95 percentile was 251 U/L. It is recommended that each labora-
th
tory establishes its own reference range.

Traceability of Standard

The units measured by the M30 Apoptosense ELISA are defined against native
antigen spiked into serum. Native antigen is calibrated against a recombinant
protein standard. 1 U/L = 1.24 pM. Note! Due to different assay buffers, standard
material cannot be exchanged between different Peviva kits.

Internal Quality Control

The supplied M30 Control Low and High with their given concentrations should
be sufficient to secure the assay performance and should be used, at least, in
duplicate each time the assay is performed.
If this procedure is not sufficient, each laboratory needs to establish its own con-
trols by the guidelines in section "Collection and Preparation of in vitro Samples
for Research Use Only" or by individual laboratory routine. These controls should
be frozen in aliquots and treated in the same way each time the assay is per-
formed.
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