BÜHLMANN Quantum Blue Manuel D'utilisation page 7

Recovery: 92%
Four stool extracts containing low calprotectin
concentrations were spiked with different amounts from a
highly concentrated calprotectin stock solution. Each
sample was measured before and after spiking on three
test cassettes according to the assay procedure. The three
replicates were averaged and the mean values are
presented in table 9. The recovery varied 83-105%.
Precision (repeatability): 15.5-22.2% CV
The repeatability of the Quantum Blue ® fCAL assay was
calculated from 2 extracted stool samples containing 49
and 138 µg/g calprotectin. Each sample was tested
according to the assay procedure in one run of 20
replicates set up within 10 minutes. The mean values of
three different lots of test cassette are presented in
table 10. The repeatability varied between 15.5-22.2% CV.
Inter-lot Precision: 20.2-24.5% CV
The inter-lot precision of the Quantum Blue ® fCAL assay
was calculated from 4 extracted stool samples containing
between 30 and 244 µg/g calprotectin. Each sample was
tested according to the assay procedure in three
independent runs of 10-20 replicates each, set up within 10
minutes using three different lots of test cassette. The inter-
lot data of the 4 samples varied from 20.2 to 24.5% CV.
Method Comparison: R = 0.806; y = 1.02x-11.1 µg/g
2
One hundred and one (101) stool extracts from subjects
undergoing IBD vs. IBS screening exhibiting calprotectin
concentrations within the indicated measuring range of the
Quantum Blue ® fCAL assay were analyzed according to
the assay procedure using a data set originated from test
cassette of six different lots and compared with the values
obtained by the BÜHLMANN fCAL ELISA (order code: EK-
®
CAL). The correlation data are illustrated in figure 4.
Release date: 2020-10-30 7/36 Quantum Blue® fCAL