BÜHLMANN Quantum Blue sCAL Manual Del Usuario página 5

Linearity: 0.5 to 10 µg/mL. Four serum samples with
elevated MRP8/14 concentrations were diluted with chase
buffer, B-LFMRP-CB. Each dilution was subsequently
assayed according to the assay procedure. The results
showed linearity within the indicated measuring range of
0.5 to 10 µg/mL of the Quantum Blue ® sCAL assay.
High Dose Hook Effect: A high dose hook effect was not
observed up to a concentration of 146 µg/mL MRP8/14.
Serum Indices: No interference is detected with the
following substances up to the listed concentrations:
®
Triglycerides (Intralipid 1320 mg/dL; equivalent to
37 mmol/L triglyceride), conjugated bilirubin (342 µmol/L;
29 mg/dL), unconjugated bilirubin (342 µmol/L; 20 mg/dL)
or haemoglobin (2 g/L (= 200 mg/dL).
2
Method Comparison: R = 0.94; y = 0.93x+0.51 µg/mL
29 samples within the indicated measuring range of the
®
Quantum Blue sCAL assay were analyzed 10 x each
according to the assay procedure and compared with the
values of 1-4 x duplicates obtained with the BÜHLMANN
sCAL ELISA. The correlation data are illustrated in Figure
3.
Limit of Quantification (LoQ):
Lower LoQ: 0.42 µg/mL MRP8/14
Upper LoQ: >10 µg/mL MRP8/14
The LoQ has been established with fifteen samples. The
samples were measured with 10 replicates each. The
resulting precision profile is shown in Figure 2. The limit of
quantification corresponds to the concentration of MRP8/14
with an imprecision below 25 % CV allowing a quantitative
measurement within the range from 0.42 µg/mL (lower
LoQ) to >10 µg/mL (upper LoQ).
Revision date: 2016-11-23 5/24 LF-MRP25