7.
Quality
Control
2011-09
Instructions for Use for INFINITE M1000 PRO No. 30064852 Rev. No. 1.0
97
7.2.5 Crosstalk
Crosstalk is defined as a measure of the influence of a well on its adjacent wells
due to optical leakage.
7.2.6 Repeatability
(Reproducibility)
Repeatability is the ability of the instrument to provide closely similar responses.
It is calculated according to the following formula:
average
stdev
CV
100
*
%
=
CV: Coefficient of variation.
Stdev: standard deviation of one well over time.
Average: average of the measurement values of one well over time.
7.3 Acceptance
Criteria
Note
All specifications are subject to change without prior notification, with
appropriate validation, verification, and approvals.
The following table provides an overview of the passed/failed criteria for the
specification tests of the
INFINITE M1000 PRO
.
Specification Acceptance
Criteria
Plate type (number of wells)
384
1536
Fluorescence Top Sensitivity
≤
3 pM Fluorescein
≤
10 pM Fluorescein
Fluorescence Top Uniformity
≤
3.5% CV
≤
5% CV
Fluorescence Bottom Sensitivity
≤
35 pM Fluorescein
≤
40 pM Fluorescein
Fluorescence Bottom Uniformity
≤
3% CV
≤
5% CV
Time Resolved Fluorescence Sensitivity
≤
0.75 pM Europium
≤
0.90 pM Europium
Fluorescence Polarization Precision
< 2 mP
< 10 mP
Luminescence Sensitivity Glow Type
≤
1 fmol/well ATP
≤
10 fmol/well ATP
Luminescence Crosstalk
≤
0.5% ATP
≤
5% ATP
AlphaScreen Detection Limit
≤
12.5 ng/ml Omnibeads
Absorbance Accuracy (0 – 2 OD)
≤
± (1 % + 6 mOD)
Absorbance Precision (0 – 2 OD)
≤
± (0.5 % + 5 mOD)
Absorbance Reproducibility (0 – 2 OD)
≤
± (1 % + 20 mOD)
Absorbance Linearity (0 – 2 OD)
R
2
> 0.999
Absorbance Baseline Flatness (300-700 nm)
± 10 mOD