Transcript Accuracy and precision

The CuBiAn XC – A universal tool for
your bioprocess analysis
CellD
20bis, rue du Chapitre
F-30150 ROQUEMAURE
Tel : +33 (0)4 66 82 82 60
Fax : +33 (0)4 66 90 21 10
Email : [email protected]
www.celld.com
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T h e C u B i A n XC p re s e ntat i o n
Sample & Reagent Handling
Accuracy and precision
The assay portfolio
The IgG assay principle
The validation package
Comparison membrane - photometry
Automation capability of CuBiAn® XC
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Sample & Reagent Handling
Overview over the analyser
Robotic Cuvette Arm
Cuvette Platform
Reagent and Sample
Pipette Unit
Reagent and Sample
Container Unit
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Mixing Unit
Incubation Reaction Unit
(below cover)
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Photometric Detector Unit
Sample & Reagent Handling
Simple, automated handling or reagents and samples
Most reagents ready-to-use
Reagents and samples kept refrigerated
on board
Reagents and samples optionally
identified by barcode reader (type,
expiry date, and consumption)
Reagents single assays obtainable
separately for maximum flexibility
Each reagent bottle allows for 96 tests
Automatic dilution steps for samples
programmable
Low sample volume required: 2µL - 35µL
per test ≤ 200µL minimum volume
The Reagent and Sample Container Unit has space for 20 assay bottles and 10 samples
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Sample & Reagent Handling
The measurement workflow
Samples and reagents automatically
pipetted into disposable cuvettes in the
Incubation Reaction Unit (IRU)
Each reaction is mixed thoroughly
Reactions constantly incubated at 37 °C
The cuvettes will be uploaded, checked before
use and discarded by the automated robot arm
Samples can be run in replicates (2-40)
Rapid delivery of results
Up to 90 results/hour possible (360 with ISE unit)
Assays measured every 40 seconds
Each reaction takes exactly 10 minutes
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Accuracy and precision
Liquid handling
The automated pipetting system for reagents
and samples guarantees for a high
reproducibility and accuracy
The reagent and sample syringes work
with a cv of less than 1%, and 2%
respectively
The accuracy of pipetting can be checked
at any time by the user via (SPT+ RPT
(Sample and Reagent Precision Tests; part
of the CuBiAn®
SST concept)
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Accuracy and precision
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Calibrator and Control liquids
Two multi- (universal) calibrators create calibration curves for the majority of
the assays (Lactate, Glucose, Ammonia, Glutamate, Inorganic Phosphate, Iron, Mg, Cholesterol,...)
Separate Calibrators for Glutamine and IgGs
Two or three levels of controls (low, medium, high) available to check the
system’s precision of the specific assay
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Accuracy and precision
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Calibration graphs
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Accuracy and precision
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Control status documented in quality graphs
(Levey-Jennings plots)
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Accuracy and precision
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Customizable warning scenarios
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The assay portfolio
Extract of current assays and ranges
Reagents
ISE unit
(hs) IgG
10.0 – 500 mg/L
(hc) IgG
2.8 – 27.55 g/ L
Total Protein
0.04 – 2.25 g / L
Glucose
0.09 - 6.3 g/L
Lactate
0.05 – 8.0 g/L
Ammonium
0.05 – 9.0 mM
Glutamine
0.06 – 10 mM
Glutamate
0.12 – 10 mM
Inorganic Phosphor
0.13 – 10.32 mM
LDH (L->P; P->L)
13 – 2800 U/L
Na+
80-180 mM
K+
1.5 - 10 mM
CL-
60-140 mM
Reruns and pre-dilutions allow to enlarge
the measurement ranges displayed above
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The assay portfolio
Recently launched, in final tests, under development
Acetic Acid (launched; 0.05 – 1.25 g/L)
Magnesium (launched; 0.2 -3.27 mMol/L)
Cholesterol (launched; 0.87 – 16.6 mMol/L)
Iron (launched; 2 – 198 µMol/L)
Glycerol (final tests; 0.016 -2.5 mMol/L)
Galactose (under development: 0.05 – 7 g/L)
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The IgG assay principle
Principle of immuno turbidimetry
Model of a human IgG
Target of the anti-serum in
the hs IgG assay
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The IgG assay principle
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Principle of immuno turbidimetry
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The IgG assay principle
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Parameter settings customizable – Instrument Factor
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CuBiAn HT vs. PorosA HPLC
2500
y = 0.8993x - 7.3577
R2 = 0.9988
[IgG] by CuBiAn HT / (mg/L)
The IgG assay principle
Comparison measurements against HPLC
2000
1500
1000
500
0
0
500
1000
1500
2000
2500
[IgG] by PorosA HPLC / (m g/L)
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The Validation Package
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Validation
Validation documents are available
(Verification documents including IQ,
OQ); PQ on demand
Experienced validation consulting and
support service by OPTOCELL technology
Documents developed in close
cooperation with customers
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Photometric vs. Membrane based analysers
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Comparison to membrane based analysers
Membrane based
(electrochemical)
systems
CuBiAn® photometric &
immuno-turbidimetric
systems
Expandability
Limited
Nearly unlimited and
customizable
Necessary Frequency of
Calibration
Very high
Once per lot of reagents
Reproducibility of Results
Low
High
Immuno-turbidimetry
Not possible
Implemented
On-line capability
Limited due to
chemical
sterilization
BayChromat® CellCount +
CuBiAn®XC with steam
sterilized sample valve
Rate analysis
Not possible
Implemented
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Photometric vs. Membrane based analysers
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Comparison to membrane based analysers
CuBiAn® photometric and
immunoturbidimetric Systems
Membrane based
electrochemical
(biosensors) systems
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Photometric vs. Membrane based analysers
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Comparison to membrane based analysers
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Automation capability
The automation capability of the CuBiAn XC
The CuBiAn® XC can be completely integrated into a fully automated
bioreactor environment without any technical hardware changes
The remote access software (developed together with Bayer Technology
Services, Germany) can be easily upgraded to an CuBiAn® XC
The steam-sterilizable automatic sample drawing system of the
BayChromat ® Cell Count has shown its high stability in several
contamination-free cultivations, lasting over more than 180 days
The BayChromat ® control software allows for the integration of additional
analysing devices
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Automation capability
Comparison to membrane based analysers
The STAT port
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The BayChromat® Cell Count by:
Bayer Technology Services,
Leverkusen, Germany
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Outlook – CuBiAn Family
Throughput: 270 tests/hour (max. 404 tests/hour with ISE
High precision pipettor und reagent pipettor
Environment-friendly semi-disposable resin cuvettes
Refrigerated Reagent Container Unit
Optional built-in ISE module available
Optional built-in degaser module available
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