Atellica® CH β2-Microglobulin Calibrator
(Atellica CH B2M CAL) Declaration of Traceability
and Uncertainty
Product Name Atellica CH β2-Microglobulin Calibrator (Atellica CH B2M CAL) 11099442
Assays Supported Atellica CH β2-Microglobulin (Atellica CH B2M)
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Atellica CH B2M CAL Declaration of Traceability and Uncertainty Atellica CH Analyzer
Traceability
Traceability is defined as the “property of the result of a measurement or the value of a standard
(or calibrator) whereby it can be related to stated references, usually national or international
standards, through an unbroken chain of comparisons all having stated uncertainties” (ISO 17511,
Section 3.21). The traceability chain of comparisons for calibrators is shown in Figure 1.
The target values of Atellica CH master lot calibrators are generated from correlation studies
between the reference method and the Atellica parent test method using patient samples. The
reference method is calibrated or verified with available reference material(s) and the test assays
are calibrated with the master lot calibrator using nominal values on the ADVIA Chemistry
systems.
The regression equation of the ADVIA Chemistry assay (Y) versus the reference (X) is used to
adjust the calibrator values of the master lot, or the calibration factors for some enzyme assays, to
give the best patient sample agreement between the two assays.
For assays without a reference method, a selected method is used in place of the reference
method, or a target value assignment of the master calibrator is obtained by linkage to a reference
material. The master lot calibrator is then used for value assignment of new production lot
calibrators or new master lot calibrators.
The calibrator value of a new production lot of Atellica CH calibrator is assigned through a Nested
Testing Protocol using the master lot calibrator as the reference material on an ADVIA 1800
Chemistry system. Assay and calibrator development studies demonstrate equivalent performance
across the ADVIA Chemistry platforms and the Atellica CH Analyzer.
The Nested Testing Protocol uses the master lot calibrator for calibration and work list containing
the nested replicates of the master lot, a previously released production lot, if available, and the
new production lot of calibrators in the same run. The recovery of the master lot calibrator from
the assay versus its target value is used to normalize the assigned value of the production lot
calibrator to correct the bias, if any, which may occur as part of the value assignment process. See
Figure 1 for the traceability chain of the assigned calibrator values of the Atellica CH assays.
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Atellica CH B2M CAL Declaration of Traceability and Uncertainty Atellica CH Analyzer
Figure 1: Traceability Chain of the Calibrator Target Value
MATERIAL METHOD
Reference Material
Reference Method (or
Selected Method)
Initial Master Lot
Calibrator
ADVIA® Chemistry Assay
Value Assignment
Product Lot
Calibrator
End-User Atellica® CH
Assay
Patient Sample
Patient Result
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Atellica CH B2M CAL Declaration of Traceability and Uncertainty Atellica CH Analyzer
Constituent (Measurand): β2-Microglobulin (B2M)
Traceability Statement
The value assigned to the Atellica CH B2M CAL (11099442) for the Atellica CH B2M assay is
traceable to the WHO 1st international standard for β2 Microglobulin. The calibrator values are
assigned as described in the Traceability Chain (see Figure 1).
Reference Method
None available.
Uncertainty Estimate
The components for the calculation of uncertainty of the assays listed were the uncertainty of the
IFCC Reference Method used to assign the Initial Master Lot Calibrator, and both the New Master
Lot Calibrator and Production Lot Calibrator Bottle Value Assignment processes.
The cumulative total uncertainty and the expanded total uncertainty using a coverage factor, k=2,
for each non-zero calibrator level were calculated. The estimated uncertainty ranges are listed in
the following table.
Traceability and Uncertainty of Assigned Calibrator Values for Atellica CH B2M CAL
Common Units SI Units
Assay Effective Cumulative Total Effective Cumulative Total Expanded
Calibrator Uncertainty Calibrator Uncertainty Total
Concentrationa Concentration Uncertainty
(k=2) (k=2) (k=2)
(mg/L) (mg/L) (mg/L) mg/L (% of value)
Atellica CH 11.0 0.132 11.0 0.132 1.16
B2M
a Approximate value, actual value varies from lot to lot.
Commutability Statement
There is no reference method for this assay. Commutability studies have not been performed.
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Atellica CH B2M CAL Declaration of Traceability and Uncertainty Atellica CH Analyzer
Technical Assistance
For customer support, contact your local technical support provider or distributor.
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Legal Information
Atellica and ADVIA are trademarks of Siemens Healthcare Diagnostics.
© 2017-2019 Siemens Healthcare Diagnostics. All rights reserved.
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