ms_11776452122V20.

PreciControl Tumor Marker

11776452 122 4 x 3.0mL
11776452 922 (QCS)

English for cobas8000 systems only. If using a cobas8000 system, please turn
the vial cap 180 into the correct position so the barcode can be read by the
Intended use system. Place the vial on the instrument as usual.
PreciControl TumorMarker is used for quality control of Elecsys
immunoassays on Elecsys and cobase immunoassay analyzers. Storage and stability
Store at 28C.
Summary
PreciControl Tumor Marker is a lyophilized control serum based on human The lyophilized control serum is stable up to the stated expiration date.
serum. The concentrations are in two clinically relevant ranges. The Stability of the components in the reconstituted control serum:
controls are used for monitoring the accuracy and precision of Elecsys
immunoassays. either at -20C 1month (freeze only once)
Reagents - working solutions or at 28C 2weeks
PCTM1: 2bottles, each for 3.0mL of control serum (human) or at 2025C 24hours
PCTM2: 2bottles, each for 3.0mL of control serum (human) on the analyzers at 2025C up to 5hours
The exact lotspecific target values and ranges are encoded in the
barcodes as well as printed on the enclosed (or electronically available) Store controls upright in order to prevent the control solution from adhering
value sheet. to the snapcap.
Target values and ranges Materials provided
The target values and ranges were determined and evaluated by Roche. PreciControl Tumor Marker, 2barcode cards, control barcode sheet,
They were obtained using the Elecsys assay reagents and analyzers 2x2 empty labeled snapcap bottles, 2x10 bottle labels
available at the time of testing. Materials required (but not provided)
If the target values and control ranges are updated, this information is 03142949122, ControlSet Vials, 2x56 empty snapcap bottles
conveyed either via the reagent barcodes, or control barcodes (or provided
electronically) and in an additional value sheet included in the reagent kit. Elecsys2010, MODULAR ANALYTICSE170 or cobase immunoassay
This value sheet lists all control lots to which the new values apply. If some analyzers and assay reagents
of the values remain unchanged, the original values conveyed via the CBC Distilled or deionized water
(Control Barcode), and in the value sheet included in the control kit (or
provided electronically), remain valid. See the appropriate assay Method Sheet and the operators manual for
additionally required materials.
Results must be within the specified ranges. In the event that increasing or
decreasing trends, or any other suddenly occurring deviations beyond the Assay
range limits are observed, all test steps must be checked. Treat the reconstituted control serum in the systemcompatible labeled
Traceability information is given in the Method Sheet of the relevant Elecsys bottles for analysis in the same way as patient samples.
assay. Read the data into the analyzer.
Each laboratory should establish corrective measures to be taken if values Ensure the controls are at 2025C prior to measurement.
fall outside the defined limits. Run controls daily in parallel with patient samples, once per reagent kit, and
Precautions and warnings whenever a calibration is performed. The control intervals and limits should
For in vitro diagnostic use. be adapted to each laboratorys individual requirements.
Exercise the normal precautions required for handling all laboratory Follow the applicable government regulations and local guidelines for
reagents. quality control.
Disposal of all waste material should be in accordance with local guidelines. References
Safety data sheet available for professional user on request.
1 Occupational Safety and Health Standards: bloodborne pathogens.
All human material should be considered potentially infectious. All products (29CFR Part 1910.1030). Fed. Register.
derived from human blood are prepared exclusively from the blood of
donors tested individually and shown to be free from HBsAg and antibodies 2 Directive 2000/54/EC of the European Parliament and Council of
to HCV and HIV. The testing methods applied were FDA-approved or 18September 2000 on the protection of workers from risks related to
cleared in compliance with the European Directive 98/79/EC, AnnexII, exposure to biological agents at work.
ListA. For further information, please refer to the appropriate operators manual for
However, as no testing method can rule out the potential risk of infection the analyzer concerned, the respective application sheets, the product
with absolute certainty, the material should be handled with the same level information and the Method Sheets of all necessary components (if
of care as a patient specimen. In the event of exposure, the directives of the available in your country).
responsible health authorities should be followed.1,2 A point (period/stop) is always used in this Method Sheet as the decimal
The controls may not be used after the expiration date. separator to mark the border between the integral and the fractional parts of
Avoid foam formation in all reagents and sample types (specimens, a decimal numeral. Separators for thousands are not used.
calibrators and controls). Symbols
Handling Roche Diagnostics uses the following symbols and signs in addition to
Carefully dissolve the contents of one bottle by adding exactly 3.0mL of those listed in the ISO 152231 standard.
distilled or deionized water and allow to stand closed for 30minutes to Contents of kit
reconstitute. Mix carefully, avoiding foam formation.
Transfer the reconstituted controls into the empty labeled snapcap bottles Analyzers/Instruments on which reagents can be used
supplied or into additional snapcap bottles (ControlSet Vials). Attach the Reagent
supplied labels to these additional bottles. Aliquots intended for storage at
-20C should be frozen immediately. Calibrator
Perform only one control procedure per aliquot. Volume after reconstitution or mixing
Please note: Both the vial labels, and the additional labels (if available)
contain 2 different barcodes. The barcode between the yellow markers is GTIN Global Trade Item Number

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PreciControl Tumor Marker

COBAS, COBASE, ELECSYS and PRECICONTROL are trademarks of Roche.
All other product names and trademarks are the property of their respective owners.
Additions, deletions or changes are indicated by a change bar in the margin.
2015, Roche Diagnostics

Roche Diagnostics GmbH, SandhoferStrasse116, D-68305 Mannheim

www.roche.com

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