PreciControl Universal - Ms 11731416190.V8.En

ms_11731416190V8.
PreciControl Universal
11731416 190 4 x 3.0mL
11731416 922 (QCS)
English Please note: Both the vial labels, and the additional labels (if available)
contain 2 different barcodes. The barcode between the yellow markers is
Intended use for cobas8000 systems only. If using a cobas8000 system, please turn
PreciControl Universal is used for quality control of Elecsys immunoassays the vial cap 180 into the correct position so the barcode can be read by the
on the Elecsys and cobase immunoassay analyzers. system. Place the vial on the instrument as usual.
Summary Storage and stability
PreciControl Universal is a lyophilized control serum based on human Store at 28C.
serum in two concentration ranges. The controls are used for monitoring the
accuracy and precision of Elecsys immunoassays. The lyophilized control serum is stable up to the stated expiration date.
Reagents - working solutions Stability of all the components - except for insulin and Tg - in the
PCU1: 2 bottles for 2x3.0mL of control serum (human) reconstituted control serum:
PCU2: 2 bottles for 2x3.0mL of control serum (human) either at -20C 1month (freeze only once)
The exact lotspecific target values and ranges are encoded in the or at 28C 3days
barcodes as well as printed on the enclosed (or electronically available)
value sheet. on the analyzers at 2025C up to5 hours
Target values and ranges Stability of insulin and Tg in the reconstituted control serum:
The target values and ranges were determined and evaluated by Roche.
They were obtained using the Elecsys assay reagents and analyzers at -20C 1month (freeze only once)
available at the time of testing. on the analyzers at 2025C up to 5hours
If the target values and control ranges are updated, this information is
conveyed either via the reagent barcodes, or control barcodes (or provided Store controls upright in order to prevent the control solution from adhering
electronically) and in an additional value sheet included in the reagent kit. to the snapcap.
This value sheet lists all control lots to which the new values apply. If some Materials provided
of the values remain unchanged, the original values conveyed via the CBC
(Control Barcode), and in the value sheet included in the control kit (or PreciControl Universal, 2barcode cards, control barcode sheet,
provided electronically), remain valid. 2x2empty labeled snapcap bottles, 2x10 bottle labels
Results must be within the specified ranges. In the event that increasing or Materials required (but not provided)
decreasing trends, or any other suddenly occurring deviations beyond the 03142949122, ControlSet Vials, 2x56 empty snapcap bottles
range limits are observed, all test steps must be checked.
Elecsys2010, MODULAR ANALYTICSE170 or cobase immunoassay
Traceability information is given in the Method Sheet of the relevant Elecsys analyzers and assay reagents
assay.
Distilled or deionized water
Each laboratory should establish corrective measures to be taken if values
fall outside the defined limits. See the appropriate assay Method Sheet and the operators manual for
additionally required material.
Precautions and warnings
Assay
For in vitro diagnostic use.
Exercise the normal precautions required for handling all laboratory Treat the reconstituted control serum in the systemcompatible labeled
reagents. bottles for analysis in the same way as patient samples.
Disposal of all waste material should be in accordance with local guidelines. Read the data into the analyzer.
Safety data sheet available for professional user on request. Ensure the controls are at 2025C prior to measurement.
All human material should be considered potentially infectious. All products Run controls daily in parallel with patient samples, once per reagent kit, and
derived from human blood are prepared exclusively from the blood of whenever a calibration is performed. The control intervals and limits should
donors tested individually and shown to be free from HBsAg and antibodies be adapted to each laboratorys individual requirements.
to HCV and HIV.
Follow the applicable government regulations and local guidelines for
The initial thyroid glandular tissue extract containing the human quality control.
thyroglobulin has shown to be free from HBsAg and antibodies to HCV and
HIV. References
The testing methods applied were FDAapproved or cleared in compliance 1 Occupational Safety and Health Standards: bloodborne pathogens.
with the European Directive 98/79/EC, AnnexII, ListA. (29CFR Part 1910.1030). Fed. Register.
However, as no testing method can rule out the potential risk of infection 2 Directive 2000/54/EC of the European Parliament and Council of
with absolute certainty, the material should be handled with the same level 18September 2000 on the protection of workers from risks related to
of care as a patient specimen. In the event of exposure, the directives of the exposure to biological agents at work.
responsible health authorities should be followed.1,2 For further information, please refer to the appropriate operators manual for
The controls may not be used after the expiration date. the analyzer concerned, the respective application sheets, the product
Avoid foam formation in all reagents and sample types (specimens, information and the Method Sheets of all necessary components (if
calibrators and controls). available in your country).
A point (period/stop) is always used in this Method Sheet as the decimal
Handling separator to mark the border between the integral and the fractional parts of
Carefully dissolve the contents of one bottle by adding exactly 3.0mL of a decimal numeral. Separators for thousands are not used.
distilled or deionized water and allow to stand closed for 30minutes to
reconstitute. Mix carefully, avoiding foam formation. Symbols
Transfer the reconstituted controls into the empty labeled snapcap bottles Roche Diagnostics uses the following symbols and signs in addition to
supplied, or freeze aliquots immediately in additional snapcap bottles those listed in the ISO 152231 standard.
(ControlSet Vials). Attach the supplied labels to these additional bottles. Contents of kit
Perform only one control procedure per aliquot.
Analyzers/Instruments on which reagents can be used
2016-03, V 8.0 English 1/2

ms_11731416190V8.0
PreciControl Universal
Reagent
Calibrator
Volume after reconstitution or mixing
GTIN Global Trade Item Number
COBAS, COBASE, ELECSYS, MODULAR and PRECICONTROL are trademarks of Roche.

All other product names and trademarks are the property of their respective owners.
Significant additions or changes are indicated by a change bar in the margin.
2014, Roche Diagnostics
Roche Diagnostics GmbH, SandhoferStrasse116, D-68305 Mannheim

www.roche.com
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ms_11731416190V8.

2016-03, V 8.0 English 1/2

COBAS, COBASE, ELECSYS, MODULAR and PRECICONTROL are trademarks of Roche.

Roche Diagnostics GmbH, SandhoferStrasse116, D-68305 Mannheim

2/2 2016-03, V 8.0 English

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