ms_04899881200V5.

PreciControl Maternal Care

04899881 200 6 x 2.0mL

English of care as a patient specimen. In the event of exposure, the directives of the
responsible health authorities should be followed.1,2
Intended use
PreciControl Maternal Care is used for quality control of the Elecsys free The controls may not be used after the expiration date.
hCG and PAPPA immunoassays on the Elecsys and cobase Avoid foam formation in all reagents and sample types (specimens,
immunoassay analyzers. calibrators and controls).
Summary Handling
PreciControl Maternal Care is a lyophilized control serum based on human Carefully dissolve the contents of one bottle by adding exactly 2.0mL of
serum matrix in three concentration ranges. The controls are used for distilled or deionized water and allow to stand closed for 30minutes to
monitoring the accuracy and precision of the Elecsys free hCG and reconstitute. Mix carefully, avoiding foam formation.
PAPPA immunoassays. Transfer the reconstituted controls into the empty labeled snapcap bottles
Reagents - working solutions supplied or into additional snapcap bottles (ControlSet Vials). Attach the
supplied labels to these additional bottles. Aliquots intended for storage at
PCMC1: 2bottles, each for 2.0mL of control serum -20C should be frozen immediately.
PCMC2: 2bottles, each for 2.0mL of control serum Perform only one control procedure per aliquot.
PCMC3: 2bottles, each for 2.0mL of control serum Please note: Both the vial labels, and the additional labels (if available)
contain 2 different barcodes. The barcode between the yellow markers is
Substance in PC MC1 PC MC2 PC MC3 Unit for cobas8000 systems only. If using a cobas8000 system, please turn
human serum the vial cap 180 into the correct position so the barcode can be read by the
matrix system. Place the vial on the instrument as usual.
free hCG approximately approximately approximately IU/L Storage and stability
15 50 100 Store at 28C.
PAPPA approximately approximately approximately mIU/L The lyophilized control serum is stable up to the stated expiration date.
5000 2500 250 Stability of the components in the reconstituted control serum:
The exact lotspecific target values and ranges are encoded in the either at -20C 3months (freeze only once)
barcodes as well as printed on the enclosed (or electronically available)
value sheet. or at 28C 8weeks
Target values and ranges on the analyzers at 2025C up to 5hours
The target values and ranges were determined and evaluated by Roche. Store controls upright in order to prevent the control solution from adhering
They were obtained using the Elecsys assay reagents and analyzers to the snapcap.
available at the time of testing.
Materials provided
If the target values and control ranges are updated, this information is
conveyed either via the reagent barcodes, or control barcodes (or provided PreciControl Maternal Care, 3barcode cards, control barcode sheet,
electronically) and in an additional value sheet included in the reagent kit. 3x2empty labeled snapcap bottles, 3x6 bottle labels
This value sheet lists all control lots to which the new values apply. If some Materials required (but not 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 03142949122, ControlSet Vials, 2x56 empty snapcap bottles
provided electronically), remain valid. Elecsys2010, MODULAR ANALYTICSE170 or cobase immunoassay
Results must be within the specified ranges. In the event that increasing or analyzers and assay reagents
decreasing trends, or any other suddenly occurring deviations beyond the Distilled or deionized water
range limits are observed, all test steps must be checked.
See the assay Method Sheet and the operators manual for additionally
Traceability information is given in the Method Sheet of the relevant Elecsys required materials.
assay.
Assay
Each laboratory should establish corrective measures to be taken if values
fall outside the defined limits. Treat the reconstituted control serum in the systemcompatible labeled
bottles for analysis in the same way as patient samples.
Precautions and warnings Read the data into the analyzer.
For in vitro diagnostic use.
Exercise the normal precautions required for handling all laboratory Ensure the controls are at 2025C prior to measurement.
reagents. Run controls daily in parallel with patient samples, once per reagent kit, and
Disposal of all waste material should be in accordance with local guidelines. whenever a calibration is performed. The control intervals and limits should
Safety data sheet available for professional user on request. be adapted to each laboratorys individual requirements.
This kit contains components classified as follows in accordance with the Follow the applicable government regulations and local guidelines for
Regulation (EC) No.1272/2008: quality control.
2-methyl-2H-isothiazol-3-one hydrochloride References
1 Occupational Safety and Health Standards: bloodborne pathogens.
EUH 208 May produce an allergic reaction. (29CFR Part 1910.1030). Fed. Register.
Product safety labeling primarily follows EU GHS guidance. 2 Directive 2000/54/EC of the European Parliament and Council of
All human material should be considered potentially infectious. All products 18September 2000 on the protection of workers from risks related to
derived from human blood are prepared exclusively from the blood of exposure to biological agents at work.
donors tested individually and shown to be free from HBsAg and antibodies For further information, please refer to the appropriate operators manual for
to HCV and HIV. The testing methods applied were FDA-approved or the analyzer concerned, the respective application sheets, the product
cleared in compliance with the European Directive 98/79/EC, AnnexII, information and the Method Sheets of all necessary components (if
ListA. available in your country).
However, as no testing method can rule out the potential risk of infection A point (period/stop) is always used in this Method Sheet as the decimal
with absolute certainty, the material should be handled with the same level separator to mark the border between the integral and the fractional parts of
a decimal numeral. Separators for thousands are not used.

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PreciControl Maternal Care

Symbols
Roche Diagnostics uses the following symbols and signs in addition to
those listed in the ISO 152231 standard.
Contents of kit
Analyzers/Instruments on which reagents can be used
Reagent
Calibrator
Volume after reconstitution or mixing
GTIN Global Trade Item Number

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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