ms_11731416190V9.

PreciControl Universal
 11731416 190 4 x 3.0 mL
 11731416 922 (QCS)

English Handling
Intended use Carefully dissolve the contents of one bottle by adding exactly 3.0 mL of
distilled or deionized water and allow to stand closed for 30 minutes to
PreciControl Universal is used for quality control of Elecsys immunoassays reconstitute. Mix carefully, avoiding foam formation.
on the Elecsys and cobas e immunoassay analyzers.
Transfer the reconstituted controls into the empty labeled snap‑cap bottles
Summary supplied or into additional snap‑cap bottles (ControlSet Vials). Attach the
PreciControl Universal is a lyophilized control serum based on human supplied labels to these additional bottles. Aliquots intended for storage at
serum in two concentration ranges. The controls are used for monitoring the -20 °C should be frozen immediately.
accuracy and precision of Elecsys immunoassays. Perform only one control procedure per aliquot.
Reagents - working solutions Please note: Both the vial labels, and the additional labels (if available)
▪ PC U1: 2 bottles for 2 x 3.0 mL of control serum (human) contain 2 different barcodes. The barcode between the yellow markers is
for cobas 8000 systems only. If using a cobas 8000 system, please turn
▪ PC U2: 2 bottles for 2 x 3.0 mL of control serum (human) the vial cap 180° into the correct position so the barcode can be read by the
cobas e 801 analyzer: The exact lot‑specific target values and ranges are system. Place the vial on the instrument as usual.
available as an electronic barcode and value sheet provided via the
cobas link. Storage and stability
All other analyzers: The exact lot‑specific target values and ranges are Store at 2‑8 °C.
encoded in the barcodes as well as printed on the enclosed (or The lyophilized control serum is stable up to the stated expiration date.
electronically available) value sheet.
Please note: The value sheets for the cobas e 801 analyzer are only Stability of all the components - except for insulin and Tg - in the
available electronically via the cobas link. reconstituted control serum:
Target values and ranges either at -20 °C 1 month (freeze only once)
The target values and ranges were determined and evaluated by Roche.
They were obtained using the Elecsys assay reagents and analyzers or at 2‑8 °C 3 days
available at the time of testing. on the analyzers at 20‑25 °C up to 5 hours
If the target values and control ranges are updated, this information is
conveyed either via the reagent barcodes, or control barcodes (or provided Stability of insulin and Tg in the reconstituted control serum:
electronically) and in an additional value sheet included in the reagent kit.
This value sheet lists all control lots to which the new values apply. If some at -20 °C 1 month (freeze only once)
of the values remain unchanged, the original values conveyed via the CBC on the analyzers at 20‑25 °C up to 5 hours
(Control Barcode), and in the value sheet included in the control kit (or
provided electronically), remain valid. Store controls upright in order to prevent the control solution from adhering
to the snap‑cap.
cobas e 801 analyzer: Updated target values and ranges are available both
as an electronic barcode and as a value sheet provided via the cobas link. Materials provided
Results must be within the specified ranges. In the event that increasing or ▪ PreciControl Universal, 2 barcode cards, control barcode sheet,
decreasing trends, or any other suddenly occurring deviations beyond the 2 x 2 empty labeled snap‑cap bottles, 2 x 10 bottle labels
range limits are observed, all test steps must be checked.
Materials required (but not provided)
Traceability information is given in the Method Sheet of the relevant Elecsys
assay. ▪  03142949122, ControlSet Vials, 2 x 56 empty snap‑cap bottles
Each laboratory should establish corrective measures to be taken if values ▪ MODULAR ANALYTICS E170 or cobas e immunoassay analyzers and
fall outside the defined limits. assay reagents
Precautions and warnings ▪ Distilled or deionized water
For in vitro diagnostic use. See the appropriate assay Method Sheet and the operator’s manual for
Exercise the normal precautions required for handling all laboratory additionally required material.
reagents. Assay
Disposal of all waste material should be in accordance with local guidelines. Treat the reconstituted control serum in the system‑compatible labeled
Safety data sheet available for professional user on request. bottles for analysis in the same way as patient samples.
All human material should be considered potentially infectious. All products Read the data into the analyzer.
derived from human blood are prepared exclusively from the blood of
donors tested individually and shown to be free from HBsAg and antibodies Ensure the controls are at 20‑25 °C prior to measurement.
to HCV and HIV. Run controls daily in parallel with patient samples, once per reagent kit, and
The initial thyroid glandular tissue extract containing the human whenever a calibration is performed. The control intervals and limits should
thyroglobulin has shown to be free from HBsAg and antibodies to HCV and be adapted to each laboratory’s individual requirements.
HIV. Follow the applicable government regulations and local guidelines for
The testing methods applied were FDA‑approved or cleared in compliance quality control.
with the European Directive 98/79/EC, Annex II, List A. References
However, as no testing method can rule out the potential risk of infection 1 Occupational Safety and Health Standards: Bloodborne pathogens.
with absolute certainty, the material should be handled with the same level (29 CFR Part 1910.1030). Fed. Register.
of care as a patient specimen. In the event of exposure, the directives of the
responsible health authorities should be followed.1,2 2 Directive 2000/54/EC of the European Parliament and Council of
18 September 2000 on the protection of workers from risks related to
The controls may not be used after the expiration date. exposure to biological agents at work.
Avoid foam formation in all reagents and sample types (specimens, For further information, please refer to the appropriate operator’s manual for
calibrators and controls). the analyzer concerned, the respective application sheets, the product
information and the Method Sheets of all necessary components (if
available in your country).

2017-07, V 9.0 English 1/2

ms_11731416190V9.0

PreciControl Universal
A point (period/stop) is always used in this Method Sheet as the decimal
separator to mark the border between the integral and the fractional parts of
a decimal numeral. Separators for thousands are not used.
Symbols
Roche Diagnostics uses the following symbols and signs in addition to
those listed in the ISO 15223‑1 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, COBAS E, 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.
© 2016, Roche Diagnostics

Roche Diagnostics GmbH, Sandhofer Strasse 116, D-68305 Mannheim

www.roche.com

2/2 2017-07, V 9.0 English