ms_07360070190V4.

PreciControl Lung Cancer

07360070190 4 x 3.0 mL

English supplied labels to these additional bottles. Aliquots intended for storage at
‑20 °C (± 5 °C) should be frozen immediately.
Intended use
PreciControl Lung Cancer is used for quality control of the Elecsys SCC, Perform only one control procedure per aliquot.
ProGRP, CYFRA 21‑1 and NSE immunoassays on the Elecsys and Please note for cobas e 602 and cobas e 801 analyzers: Both the vial
cobas e immunoassay analyzers. labels, and the additional labels (if available) contain 2 different barcodes.
Please turn the vial cap 180° into the correct position so that the barcode
Summary between the yellow markers can be read by the system. Place the vial on
PreciControl Lung Cancer is a lyophilized control based on human serum in the analyzer as usual.
two concentration ranges. The controls are used for monitoring the PreciControl Lung Cancer also contains SCC antigen. SCC reactive
accuracy and precision of the specified Elecsys immunoassays. determinants are shed naturally in skin particles, saliva and other body
Reagents - working solutions fluids and can easily be distributed in dust or aerosols, e.g. as a result of
sneezing. Contamination of the samples, the CalSet Vials or the Elecsys
▪ PC LC 1: 2 bottles, each for 3.0 mL of control serum consumables with SCC may cause falsely elevated SCC results. Gloves
▪ PC LC 2: 2 bottles, each for 3.0 mL of control serum should be used throughout the test procedure when handling reagents,
cobas e 801 analyzer: The exact lot‑specific target values and ranges are samples, CalSet Vials etc. A face mask is also recommended.
available as an electronic barcode and value sheet provided via the Storage and stability
cobas link.
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 the reconstituted controls:
available electronically via the cobas link. either at -20 °C (± 5 °C) 28 days (freeze only once)
Target values and ranges or at 2‑8 °C 7 days
The target values and ranges were determined and evaluated by Roche.
They were obtained using the specified Elecsys assay reagents and or at 20‑25 °C 7 hours
analyzers available at the time of testing. Store controls upright in order to prevent the control solution from adhering
If the target values and control ranges are updated, this information is to the snap‑cap.
conveyed either via the reagent barcodes, or control barcodes (or provided
electronically) and in an additional value sheet included in the reagent kit. Materials provided
This value sheet lists all control lots to which the new values apply. If some ▪ PreciControl LC, 2 barcode cards, control barcode sheet, 2 x 2 labeled
of the values remain unchanged, the original values conveyed via the CBC empty snap-cap bottles, 2 x 6 bottle labels
(Control Barcode), and in the value sheet included in the control kit (or Materials required (but not provided)
provided electronically), remain valid.
cobas e 801 analyzer: Updated target values and ranges are available both ▪ 03142949122, ControlSet Vials, 2 x 56 empty snap‑cap bottles
as an electronic barcode and as a value sheet provided via the cobas link. ▪ cobas e immunoassay analyzers and assay reagents
Results must be within the specified ranges. In the event that increasing or ▪ Distilled or deionized water
decreasing trends, or any other suddenly occurring deviations beyond the See the assay Method Sheet and the operator’s manual for additionally
range limits are observed, all test steps must be checked. required materials.
Traceability information is given in the Method Sheet of the relevant Elecsys
assay. Assay
Treat the reconstituted control serum in the system‑compatible labeled
Each laboratory should establish corrective measures to be taken if values bottles for analysis in the same way as patient samples.
fall outside the defined limits.
Read the data into the analyzer.
Precautions and warnings
Ensure the controls are at 20‑25 °C prior to measurement.
For in vitro diagnostic use.
Exercise the normal precautions required for handling all laboratory Run controls daily in parallel with patient samples, once per reagent kit, and
reagents. whenever a calibration is performed. The control intervals and limits should
Disposal of all waste material should be in accordance with local guidelines. be adapted to each laboratory’s individual requirements.
Safety data sheet available for professional user on request. Follow the applicable government regulations and local guidelines for
All human material should be considered potentially infectious. All products quality control.
derived from human blood are prepared exclusively from the blood of References
donors tested individually and shown to be free from HBsAg and antibodies 1 Occupational Safety and Health Standards: Bloodborne pathogens.
to HCV and HIV. The testing methods used assays approved by the FDA or (29 CFR Part 1910.1030). Fed. Register.
cleared in compliance with the European Directive 98/79/EC, Annex II,
List A. 2 Directive 2000/54/EC of the European Parliament and Council of
However, as no testing method can rule out the potential risk of infection 18 September 2000 on the protection of workers from risks related to
with absolute certainty, the material should be handled with the same level exposure to biological agents at work.
of care as a patient specimen. In the event of exposure, the directives of the For further information, please refer to the appropriate operator’s manual for
responsible health authorities should be followed.1,2 the analyzer concerned, the respective application sheets, the product
The controls may not be used after the expiration date. information and the Method Sheets of all necessary components (if
available in your country).
Avoid foam formation in all reagents and sample types (specimens,
calibrators and controls). 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
Handling a decimal numeral. Separators for thousands are not used.
Carefully dissolve the contents of one bottle by adding exactly 3.0 mL of
distilled or deionized water and allow to stand closed for 15 minutes to SCC antigens and ProGRP antigen used in
reconstitute. Mix carefully, avoiding foam formation. the Roche PreciControl Lung Cancer are
Transfer the reconstituted controls into the empty labeled snap‑cap bottles licensed by Fujirebio Diagnostics, Inc.
supplied or into additional snap‑cap bottles (ControlSet Vials). Attach the

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PreciControl Lung Cancer

Symbols
Roche Diagnostics uses the following symbols and signs in addition to
those listed in the ISO 15223‑1 standard (for USA: see dialog.roche.com for
definition of symbols used):
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.
© 2020, Roche Diagnostics

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

www.roche.com

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