11965000001V11.

PreciControl HBeAg
11876376 122 16 x 1.3mL

English performance of quality control. After use, close the bottles as soon as
possible and store upright at 28C.
Intended use
PreciControl HBeAg is used for quality control of the Elecsys HBeAg Due to possible evaporation effects, not more than 7 quality control
immunoassay on the Elecsys and cobase immunoassay analyzers. procedures per bottle should be performed.
Summary Storage and stability
PreciControl HBeAg is a readyforuse control serum based on human Store at 28C.
serum in the negative concentration range and based on buffer for the Store controls upright in order to prevent the control solution from adhering
positive concentration range. The controls are used for monitoring the to the snapcap.
accuracy of the Elecsys HBeAg immunoassay.
Stability:
Reagents - working solutions
unopened at 28C up to the stated expiration date
PC HBEAG1: 8bottles, each containing 1.3mL of control serum
after opening at 28C 8weeks
Human serum, negative for HBeAg; preservative.
Target range for the cutoff index: 00.5 on the analyzers up to 6hours
PC HBEAG2: 8bottles, each containing 1.3mL of control serum Materials provided
HBeAg (E.coli, rDNA) approx. 2.5U/mL (PaulEhrlichInstitute units) in PreciControl HBeAg, 2barcode cards, control barcode sheet
HEPESa) buffer, pH7.4; preservative. Materials required (but not provided)
Target value for cutoff index: approx.13 Elecsys2010, MODULAR ANALYTICSE170 or cobase immunoassay
The exact target ranges (target value 44%), given in the form of a cutoff analyzers and assay reagents
index, are encoded in the barcodes as well as printed on the enclosed (or See the assay Method Sheet and the operators manual for additionally
electronically available) value sheet. required material.
a) HEPES = [4-(2-hydroxyethyl)-piperazine]-ethane sulfonic acid
Assay
Target values and ranges Treat the control serum in the system-compatible labeled bottles for
The target values and ranges were determined and evaluated by Roche. analysis in the same way as patient samples.
They were obtained using the Elecsys HBeAg assay reagents and
analyzers available at the time of testing. Read the data into the analyzer.
Traceability information is given in the Method Sheet of the relevant Elecsys Ensure the controls are at 2025C prior to measurement.
assay. Run controls daily in parallel with patient samples, once per reagent kit, and
Results must be within the specified ranges. In the event that increasing or whenever a calibration is performed. The control intervals and limits should
decreasing trends, or any other suddenly occurring deviations beyond the be adapted to each laboratorys individual requirements.
range limits are observed, all test steps must be checked. Follow the applicable government regulations and local guidelines for
When necessary, measurement of the patient sample tested should be quality control.
repeated. References
Each laboratory should establish corrective measures to be taken if values 1 Occupational Safety and Health Standards: bloodborne pathogens.
fall outside the defined limits. (29CFR Part 1910.1030). Fed. Register.
Note: 2 Directive 2000/54/EC of the European Parliament and Council of
For technical reasons re-assigned target values valid only for a specific 18September 2000 on the protection of workers from risks related to
reagent and control lot combination, must be entered manually on all exposure to biological agents at work.
analyzers (except for the cobase602 analyzer). Therefore always refer to
the value sheet included in the rackpack or PreciControl kit to make sure For further information, please refer to the appropriate operators manual for
that the correct target values are used. the analyzer concerned, the respective application sheets, the product
information and the Method Sheets of all necessary components (if
When a new reagent or control lot is used, the analyzer will use the original available in your country).
values encoded in the control barcodes.
A point (period/stop) is always used in this Method Sheet as the decimal
Precautions and warnings separator to mark the border between the integral and the fractional parts of
For in vitro diagnostic use. a decimal numeral. Separators for thousands are not used.
Exercise the normal precautions required for handling all laboratory Symbols
reagents.
Disposal of all waste material should be in accordance with local guidelines. Roche Diagnostics uses the following symbols and signs in addition to
Safety data sheet available for professional user on request. those listed in the ISO 152231 standard.
All human material should be considered potentially infectious. All products Contents of kit
derived from human blood are prepared exclusively from the blood of
donors tested individually and shown to be free from HBsAg and antibodies Analyzers/Instruments on which reagents can be used
to HCV and HIV. The testing methods applied were FDA-approved or Reagent
cleared in compliance with the European Directive 98/79/EC, AnnexII,
ListA. Calibrator
However, as no testing method can rule out the potential risk of infection Volume after reconstitution or mixing
with absolute certainty, the material should be handled with the same level
of care as a patient specimen. In the event of exposure, the directives of the COBAS, COBASE, ELECSYS, MODULAR and PRECICONTROL are trademarks of Roche.
responsible health authorities should be followed.1,2 All other product names and trademarks are the property of their respective owners.
The controls may not be used after the expiration date. Significant additions or changes are indicated by a change bar in the margin.
Avoid foam formation in all reagents and sample types (specimens, 2013, Roche Diagnostics
calibrators and controls).
Handling
The controls are supplied readyforuse in bottles compatible with the
system. The controls should only be left on the analyzer during

2015-07, V 11.0 English 1/2

PreciControl HBeAg
Roche Diagnostics GmbH, SandhoferStrasse116, D-68305 Mannheim
www.roche.com

2/2 2015-07, V 11.0 English