12173697001V12.

Precipath U plus
12149443 122 10 x 3mL Control

English A clinically insignificant difference may be seen between the value(s) listed
on the value sheet and the value(s) obtained from the instrument readable
System information data. This is caused by:
For use on Roche/HitachiMODULAR and cobasc analyzers the control
code is 301. the rounding of value(s) during conversion from the unit in the
instrument readable data to the unit that is being used.
For use on COBASINTEGRA analyzers the systemID is 0780006.
the calculation of the ranges by the analyzer using the percentage
Intended use values for the ranges encoded in the barcodes.
PrecipathUplus is for use in quality control by monitoring accuracy and The traceability of the target value is given in the respective Method Sheets
precision for the quantitative methods as specified in the value sheets. for the system reagents to be used in combination with the recommended
Summary calibrator.
PrecipathUplus is a lyophilized control based on human serum. The Precautions and warnings
adjusted concentrations and activities of the control components are usually For in vitro diagnostic use.
in the pathological range or at the normal/pathological threshold. Exercise the normal precautions required for handling all laboratory
Some methods specified in the relevant value sheet may not be available in reagents.
all countries. Disposal of all waste material should be in accordance with local guidelines.
Safety data sheet available for professional user on request.
Reagents working solutions
Reactive components in the lyophilizate: All human material should be considered potentially infectious. All products
derived from human blood are prepared exclusively from the blood of
Human serum with chemical additives and material of biological origin as donors tested individually and shown to be free from HBsAg and antibodies
specified. to HCV and HIV.
The origin of the biological additives is as follows: The testing methods applied were FDA-approved or cleared in compliance
with the European Directive 98/79/EC, AnnexII, ListA.
Analyte Origin However, as no testing method can rule out the potential risk of infection
with absolute certainty, the material should be handled with the same level
ALT (GPT) porcine heart of care as a patient specimen. In the event of exposure, the directives of the
AST (GOT) porcine heart responsible health authorities should be followed.1,2
Aldolase rabbit muscle Handling
Alkaline phosphatase placenta (human, recombinant) Carefully open one bottle 1, avoiding the loss of lyophilizate, and pipette in
exactly 3.0mL of diluent (bottle 2). Carefully close the bottle and dissolve
Amylase, total human saliva / porcine pancreas the contents completely by occasional gentle swirling within 30minutes.
Avoid the formation of foam.
Amylase, pancreatic porcine pancreas
Important: When determining acid phosphatase and prostatic
Cholesterol bovine plasma phosphatase dissolve the lyophilizate (bottle 1) with 3.0mL of distilled or
Creatine kinase rabbit muscle deionized water.
The enclosed barcoded labels are intended exclusively for the
-GT porcine, kidney Roche/HitachiMODULAR analyzers and cobasc systems to identify the
GLDH bacterial, recombinant control. Attach the barcoded labels to the tubes carrying the sample cups
containing the control material.
LD (LDH) porcine heart
Storage and stability
Lipase pancreas (human, recombinant)
Store at 28C.
Acid phosphatase human prostate / potato Criterion for the stability data stated by Roche:
Transferrin human Cohn IV-fraction Recovery within 10% of initial value.
Non-reactive components: Stability of the lyophilized control serum:
Stabilizers Up to the stated expiration date at 28C.
Reactive components in the diluent: Stability of components in reconstituted control*:
Sodium carbonate
at 1525C 12hours
The concentrations and activities of the components are lotspecific. The
exact target values are given in the electronically available or enclosed at 28C 5days
value sheets. at (-15)(-25)C 28days (when frozen once)
The values are also encoded in the enclosed control barcode sheets for
*Exceptions: see below
Roche/HitachiMODULAR, COBASINTEGRA and cobasc111 analyzers.
For the cobasc analyzers (except for the cobasc111 analyzer) the values Stability of bicarbonate in reconstituted control serum:
are encoded in electronic files sent via the cobas link to the analyzers.
closed bottle at 1525C 1day
Target values and ranges
open bottle at 1525C 1hour
The target values were determined using the method stated in the
electronically available or enclosed value sheets. Determinations for Roche Stability of total bilirubin in reconstituted control serum (stored protected
methods were performed under strictly standardized conditions on Roche from light):
analyzers using Roche system reagents and the Roche master calibrator.
The target value specified is the mean of all values obtained. The at 1525C 8hours
corresponding control range is calculated as the target value 3standard at 28C 24hours
deviations (the standard deviation being the value obtained from several
target value determinations). Results should be within the defined ranges. at (-15)(-25)C 14days (when frozen once)
Each laboratory should establish corrective measures to be taken if values Stability of direct bilirubin in reconstituted control serum (stored protected
fall outside the range. from light):

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12173697001V12.0

Precipath U plus
at 1525C 4hours
at 28C 8hours
at (-15)(-25)C 14days (when frozen once)
Stability of UIBC in reconstituted control serum:
at 1525C 4hours
at 28C 1day
at (-15)(-25)C 14days (when frozen once)
Stability of acid phosphatase and prostatic acid phosphatase in
reconstituted control serum:
at 1525C 4hours
at 28C 1day
at (-15)(-25)C 14days (when frozen once)
Store control tightly capped and protected from light when not in use.
Materials provided
See Reagents working solutions section
Barcoded labels
Materials required (but not provided)
Roche system reagents and clinical chemistry analyzers
General laboratory equipment
Assay
Dispense the required volume into a sample cup and analyze in the same
way as patient samples.
The controls should be run daily in parallel with patient samples and after
every calibration. Control intervals must be adapted to individual
laboratorys requirements.
Follow the applicable government regulations and local guidelines for
quality control.
References
1 Occupational Safety and Health Standards: bloodborne pathogens.
(29CFR Part 1910.1030). Fed. Register.
2 Directive 2000/54/EC of the European Parliament and Council of
18September 2000 on the protection of workers from risks related to
exposure to biological agents at work.
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 152231 standard.
Contents of kit
Volume after reconstitution or mixing

COBAS, COBASC, COBASINTEGRA, MODULAR and PRECIPATH 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.
2013, Roche Diagnostics

Roche Diagnostics GmbH, SandhoferStrasse116, D-68305 Mannheim

www.roche.com

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