05618878001V1

PreciControl ClinChem Multi 2

05117216 190 for 20 x 5 mL Exercise the normal precautions required for handling all laboratory reagents.
English All human material should be considered potentially infectious. All products
derived from human blood are prepared exclusively from the blood of donors
System information
tested individually and shown to be free from HBsAg and antibodies to HCV
For use on Roche/Hitachi MODULAR and cobas c analyzers
and HIV. The testing methods applied were FDA-approved or cleared in
the control code is 392 (PCCC2).
compliance with the European Directive 98/79/EC, Annex II, List A.
For use on COBAS INTEGRA analyzers the system ID is 07 7470 7.
However, as no testing method can rule out the potential risk of infection
Intended use with absolute certainty, the material should be treated just as carefully
PreciControl ClinChem Multi 2 is for use in quality control by monitoring accuracy as a patient specimen. In the event of exposure the directives of the
and precision for the quantitative methods as specified in the value sheets. responsible health authorities should be followed.1,2
Summary Disposal of all waste material should be in accordance with local guidelines.
PreciControl ClinChem Multi 2 is a lyophilized control based on human Safety data sheet for professional user available on request.
serum. The adjusted concentrations and activities of the control components Handling
are in the pathological range. Some of the methods as specified in the Carefully open one bottle, avoiding the loss of lyophilizate, and pipette
value sheets may not be available in all countries. in exactly 5.0 mL of distilled/deionized water. Carefully close the bottle
Reagents – working solutions and dissolve the contents completely by occasional gentle swirling
Reactive components in the lyophilizate: within 30 minutes. Avoid the formation of foam.
Human serum with chemical additives and material of biological The enclosed barcoded labels are intended exclusively for the
origin as specified. Roche/Hitachi 912/917 and Roche/Hitachi MODULAR analyzers and cobas c
The origin of the biological additives is as follows: systems to identify the control. Attach the barcoded labels to the tubes
carrying the sample cups containing the control material.
Analyte Origin
ALT (GPT) human, recombinant Storage and stability
AST (GOT) human, recombinant Store at 2–8 °C.
Aldolase rabbit muscle Criterion for the stability data stated by Roche:
Alkaline phosphatase human placenta (recombinant) Recovery within ± 10 % of initial value.
Amylase, total human saliva / porcine pancreas Stability of the lyophilized control serum:
Amylase, pancreatic porcine pancreas Up to the stated expiration date at 2–8 °C.
Cholesterol bovine plasma Stability of components after reconstitution*:
Creatine kinase human CK-MM / human CK-MB (recombinant) at 15–25 °C 12 hours
CK-MB human CK-MB (recombinant) at 2–8 °C 5 days
γ-GT human, recombinant at (-15)–(-25) °C 28 days (when frozen once)
GLDH bacterial, recombinant *Exceptions: see below
LDH porcine heart Stability of total bilirubin, direct bilirubin, acid phosphatase,
Lipase human pancreas (recombinant) prostatic acid phosphatase and UIBC in reconstituted control
Acid phosphatase human prostate / potato serum (stored protected from light):
ASLO human at 15–25 °C 8 hours
CRP human at 2–8 °C 24 hours
Transferrin human at (-15)–(-25) °C 14 days (when frozen once)
Non-reactive components in the lyophilizate: Stability of ALT in reconstituted control serum:
Preservatives and stabilizers at 15–25 °C 12 hours
The concentrations and activities of the components are lot-specific. at 5 days
2–8 °C
The exact target values are given in the enclosed (or respective
at (-15)–(-25) °C 14 days (when frozen once)
electronically available) value sheets.
The possible appearance of a slight green coloration has no
The values are also encoded in the enclosed control barcode sheets
effect on the recovery of the values.
for Roche/Hitachi 912/917 (not for USA), Roche/Hitachi MODULAR
and COBAS INTEGRA analyzers. Store control tightly capped and protected from light when not in use.
For the cobas c analyzers the values are encoded in electronic Materials provided
files sent via cobas link to the analyzers. • See “Reagents - working solutions” section
Target values and ranges • Barcoded labels
The target values were determined using the method stated in the enclosed
Materials required (but not provided)
(or respective electronically available) value sheets. Determinations for
Roche methods were performed under strictly standardized conditions • Roche system reagents and clinical chemistry analyzer
on Roche analyzers using Roche system reagents and the Roche • General laboratory equipment
master calibrator. The target value specified is the mean of all values Assay
obtained. The corresponding control range is calculated as the target Dispense the required volume into a sample cup and analyze in
value ± 3 standard deviations (with the standard deviation being the the same way as patient samples.
value obtained from several target value determinations). The control should be run daily in parallel with the patient samples
Results should be within the defined ranges. Each laboratory should establish and after every calibration. The control intervals should be adapted
corrective measures to be taken if values fall outside the range. to each laboratory’s individual requirements.
The traceability of the target values is given in the respective Follow the applicable government regulations and local guidelines
instructions for use of the system reagents to be used in combination for quality control.
with the recommended calibrator.
References
Precautions and warnings 1. Occupational Safety and Health Standards: bloodborne pathogens.
For in vitro diagnostic use. (29 CFR Part 1910.1030). Fed. Register. July 1, 2001;17:260–273.

2010-01, V 1 English 1/2 Roche systems

PreciControl ClinChem Multi 2
2. Directive 2000/54/EC. Official Journal of the European Communities
No. L262 from October 17, 2000.
FOR US CUSTOMERS ONLY: LIMITED WARRANTY
Roche Diagnostics warrants that this product will meet the specifications
stated in the labeling when used in accordance with such labeling and
will be free from defects in material and workmanship until the expiration
date printed on the label. THIS LIMITED WARRANTY IS IN LIEU OF ANY
OTHER WARRANTY, EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED
WARRANTY OF MERCHANTABILITY OR FITNESS FOR PARTICULAR
PURPOSE. IN NO EVENT SHALL ROCHE DIAGNOSTICS BE LIABLE FOR
INCIDENTAL, INDIRECT, SPECIAL OR CONSEQUENTIAL DAMAGES.

COBAS, COBAS C, COBAS INTEGRA and MODULAR are trademarks of Roche.

Other brand or product names are trademarks of their respective holders.
Significant additions or changes are indicated by a change bar in the margin.
© 2010, Roche Diagnostics

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

www.roche.com
Distribution in USA by:
Roche Diagnostics, Indianapolis, IN
US Customer Technical Support 1-800-428-2336

Roche systems 2/2 2010-01, V 1 English