05947626500V9.
PreciControl ClinChem Multi 1
05947626190 05947626500 4 x 5 mL Control
05117003190 05947626500 20 x 5 mL Control
05117208922 05947626500 20 x 5 mL Control (QCS)
English corresponding control range is calculated as the target value ± 3 standard
deviations (the standard deviation being the value obtained from several
System information target value determinations). Results should be within the defined ranges.
For use on cobas c and COBAS INTEGRA analyzer systems, refer to the Each laboratory should establish corrective measures to be taken if values
corresponding method sheet of the assay for the identification on the fall outside the range.
systems.
A clinically insignificant difference may be seen between the value(s) listed
Intended use on the value sheet and the value(s) obtained from the instrument readable
PreciControl ClinChem Multi 1 is for use in quality control by monitoring data. This is caused by:
accuracy and precision for the quantitative methods as specified in the ▪ the rounding of value(s) during conversion from the unit in the
value sheets. instrument readable data to the unit that is being used.
Summary ▪ the calculation of the ranges by the analyzer using the percentage
PreciControl ClinChem Multi 1 is a lyophilized control based on human values for the ranges encoded in the barcodes.
serum. The adjusted concentrations and activities of the control The traceability of the target value is given in the respective Method Sheets
components are usually in the normal range or at the normal/pathological for the system reagents to be used in combination with the recommended
threshold. calibrator.
Some methods specified in the relevant value sheet may not be available in Precautions and warnings
all countries.
For in vitro diagnostic use for laboratory professionals. Exercise the normal
Reagents – working solutions precautions required for handling all laboratory reagents.
Reactive components in the lyophilizate: Infectious or microbial waste:
Human serum with chemical additives and material of biological origin as Warning: handle waste as potentially biohazardous material. Dispose of
specified. waste according to accepted laboratory instructions and procedures.
The origin of the biological additives is as follows: Environmental hazards:
Apply all relevant local disposal regulations to determine the safe disposal.
Analyte Origin Safety data sheet available for professional user on request.
ALT (GPT) human, recombinant All human material should be considered potentially infectious. All products
AST (GOT) human, recombinant derived from human blood are prepared exclusively from the blood of
donors tested individually and shown to be free from HBsAg and antibodies
Aldolase rabbit muscle to HCV and HIV. The testing methods use assays that have been approved
or cleared by the FDA or that are in compliance with the legal rules of the
Alkaline phosphatase human placenta (recombinant) European Union (IVDR 2017/746/EU, IVDD 98/79/EC, Annex II, List A).
Amylase, total human saliva / porcine pancreas 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
Amylase, pancreatic porcine pancreas of care as a patient specimen. In the event of exposure, the directives of the
Creatine kinase human CK-MM / human CK-MB (recombinant) responsible health authorities should be followed.1,2
CK-MB human CK-MB (recombinant) Handling
Carefully open one bottle, avoiding the loss of lyophilizate, and pipette in
γ-GT human, recombinant exactly 5.0 mL of distilled/deionized water. Carefully close the bottle and
GLDH bacterial, recombinant dissolve the contents completely by occasional gentle swirling within
30 minutes. Avoid the formation of foam.
LDH porcine heart
The enclosed barcoded labels are intended exclusively for the
Lipase human pancreas (recombinant) cobas c systems (except for the cobas c 513 analyzer) to identify the
Acid phosphatase human prostate / potato control. Attach the barcoded labels to the tubes carrying the sample cups
containing the control material.
ASLO sheep
Storage and stability
CRP human Store at 2‑8 °C.
Transferrin human Criterion for the stability data stated by Roche:
Ferritin human Recovery within ± 10 % of initial value.
Non-reactive components in the lyophilizate: Stability of the lyophilized control serum:
Stabilizers Up to the stated expiration date at 2‑8 °C.
The concentrations and activities of the components are lot‑specific. The Stability of components after reconstitution*:
exact target values are given in the electronically available or enclosed
value sheets. at 15‑25 °C 12 hours
The values are also encoded in the enclosed control barcode sheets for at 2‑8 °C 5 days
COBAS INTEGRA and cobas c 111 analyzers.
at -20 °C (± 5 °C) 28 days (when frozen once)
For the cobas c analyzers (except for the cobas c 111 analyzer) the values
are encoded in electronic files sent via the cobas link to the analyzers. *Exceptions: see below
Target values and ranges Stability of total bilirubin, acid phosphatase, non-prostatic acid
The target values were determined using the method stated in the phosphatase, prostatic acid phosphatase and UIBC in reconstituted control
electronically available or enclosed value sheets. Determinations for Roche serum (stored protected from light):
methods were performed under strictly standardized conditions on Roche
analyzers using Roche system reagents and the Roche master calibrator. at 15‑25 °C 8 hours
The target value specified is the mean of all values obtained. The
2025-03, V 9.0 English 1/2
05947626500V9.0
PreciControl ClinChem Multi 1
at 2‑8 °C 24 hours
at -20 °C (± 5 °C) 14 days (when frozen once)
Roche Diagnostics GmbH
Stability of direct bilirubin in reconstituted control serum (stored protected Sandhofer Strasse 116
68305 Mannheim, Germany
from light): [Link]
at 15‑25 °C 8 hours +800 5505 6606
at 2‑8 °C 24 hours
at -20 °C (± 5 °C) 10 days (when frozen once)
Stability of ALT in reconstituted control serum:
at 15‑25 °C 12 hours
at 2‑8 °C 5 days
at -20 °C (± 5 °C) 14 days (when frozen once)
The possible appearance of a slight green coloration has no effect on the
recovery of the values.
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
laboratory’s requirements.
Follow the applicable government regulations and local guidelines for
quality control.
References
1 Occupational Safety and Health Standards: Bloodborne pathogens.
(29 CFR Part 1910.1030). Fed. Register.
2 Directive 2000/54/EC of the European Parliament and Council of
18 September 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.
Any serious incident that has occurred in relation to the device shall be
reported to the manufacturer and the competent authority of the Member
State in which the user and/or the patient is established.
The Summary of Safety & Performance Report can be found here:
[Link]
Symbols
Roche Diagnostics uses the following symbols and signs in addition to
those listed in the ISO 15223‑1 standard:
Contents of kit
Volume for reconstitution
GTIN Global Trade Item Number
Rx only For USA: Caution: Federal law restricts this
device to sale by or on the order of a
physician.
COBAS, NAVIFY 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.
© 2024, Roche Diagnostics
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