ms_05915686190_USAV4.

Elecsys BRAHMS PCT CalCheck 5

Order information

Check 1 1 x 1.0 mL
Check 2 1 x 1.0 mL cobas e 411
05915686190 Check 3 1 x 1.0 mL cobas e 601
Check 4 1 x 1.0 mL cobas e 602
Check 5 1 x 1.0 mL cobas e 801

English
For use in the USA only
Intended use
This CalCheck set is an assayed control for use in calibration verification Warning
and for use in the verification of the assay range established by the Elecsys
BRAHMS PCT reagent on the indicated cobas e immunoassay analyzers. H317 May cause an allergic skin reaction.
Summary
H412 Harmful to aquatic life with long lasting effects.
This CalCheck set contains 5 lyophilized levels of analyte in human serum.
The solutions assist in the documentation of calibration verification and Prevention:
verification of the assay range.
P261 Avoid breathing dust/fume/gas/mist/vapours/spray.
Principle
Calibration verification is not a requirement of the Elecsys and cobas e P273 Avoid release to the environment.
immunoassay systems based on the manufacturer's recommendations.
However, in instances where such a test procedure is required by P280 Wear protective gloves.
certification agencies, or where the user wishes to document calibration
verification, these CalCheck solutions provide an appropriate material for Response:
such testing. College of American Pathologists, CAP, defines Calibration
Verification by referring to two distinct processes: 1) validation of the current P333 + P313 If skin irritation or rash occurs: Get medical
method calibration and 2) validation of the assay range.1 advice/attention.
CAP defines the ANALYTICAL MEASUREMENT RANGE (AMR) as the
range of analyte values that a method can directly measure on the P362 + P364 Take off contaminated clothing and wash it before reuse.
specimen without any dilution, concentration, or other pretreatment not part Disposal:
of the usual assay process.1
P501 Dispose of contents/container to an approved waste
Reagents
disposal plant.
Check 1 - 5
Each set contains 5 lyophilized levels Contact phone: 1-800-428-2336
Each bottle, reconstituted to 1.0 mL Product safety labeling follows EU GHS guidance.
Reactive ingredient (after reconstitution):
Check 1: Human serum buffer matrix All human material should be considered potentially infectious. All products
Check 2 - 5: PCT (recombinant) in human serum buffer matrix derived from human blood are prepared exclusively from the blood of
Nonreactive ingredients: donors tested individually and shown to be free from HBsAg and antibodies
Preservatives to HCV and HIV. The testing methods used assays approved by the FDA or
cleared in compliance with the European Directive 98/79/EC, Annex II,
BRAHMS PCT CalCheck contains 5 levels (Approximately ≤ 0.06, 0.5, 40, List A.
78, 85 ng/mL). However, as no testing method can rule out the potential risk of infection
Target values and ranges with absolute certainty, the material should be handled with the same level
Traceability: This CalCheck set has been standardized against the of care as a patient specimen. In the event of exposure, the directives of the
BRAHMS PCT LIA assay. responsible health authorities should be followed.2,3
The target values and ranges were determined and evaluated by Roche. Avoid foam formation in all reagents and sample types (specimens,
They were obtained using the Elecsys BRAHMS PCT assay reagents and calibrators and controls).
analyzers available at the time of testing. Handling
The exact lot‑specific target values and ranges are printed on the Reconstitute the contents of each CalCheck vial with exactly 1.0 mL
lot‑specific value sheet. distilled or deionized water. Allow the bottle to stand closed for 15 minutes.
Results must be within the specified ranges. If results are out of range then Mix gently by inversion to ensure homogeneity.
all test steps must be checked.
Storage and stability
Each laboratory should establish corrective measures to be taken if values Store unopened at 2‑8 °C.
fall outside the defined limits. Stability unopened: up to the printed expiration date on the bottle labels at
Precautions and warnings 2‑8 °C.
For in vitro diagnostic use. Stability reconstituted: 2 hours at 20‑25 °C.
Exercise the normal precautions required for handling all laboratory
reagents. Materials provided
Disposal of all waste material should be in accordance with local guidelines. ▪ See "Order information" section
Safety data sheet available for professional user on request. Materials required (but not provided)
For USA: Caution: Federal law restricts this device to sale by or on the
order of a physician. ▪ cobas e analyzer
This kit contains components classified as follows in accordance with the ▪ Elecsys BRAHMS PCT reagent kit, 05056888200 or
Regulation (EC) No. 1272/2008: Elecsys BRAHMS PCT reagent kit, 07301715190
Elecsys BRAHMS PCT reagent kit, 08828644190 or
Elecsys BRAHMS PCT reagent kit, 08828679190

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Elecsys BRAHMS PCT CalCheck 5

▪ Distilled or deionized water GTIN Global Trade Item Number
▪ General laboratory equipment
FOR US CUSTOMERS ONLY: LIMITED WARRANTY
Assay Roche Diagnostics warrants that this product will meet the specifications
• For calibration verification only, recommended levels are Check 2, 3 stated in the labeling when used in accordance with such labeling and will
and 4.
be free from defects in material and workmanship until the expiration date
1. Run the recommended levels of this CalCheck in duplicate on the printed on the label. THIS LIMITED WARRANTY IS IN LIEU OF ANY
cobas e analyzer. Program the 6 samples as you would patient OTHER WARRANTY, EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED
samples.
WARRANTY OF MERCHANTABILITY OR FITNESS FOR PARTICULAR
2. Determine the average value for each level and compare it to the PURPOSE. IN NO EVENT SHALL ROCHE DIAGNOSTICS BE LIABLE
appropriate acceptable range listed in the electronically available value
sheet. The average value should fall within the specified limits. FOR INCIDENTAL, INDIRECT, SPECIAL OR CONSEQUENTIAL
If Check 2, Check 3 or Check 4 does not fall within the specifed limits: DAMAGES.
Repeat to exclude error in technique. If recovery is still outside the specified COBAS, COBAS E and ELECSYS are trademarks of Roche.
limits, contact your Local Customer Technical Support. B·R·A·H·M·S and B·R·A·H·M·S PCT are registered trademarks of BRAHMS GmbH.
• For verification of the assay range only or verification of the assay
range and calibration verification, recommended levels are Check 1, 2,
3, 4 and 5.
1. Run each CalCheck level in duplicate on the cobas e analyzer. Program
the 10 samples as you would patient samples. 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.
2. Determine the average value for each level and compare it to the
© 2020, Roche Diagnostics
appropriate acceptable range listed in the electronically available value
sheet. The average value should fall within the specified limits. Roche Diagnostics GmbH, Sandhofer Strasse 116, D-68305 Mannheim
If Check 1 extends below the assay range: www.roche.com
Mix equal parts of Check 1 and Check 2. Analyze the diluted sample in Distribution in USA by:
duplicate. This results in values above the low end of the assay range but Roche Diagnostics, Indianapolis, IN
US Customer Technical Support 1-800-428-2336
below the value for Check 2. If recovery is still below the assay range,
contact your Local Customer Technical Support.
If Check 2, Check 3 or Check 4 does not fall within the specifed limits:
Repeat to exclude error in technique. If recovery is still outside the specified
limits, contact your Local Customer Technical Support.
If Check 5 exceeds the assay range:
Mix equal parts of Check 4 and Check 5. Analyze the diluted sample in
duplicate. If recovery is still above the assay range, contact your Local
Customer Technical Support.
Note
To ensure sufficient volume to run the samples, it is recommended to use
250 µL.
Limitations
This CalCheck is not intended to be used as primary calibrator or control
material. Accuracy and reproducibility of results are dependent upon proper
functioning of the instrument and reagent as well as good laboratory
practices.
References
1 College of American Pathologists User's Guide: Calibration
Verification/Linearity Surveys. Chapter 3.
2 Occupational Safety and Health Standards: Bloodborne pathogens.
(29 CFR Part 1910.1030). Fed. Register.
3 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.
For further information, please refer to the appropriate operator’s manual for
the analyzer concerned, the respective application sheets, the product
information and the Method Sheets of all necessary components (if
available in your country).
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

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