Hematologické kalibrátory / Les calibrateurs Hématologie Streck / Die Streck Hämatologie-Kalibratoren /
I Calibratori ematologici Streck / Streck Hematologikalibratorer / Los Calibradores Hematológicos Streck /
Streck Hematologikalibratorer
Cal-Chex, Cal-Chex A Plus
INSTRUCTIONS FOR USE
INTENDED USE
Streck Hematology Calibrators are manufactured for calibrating multi-parameter hematology analyzers.
SUMMARY AND PRINCIPLES
Multi-parameter hematology analyzers require regular calibration in order to produce accurate results on
patient samples. Calibration can be accomplished by transferring information to the analyzer through fresh
blood samples which have been assayed by reference methods. A more direct and convenient approach is
to use a calibrator material with System Specific Values (SSV) assigned.
Streck Calibrators are stable suspensions of red blood cells, white blood cells and platelets. Assigned
values are derived from replicate analysis on whole-blood calibrated hematology analyzers. Users analyze
the calibrator on their instruments and compute calibration factors by comparing recovered values and
assigned values. These factors provide the basis for making adjustments to the instrument.
REAGENTS
This whole blood reagent may contain any or all of the following: stabilized human or animal red blood
cells, human, animal or simulated white blood cells and a platelet component in a preservative medium.
PRECAUTIONS
1. For In Vitro Diagnostic Use.
2. CAUTION: All blood products should be treated as potentially infectious. Source material from which this
product was derived was found negative when tested in accordance with current FDA required tests.
No known test methods can offer assurance that products derived from human blood will not transmit
infectious agents. See the Instructions (IFU) tab under Resources on the product page at streck.com for
specific FDA required blood tests.
3. This product should not be disposed of in general waste, but should be disposed of with infectious
medical waste. Disposal by incineration is recommended.
4. This product is intended for use as supplied. Adulteration by dilution or addition of any materials to the
product as supplied invalidates any diagnostic use of the product.
5. SDS can be obtained at streck.com, by calling 800-843-0912, or by calling your local supplier.
STORAGE AND STABILITY
Streck Calibrators are stable through the expiration date when stored at 2 °C to 10 °C. After opening, the
product is stable throughout the open-vial dating, as indicated on the assay sheet, when stored at 2 °C to
10 °C.
INDICATION OF PRODUCT DETERIORATION
Gross hemolysis (darkly colored supernatant) may be indicative of product deterioration
or damage. If this is apparent, contact Streck Technical Services at 800-843-0912 or
INSTRUCTIONS FOR USE
1. Perform instrument start-up and routine cleaning procedures as defined in instrument manufacturer’s
operator’s manual (i.e., blood sampling valve, counting apertures).
2. Remove vials of calibrator from refrigeration and warm to room temperature (18 °C to 30 °C) for 15
minutes before use.
3. To mix:
(Do NOT mix mechanically or vortex.)
For a video demonstration, visit streck.com/mixing
.
a. Hold the vial vertically and roll each vial between the palms of the hands for 15-20 seconds.
b. Continue to mix by holding the vial by the ends between the thumb and finger, rapidly inverting the
vial 20 times end-over-end using a very quick turning motion of the wrist.
c. Analyze immediately after mixing. Subsequent analyses during this test period may be performed by
inverting the vial 5 times prior to instrument analysis.
d. Steps a-c must be repeated upon removing the sample from the refrigerator for the entire open-vial
time period regardless of the method of analysis (open tube, cap piercing, auto sample or manual
sample).
4. Prime the instrument by aspirating two normal blood samples. Disregard results.
5. Verify instrument precision. Refer to operator’s manual for instructions and specifications.
6. Analyze the calibrator 11 times, disregard results of first run. (For auto-calibration, refer to procedure
in operator’s manual.) Record the values recovered on remaining 10 runs. (Analyzing the calibrator 11
times is recommended. However, some instruments may require fewer test runs.)
7. Calculate the mean value for each parameter.
8. Compare the results of your calculations to the values listed on the assay for your instrument.
a. If the difference between your recovered mean values and the system specific values are less than
the listed tolerance limits, the instrument does not require calibration.
b. If the difference is greater, calibrate using the system specific values.
9. Calibration of the specific parameter(s) should be done in accordance with the procedure in your
instrument manual. Calibration may not be required for all parameters.
10. Verify calibration by analyzing the calibrator three times and confirm the mean value for each
parameter lies within the published ranges.
11. After sampling, return to refrigeration for maximum open-vial stability. If run in the open mode, wipe
the threads of both the vial and cap before replacing cap and returning to refrigeration.
12.
For further assistance, contact Streck Technical Services at 800-843-0912 or
EXPECTED RESULTS
Assay values are derived from replicate testing on instruments operated and maintained according to
manufacturer’s instructions.
The following reference methods are used to whole blood calibrate instruments prior to system specific
value assignment as indicated in CLSI H26-A2.
1
WBC
- A series of 1:500 dilutions are made using class A glassware. The lytic agent is placed in the initial
dilution flask before diluting to volume. The diluting agent is an isotonic non-interfering solution.
The samples are counted on a single aperture volume displacing particle counter.
RBC
- A series of 1:50,000 dilutions are made using class A glassware. The diluting agent is an isotonic
non-interfering solution. The samples are counted on a single aperture volume displacing particle
counter.
Hb
- Hemoglobin concentration is determined by converting hemoglobin to hemiglobincyanide (HiCN)
and measuring absorbance at 540nm according to CLSI H15-A3
2
and ICSH recommendations.
Hemoglobin concentration is calculated using millimolar absorption of 11.0.
Hct
- Microhematocrit values are done in replicate on each sample, with capillary tubes filled and
centrifuged according to the CLSI H07-A3
3
document. K
2
EDTA is used as the anticoagulant for the
collection of fresh specimens. The packed cell volume (hematocrit) is read directly using a precision
metric scale. No correction is made for trapped plasma.
Plt
- Platelet counting by the RBC/platelet ratio method (ICSH) is utilized as the reference method.
REFERENCES
1. Clinical Laboratory Standards Institute, H26-A2. Validation, verification and quality assurance of
automated hematology analyzers. Approved Standard - Second Edition.
2. Clinical Laboratory Standards Institute, H15-A3, Reference and selected procedures for the quantitative
determination of hemoglobin in blood. Approved Standard - Third Edition.
3. Clinical Laboratory Standards Institute, H07-A3, Procedure for determining packed cell volume by the
microhematocrit method. Approved Standard - Third Edition.
ORDERING INFORMATION
Please call our Customer Service Department at 800-228-6090 for assistance. Additional information can
be found online at streck.com.
Rx Only
GLOSSARY OF SYMBOLS
See the Instructions (IFU) tab under Resources on the product page at streck.com.
See streck.com/patents for patents that may be applicable to this product.
350492-15
2020-03
Streck
7002 S. 109 Street, La Vista, NE 68128 USA
M
EDI
M
ARK®
Europe
11, rue Emile Zola, BP 2332
38033 Grenoble Cedex 2, France
EC REP
Hematology Calibrators
