INSTRUCTIONS FOR USE
INTENDED USE
A1c-Cellular
®
is a bi-level, whole blood based, assayed control material for evaluating the accuracy
and precision of HbA1c procedures.
SUMMARY AND PRINCIPLES
Laboratories require assayed material for quality control of automated and semi-automated
procedures that measure whole blood parameters. Daily use of this whole blood control provides
quality control data for confirming the precision and accuracy of the instrument. A1c-Cellular’s intact
RBC formulation allows users to verify all steps of analysis procedures, including lysing of the RBC.
REAGENTS
A1c-Cellular contains stabilized human red blood cells 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 www.streck.com for specific FDA required blood tests.
3. This product should not be disposed in general waste, but should be disposed 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, unless pretreatment is
recommended by individual instrument manufacturers.
5. Control products are not to be used as calibrators.
6. SDS can be obtained at www.streck.com, by calling 800-843-0912, or by calling your local
supplier.
STORAGE AND STABILITY
A1c-Cellular should be stored at refrigerated temperatures (2 °C to 10 °C) before and after opening.
Under these conditions, unopened vials of A1c-Cellular are stable through the expiration date. After
opening, A1c-Cellular 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
Inability to obtain expected values may indicate product deterioration. Discoloration of the product
may be caused by overheating or freezing during shipping or storage. Darkly colored supernatant
may be indicative of product deterioration; however, moderately colored supernatant is normal
and should not be confused with product deterioration. If the recovered values are not within the
expected ranges:
1. Review control product package insert and the operating procedure of the instruments.
2. Check expiration date of the product on the vial. Discard outdated products.
3. Assay an unopened vial of the control. If the values are still outside the Expected Range, contact
Streck Technical Services at 800-843-0912 or technicalservices@streck.com.
INSTRUCTIONS FOR USE
1. Remove vials of A1c-Cellular from the refrigerator and warm to room temperature (18 °C to 30 °C)
for 15 minutes before use.
2. To mix:
(Do NOT mix mechanically or vortex.)
For a video demonstration, visit www.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).
3. Refer to the instrument manual for the system in use for analyzing control materials.
4. After sampling, return to refrigeration for maximum open-vial stability.
Barcodes on the cap-pierceable vials are intended for use with Bio-Rad
®
Variant II™ Turbo and Tosoh
G8. To use the barcode, align the barcode on the vial(s) with the barcode reader on the instrument.
The barcode will label the control with “LC” for Level 1 and “HC” for Level 2. The Bio-Rad Variant
instrument can use these barcodes to transfer the data into a QC log file. In order to not use the
barcode function, face the barcode away from the instrument’s barcode reader.
LIMITATIONS
Do not use the product past the expiration date or if there is evidence of gross hemolysis or microbial
contamination.
EXPECTED RESULTS
The mean assay values provided are derived from replicate analysis. The values are lot specific
and were performed by the control manufacturer and/or independent laboratories using the same
lot. The mean values recovered on your system should be within the stated expected range. Good
laboratory practice includes establishment of a laboratory mean and standard deviation by replicate
analyses. Assay ranges are provided only as a guide.
Assay values and expected ranges for instruments not listed on the assay sheet must be established
by the user. Per CLSI H26-A2
1
it is recommended that each level of control be run twice a day for
3-5 days to establish individual lab means for each measurand.
REFERENCES
1. Clinical and Laboratory Standards Institute, H26-A2, Validation, verification, and quality assurance
of automated hematology analyzers; Approved Standard - Second Edition.
QUALITY CONTROL PROGRAM
Streck offers
STATS
®
, an interlaboratory quality control program, to all customers at no charge.
For more information, contact the
STATS
Department at 800-898-9563 or statsdata@streck.com.
Additional information can be found at www.streck.com.
ORDERING INFORMATION
Please call our Customer Service Department at 800-843-0912 for assistance. Additional information
can be found online at www.streck.com.
Rx Only
GLOSSARY OF SYMBOLS
See the Instructions (IFU) tab under Resources on the product page at www.streck.com.
The brand and product names of the instruments are trademarks of their respective holders.
See www.streck.com/patents for patents that may be applicable to this product.
350479-17
2018-11
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
A1c-Cellular
®
