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Control 29P
04U72
Control 29P 80000318-103 350707-3

Revised June 2017.

04U7206
04U7212
lINTENDED USE lINSTRUCTIONS FOR USE
Alinity h-series Control 29P is a Whole Blood hematology quality Refer to the Alinity h-series Operations Manual for proper use of
control material used to monitor results obtained on Alinity h-series the Alinity Calibrator and Control Products.
systems. IMPORTANT: Mixing and Handling
lSUMMARY AND PRINCIPLE Before use, refer to the information sheet for complete product
It is an established laboratory procedure to use stable quality control information.
material to monitor the performance of diagnostic tests. Alinity 1. Remove a vial of control from the refrigerator and warm to room
h-series Control 29P is composed of stable materials that provide a temperature (18°C to 30°C) for 15 minutes before use.
means to verify the accuracy and precision of results for hemogram, 2. To mix: (Do NOT mix mechanically or vortex.)
WBC differential, and reticulocyte parameters; it is handled and For a video demonstration, visit www.abbottdiagnostics.com and
run in the same manner as patient specimens and is available in navigate to the Customer Portal --> Technical Library --> Other
three levels representing low hemogram/high reticulocyte, normal Reference Documents --> Hematology Aids.
hemogram/intermediate reticulocyte, and high hemogram/low a. Hold the vial vertically and roll each vial between the palms
reticulocyte results. of the hands for 15–20 seconds.
lREAGENT
Kit Contents
04U7206 04U7212
Alinity h-series Control 29P 6 x 3.0-mL Vials 12 x 3.0-mL Vials
Alinity h-series Control 29P is an in vitro diagnostic product b. Continue to mix by holding the vial by the ends between the
that may contain any or all of the following: stabilized human or thumb and finger, rapidly inverting the vial 20 times
mammalian red blood cells, human, mammalian or simulated white end-over-end using a very quick turning motion of the wrist.
blood cells, and a platelet component in a preservative medium.

lWARNINGS AND PRECAUTIONS

•
• For In Vitro Diagnostic Use.

CAUTION: This product contains human sourced and/or

potentially infectious components. Refer to the REAGENT section of c. Analyze immediately after mixing. Subsequent analyses
this package insert. No known test method can offer complete during this test period may be performed by inverting the vial
assurance that products derived from human sources or inactivated 5 times prior to instrument analysis.
microorganisms will not transmit infection. Therefore, all human d. Steps a–c must be repeated upon removing the sample from
sourced materials should be considered potentially infectious. It is the refrigerator for the entire open-vial time period regardless
recommended that these reagents and human specimens be of the method of analysis (open tube, cap piercing, auto
handled in accordance with the OSHA Standard on Bloodborne sample, or manual sample).
Pathogens. Biosafety Level 2 or other appropriate biosafety practices 3. Refer to the Alinity h-series Operations Manual for information
should be used for materials that contain or are suspected of about analyzing control specimens.
containing infectious agents.1-4 4. FOR AUTOMATED CLOSED TUBE PROCESSING:
• The human source material in the Alinity h-series Control 29P – Refer to the Alinity h-series Operations Manual. Remove the
Low, Normal, and High is nonreactive for HBsAg, HIV-1 RNA, anti- vial(s) from the rack immediately after sampling.
HCV, HCV RNA, anti-HIV-1/HIV-2, West Nile Virus, and Chagas FOR AUTOMATED OPEN TUBE PROCESSING:
Disease. – Refer to the Alinity h-series Operations Manual. Remove the
For additional information, refer to the Alinity h-series Operations vial(s) from the rack immediately after sampling.
Manual. – Carefully wipe the vial rim and cap with a lint-free tissue.
Safety Data Sheets are available at www.abbottdiagnostics.com or – Replace the cap, ensuring it is on tight.
contact your local representative. After sampling, return vial to refrigerator for maximum open-vial
stability.

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PROCEDURE ll
PERFORMANCE CHARACTERISTICS
Refer to the quality control procedures provided in the appropriate The target values, with their associated ranges, reflect the expected
Alinity h-series Operations Manual. biological variability of the control materials and the estimated
ll
STORAGE AND STABILITY interlaboratory variation.
Each laboratory should establish a target and acceptable range for
Protect vials from overheating and freezing. Alinity each lot of control material. The laboratory target should fall within
h-series Control 29P is stable through the expiration date when the listed target range. An individual laboratory’s range may include
stored at 2° to 10°C (36-50°F). After opening, Alinity h-series Control results above and below the listed target range. Laboratories may
29P is stable throughout the open-vial dating, as indicated on the consider results acceptable when at least 95% of test results are
Assay Sheet, when stored at 2° to 10°C. Once opened, vials can be within the laboratory’s expected range. For additional information,
used only for the number of days stated on the assay sheet, provided refer to the appropriate Alinity h-series Operations Manual.
that they are handled properly: avoid unnecessary cycles of warming ll
BIBLIOGRAPHY
and cooling, prolonged exposure to ambient temperature, or vigorous 1. US Department of Labor, Occupational Safety and Health
mixing, all of which may damage the control. In addition, the volume Administration, 29 CFR Part 1910.1030, Bloodborne pathogens.
in the vial must meet or exceed the minimum sample volume stated 2. US Department of Health and Human Services. Biosafety in
in the Alinity h-series Operations Manual. Microbiological and Biomedical Laboratories. 5th ed. Washington, DC:
Trending in the MCV or RDW parameters over the product shelf life is US Government Printing Office; December 2009.
3. World Health Organization. Laboratory Biosafety Manual. 3rd ed.
inherent to hematology control products. This characteristic does not Geneva: World Health Organization; 2004.
indicate product instability. Ranges and limits for these parameters 4. Clinical and Laboratory Standards Institute (CLSI). Protection
may need to be adjusted. of Laboratory Workers from Occupationally Acquired Infections;
ll
INDICATIONS OF DETERIORATION Approved Guideline—Fourth Edition. CLSI Document M29-A4. Wayne,
PA: CLSI; 2014.
Alinity h-series Control 29P, after mixing, should be similar in 5. The Expert Panel in Cytometry on the ICSH, J.M. England, et.al.:
appearance to fresh whole blood. In unmixed, refrigerated containers, Recommended Methods for the Visual Determination of White Cell
the supernatant fluid may appear cloudy and reddish. Other and Platelet Counts. World Health Organization, WHO/LAB/88.3,
discoloration of the supernatant fluid, or marked hemolysis, may 1988.
indicate deterioration. Inability to obtain expected values may indicate 6. International Council for Standardization in Haematology Expert
product deterioration. Rough handling, freezing, overheating, and Panel on Cytometry. Reference method for the enumeration of
erythrocytes and leucocytes. Clin Lab Haematol 1994;16(2):131-138.
contamination are frequent causes of product damage. Incomplete 7. Clinical and Laboratory Standards Institute (CLSI). Reference
mixing or instrument malfunction may also cause unacceptable and Selected Procedures for the Quantitative Determination of
results. Do not use the product if deterioration is suspected; Hemoglobin in Blood; Approved Standard–Third Edition. CLSI
contact Abbott Customer Service. Document H15-A3. Wayne, PA: CLSI; 2000.
Customer Service: Contact your local representative 8. Clinical and Laboratory Standards Institute (CLSI). Procedure for
or find country specific contact information on Determining Packed Cell Volume by the Microhematocrit Method;
Approved Standard–Third Edition. CLSI Document H07-A3. Wayne,
www.abbottdiagnostics.com
PA: CLSI; 2000.
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PRODUCT LIMITATIONS 9. International Committee for Standardization in Haematology Expert
Panel on Cytometry. The assignment of values to fresh blood used
Proper storage and use of this product as described in this document
for calibrating automated blood cell counters. Clin Lab Haematol
is required for optimal performance. The components of this 1988;10(2):203-212.
product are not suitable for microscopic differential analysis or spun 10. Clinical and Laboratory Standards Institute (CLSI). Validation,
microhematocrit. Values are not transferable to systems not listed Verification, and Quality Assurance of Automated Hematology
on the assay sheet. The product is intended for use as supplied. Analyzers; Approved Standard—Second Edition. CLSI Document
Adulteration by dilution or addition of any materials to the product as H26-A2. Wayne, PA: CLSI; 2010.
supplied invalidates any diagnostic use of the product.
Control products are not to be used as calibrators. The white blood
cell components simulate white blood cells in size, not morphology.
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EXPECTED VALUES AND THEIR DERIVATION
Refer to the table of values on the enclosed assay sheet for target
results. The assay values are obtained from replicate testing on
Alinity h-series Systems. The target range is an estimate of observed
interlaboratory variation due to reagent differences, maintenance,
calibration, and operating technique. The Systems are calibrated as
follows:
• using whole blood according to CLSI and ICSH-recommended
manual, reference methods5-10
• using an Alinity h-series calibrator
• using the appropriate, reliably calibrated Alinity h-series
hematology analyzer.

2
Key to Symbols
Consult instructions for use

Caution

Date of Manufacture

Manufacturer

Temperature limitation

Use By

Control H
Control L
Whole Blood Control, Tri-Level
Control N
In Vitro Diagnostic Medical Device
Batch Code
Product of USA
Range
Catalogue Number
System
Target

Abbott GmbH & Co. KG

Max-Planck-Ring 2
65205 Wiesbaden
Germany
+49-6122-580
Revised June 2017.
©2017 Abbott Laboratories