Body Fluid-I
HEMATOLOGY CONTROLS
CONTROL
INTENDED USE
The Body Fluid-I Control is an assayed hematology control intended to
monitor the reliability of hematology instruments that quantitatively
measure red and white blood cell counts in cerebrospinal fluids, serous
fluids and synovial fluids.
SUMMARY AND PRINCIPLE
It is an established laboratory practice to use a stable control to monitor the
performance of diagnostic tests. This control is composed of stable
materials which provide a means of monitoring the performance of
hematology blood cell counters. It is sampled in the same manner as a
patient specimen.
REAGENTS
Body Fluid-I Control is an
in vitro
diagnostic reagent composed of human
erythrocytes and bovine leukocytes suspended in a fluid with preservatives.
PRECAUTION
Body Fluid-I Control is intended for
in vitro diagnostic use
only by trained
personnel.
WARNING
POTENTIAL BIOHAZARDOUS MATERIAL.
For
in vitro
diagnostic use.
Each human donor/unit used in the preparation of this product has been
tested and yielded non-reactive / negative results for all conditions
referenced in 21 CFR 610.40 (a) (b), as required by the FDA. Testing was
conducted using FDA-licensed tests. Additional details can be found at:
http://www.rndheme.com/TechnicalInformation.aspx.
No test method can offer complete assurance that infectious agents are
absent; therefore, this material should be handled as potentially infectious.
When handling or disposing of vials follow precautions for patient
specimens as specified in the OSHA Bloodborne Pathogen Rule (29 CFR
Part 1910, 1030) or other equivalent biosafety procedures.
2°C
8°C
STABILITY AND STORAGE
Store Body Fluid-I upright at 2 - 8° C (35 - 46° F) when not in use
. Protect
tubes from overheating and freezing.
Unopened tubes are stable through
the expiration date. Opened tubes are stable 30 days, provided they are
handled properly.
INDICATIONS OF DETERIORATION
After mixing, product should be similar in appearance to diluted whole
blood. In unmixed tubes the supernatant may appear cloudy and
reddish; this is normal and does not indicate deterioration. Other
discoloration, very dark red supernatant or unacceptable results may
indicate deterioration.
Do not use the product if deterioration is
suspected.
INSTRUCTIONS FOR USE
Note: Begin with a system rinse to reduce carryover. It is critical that the
background counts be low prior to running Body Fluid controls. Run controls
from lowest to highest concentration to reduce carryover.
1. Remove tubes from the refrigerator and allow to warm to room
temperature (15 to 30°C or 59 to 86°F) for 15 minutes before mixing.
2. To mix, hold a tube horizontally between the palms of the hands. Do not
pre-mix on a mechanical mixer.
a) Roll the tube back and forth for 20 - 30 seconds; occasionally invert
the tube. Mix vigorously, but do not shake.
b) Continue to mix in this manner until the red cells are completely
suspended. Tubes stored for a long time may require extra mixing.
c) Gently invert the tube 8 - 10 times immediately before sampling.
3.
Analyze the sample as instructed in the Operator’s manual for your
instrument.
Coulter LH-700 Series:
QC material must be run in secondary mode
with the BF CBC mode on.
Coulter UniCel DxH800:
Assay values collected in the CSF or BFC
mode.
4. After sampling:
a) If tube has been open for sampling, clean residual material
from the cap and tube rim with a lint-free tissue. Replace the
cap tightly.
b)
Return tubes to refrigerator within 30 minutes of use.
EXPECTED RESULTS
Verify that the lot number on the tube matches the lot number on the table
of assay values. Assay values are determinate on well-maintained, properly
calibrated instruments using the instrum
ent manufacturer’s recommended
reagents. Reagents differences, maintenance, operating technique and
calibration may contribute to inter-laboratory variation.
PERFORMANCE CHARACTERISTICS
Assigned values are presented as a Mean and Range. The Mean is derived
from replicate testing on instruments operated and maintained according to
the manufacturer’s instructions. The Range is based on a 2 SD to 3 SD
estimate of variation, depending on the level. This takes into account
inherent imprecision of the method, instrument variation and expected
biological variability of the control material.
Assay values on a new lot of control should be confirmed before the new lot
is put into routine use. Test the new lot when the instrument is in good
working order and quality control results on the old lot are acceptable. The
laboratory’s recovered mean should be within the assay range.
Precision studies:
Precision data collected using CLSI guideline EP5-A2.
Duplicates of each level of control were tested twice a day, on three lots, at
three different sites for a minimum of 20 days with outliers removed per
EP5-A2.
The typical performance data is summarized below.
WBC 10³/µL
N
Mean
SD
%CV
Level 1
228
0.14
0.02
14.3
Level 2
228
0.32
0.02
6.3
Level 3
230
1.05
0.02
1.9
RBC 10
6
/µL
N
Mean
SD
%CV
Level 1
230
0.025
0.001
4.00
Level 2
226
0.064
0.001
1.56
Level 3
230
0.422
0.003
0.71
LIMITATIONS
The performance of this product is assured only if it is properly stored and
used as described in this insert. Incomplete mixing of a tube prior to use
invalidates both the sample withdrawn and any remaining material in the
tube.
Assay values and expected ranges given are intended only as guidelines
and each laboratory should perform their own test system validation and
establish tolerance limits.
QC materials should be used in accordance with local, state, and/or federal
regulations or accreditation requirements.
TECHNICAL ASSISTANCE AND CUSTOMER SERVICE
For technical assistance or additional information, please call your
dealer or local distributor. If there is no, you may call EUROCELL
Diagnostics Technical Service at 33 (0)2 99 35 19 36.
QUALITY CONTROL PROGRAM
For information on the Inter-Laboratory Quality Control Program, please
call EUROCELL Diagnostics Technical Service at 33 (0)2 99 35 19 36.
All brands and products are trademarks or registered trademarks of their respective
companies.
R & D Systems, Inc.
614 McKinley Place NE
Minneapolis, MN USA 55413
AIS142-006 Rev 04/17
EUROCELL Diagnostics
19 Rue Louis Delourmel
35230 Noyal Châtillon / Seiche
France
IS0BI00-V05 06/2017
