D-Check 5Diff Hematology Control Guide
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ScribdTranslationsD-Check 5Diff Hematology Control Guide
Translated by
ScribdTranslationsD-CHECK5DIFF
CONTROLS OF
HEMATOLOGY
NAME OF 4. After analysis:
PRODUCT
D-Check 5Diff 3ml L; D-Check 5Diff 3ml N; D-Check 5Diff 3ml H; D- a)Ifthetubehasbeenopened,[Link].
Check 5Diff 4,5ml L; D-Check 5Diff 4,5ml N; D-Check 5Diff 4,5ml H b) Return the tube to refrigeration within a
maximum of 30 minutes.
Cat. No.:DDC5DT3L; DDC5DT3N; DDC5DT3H; DDC5DT4,5L;
DDC5DT4,5N; DDC5DT4,5H EXPECTED VALUES
Check that the batch of the tube corresponds to the batch in the value table.
USE
In Vitro PERFORMANCE
D-Check 5Diff is a control designed to monitor the values in The assigned values are presented as mean and range. The mean is derived from
automated hematology analyzers. replicated obtained from instruments handled according to the instructions of
manufacturer. The range is an estimate of the variation between laboratories, taking
SUMMARY AND PRINCIPLE consider the imprecision of the method and the biological variability of the material
It is a laboratory practice to use a stable control to monitor the control.
performance of diagnostic tests. This control consists of materials The values of a new batch must be tested before starting its routine use.
establishments that provide known values that monitor performance of Test the new batch when the analyzer is being monitored by the old one.
hematology cell counters. This control is managed in the same way batch with good results. The average collected by the laboratory must be
that the patient's sample. within the expected range.
Each laboratory must establish its own average and acceptable range and
REACTIVE periodically reevaluate them
D-Check 5Diff is an in vitro reagent made of human erythrocytes.
simulated leukocytes, simulated platelets, which are suspended in LIMITATIONS
plasma with preservatives. The performance of this product is only guaranteed if it is stored correctly and
follow the instructions for use of this insert.
CAUTION
D-Check 5Diff for personal trained in glass use. TECHNICAL ASSISTANCE
For technical assistance, please contact your local distributor. If not,
ALERT If possible, contact DIAGON Ltd. Technical Service at +36 1-369-
For in vitro use. Each human donor used in the preparation, 6500.
it has been analyzed against HBsAg, anti-HIV 1-2, anti-HCV, anti-TP,
with reagents CE <3/2005.(II.10.); 8/2003.(III.13.), and have been reported
asNOT REACTIVES.
Because no method offers complete security of absence of
infectious agents, this material should be handled as potentially
infectious.
STABILITY Y
STORAGE
Store D-Check 5Diff between 2 - 8° C when not in use. Protect from
heat and freezing the tubes. The sealed tubes are stable to date.
of expiration. Open tubes are stable for 21 days when they
they manage correctly.
Deterioration Indicator
After mixing, the product should have an appearance similar to fresh whole blood.
In the unmixed tube, the supernatant usually appears cloudy and reddish.
very dark red tone may indicate deterioration. Do not use the product if
suspected deterioration.
USAGE INSTRUCTIONS
Remove the tubes from the refrigerator and allow them to reach room temperature.
ambient (15 to 25°C) for 15 minutes before mixing them.
2. When mixing, hold the tube horizontally between the palms of the hands.
hands. Do not use automatic mixer. DIAGON LTD.
Baross str. 48-52. Budapest
a) Move the tube back and forth for 20 - 30 seconds; Hungary-1047
[Link].
butdonotshakeit. Tel: +36 1 369 6500
b) Continue mixing this way until the red cells are +36 1 369 6301
completely suspended. Tubes stored for a long period E-mail:diagon@[Link]
they require more mixing time. [Link]
Gently invert the tube 8-10 times immediately before analyzing.
3. Analyze the samples as indicated in the analyzer's operation manual.
Issued: 10-10-2016 1