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Sop of XN 550

The document outlines the procedures for performing a complete blood count and body fluid count using the Sysmex XN-550 Hematology Analyzer, detailing responsibilities, equipment, reagents, and testing parameters. It includes step-by-step instructions for reagent replacement, equipment startup, calibration, quality control, and patient sample processing. The document emphasizes the importance of quality control and proper handling of samples and reagents throughout the testing process.

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Payal Thakker
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0% found this document useful (0 votes)
798 views5 pages

Sop of XN 550

The document outlines the procedures for performing a complete blood count and body fluid count using the Sysmex XN-550 Hematology Analyzer, detailing responsibilities, equipment, reagents, and testing parameters. It includes step-by-step instructions for reagent replacement, equipment startup, calibration, quality control, and patient sample processing. The document emphasizes the importance of quality control and proper handling of samples and reagents throughout the testing process.

Uploaded by

Payal Thakker
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOCX, PDF, TXT or read online on Scribd
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Purpose: To perform a complete blood count and Body fluid count

Responsibility: technician

Reporting authority : Senior technician /Pathologist


EQUIPMENT: Six-part differential Sysmex XN-550 Hematology Analyzer.

SAMPLE TYPE: Whole blood , body fluids.

REAGENTS
1. CELLPACK DCL- 20L
2. LYSERCELL WDF -5L
3. FLUOROCELL WDF 42mL x 2
4. SULFOLYSER 1.5L x 2
5. CELLCLEAN AUTO 3mL x 20
6. XN-CHECK/ XNL-CHECK

Principle :
The devices perform hematology analyses based on the hydrodynamically focused impedance
measurement, the flow cytometry method (using a semiconductor laser) and the SLS- hemoglobin
method

TEST PROGRAMME PARAMETERS :

CBC, Body fluids

PROCEDURE :
Reagent Replacement:
(Only change reagent when prompted or when trouble shooting):
1. When the replacement of reagent is required, an error message appears.
Promptly acknowledge the error message by clicking execute to enter the reagent
replace dialog box and proceed to replace the indicated reagent. Verify that “CAPS
LOCK is off.
2. Replacing a new diluent/ hemolytic agent
 Touch the name of the reagent to be replaced.
 Place a check-mark next to ‘Replace the reagent,’ then place the cursor in the
reagent code text box.
 Using the hand-held reader, scan the reagent code on the new reagent
container. NOTE: Scan Reagent Code 2 when available on the reagent container.
 Remove the cap from the expired/empty container and carefully remove the
spout.
 Pull out the dispensing, set straight up.
 Insert the dispensing set straight into the new reagent container and close the cap.
 Select [Execute]
 Reagent replacement starts. When complete, the dialog box closes
automatically
3. Replacing Dye
 Display the [Reagent Replacement] dialog box.
 Prepare the new reagent cartridge.
 Confirm the reagent has not expired.
 Pull out the dye holder.
 Slowly remove the dye cover, taking care that dye does not drip.
 Remove the entire dye holder.
 When the dye holder is removed, a Help dialog box appears in the IPU screen.
 Remove the old reagent cartridge from its holder.
 Install the new reagent cartridge into the holder
 Make sure the color of the label on the new reagent cartridge matches the
color of the dye cover and install. Analyzer will beep as confirmation of new
reagent installation.
 If the wrong reagent is installed, the analyzer beeps
 Place the dye cover.
 Place into dye holder.
 The ID of the new reagent is read automatically, and the information is
registered.
 Close the dye holder.
 Reagent replacement starts.
 When complete, the reagent replacement window close automatically.

D. Start-up of Equipment:
Procedure
1. Checks prior to turning on:
 Visual inspections of analyzer / system / reagents
 If applicable, verify waste container is empty.
 Verify network / host connections are properly working.
 Verify sufficient reagent supply is nearby.
2. Turning ON the entire system
 Verify that all power switches for the device is in the ON position
 Press the GREEN power button on the front of the XN-550 to power ON
the entire system.
3. Log on to the XN-550
When the logon dialog box appears, enter user name and password
4. Analyzers self-checks
5. Initialization of the mechanical parts; Rinse; Temperature stabilization;
Background Check (up to 3 times).

XN-L Acceptable Background Counts


Parameters Acceptable Limit
WBC 0.10 x 103 / uL
RBC 0.02 x 106 / uL
HGB 0.1 g/dL
PLT-I 10 x 103 / uL
E. Calibration:
Calibration Performed by Sysmex Technical Service Representative as when required.

F. Quality Control:
 XNL-CHECK bi level whole blood commercial controls are used. Two level
of controls are run on daily basis (Morning & Evening) or as and when
needed, like after reagent change etc.
 Vials stored at 2-8°C and are stable until expiration date stated on vial. Open vial
stability is 15 days when promptly refrigerated after each use.
 Vials should be dated when opened. XNL-CHECK are made from human material
and standard precautions should be used while handling, if further information on
hazardous effect are needed refer to product MSDS.
 Controls are analyzed by L-J control programs and data is stored in a Sysmex quality
control file.
.
External Quality Control:
External Quality Control will be run as per EQAS schedule. Supervisor of the
section will be responsible for run and maintaining

G. QC Analysis:
Note: Quality control can be run only in the Manual Mode
1. Confirm the analyzer is in a Ready state.
2. Switch the analyzer in to the Manual Mode by pressing the mode change switch.
3. Touch [Mode] on the control Menu.
4. Touch the Analysis Mode. Select Whole Blood.
5. Touch OK.
6. Touch the [QC] icon on the Menu screen.
7. Touch the [QC Analysis] icon.
8. From the QC file list, touch the file you want to analyze.
9. Perform Manual analysis on thoroughly mixed vial.
10. Check the analysis results in dialog box. Touch [Accept].
a. If analyzer displays GREEN, this indicates QC passed and analyzer is
ready to process samples.
b. If analyzer displays YELLOW, more information is needed, or QC is
overdue. The resolve button becomes active if there is a QC value outside of
limits.
c. RESOLVE is activated: If a QC error has been detected, resolve button
becomes active and dynamic troubleshooting prompt guides the end user to
the next course of action. The instructions button gives details on how to
perform the troubleshooting action.
d. QC is overdue: End user needs to analyze QC since it exceeds the
timeframe from the preferences screen.
e. If analyzer displays RED, QC failed analysis and analyzer is
determined out of service with a reference to a service call.
For a calendar view of whether the QC passed or failed, access the Summary report
which will also display background status,
H. Patient Sample Processing:
System Analysis (sampler analysis)
a. Make sure the sampler cover (front) and sampler cover (manual
unit) are closed.
b. Make sure the button on the right edge of the control menu is set as
sampler. When the mode is set to manual, press the mode switch.
c. Make sure that either the left or right sampler adapter holder is in a
state to be pulled out.
a. A sampler adapter holder can be pulled out when the sampler
adapter status indicator LED is solid green or OFF.
d. Pull out the sampler adapter holder that you want to use.
e. Remove the sampler adapter.
f. Mix the sample.
g. Place the sample tube in the sampler adapter.
h. Touch Sampler on the right edge of the control menu.
i. Touch an item to set the condition.
j. Touch [OK].
k. Place the sampler adapter in the sampler adapter holder
selected in the sampler settings box.
l. Push in the sampler adapter holder.
m. Press the sampler analysis start/stop switch.
n. On-Board rules engine will determine repeat or reflex testing.
o. Rack will run in reverse to perform repeat or reflex testing.
p. Remove the rack from the left sampler pool when analysis in completed.
q. Make smear .
Manual Analysis
a. Check the status of the analyzer. Confirm the analyzer is ready.
b. Make sure the button on right side of control menu is Manual. When
it’s set to Sampler, touch [Mode] in the control menu.
c. Select the Change Analysis Mode button on the control menu.
d. Select analysis mode
a. [Whole blood] is selected when whole blood is being analyzed
b. [Low WBC] Select this to perform low WBC analysis on whole
blood
e. Select [OK]
f. Select Manual Analysis button on the control menu
g. Input sample ID or use handheld barcode reader to scan sample ID.
a. Patient information - Touch input to enter patient ID.
b. Query to Host-Specify whether or not the host is queried
for the analysis order.
c. Aspiration Sensor - Specify whether or not the aspiration
sensor is used.
d. Cap Open - Select this checkbox to perform micro sample
analysis (analysis with the sample tube cap open.)
e. Raised Bottom Tube - Assure appropriate adaptor in
use – See Instructions for Use Manual.
 Open the Sampler cover (manual unit).
 Properly mix the specimen and place in the tube holder.
If running microtainer, remove the cap using caution to avoid splattering.
 Press the start switch on the analyzer
 The tube holder will slide in and the sample will be aspirated.
 When the analysis is complete, the tube holder slides out.
 Remove the sample, repeat steps for additional samples
 Review results in IPU to determine whether repeat or reflex
testing is required.
 Rerun sample if required. Make smear .

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