Micropoint mLabs Multi-level D-Dimer Control Level I Handbuch

mLabs Multi-level D-Dimer Controls
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mLabs D-Dimer Control Kit Specification / Order Information
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REF Quantity
2 x 1 ml
M101-091002
2 x 1 ml
For Health Care Professional Use Only
INTENDED USE
The mLabs Multi-level D-Dimer controls are intended for use as quality control
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materials to assess the performance of mLabs
mLabs ImmunoMeter. It is recommended that two levels of controls are used to
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perform the test.
WARNING AND PRECAUTIONS
1. For in vitro diagnostics use only.
2. Carefully read instructions prior to use.Failure to follow the procedures may result
in erroneous results.
3. Do not use expired controls.
4. Do not use for any purpose other than described in the "Intended Use" section.
5. Take all necessary precautions required when handling laboratory reagents.
6. Refer to local biohazard procedures for safe waste disposal.
COMPOSITION
• 2 vials of level I controls
• 2 vials of level II controls
• 1 USB or 1 IC Card
• 1 Product insert
STORAGE AND STABILITY
1. Unopened controls are stable at 2-8 °C until expiration date stated on the label.
2. Once opened, the control is stable for 48 hours at 2-8°C.
TEST PROCEDURES
1. Control Sample Preparation
• The mLabs Multi-level D-Dimer controls can only be used with mLabs
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ImmunoMeter and mLabs D-Dimer test cartridge.
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• Retrieve the controls from the packaging, reconstitute with 1.0 ml of deionized
water using a volumetric pipet, and gently swirl occasionally for 10 minutes.
Do not shake. Do not mix mechanically.
• It is recommended that the quality control test be performed immediately after mixing.
2. mLabs ImmunoMeter Preparation
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• Please install Data Drives for the cartridges and the controls you purchased
before preforming quality control test.USB /IC cards which contains mLabs
Data Drive is provided along with each lot of cartridges and each lot of controls.
• Install Cartridge Data Drive: for U-disk, please insert the USB into the USB port
at the rear of the ImmunoMeter. For IC card, please insert it into the IC card port
located in the right side of the meter.
• Press "Data Drive Installation" button on the main screen, select "Sample Data
Drive" tab, for U-disk, press "U DISK" ; for IC card, press "IC card", the meter
will automatically install data drive.
• Remove USB/IC cards from the cartridge box.
• Install Control Data Drive: for U-disk, please insert the USB drive into the USB
port. For IC card, please insert it into the IC card port.
• Press "Data Drive Installation" button on the main screen, select "QC Data
Drive" tab, for U-disk, press "U DISK" ; for IC card, press "IC card", the meter
will automatically install data drive.
• Once both Data Drives have been installed into the ImmunoMeter, remove the
USB/IC card and store in a clean, dry location for furure use.
Name
mLabs Multi-level D-Dimer
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Control Level I
mLabs Multi-level D-Dimer
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Control Level II
D-Dimer test performed on
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3. Sample Addition
• Equilibrate the pouched test cartridges to room temperature (20-30 minutes)
before use.
• Remove test cartridge from pouch and label with Level I and Level II.
• Use the transfer pipette provided in the cartridge kit box, hold the pipette vertically
over the sample inlet of the test cartridge and add 250 μL of the control sample.
Storage
• Do not place the pipette tip into the inlet during sample transfer as air bubbles
2-8 C
o
may be generated.
• To avoid cross contamination, use a new transfer pipette for each level of control.
2-8 C
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4. Performing Test and Reading Results
• On the main menu, press "System Setting" button, select "Test Mode" as "inside
test mode" in commen setting tab, press save button and then go back to main
menu.
• Insert the test cartridge to the cartridge holder of the mLabs
Note: Make sure the cartridge barcode is face-up and the arrow is facing
towards the meter when inserted.
• Start test by pressing "QC TEST" from the main menu of the ImmunoMeter.
• Add 250ul sample with pipette to the sample well and click "START" to start
quality control test.
• On the next interface, edit the Assay Name, Concentration Level, Upper
Limit, Lower Limit and click "Confirm", a dialog box pops up and enter a code
consisting 1 to 13 digits or letters which is defined by the user, then press
"Confirm" to start QC test.
• After QC test completes, a control results will display on the screen, then discard
the cartridge to the designated medical waste container.
• If the 1st test fails, retest at least one more time.
• If subsequent tests fail, contact Micropoint Bioscience for assistance.
Note: For different software and meter version test procedure may be
different, user can refer to meter's user manual QC part to get more detailed
operation information.
SAFETY WARNING
The controls have been prepared exclusively from the blood of donors tested
individually and shown by official approved methods to be free from HbsAg and
antibodies to HIV 1, HIV 2 and HCV. As the risk of infection cannot be ruled out
with certainty, however, the product must be handled just as carefully as patient
specimens.
ADDITIONAL INFORMATION
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For additional information about this product, please call your local distributor
or call Micropoint Bioscience customer service at +1 408-588-1682 or email to
customerservice@micropointbio.com
Note: Micropoint recommends QC to be run, once per lot number, or when storage
conditions/system are questioned. Please follow facility standard procedures for
quality control.
EN
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ImmunoMeter.
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