LumiraDx SARS-CoV-2, Manual

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Document Name: SARS-CoV-2 Antigen (Ag) Quality Controls Pack Insert
Document Number: S-COM-DOUT-00132 Revision: 2
This document is controlled and released electronically in Grand Avenue. Hard copies are uncontrolled and should not be relied upon for
the most recent version unless formally issued and stamped by QA. Created with S-QMS-TEM-00002
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All components of this kit can be discarded as biohazard waste according to the local
guidelines.
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Refer to the product safety data sheet for risk and safety phrases and disposal information.
The product safety data sheet is available for users upon request.
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Requirements of the appropriate licensing or accrediting body should be incorporated into
your quality control program.
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Exercise the normal precautions required for handling all laboratory reagents.
Storage and stability:
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Store controls between 2°C and 8°C (36 - 46°F).
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Unopened controls that are stored between 2°C and 8°C (36 and 46°F) can be used until the
expiration date. Do not use kits or components beyond the expiration date given on the label.
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Once opened, the vial has a 30 day expiry.
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Open the Control Vials only when you are performing tests.
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Recap and store the Control Vials in their original container at 2°C and 8°C (36 and 46°F)
after use.
Carton Contents:
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2 x 0.5ml vial SARS-CoV-2 Ag Positive Control
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2 x 0.5ml vial SARS-CoV-2 Ag Negative Control
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24 Transfer pipettes (20µl)
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LumiraDx SARS-CoV-2 Ag Quality Control Pack Insert
Materials required but not provided with the Control Carton:
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LumiraDx Instrument
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LumiraDx SARS-CoV-2 Ag Test Strips
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LumiraDx Connect– if connectivity required (refer to LumiraDx Connect User Manual)
Getting ready to test :
You will need the LumiraDx Instrument and the following supplies:
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LumiraDx SARS-CoV-2 Ag Test strip(s)
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LumiraDx SARS-CoV-2 Ag Positive or Negative Quality Controls
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Transfer pipette
Preparing the Quality Controls:
The liquid controls are supplied ready to use.
Handling the LumiraDx SARS-CoV-2 Ag Test Strips : To ensure that you are using the SARS-CoV-
2 Ag Test and the Instrument correctly, read the appropriate SARS-CoV-2 Ag Test Strip Product Insert
and Platform User Manual.
Procedure/Performing a Test: Consult the LumiraDx Platform User Manual for instructions on how to
analyse a Quality Control sample. Open the foil pouch of the SARS-CoV-2 Ag Test Strip just before use
and insert the Test Strip into the LumiraDx Instrument. The Instrument will indicate when ready for the
sample to be applied.