LumiraDx SARS-CoV-2 Manual

ENGLISH
For Professional Use Only
For In Vitro Diagnostic Use
SPEC-32190 Rev3
ART-00438 Rev5
The LumiraDx SARS-CoV-2 Ab Quality Controls (hereafter referred to as
Quality Controls) are liquid quality controls to be used with the LumiraDx
Instrument (hereafter referred to as the Instrument) and the LumiraDx
SARS-CoV-2 Test Ab Test (hereafter referred to as SARS-CoV-2 Ab Test).
Read these instructions thoroughly before using the Quality Controls.
Inspect the Quality Controls packaging and contents for damage before
use. Report any damage to LumiraDx Customer Services and do not use
the kit if any damage is observed to the contents.
To ensure that you are using the Instrument, the SARS-CoV-2 Ab Test and
the Quality Controls correctly, read the appropriate Platform User Manual,
SARS-CoV-2 Ab Test Product Insert and this entire pack insert. In addition,
please watch the LumiraDx Platform Training video available at lumiradx.
com. The Quality Controls are intended for healthcare professional use
only.
Intended use
The LumiraDx SARS-CoV-2 Ab Quality Controls are intended for liquid
quality control testing performed on the LumiraDx Instrument when used
with the LumiraDx SARS-CoV-2 Ab Test Strip. The Quality Controls provide
users with assurance that the device is performing within specification.
Summary and explanation of the test
The LumiraDx SARS-CoV-2 Ab Quality Controls are normal human,
plasma-based reagents. The controls are specifically formulated and
manufactured to ensure performance of the test and are used to verify
the user's ability to properly perform the test and interpret the results.
It is the responsibility of each laboratory or healthcare setting using the
LumiraDx SARS-CoV-2 Ab Test to establish an adequate quality assurance
program to ensure the performance of the device under its specific
locations and conditions of use. Quality control requirements should
be followed in conformance with local regulations or accreditation
requirements and the user laboratory's standard quality control
procedures.
Warnings and precautions
• For in vitro diagnostic use.
• This control contains human source material that was tested
and found nonreactive for the Human Immunodeficiency Virus
(HIV 1 and 2) antibody, Hepatitis B Surface Antigen (HbsAg) and
Hepatitis C Virus (Anti-HCV) at the donor stage. This product, as
with all human based specimens, should be treated as potentially
infectious and handled with proper laboratory safety procedures to
minimize the risk of transmission of infectious disease.
• All components of this kit can be discarded as Biohazard waste
according to the local guidelines.
• 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.
• Requirements of the appropriate licensing or accrediting body
should be incorporated into your quality control program.
• Exercise the normal precautions required for handling all laboratory
reagents.
Storage and stability
• Store controls between 2°C and 8°C (36 - 46°F).
• 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.
• Once opened, the vial has a 30 day expiry.
• Open the Control Vials only when you are performing tests.
• Recap and store the Control Vials in their original container at 2°C
and 8°C (36 and 46°F) after use.
Carton contents
• 2 x 0.5ml vial SARS-CoV-2 Ab Positive Quality Control
• 2 x 0.5ml vial SARS-CoV-2 Ab Negative Quality Control
• 40 Transfer pipettes (20uL)
• LumiraDx SARS-CoV-2 Ab Quality Control Pack Insert
Materials required but not provided with the Control Carton:
• LumiraDx Instrument
• LumiraDx SARS-CoV-2 Ab Test Strips
• 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:
• LumiraDx SARS-CoV-2 Ab Test strip(s)
• LumiraDx SARS-CoV-2 Ab Positive or Negative Quality Controls
• Transfer pipette
Preparing the Quality Controls
The liquid controls are supplied ready to use.
Handling the LumiraDx SARS-CoV-2 Ab Test Strips:
To ensure that you are using the SARS-CoV-2 Ab Test and the Instrument
correctly, read the appropriate SARS-CoV-2 Ab Test Strip Product Insert
and Platform User Manual.
SARS-CoV-2 Ab Quality Controls