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Document Name:
SARS-CoV-2 Ag Test Strip Product Insert
Document Number:
S-COM-DOUT-00112
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-00001
Built-in controls:
The instrument reads the 2D bar code on each Test Strip and can identify if the strip
has exceeded the expiry date for use, and if the strip Lot Calibration file has not yet been loaded, at
which point it will request it.
The LumiraDx Instrument and LumiraDx SARS-CoV-2 Ag Test Strips have several quality control
functions integrated to ensure validity of each test run. These checks ensure that the volume of sample
added is sufficient and the assay sequence of the Test Strip is as expected. The checks also ensure
that the Test Strip has not been damaged or used previously. If these checks are not verified, the test
run will be rejected and an error message displayed on the Instrument touchscreen.
The LumiraDx Instrument ensures the quality of test results obtained through the following features:
•
Automated checks of the correct functioning of the Instrument at power on and during operation.
•
This includes electrical component operation, heater operation, battery charge state,
mechanical actuators and sensors and optical system performance.
•
Monitoring of Test Strip performance and controls during test runtime.
•
Ability to perform Quality Control Tests using LumiraDx Quality Control solutions to meet
regulatory compliance requirements.
Quality controls:
Liquid Controls for SARS-CoV-2 Ag are available from LumiraDx. Details can be found via the website
(lumiradx.com) or at the Customer Services telephone number 1-888-586-4721. Quality Control testing
policy is at the discretion of your organization. Good laboratory practice recommends the use of control
materials. Follow the appropriate federal, state and local guidelines concerning the frequency of testing
quality control material. To complete Quality Control assessment of the LumiraDx Instrument and
SARS-CoV-2 Ag Test Strips, you must use the LumiraDx SARS-CoV-2 Ag Quality Control Pack. The
Quality Controls come as Positive and Negative controls.
LumiraDx recommends controls be run once for:
•
each new kit lot
•
each new operator
•
as required by internal quality control procedures and in accordance with local, state and federal
regulations or accreditation requirements.
If the LumiraDx Antigen Quality Controls do not perform as expected, repeat the QC Test and if the
problems persists, do not report patient results and contact LumiraDx Customer Services on telephone
number 1-888-586-4721.
Cleaning and Disinfection.
Always clean the Instrument after each patient use. Wipe the external
surfaces of the LumiraDx Instrument with a soft, slightly damp cloth when it appears visibly dirty.
Disinfect the Instrument between each patient test using either the LumiraDx approved wipes such as
TECcare CONTROL wipes or Virkon or Clorox Wipes. Use the wipe until the surface of the Instrument
is visibly wet. Allow the surface to remain wet for
5 minutes
and let air dry.
Avoid USB ports and
power inlet.
Do
not spray or pour
solution directly onto the Instrument. Do not put any objects
or cleaning
materials into the Test
Strip slot.
Summary of Contents for SARS-CoV-2
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