LumiraDx SARS-CoV-2, Руководство пользователя

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INTERPRETATION OF RESULTS
Positive Test Results – SARS-CoV-2 antigen present; does not rule out coinfection with other
pathogens.
Negative Test Results – Negative results are presumptive for patients with symptom onset beyond
12 days. Negative test results do not preclude infection and should not be used as the sole basis for
treatment or other patient management decisions, including infection control decisions, particularly
in the presence of clinical signs and symptoms consistent with COVID-19, or in those who have been
in contact with the virus. It is recommended that these results be confirmed by a molecular testing
method, if necessary for patient management.
Invalid Results - If an issue occurs, a message will be displayed on the Instrument touch-screen.
Alert messages include useful information and are highlighted by an orange banner. Error messages
also include a
symbol. All messages will contain a description of the Instrument status or error
and an instruction. Error messages contain an identifying code that may be used for further
troubleshooting purposes.
Quality Controls -
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 which are available separately. If the LumiraDx Antigen Quality Controls do not
perform as expected, do not report patient results. Retest using a new Test Strip – if
problems persist contact LumiraDx Customer Services on telephone number 1-888-586-
4721.
In the USA, this test has not been FDA cleared or approved; this test has been authorized by FDA
under an EUA for use by authorized laboratories; use by laboratories certified under the CLIA, 42
U.S.C. §263a, that meet requirements to perform moderate, high or waived complexity tests. This
test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a
CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. This test has
been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or
pathogens. In the USA, - this test is only authorized for the duration of the declaration that
circumstances exist justifying the authorization of emergency use of in vitro diagnostics for
detection and/or diagnosis of the virus that causes COVID-19 under Section 564(b)(1) of the Federal
Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or
revoked sooner.
Cleaning and Disinfecting
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 LumiraDx approved
wipes such as TECcare CONTROL 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.
Manufacturer Information: LumiraDx UK Ltd, Dumyat Business Park, Alloa, FK10 2PB, UK
Registration Number: 09206123
Customer Services
If the LumiraDx SARS-CoV-2 Ag Test or the LumiraDx Instrument do not perform as expected,
contact LumiraDx Customer Services 1-
888-586-4721
or customerservices.us@lumiradx.com
Example of an error screen: If the
On Board Control (OBC) fails, an
error message will be shown and no
test result will be returned. Follow
the on screen instructions to dispose
of the Test Strip and start a new test.
If the problem persists, contact
Customer Services.
Copyright © 2020 LumiraDx UK and affiliates. All rights reserved. LumiraDx and Flame logo are
protected trademarks of LumiraDx International LTD. Full details of these and other registrations of
LumiraDx can be found at lumiradx.com/IP. All other trademarks are the property of their respective
owners