LumiraDx SARS-CoV-2 Manual

SARS-CoV-2 Ag Test Strip Product Insert
LumiraDx SARS-CoV-2 Ag Test
For Professional Use Only
For use under an Emergency Use Authorization (EUA) Only
For In Vitro Diagnostic Use Only
Rx Use Only
SPEC-32311 Rev 1; ART-00570 Rev 1
LumiraDx SARS-CoV-2 Ag Test
The LumiraDx Severe Acute Respiratory Syndrome (SARS) CoV-2 Antigen (Ag) Test Strips (hereafter
referred to as Test Strips) are to be used with the LumiraDx Platform. The LumiraDx Platform is a point
of care system for professional use which is used for in vitro diagnostic tests. It comprises a portable
LumiraDx Instrument and a LumiraDx Test Strip for the required test. This test is for HEALTHCARE
PROFESSIONAL USE ONLY and allows users to perform tests using small sample volumes and to
view results quickly on the Instrument touchscreen.
Intended use:
The LumiraDx SARS-CoV-2 Ag Test is a rapid microfluidic immunofluorescence assay for use with the
LumiraDx Platform intended for the qualitative detection of the nucleocapsid protein antigen to SARS-
CoV-2 directly from nasal swab specimens collected from individuals suspected of COVID-19 by their
healthcare provider within the first twelve days of symptom onset. Testing is limited to laboratories
certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, that
meet the 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.
The LumiraDx SARS-CoV-2 Ag test does not differentiate between SARS-CoV and SARS-CoV-2.
Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally
detectable in nasal swab specimens during the acute phase of infection. Positive results indicate the
presence of viral antigens, but clinical correlation with patient history and other diagnostic information
is necessary to determine infection status. Positive results do not rule out bacterial infection or co-
infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories
within the United States and its territories are required to report all positive results to the appropriate
public health authorities.
Negative results, from patients with symptoms onset beyond twelve days, should be treated as
presumptive and confirmation with a molecular assay, if necessary, for patient management, may be
performed. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole
basis for treatment or patient management decisions, including infection control decisions. Negative
results should be considered in the context of a patient's recent exposures, history and presence of
clinical signs and symptoms consistent with COVID-19.
The LumiraDx SARS-CoV-2 Ag Test is intended for use by trained clinical laboratory personnel and
individuals trained in point of care settings, and proficient in performing tests using the LumiraDx
Instrument.
The LumiraDx SARS-CoV-2 Ag Test is only for use under the Food and Drug Administration's
Emergency Use Authorization.
Document Name:
1 of 21
Document Number:
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
SARS-CoV-2 Ag Test Strip Product Insert
S-COM-DOUT-00112
Date of Revision 2020/08
Revision: 2