LumiraDx SARS-CoV-2 User manual

1 of 21
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
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 Date of Revision 2020/08
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.

2 of 21
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
Caution: For in vitro diagnostic use.
Before you start testing, if you are new to the LumiraDx Instrument and LumiraDx Platform,
you must read the LumiraDx Platform User Manual, the LumiraDx SARS-CoV-2 Ag Test Quick
Reference Instructions and this entire Product Insert. Information available here:
https://www.lumiradx.com/us-en/what-we-do/diagnostics/test-technology/antigen-test
Summary and explanation of the Test:
The World Health Organisation (WHO) have named the disease caused by SARS-CoV-2 virus as
coronavirus 2019 or COVID-191. The most common symptoms of COVID-19 are fever, tiredness, and
dry cough. Some patients may have aches and pains, nasal congestion, headache, conjunctivitis, sore
throat, diarrhea, loss of taste or smell, or a rash on skin or discoloration of fingers or toes. These
symptoms are usually mild and begin gradually. Some people become infected but do not develop any
symptoms and do not feel unwell. However, the disease can develop rapidly and have high morbidity
in certain populations, especially those with underlying health conditions. The disease can spread from
person to person through small droplets from the nose or mouth which are spread when a person with
COVID-19 coughs or exhales. Most estimates of the incubation period for COVID-19 range from 2-14
days2.
The use of a LumiraDx SARS-CoV-2 Ag Test will enable the physician to verify infection quickly, begin
proper treatment and to initiate isolation precautions helping prevent further spread of infection.
Principle of the assay:
The LumiraDx SAR-CoV-2 Ag Test is a single use fluorescence immunoassay device designed to
detect the presence of the nucleocapsid protein antigen directly from SARS-CoV-2 in nasal swab
specimens, without transport media.
The test procedure involves collecting a nasal specimen using a recommended swab which is eluted
into a vial containing extraction buffer. A single drop of the specimen in extraction buffer is added to the
Test Strip using the vial dropper cap provided. The LumiraDx Instrument is programmed to perform the
test protocol using the dried reagents contained within the strip. The test result is determined from the
amount of fluorescence the Instrument detects within the measurement zone of the Test Strip. The
concentration of the analyte in the specimen is proportional to the fluorescence detected. The results
are displayed on the Instrument touchscreen within 12 minutes from the addition of the sample.
Materials provided:
•LumiraDx Test Strips packed individually in sealed desiccant foil pouches.
•LumiraDx Test Product Insert
•RFID (Radio frequency ID) Tag held inside the Test Strip carton
•Extraction Buffer Vials
•Dropper Lids
•LumiraDx SARS-CoV-2 Ag Test Quick Reference Instructions

3 of 21
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
Materials required but not provided with the Test Strip carton:
•LumiraDxInstrument
•Standard nasal swab collection equipment. Please refer to the Limitations section of this
product insert for information on recommended swabs.
•LumiraDx SARS-CoV-2 Ag Quality Controls (as required to meet local and organisational
compliance)
•LumiraDxConnect if connectivity required (refer to LumiraDxConnect User Manual)
Warnings and precautions
•For in vitro diagnostic use only
•For prescription use only.
•This test has not been FDA cleared or approved; the test has been authorized by FDA under
an Emergency Use Authorization (EUA) for use by laboratories certified under the CLIA 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.
•This test is only authorized for the duration of the declaration that circumstances exist
justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or
diagnosis of 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.
•This test has been authorized only for the detection of proteins from SARS-CoV-2, not for any
other viruses or pathogens.
•Do not open the test strip until ready for immediate use.
•Discard and do not use any damaged or dropped Test Strips or other materials.
•Inadequate or inappropriate sample collection, storage, and transport can result in incorrect
results.
•The test cannot be visually interpreted; the LumiraDx Instrument must be used to generate
results.
•Do not use the kit components beyond the expiration date
•Do not reuse any kit components.
•Specimens must be processed as indicated in the Sample Extraction and Performing a Test
sections of this Product Insert. Failure to follow the instructions for use can result in inaccurate
results.
•All components of this kit should be discarded as Biohazard waste according to Federal, State
and local regulatory requirements.
•Refer to the product safety data sheet for risk and safety phrases and disposal information. The
product safety data sheet is available via our website at https://lumiradx.com/us-en/what-we-
do/diagnostics/test-technology/antigen-test.
•Exercise the normal precautions required for handling all laboratory reagents. Wear protective
clothing such as laboratory coats, disposable gloves, and eye protection when specimens are
collected and evaluated.
•Proper laboratory safety techniques should be followed at all times when working with SARS-
CoV-2 patient samples. Patient swabs, used Test Strips and used extraction buffer vials may
be potentially infectious. Proper handling and disposal methods should be established by the
laboratory in accordance with local, state and federal regulations.
•Reagents encapsulated within the Test Strip are present in extremely small amounts and where
any component is of animal origin, the source is certified as free from infectious or contagious
material – however, should any reagent become exposed it should be treated as potentially
infectious.

4 of 21
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
Storing the Test Strips: Store the Test Strips in their original carton. You can store the Test Strips at
a temperature between 2°C and 30°C (36°F and 86°F). Avoid freezing or storing in any area that could
exceed 30°C. When stored properly, the Test Strips can be used until the expiration date printed on the
Test Strip foil pouch and the Test Strip carton. Discard the Test Strips if they are passed the expiration
date.
Handling the Test Strips: When you are ready to perform a test, open the Test Strip carton, take out
a Test Strip, and remove it from the foil pouch. After removing the Test Strip from the foil pouch, it
should be used immediately. Do not use the Test Strip if there are any visible signs of damage to the
foil pouch such as tears or holes.
Sample material:
The following samples can be used with the LumiraDx SARS-CoV-2 Ag Test Strip:
•Nasal Swab Specimen (NS)
The Test device contains:
•Rabbit and mouse monoclonal antibodies
•Fluorescent particles
•Magnetic particles
•Buffer and stabilising agents
Preparing the Instrument to perform a Test:
Power on the Instrument by pressing the power button at the rear of the Instrument. You will hear the
Instrument powering on, and the display will be a blank black screen for several seconds before starting
up. If the screen is just dimmed tap the touch-screen to wake up the Instrument.
Refer to the section on Performing a Test in this Product Insert for information on how to test a Patient
sample. The LumiraDx Quick Reference Instructions (QRI) provide an illustrated step-by-step
procedure on how to run a Test.
The Instrument will prompt to install the Lot Calibration File when inserting a new Test Strip Lot. Once
installed, the Instrument will have all the information required to process the test, and any future tests
from the same Lot of Test Strips.

5 of 21
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
When indicated by the touchscreen, open the foil pouch just before use and insert the LumiraDx Test
Strip into the LumiraDx Instrument. The Instrument will indicate when it is ready for the sample to be
applied.
The LumiraDx SARS-CoV-2 Ag Test results should be evaluated by a Healthcare Professional in the
context of all available clinical and laboratory data.
Instructions for sample collection:
When collecting any type of sample, follow universal collection precautions and guidelines according to
your organization. For specimen collection of nasal swabs, follow the Centers for Disease Control and
Prevention (CDC) Swab Collection Guidelines and swab manufacturers’ recommendations. Users
should be trained in appropriate specimen collection and handling procedures.
The steps that follow apply to a nasal swab. For information on recommended swabs to use with the
LumiraDx SARS-CoV-2 Ag Test, please refer to the Limitations section of this Product Insert.

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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
Sampling from a nasal swab:
After patient swabbing, process the Swab in the Extraction Vial as soon as possible. Do not
place the swab back into the swab packaging sleeve after specimen collection.
1. Tilt patient’s head back 70°
2. A swab sample is needed from both nostrils, and this
is taken using the same swab. While gently rotating
the swab, insert swab less than one inch into the first
nostril until resistance is met at Turbinates.
(Turbinates are the small structures inside the nose).
3. Rotate the swab several times against the nasal
wall. Remove and repeat this process by using the
same swab into the second nostril. Then place the
Swab into the Extraction Vial. See instructions for
Sample Extraction.

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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
Instructions for sample extraction:
1)
2)
3)
4)
Remove the seal from the top of the Extraction Vial containing the
Extraction Buffer.
Place and soak the Patient Swab in the Extraction Buffer for 10
seconds and then stir well by rotating the swab against the side of
the vial 5 times.
Firmly attach Dropper Lid to the top of the Extraction Vial. The
extracted sample must be used within 5 hours of preparation when
stored at room temperature. Extracted nasal specimens may be
frozen at -80°C and used up to 5 days after freezing.
Squeeze Swab Remove the Patient Swab while squeezing the
middle of the Extraction Vial to remove the liquid from the swab.
Discard the swab in biohazard waste.

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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
5)
Performing a Test (refer to the Quick Reference Instructions to make sure that your Instrument
has been prepared before starting this step).If using a frozen sample, the sample must be at room
temperature before testing.
1. Gently invert the Extraction Vial five times (5x) just before applying the sample to the Test Strip.
2. Apply the extracted sample from the Extraction Vial onto the Sample Application Area of the
inserted Test Strip. To do this gently press the sides of the extraction vial until one whole drop is
visible and allow it to touch the Sample Application Area of the Test Strip. The sample will then be
drawn by capillary action into the Test Strip. When the sample is detected the Instrument will sound
(if sounds are enabled) and a confirmation message will be displayed. The touchscreen of the
LumiraDx Instrument will request the user to immediately close the door (Note: you have 10
seconds only to close the door).
3. Do not add more than one drop of sample. Do not open the door while the test is in progress.
The touchscreen will indicate test progress.
4. The result will appear on the Instrument touchscreen within 12 minutes of applying the sample and
starting the test. The results will be displayed as a positive or negative result SARS-CoV-2-Ag
on the Instrument screen. (see Fig 1 and Fig 2).
5. Dispose of the swab, Extraction Vial and Test Strip in the appropriate biohazard waste.
6. 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.
7. If you need to retest, you will use a new Test Strip. Use the same extraction vial and repeat the
test. The extracted sample must be used within 5 hours of preparation when stored at room
temperature. Extracted nasal specimens may be frozen at -80°C and used up to 5 days after
freezing.
Gently invert the Extraction Vial five times just before applying
the sample to the Test Strip.

9 of 21
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
Result interpretation:
The results will be displayed on the Instrument screen - examples of result screen display:
NOTE: A negative result, 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
Invalid test 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. Refer to the
LumiraDx Platform User Manual if an error message is
displayed on the LumiraDx Instrument touch-screen
and contact LumiraDx Customer Services on
telephone number 1-888-586-4721.
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.
Fig 1: Negative result for
SARS-CoV-2 Ag
Fig 2: Positive result for
SARS-CoV-2 Ag

10 of 21
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 qualitycontrol 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.