Abbot NAVICA App Administrator Quick Reference Guide
NAVICA™
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ADMINISTRATOR
Perform the BinaxNOW™ COVID-19 Ag Card
test and communicate encrypted test results
using the NAVICA™ Administrator App.
QUICK REFERENCE GUIDE
1
3
Log in to the NAVICA™ Administrator
App, and select Begin New Test.
Verify the participant’s
identity with a photo ID.
4
Scan the participant’s unique NAVICA ID
2
Scan the BinaxNOW™ COVID-19 Ag Card QR code
to link the participant’s NAVICA ID to the test card.
QR code using the camera on your tablet.
5
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1 BinaxNOW COVID-19 Ag Product Insert
For Use Under an Emergency Use Authorization (EUA) Only
For use with nasal swab specimens
For in vitro Use Only
INTENDED USE
The BinaxNOW
™
COVID-19 Ag Card is a lateral flow immunoassay intended
for the qualitative detection of nucleocapsid protein antigen from SARS-
CoV-2 in direct nasal swabs from individuals suspected of COVID-19 by their
healthcare provider within the first seven 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 BinaxNOW COVID-19 Ag Card does not dierentiate 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 swabs 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 symptom onset beyond seven 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 the presence of clinical signs and symptoms consistent with
COVID-19.
The BinaxNOW COVID-19 Ag Card is intended for use by medical
professionals or trained operators who are proficient in performing rapid lateral
flow tests. BinaxNOW COVID-19 Ag Card is only for use under the Food and
Drug Administration’s Emergency Use Authorization.
SUMMARY and EXPLANATION of the TEST
Coronaviruses are a large family of viruses which may cause illness in animals
or humans. SARS-CoV-2 is an enveloped, single-stranded RNA virus of the
β genus. The virus can cause mild to severe respiratory illness and has spread
globally, including the United States.
BinaxNOW COVID-19 Ag Card is a rapid lateral flow immunoassay for the
qualitative detection and diagnosis of SARS-CoV-2 directly from nasal swabs,
without viral transport media.
The BinaxNOW COVID-19 Ag Card kit contains all components required to
carry out an assay for SARS-CoV-2.
PRINCIPLES of the PROCEDURE
The BinaxNOW COVID-19 Ag Card is an immunochromatographic membrane
assay that uses highly sensitive antibodies to detect SARS-CoV-2 nucleocapsid
protein from nasal swab specimens. SARS-CoV-2 specific antibodies and a
control antibody are immobilized onto a membrane support as two distinct
lines and combined with other reagents/pads to construct a test strip. This test
strip and a well to hold the swab specimen are mounted on opposite sides of a
cardboard, book-shaped hinged test card.
To perform the test, a nasal swab specimen is collected from the patient, 6 drops
of extraction reagent from a dropper bottle are added to the top hole of the swab
well. The patient sample is inserted into the test card through the bottom hole of
the swab well, and firmly pushed upwards until the swab tip is visible through the
top hole. The swab is rotated 3 times clockwise and the card is closed, bringing
the extracted sample into contact with the test strip. Test results are interpreted
visually at 15 minutes based on the presence or absence of visually detectable
pink/purple colored lines. Results should not be read after 30 minutes.
REAGENTS and MATERIALS
Materials Provided
Test Cards (40): A cardboard, book-shaped hinged test card containing the
test strip
Extraction Reagent (1): Bottle containing 10 mL of extraction reagent
Nasal Swabs (40): Sterile swabs for use with BinaxNOW COVID-19 Ag Card test
Positive Control Swab (1): Non-infectious recombinant SARS-CoV-2
nucleocapsid antigen dried onto a swab
Negative Control Swab: The use of a sterile patient swab ensures appropriate
negative results are obtained
Product Insert (1)
Procedure Card (1)
Materials Required but not Provided
Clock, timer or stopwatch
Materials Available as an Optional Accessory
Swab Transport Tube Accessory Pack
PRECAUTIONS
1. For in vitro diagnostic use.
2. This test has not been FDA cleared or approved; this test has been
authorized by FDA under an EUA for use by laboratories certified under
the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42
U.S.C. §263a, to perform moderate, high, or waived complexity tests and
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.
3. Federal Law restricts this device to sale by or on the order of a licensed
practitioner (US only).
4. This test has been authorized only for the detection of SARS-CoV-2
antigen, not for any other viruses or pathogens.
5. 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 Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization
is terminated or revoked sooner.
COVID-19 Ag
BinaxNOW
™
CARD
6
Collect the nasal swab
and perform the test.
(See the BinaxNOW™
COVID-19 Ag Card Product
Insert, including the quality
control section, for complete
use instructions, warnings,
precautions and limitations.)
To enter the result into the NAVICA™ Administrator App, rescan the QR
code on the test card to confirm the link between the test and the participant.
Visually interpret the results
7
on the test card and enter
the results in the NAVICA
Administrator App with a
single tap.
THE PARTICIPANT WILL RECEIVE A PUSH NOTIFICATION AND BE NOTIFIED
VIA EMAIL TO REVIEW THEIR ENCRYPTED RESULT IN THE NAVICA APP.
YOUR FACILITY WILL SEPARATELY NOTIFY THE PARTICIPANT
VIA YOUR REGULAR PROCESS FOR LAB TEST REPORTING.
The BinaxNOW™ COVID-19 Ag Card EUA has not been FDA cleared or approved. It has been authorized by the FDA under an
emergency use authorization for use by authorized laboratories. The test has been authorized only for the detection of proteins from
SARS-CoV-2, not for any other viruses or pathogens, and 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 Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
© 2020 Abbott. All rights reserved. All trademarks referenced are trademarks of either the Abbott group of companies or their
respective owners. Any photos displayed are for illustrative purposes only. 120007266-01 09/20
PINK/PURPLE
CONTROL LINE
PINK/PURPLE
SAMPLE LINE
POSITIVE
RESULT
NEGATIVE
RESULT
See the Product Insert for full result interpretation instructions.
INVALID
RESULT
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