BinaxNOW COVID-19 Ag Card Home Test

BinaxNOW

™

CARD HOME TEST

COVID19 Ag

1 BinaxNOW COVID-19 Ag Card Home Test Instructions for Use

For Use Under an Emergency Use Authorization (EUA) Only

For use with nasal swab specimens

For in vitro Diagnostic Use Only

For Prescription Home Use

INTENDED USE

The BinaxNOW

™

COVID-19 Ag Card Home Test is a lateral ﬂow immunoassay intended for the qualitative detection

of nucleocapsid protein antigen from SARS-CoV-2. This test is authorized for prescription home use with self-collected

observed direct anterior nasal (nares) swab samples from individuals aged 15 years or older who are suspected of COVID-19

by their healthcare provider within the ﬁrst seven days of symptom onset or adult collected nasal swab samples from

individuals aged four years or older who are suspected of COVID-19 by their healthcare provider within the ﬁrst seven

days of symptom onset. The BinaxNOW COVID-19 Ag Card Home Test is to be performed only with the supervision of

a telehealth proctor.

The BinaxNOW COVID-19 Ag Card Home Test does not dierentiate between SARS-CoV and SARS-CoV-2.

Results are for the identiﬁcation of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in anterior

nasal (nares) 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.

Negative results 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.

Individuals who test negative and continue to experience COVID-like symptoms should seek follow up care from their

healthcare provider.

BinaxNOW COVID-19 Ag Card Home Test is only for use under the Food and Drug Administration’s Emergency Use

Authorization.

All prescribing healthcare providers will report all test results they receive from individuals who use the authorized product

to relevant public health authorities in accordance with local, state, and federal requirements using appropriate LOINC and

SNOMED codes, as deﬁned by the Laboratory In Vitro Diagnostics (LIVD) Test Code Mapping for SARS-CoV-2 Tests

provided by CDC.

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.

The BinaxNOW COVID-19 Ag Card Home Test is a rapid lateral ﬂow immunoassay for the qualitative detection of

SARS-CoV-2 directly from nasal swabs, without viral transport media. The BinaxNOW COVID-19 Ag Card Home Test kit

contains all components required to carry out an assay for SARS-CoV-2.

PRINCIPLES of the PROCEDURE

The BinaxNOW COVID-19 Ag Card Home Test 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 under observation by or from the patient, then 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 (1): A cardboard, book-shaped hinged test card containing the test strip

Extraction Reagent (1): Bottle containing <1 mL of extraction reagent

Nasal Swabs (1): Sterile swab for use with BinaxNOW COVID-19 Ag Card Home test

Materials Required but not Provided

Clock, timer or stopwatch

Smart Phone:* Apple is ios11 or newer

Android is version 8 or newer

*Required to download the NAVICA app from the Google play store or Apple app store

COVID19 Ag

BinaxNOW

™

CARD HOME TEST

Healthcare Provider Instructions for Use

2 BinaxNOW COVID-19 Ag Card Home Test Instructions for Use

Set Up

It is recommended gloves (not provided) also be used during testing.

DO NOT open items until instructed.

1 Swab 1 Test Card 1 Bottle

nax

NOW

™

AMPLE

CON

Open Pouch and Scan QR Code on Card

If using a mobile device: If using a computer:

BinaxNOW

™

COVID-19 Ag

CARD

SAMPLE

CONTROL

PRECAUTIONS

1. For in vitro diagnostic use.

2. This test has not been FDA cleared or approved but has been authorized by FDA under an EUA.

3. Federal Law restricts this device to sale by or on the order of a licensed practitioner (US only).

4. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or

pathogens.

5. This product 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 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 declaration is terminated or

authorization is revoked sooner.

6. Proper sample collection and handling are essential for correct results.

7. Leave test card sealed in its foil pouch until just before use. Do not use if pouch is damaged or open.

8. Do not touch swab tip when handling the swab sample.

9. Do not use kit past its expiration date.

10. Do not mix components from dierent kit lots.

11. All kit components are single use items. Do not use with multiple specimens. Do not reuse the used test card.

12. Wash hands thoroughly or use hand sanitizer after handling.

13. Dispose of kit components and patient samples in household trash.

14. INVALID RESULTS can occur when an insucient volume of extraction reagent is added to the test card. To ensure

delivery of adequate volume, hold vial vertically, 1/2 inch above the swab well, and add drops slowly.

STORAGE and STABILITY

Store kit between 35.6-86°F (2-30°C). Ensure all test components are at room temperature before use. The BinaxNOW

COVID-19 Ag Card Home Test is stable until the expiration date marked on the outer packaging and containers.

INITIATING the TELEHEALTH VISIT

Upon receipt of the BinaxNOW COVID-19 Ag Home Test, the patient logs into NAVICA and selects, “I Already Have

a Test Kit”. The home user then visits the telehealth provider website to start testing and waits in queue to connect to the

telehealth proctor.

DIRECTIONS for RUNNING the BinaxNOW

™

COVID-19 Ag CARD HOME TEST

DO NOT OPEN ITEMS UNTIL INSTRUCTED TO DO SO

Wash or sanitize your hands. Make sure they are dry

before starting.

3 BinaxNOW COVID-19 Ag Card Home Test Instructions for Use

Open Card

Card must stay FLAT on table for entire test.

DO NOT

touch any

parts on

inside of card.

Apply Fluid to Top Hole

A. Remove dropper

bottle cap.

B. Hold dropper bottle

straight over TOP HOLE,

not at an angle.

C. Put 6 DROPS into

TOP HOLE. Do not

touch card with tip.

Note: False negative results may occur if less than 6 drops of fluid is used.

Open Swab

Keep fingers away from swab end.

A. Open swab package at stick end. B. Take swab out.

Swab Left Nostril

A. Insert the entire absorbent tip

of the swab (usually 1/2 to 3/4 of

an inch) into left nostril.

B. Firmly brush against insides of

nostril in a circular motion 5 times

or more for at least 15 seconds.

6 drops

Result Window

Test Strip

Top Hole

Bottom Hole

Up to 3/4 of

an inch.

4 BinaxNOW COVID-19 Ag Card Home Test Instructions for Use

Swab Right Nostril

A. Remove swab and insert it

into right nostril.

B. Firmly brush against insides of

nostril in a circular motion 5 times

or more for at least 15 seconds.

Note: False negative results may

occur if the nasal swab is not properly

collected.

Insert Swab Into Bottom Hole

Keep card FLAT on table.

Insert swab tip into BOTTOM HOLE and firmly push up until tip fills TOP HOLE.

Turn Swab 3 Times

Keep card FLAT on table.

Turn swab to right 3 times in card and leave it in place.

Note: False negative results can occur if the sample swab is not turned prior to closing the card.

Peel Strip

DO NOT remove swab.

Keep card FLAT on table.

Keep swab in place. Peel adhesive liner off.

5 BinaxNOW COVID-19 Ag Card Home Test Instructions for Use

Close Card and Seal

DO NOT remove swab.

Keep card FLAT on table.

Close left side of card over swab to seal it. Keep card face up on table.

Wait 15 Minutes

DO NOT disturb card during this time.

15:00

Note: False results can occur if the card is disturbed/moved or test results are read before 15 minutes.

Scan QR Code

If using a mobile device: If using a computer:

BinaxNOW

™

COVID-19 Ag

CARD

SAMPLE

CONTROL

Show Result to Your Proctor

BinaxNOW

™

COVID-19 Ag

CARD

SAMPLE

CONTROL

SAMPLE

CONTROL

6 BinaxNOW COVID-19 Ag Card Home Test Instructions for Use

RESULT INTERPRETATION

There are three types of results possible. You will be instructed how to read each type in a specific order. Follow this order

with your proctor:

1. Check for a Positive Result

2. Check for a Negative Result

3. Check for an Invalid Result

Check for Positive COVID-19 Result

Find result window and look carefully for two pink/purple lines in window.

• Positive Result: Two pink/purple lines will appear. One on the top half and one on the bottom half.

COVID-19 was detected.

CONTROL

PositivePositive

Solid Line Faint Line

SAMPLE

Look very closely!

The bottom line can be very

faint. Any pink/purple line

visible here is positive.

Here are photos of actual positive tests. On the right, note how faint the bottom line can get.

A positive test result for COVID-19 indicates that antigens from SARS-CoV-2 were detected, and the patient is

very likely to be infected with the virus and presumed to be contagious. Test results should always be considered in the

context of clinical observations and epidemiological data (such as local prevalence rates and current outbreak/epicenter

locations) in making a ﬁnal diagnosis and patient management decisions. Patient management should follow current

CDC guidelines.

Check for Negative COVID-19 Result

Find result window and look for a single pink/purple line in window.

• Negative Result: A single pink/purple line on the top half where it says "Control." COVID-19 was not detected.

CONTROL

No Line

Negative

A negative test result for this test means that antigens

from SARS-CoV-2 were not present in the specimen

above the limit of detection. However, a negative result

does not rule out COVID-19 and should not be used

as the sole basis for treatment or patient management

decisions, including infection control decisions. The

amount of antigen in a sample may decrease as the

duration of illness increases. Negative results should be

treated as presumptive and conﬁrmed with a molecular

assay, if necessary, for patient management.

SAMPLE

Check for Invalid Result

If you see any of these, the test is invalid.

CONTROL

No lines seen

Blue control

line only

Pink/purple

sample line only

Blue control line AND

pink/purple sample line

SAMPLE

Dispose In Trash

BinaxNOW

™

COVID-19 Ag

CARD

SAMPLE

CONTROL

7 BinaxNOW COVID-19 Ag Card Home Test Instructions for Use

Reporting Patient Results Using the NAVICA app

Upon completion of the test and result interpretation by the user, the telehealth proctor will send the results to the

user via the NAVICA app and the telehealth provider will report results to relevant public health authorities. The user

will be notiﬁed by email and on their mobile device that their results are ready. The user will go to the results screen in

NAVICA to obtain their results.

If the BinaxNOW COVID-19 Ag Card Home Test result is Negative, the user will receive the following:

If the BinaxNOW COVID-19 Ag Card Home Test result is Positive, the user will receive the following:

8 BinaxNOW COVID-19 Ag Card Home Test Instructions for Use

If the BinaxNOW COVID-19 Ag Card Home Test result is Invalid, the user will receive the following:

LIMITATIONS

• This test detects both viable (live) and non-viable, SARS-CoV, and SARS-CoV-2. Test performance depends on the

amount of virus (antigen) in the sample and may or may not correlate with viral culture results performed on the same

sample.

• A negative test result may occur if the level of antigen in a sample is below the detection limit of the test.

• The performance of the BinaxNOW COVID-19 Ag Card Home Test was evaluated using the procedures provided in

this product insert only. Modiﬁcations to these procedures may alter the performance of the test.

• False negative results may occur if a specimen is improperly collected or handled.

• False negative results may occur if inadequate extraction buer is used (e.g., <6 drops).

• False negative results may occur if specimen swabs are not twirled within the test card.

• False negative results may occur if swabs are stored in their paper sheath after specimen collection.

• Positive test results do not rule out co-infections with other pathogens.

• False negative results are more likely after eight days or more of symptoms.

• Positive test results do not dierentiate between SARS-CoV and SARS-CoV-2.

• Negative test results are not intended to rule in other non-SARS viral or bacterial infections.

• The presence of mupirocin may interfere with the BinaxNOW COVID-19 Ag test and may cause false negative

results.

• Negative results do not rule out COVID-19 infection and it may be necessary to obtain additional testing with a

molecular assay, if needed for patient management.

• Performance of nasal swabs collected by an adult caregiver from a pediatric patient has not been determined, a study to

support use in a pediatric population is ongoing.

CONDITIONS of AUTHORIZATION for HEALTHCARE PROVIDERS

The BinaxNOW COVID-19 Ag Card Home Test Letter of Authorization, along with the authorized Fact Sheet for

Healthcare Providers, and authorized labeling are available on the FDA website: https://www.fda.gov/medical-devices/

coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas.

However, to assist Healthcare providers using the BinaxNOW COVID-19 Ag Card Home Test, the relevant Conditions of

Authorization are listed below:

A. All prescribing healthcare providers must collect information on the performance of your product in the ordinary

course of business and report to DMD/OHT7-OIR/OPEQ/CDRH (via email: CDRH-EUA-[email protected].

gov) and you (via email: [email protected], or via phone by contacting Abbott Diagnostics Scarborough, Inc.

Technical Service at 1-800-257-9525) any suspected occurrence of false positive or false negative results and

signiﬁcant deviations from the established performance characteristics of your product of which they become aware.

9 BinaxNOW COVID-19 Ag Card Home Test Instructions for Use

B. All prescribing healthcare providers must report all test results they receive from patients who use your product to

relevant public health authorities in accordance with local, state, and federal requirements, using appropriate LOINC

and SNOMED codes, as deﬁned by the Laboratory In Vitro Diagnostics (LIVD) Test Code Mapping for SARS-CoV-2

Tests provided by the Centers for Disease Control and Prevention (available at: https://www.cdc.gov/csels/dls/sars-cov-

2-livd-codes.html).

PERFORMANCE CHARACTERISTICS

CLINICAL PERFORMANCE

Clinical performance characteristics of BinaxNOW COVID-19 Ag Card Home Test was evaluated in an ongoing multi-site

prospective study in the U.S. A total of four (4) investigational sites throughout the U.S. participated in the study. To be

enrolled in the study, patients had to be presenting at the participating study centers with suspected COVID-19 within 7

days of symptom onset. Each Subject was provided a BinaxNOW COVID-19 Ag Card Home Test. Under the observation

and coaching of a clinical site sta member trained as a proctor, the Subject self-collected one (1) nasal swab and performed

the BinaxNOW COVID-19 Ag Card Home Test. Test results were interpreted and recorded by the Subject or other

home user and independently by the proctor. Parents of pediatric Subjects under the age of 14 or Legally Authorized

Representatives of adult Subjects unable to perform self-collection collected one (1) nasal swab from the Subject,

performed the BinaxNOW COVID-19 Ag Card Home Test, then interpreted and recorded the result for the patient.

An FDA Emergency Use Authorized real-time Polymerase Chain Reaction (RT-PCR) assay for the detection of SARS-

CoV-2 was utilized as the comparator method for this study.

The performance of BinaxNOW COVID-19 Ag Card Home Test was established with 53 nasal swabs collected from

individual symptomatic patients (within 7 days of onset) who were suspected of COVID-19.

BinaxNOW

™

COVID-19 Ag Card Home Test Performance within 7 days of symptom onset against the

Comparator Method

BinaxNOW

™

COVID-19 Ag

Card Home Test

Comparator Method

Positive Negative Total

Positive 22 0 22

Negative

28 30

Total

24 28 52*

Positive Agreement: 22/24 91.7% (95% CI: 73.0% - 98.9%)

Negative Agreement: 28/28 100.0% (95% CI: 87.7% - 100.0%)

*1 sample generated an invalid BinaxNOW COVID-19 Ag Card result (0.1% invalid rate)

Performance of BinaxNOW COVID-19 Ag Home Test, with the test performed and results interpreted by the home

user is similar to performance obtained by test operators with no laboratory experience. Due to the relatively small sample

size for the home use clinical study, at the time of the interim analysis, the BinaxNOW COVID-19 Ag Card Home Test

positive agreement established in this ongoing clinical study is estimated to be between 73.0% and 98.9% as reflected

in the 95% Confidence Interval. This is consistent with the performance established in a separate multi-site study in the

US, where the BinaxNOW COVID-19 Ag Card test was performed and results interpreted by test operators with no

laboratory experience. In that study, BinaxNOW COVID-19 Ag Card test positive agreement was 84.6% (95% CI: 76.8%

- 90.6%), refer below:

The performance of BinaxNOW COVID-19 Ag Card was established with 460 nasal swabs collected from individual

symptomatic patients (within 7 days of onset) who were suspected of COVID-19.

BinaxNOW

™

COVID-19 Ag Card Performance within 7 days of symptom onset against the Comparator

Method

BinaxNOW

™

COVID-19 Ag Card

Comparator Method

Positive Negative Total

Positive 99 5 104

Negative 18 338 356

Total 117 343 460

Positive Agreement: 99/117 84.6% (95% CI: 76.8% - 90.6%)

Negative Agreement: 338/343 98.5% (95% CI: 96.6% - 99.5%)

Hazardous Ingredients for the Reagent So

lution

Chemical Name/CAS GHS Code for each Ingredient Concentration

Sodium Azide/26628-22-8 Acute Tox. 2 (Oral), H300

Acute Tox. 1 (Dermal), H310

0.0125%

The solution in the tube contains a hazardous ingredient (see table above). If the solution contacts the skin or eye, ﬂush

with plenty of water. If irritation persists, seek medical advice. http://www.poison.org/contact-us or 1-800-222-1222.

10 BinaxNOW COVID-19 Ag Card Home Test Instructions for Use

Patient demographics, time elapsed since onset of symptoms for all patients enrolled in the above study, are presented in

the table below. Positive results broken down by days since symptom onset:

Days Since

Symptom Onset

Cumulative RT-

PCR Positive (+)

Cumulative BinaxNOW

™

COVID-19 Ag Card Positive (+)

PPA

95 % Conﬁdence

Interval

1 12 10 83.3% 51.6% 97.9%

2 34 28 82.4% 65.5% 93.2%

3 50 41 82.0% 68.6% 91.4%

4 63 50 79.4% 67.3% 88.5%

5 78 63 80.8% 70.3% 88.8%

6 90 75 83.3% 74.0% 90.4%

7 117 99 84.6% 76.8% 90.6%

8 to 10 144 118 81.9% 74.7% 87.9%

11 to 14 161 126 78.3% 71.1% 84.4%

All specimens 167 129 77.2% 70.1% 83.4%

A cohort of patients who presented with symptom onset greater than seven days were enrolled in the clinical study

(n = 161). The positive agreement in patients with symptoms greater than seven days was 60% (30/50) and negative

agreement was 98% (109/111). Therefore, negative results in patients with symptom onset greater than seven days should

be interpreted with caution, as the sensitivity of the assay decreases over time.

ANALYTICAL PERFORMANCE

Limit of Detection (Analytical Sensitivity)

BinaxNOW COVID-19 Ag Card Home Test limit of detection (LOD) was determined by evaluating dierent

concentrations of heat inactivated SARS-CoV-2 virus. Presumed negative natural nasal swab specimens were eluted

in PBS. Swab eluates were combined and mixed thoroughly to create a clinical matrix pool to be used as the diluent.

Inactivated SARS-CoV-2 virus was diluted in this natural nasal swab matrix pool to generate virus dilutions for testing.

Contrived nasal swab samples were prepared by absorbing 20 microliters of each virus dilution onto the swab. The contrived

swab samples were tested according to the test procedure.

The LOD was determined as the lowest virus concentration that was detected ≥ 95% of the time (i.e., concentration at

which at least 19 out of 20 replicates tested positive).

The BinaxNOW COVID-19 Ag Card Home Test LOD in natural nasal swab matrix was conﬁrmed as 140.6 TCID/mL.

Limit of Detection (LoD) Study Results

Concentration

TCID/mL

Number

Positive/Total

% Detected

140.6 20/20 100%

Cross Reactivity (Analytical Speciﬁcity) and Microbial Interference

Cross reactivity and potential interference of BinaxNOW COVID-19 Ag Card Home Test was evaluated by testing 37

commensal and pathogenic microorganisms (8 bacteria, 14 viruses, 1 yeast and pooled human nasal wash) that may be

present in the nasal cavity. Each of the organism, viruses, and yeast were tested in triplicate in the absence or presence of

heat inactivated SARS-CoV-2 virus (45 TCID/swab). No cross-reactivity or interference was seen with the following

microorganisms when tested at the concentration presented in the table below.

Potential Cross-Reactant Test Concentration

Virus

Adenovirus

1.0 x 10

⁵

TCID



/mL

Human metapneumovirus (hMPV) 1.0 x 10⁵ TCID/mL

Rhinovirus 1.0 x 10⁵ PFU/mL

Enterovirus/Coxsackievirus B4 1.0 x 10⁵ TCID/mL

Human coronavirus OC43 1.0 x 10⁵ TCID/mL

Human coronavirus 229E 1.0 x 10⁵ TCID/mL

Human coronavirus NL63 1.0 x 10⁵ TCID/mL

Human parainﬂuenza virus 1 1.0 x 10⁵ TCID/mL

Human parainﬂuenza virus 2 1.0 x 10⁵ TCID/mL

Human parainﬂuenza virus 3 1.0 x 10⁵ TCID/mL

Human parainﬂuenza virus 4 1.0 x 10⁵ TCID/mL

Inﬂuenza A 1.0 x 10⁵ TCID/mL

Inﬂuenza B 1.0 x 10⁵ TCID/mL

Respiratory Syncytial Virus A 1.0 x 10⁵ PFU/mL

11 BinaxNOW COVID-19 Ag Card Home Test Instructions for Use

Potential Cross-Reactant Test Concentration

Bacteria

Bordetella pertussis 1.0 x 10⁶ cells/mL

Chlamydia pneumoniae 1.0 x 10⁶ IFU/mL

Haemophilus inﬂuenzae 1.0 x 10⁶ cells/mL

Legionella pnuemophila 1.0 x 10⁶ cells/mL

Mycoplasma pneumoniae 1.0 x 10⁶ U/mL

Streptococcus pneumoniae 1.0 x 10⁶ cells/mL

Streptococcus pyogenes (group A) 1.0 x 10⁶ cells/mL

Mycobacterium tuberculosis 1.0 x 10⁶ cells/mL

Staphylococcus aureus 1.0 x 10 org/mL

Staphylococcus epidermidis 1.0 x 10 org/mL

Pooled human nasal wash N/A

Yeast Candida albicans 1.0 x 10⁶ cells/mL

To estimate the likelihood of cross-reactivity with SARS-CoV-2 virus in the presence of organisms that were not available

for wet testing, In silico analysis using the Basic Local Alignment Search Tool (BLAST) managed by the National Center for

Biotechnology Information (NCBI) was used to assess the degree of protein sequence homology.

• For P. jirovecii one area of sequence similarity shows 45% homology across 18% of the sequence, making cross-

reactivity in the BinaxNOW COVID-19 Ag Card highly unlikely.

• No protein sequence homology was found between M. tuberculosis, and thus homology-based cross-reactivity can be

ruled out.

• The comparison between SARS-CoV-2 nucleocapsid protein, MERS-CoV and human coronavirus HKU1 revealed that

cross-reactivity cannot be ruled out. Homology for KHU1 and MERS-CoV is relatively low, at 37.8% across 95% of

the sequence and 57.14% across 87% of the sequence, respectively.

High Dose Hook Eect

No high dose hook eect was observed when tested with up to a concentration of 1.6 x 10 TCID/mL of heat inactivated

SARS-CoV-2 virus with the BinaxNOW COVID-19 Ag Card Home Test.

Endogenous Interfering Substances

The following substances, naturally present in respiratory specimens or that may be artiﬁcially introduced into the nasal

cavity or nasopharynx, were evaluated with the BinaxNOW COVID-19 Ag Card Home Test at the concentrations listed

below and were found not to aect test performance.

Substance Active Ingredient Concentration

Endogenous

Mucin 2% w/v

Whole Blood 1% v/v

OTC Nasal Drops Phenylephrine 15% v/v

OTC Nasal Gel Sodium Chloride (i.e. NeilMed) 5% v/v

OTC Nasal Spray 1 Cromolyn 15% v/v

OTC Nasal Spray 2 Oxymetazoline 15% v/v

OTC Nasal Spray 3 Fluconazole 5% w/v

Throat Lozenge Benzocaine, Menthol 0.15% w/v

OTC Homeopathic Nasal Spray 1

Galphimia glauca, Sabadilla, Lua

opperculata

20% v/v

OTC Homeopathic Nasal Spray 2 Zincum gluconium (i.e., Zicam) 5% w/v

OTC Homeopathic Nasal Spray 3 Alkalol 10% v/v

OTC Homeopathic Nasal Spray 4 Fluticasone Propionate 5% v/v

Sore Throat Phenol Spray Phenol 15% v/v

Anti-viral Drug Tamiﬂu (Oseltamivir Phosphate) 0.5% w/v

Antibiotic, Nasal Ointment Mupirocin 0.25% w/v

Antibacterial, Systemic Tobramycin 0.0004% w/v

 Testing demonstrated false negative results at concentrations of 5 mg/mL (0.5% w/v). Standard dose of nasal ointment:

2 mg (2% w/w) of mupirocin in single-use 1-gram tubes.

12 BinaxNOW COVID-19 Ag Card Home Test Instructions for Use

Human Factors Study

Abbott conducted a human factor’s study to evaluate whether home user patients or caregivers (lay user) could perform

the test and accurately interpret test results from the BinaxNOW COVID-19 Ag Card under the supervision of a trained

proctor.

In this study, a total of 31 lay users, age 15 and older with either good or corrected vision (far/near-sighted or wear bifocals)

participated in a 45-minute session including an introduction, a product overview, and simulated use cases of BinaxNOW

COVID-19 Ag Card Home test result interpretation. Participants were asked to read and interpret a panel of 9 dierent

BinaxNOW COVID-19 Ag Card test results, including high positive, low positive, negative and invalid under the guidance

of a virtual proctor. Participants and virtual proctors were blinded to the test card results.

22/30 participants described the process of reading and interpreting the test card results as being easy. However, 8/30 of

the participants commented that it was dicult to see some of the fainter line conditions.

A total of 270 trials were recorded in this study. Participants were able to perceive and interpret the results correctly for

239 trials, or 89% of the time. Positive results with stronger intensity lines were easier to read than the positive lines with

less intensity. As the line intensity became fainter, the ability to read the result correctly ranged from 83% to 60%, with an

overall rate of 70%.

After the human factors evaluation, participants were asked for their overall impressions of the instructional materials they

were provided. Nearly all participants (29/30) thought the instructions were straightforward and easy to understand and

follow.

Based on the learnings from this study improvements were made to the Quick Reference Guide and Proctor training.

Usability Study

Abbott conducted a study to evaluate whether a home user can follow instructions from a trained proctor through a

virtual platform and successfully perform the test steps for the BinaxNOW COVID-19 Ag Card test, including nasal swab

collection at home, and correctly interpreting the results.

60 home users, including individuals (n=30) and caregivers (n=30), participated in the study. Each individual or caregiver

pair participated in a 45-minute session with a single proctor. The usability evaluation session included one simulated use

of the BinaxNOW COVID-19 Home Test Kit in which a user was already connected with a proctor, knowledge tasks, and

opportunities to provide feedback.

96.7% (58 out of 60) home users produced a valid result (all negative) and 2 participants produced an invalid result.

(The causes of the invalid tests were insucient amount of reagent added, and damage to the test strip). 58 out of 60

participants interpreted their test result correctly and 2 participants interpreted their result incorrectly (where they

perceived a faint line in the sample window (as positive) when there was none (all results were veriﬁed by the study

moderator).

The individual home use group completed 96.8% (1103/1140) of the total tasks/steps correctly. The caregiver home user

group completed 97.3% (1109/1140) of the total tasks/steps correctly. The most common use errors observed during

critical tasks included incorrectly swabbing the nostril to obtain a nasal sample and contacting the test strip with the hands

or with the surface.

90% (56 out of 60) of the home (individual and caregiver) participants had positive impressions of the BinaxNOW

COVID-19 Ag Card Home Test Kit. The test was perceived as being easy to use. The mixed feedback from three home user

participants included that some of the labeling on the dierent components was confusing and one participant reported

that they would not be comfortable performing this test without a medical professional present.

88% (53 out of 60) participants stated the Quick Reference Guide (QRG) shown on the screen while the participant

performed simulated use of the BinaxNOW COVID-19 Ag Card Home test was clear and easy to understand. 54 out of

60 participants felt their proctor that helped guide them through the workﬂow was helpful and provided clear instructions.

SYMBOLS

This symbol indicates that the product has a temperature limitation.

This symbol indicates the total number of tests provided in the kit box.

This symbol indicates that the product is for single use only. It is not to be re-used.

IVD

For In Vitro Diagnostic Use.

This symbol indicates that you should consult the instructions for use.

For Prescription Use Only.

This symbol indicates the product’s catalog number.

This symbol indicates the name and location of the product manufacturer.

13 BinaxNOW COVID-19 Ag Card Home Test Instructions for Use

TECHNICAL SUPPORT ADVICE LINE

Further information can be obtained from your Telehealth provider, or by contacting Technical Support on:

+ 1 800 257 9525 [email protected]

All trademarks referenced are trademarks of either the Abbott group of companies or their respective owners.

IN195100 Rev.3 2021/03

Abbott Diagnostics Scarborough, Inc.

10 Southgate Road

Scarborough, Maine 04074 USA

www.globalpointofcare.abbott

Abbott

BinaxNOW

COVID-19 Ag Card Home Test

PI - EN

Size:

Flat size: 8.375" x 10.75"

Finished: 8.375" x 5.375"

Printed Colors

PN: IN195100

Rev: 3

CMYK

Incoming Inspection Colors

Date of Last Revision:

3.4 2021/03/28

PMS 2995 U

Primary Blue

PMS 224 U

Magenta-Pink

PMS 303 U

Dark Blue