Abbott BinaxNOW COVID-19 Ag Card Home Test Instruction Manual

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Abbott BinaxNOW COVID-19 Ag Card Home Test Instruction Manual

Abbott BinaxNOW COVID-19 Ag Card Home Test Instruction Manual

BinaxNOW ™COVID-19 AgCARD HOME TESTHealthcare Provider Instructions for UseFor Use Under an Emergency Use Authorization (EUA) OnlyFor use with nasal swab specimensFor in vitro Diagnostic Use OnlyFor 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-19by 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 differentiate between SARS-CoV and SARS-CoV-2.Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. The 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 onsistent 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 that 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 in 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 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 ProvidedTest Cards (1): A cardboard, book-shaped hinged test card containing the test stripExtraction Reagent (1): Bottle containing <1 mL of extraction reagentNasal Swabs (1): Sterile swab for use with BinaxNOW COVID-19 Ag Card Home testMaterials Required but not ProvidedClock, timer or stopwatchSmart Phone:* Apple is ios11 or newerAndroid is version 8 or newer*Required to download the NOVICA app from the Google play store or Apple app store

PRECAUTIONS

For in vitro diagnostic use.
This test has not been FDA cleared or approved but has been authorized by FDA under a EUA.
Federal Law restricts this device to sale by or on the order of a licensed practitioner (the US only).
This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.
This product is only authorized for the duration of the declaration that circumstances exist justifying the authorizationof emergency use of in vitro diagnostics for the 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.
Proper sample collection and handling are essential for correct results.
Leave test card sealed in its foil pouch until just before use. Do not use if the pouch is damaged or open.
Do not touch the swab tip when handling the swab sample.
Do not use the kit past its expiration date.
Do not mix components from different kit lots.
All kit components are single-use items. Do not use with multiple specimens. Do not reuse the used test card.
Wash hands thoroughly or uses hand sanitizer after handling.
Dispose of kit components and patient samples in household trash.
INVALID RESULTS can occur when an insufficient 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 is 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 TESTDO NOT OPEN ITEMS UNTIL INSTRUCTED TO DO SOWash or sanitize your hands. Make sure they are drybefore starting.

Set-UpIt is recommended gloves (not provided) also be used during testing.DO NOT open items until instructed.
Open Pouch and Scan QR Code on
Open CardCard must stay FLAT on the table for the entire test.

DO NOT touch any parts of the inside of the card.
Apply Fluid to Top Hole

A. Remove dropper bottle cap. B. Hold dropper bottle straight over TOP HOLE,not at an angle. B. Hold dropper bottle straight over TOP HOLE,not at an angle.

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

Open SwabKeep fingers away from the 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 the left nostril.	B. Firmly brush against insides of the nostril in a circular motion 5 times or more for at least 15 seconds

Swab Right NostrilA. Remove the swab and insert it into the right nostril.B. Firmly brush against the insides of the 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 HoleKeep card FLAT on the table.Insert swab tip into BOTTOM HOLE and firmly push up until tip fills TOP HOLE.
Turn Swab 3 TimesKeep card FLAT on the 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 in prior to closing the card.
Peel StripDO NOT remove the swab. Keep card FLAT on the table.Keep the swab in place. Peel adhesive liner off.
Close Card and SealDO NOT remove the swab. Keep card FLAT on the table.The close left side of the card over the swab to seal it. Keep card face up on the table.
Wait 15 MinutesDO NOT disturb the card during this time.Note: False results can occur if the card is disturbed/moved or test results are read before 15 minutes.
Scan QR Code
Show Result to Your Proctor

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:

Check for a Positive Result
Check for a Negative Result
Check for an Invalid Result

Check for Positive COVID-19 Result

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

Positive Result: Two pink/purple lines will appear. One on the top half and one on the bottom half.COVID-19 was detected.

CONTROLSAMPLE

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

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

CONTROLSAMPLE

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.

Check for Invalid ResultIf you see any of these, the test is invalid.

CONTROLSAMPLE

Dispose In Trash

Reporting Patient Results Using the NAVICA appUpon 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:

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 an inadequate extraction buffer 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 differentiate 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 PROVIDERSThe 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: [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.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-2Tests provided by the Centers for Disease Control and Prevention (available at: https://www.cdc.gov/csels/dls/sars-cov2-livd-odes.html).

PERFORMANCE CHARACTERISTICSCLINICAL PERFORMANCEClinical 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 staff 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

BinaxNOWT” COVI D-19 AgCard Home Test	Comparator Method
Positive	Negative	Total
Positive	22	0	22
Negative	2	28	30
Total	24	28	52′
Positive Agreement: 22/24 91.7% (95% CI: 73.0% – 989%)
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 the 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 the 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” COVI D-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: 3381343 98.5% (95% CI: 96.6% – 99.5%)

Hazardous Ingredients for the Reagent Solution

Chemical Name/CAS	G HS Code for each Ingredient	Concentration
Sodium Azide/26628-22-8	Acute Tox. 2 (Oral), H300Acute 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.

Patient demographics, the time elapsed since the onset of symptoms for all patients enrolled in the above study, are presented in the table below. Positive results are broken down by days since symptom onset:

Days SinceSymptom Onset	Cumulative RT-PC R Positive (+)	Cumulative BinaxNOW’COVI D-19 Ag Card Positive (+)	PPA	95 % ConfidenceInterval
1	12	10	83.%	52.%	98.%
2	34	28	82.%	66.%	93.%
3	50	41	82.%	69.%	91A%
‘1	63	50	79A%	67.%	89.%
5	78	63	81.%	70.%	89.%
6	90	75	83.%	74.%	90.%
7	117	99	85.%	77.%	91.%
8 to 10	144	118	82.%	75.%	88.%
11 to 14	161	126	78.%	71.%	84.%
All specimens	167	129	77.%	70.%	83.%

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 PERFORMANCELimit of Detection (Analytical Sensitivity)BinaxNOW COVID-19 Ag Card Home Test limit of detection (LOD) was determined by evaluating different 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 TCID50/mL.Limit of Detection (LoD) Study Results

ConcentrationTCID50/Ml	ConcentrationTCID50/mL	% Detected
140.6	20/20	100%

Cross-Reactivity (Analytical Specificity) and Microbial InterferenceCross-reactivity and potential interference of BinaxNOW COVID-19 Ag Card Home Test were 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 organisms, viruses, and yeast were tested in triplicate in the absence or presence of heat-inactivated SARS-CoV-2 virus (45 TCID50/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′ TCIDso /mL
Human metapneumovirus (hMPV)	1.0 x 10′ TCIDso/mL
Rhinovirus	1.0 x 10′ PFU/mL
Enterovirus/Coxsackievirus B4	1.0 x 10′ TCIDso/mL
Human coronavirus 0C43	1.0 x 10′ TCIDso/mL
Human coronavirus 229E	1.0 x 10′ TCIDso/mL
Human coronavirus N L63	1.0 x 10′ TCIDso/mL
Human parainfluenza virus 1	1.0 x 10′ TCIDso/mL
Human parainfluenza virus 2	1.0 x 10′ TCIDso/mL
Human parainfluenza virus 3	1.0 x 10′ TCIDso/mL
Human parainfluenza virus 4	1.0 x 10′ TCIDso/mL
Influenza A	1.0 x 10′ TCIDso/mL
Influenza B	1.0 x 10′ TCIDso/mL
Respiratory Syncytial Virus A	1.0 x 10′ PFU/mL

Bacteria	Bordetella pertussis	1.0 x 10° cells/mL
Chlomydio pneumoniae	1.0 x 10° IFU/mL
Haemophilus influence	1.0 x 10° cells/mL
Legionello pnuemophila	1.0 x 10° cells/mL
Mycoplasmo pneumonioe	1.0 x 10° U/mL
Streptococcus pneumoniae	1.0 x 10° cells/mL
Streptococcus pyogenes (group A)	1.0 x 10° cells/mL
Mycobacterium tuberculosis	1.0 x 10° cells/mL
Staphylococcus oureus	1.0 x 106 org/mL
Staphylococcus epidermidis	1.0 x 106 org/mL
Pooled human nasal wash	N/A
Yeast	Candida Albicans	1.0 x 10° 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 crossreactivity in theBinaxNOW COVID-19 Ag Card is 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 EffectNo high dose hook effect was observed when tested with up to a concentration of 1.6 x 105 TCID50/mL of heat-inactivated SARS-CoV-2 virus with the BinaxNOW COVID-19 Ag Card Home Test.Endogenous Interfering SubstancesThe 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 affect 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, Luffaopperculata	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

1 Testing demonstrated false negative results at concentrations of 5 mg/mL (0.5% w/v). Standard dose of nasal ointment:20 mg (2% w/w) of mupirocin in single-use 1-gram tubes.

Human Factors StudyAbbott conducted a human factor study to evaluate whether home user patients or caregivers (lay users) 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 in interpretation. Participants were asked to read and interpret a panel of 9 different 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 difficult 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 StudyAbbott 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) of home users produced a valid result (all negative) and 2 participants produced an invalid result.(The causes of the invalid tests were the insufficient to 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 labelings on the different 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.
	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.

TECHNICAL SUPPORT ADVICE LINEFurther information can be obtained from your Telehealth provider, or by contacting Technical Support on:US+ 1 800 257 9525[email protected]

Abbott Diagnostics Scarborough, Inc.10 Southgate RoadScarborough, Maine 04074 USAwww.globalpointofcare.abbott© 2021 Abbott. All rights reserved.All trademarks referenced are trademarks of either the Abbott group of companies or their respective owners.IN195100 Rev.3 2021/03

AbbottBinaxNOWCOVID-19 Ag Card Home TestPI – ENSize:Flat size: 8.375″ x 10.75″Finished: 8.375″ x 5.375″

Incoming Inspection Colors

PN: IN195100Rev: 3Date of Last Revision:3.4 2021/03/28

FAQS

What is the BinaxNOW™ COVID-19 Ag Card Home Test?

What is SARS?

Severe acute respiratory syndrome (SARS) is a viral respiratory illness that was first reported in November 2002 in Southern China. SARS belongs to a group of viruses called coronaviruses.

What are the symptoms of SARS?

Symptoms include fever, cough, sore throat, muscle aches, headache, and chills. Some people also have nausea, vomiting, diarrhea, or abdominal pain. People usually develop these symptoms one to seven days after being exposed to SARS. Most people recover in a few days without serious complications. However, some people may develop pneumonia or other life-threatening conditions. There is no specific treatment for SARS; most people recover on their own in about two weeks.

How does one get infected with SARS?

The virus spreads from person to person when an infected person coughs or sneezes and another person inhales the virus. People can also become infected through direct contact with infected animals such as civet cats and other wild animals that carry the virus; however, this type of transmission has been rare since 2003 when the last known animal infection was reported in China. No cases have been reported in the United States since 2004.

How common is SARS?

The disease was first identified in November 2002 and spread rapidly throughout Asia and then to North America and Europe before it began to decline around mid-2003 as a result of effective control measures implemented by public health authorities worldwide. Since 2004 there have been no known cases of human infection with SARS anywhere in the world outside China and Taiwan where both human and animal infections continue to occur sporadically; however, there have been no recent reports indicating that human infections have occurred in either country since 2006. In addition, there have been no reports indicating that any individual has contracted SARS outside China or Taiwan since 2004 despite over 10 million visitors from these countries entering the United States each year during that time period. Therefore, CDC considers it extremely unlikely that any traveler will contract S

Why use COVID Self Tests?

Our BinaxNOW Self Tests can provide the confidence needed to continue engaging in your communities as other COVID-19 safety measures begin to dissipate. Testing before and after events, school, work or social engagements gives you and your loved ones confidence, especially if you have loved ones who are at a higher risk.

How do I test myself or someone else?

Using the BinaxNOW Self Test is simple, even if you have never tested yourself before. You simply will perform a lower nostril nasal swab (not the deeper nasopharyngeal swab) and everything you need (swab, test card and reagent solution) is included in the box. Each test kit comes with an illustrated quick reference guide to walk you through the process step by step.

Who should use this test?

The test is indicated for all people aged 15 years or older and for children as young as 2 years old when samples are collected by an adult. The test can be used for people with and without symptoms.

Should people who were vaccinated use this test?

Testing will remain an essential part of our short- and long-term COVID-19 recovery strategy. The BinaxNOW Self Test will be a key tool alongside vaccination as we get back to life. We don’t yet know how long vaccines confer immunity and how variants will evolve.

How will people report their test results?

People can now self-report test results through our NAVICA app. In addition, people are encouraged to follow the latest CDC guidelines, which is to communicate your results to your healthcare provider, who is responsible for reporting your test results to the state health department.

How many tests come in a package?

There are two tests (as well as two swabs and reagents) in each box.

How long should people wait between taking BinaxNOW Self Tests?

The tests should be administered twice over three days with at least 24 hours (and no more than 48 hours) between tests.

Can the BinaxNOW Self Test be thrown into the garbage after use?

You can recycle the box, but should dispose of the test card, nasal swab and test solution in common household waste, in line with the test’s instructions for use.

How do I know if I have a positive or negative test?

To check for a positive result, look at the result window for two pink or purple lines. Even a faint line next to the word “sample” on the test card is a positive result. A negative result will have only one pink or purple line on the top half of the results window where it says “control.”

What if my test result is invalid?

If your results window has any of the following, the test result may be invalid:No lines appear by control or sampleThe control line is blue and not pink/purpleThere is a pink/purple line by sample, but no line by controlThe control line is blue, but the sample is pink/purpleIf you see an invalid result, contact our technical support on this number: +1 833-637-1594.

Can the tests still work after sitting in cold or hot temperatures?

Yes. A storage temperature range is very common in OTC health products. For BinaxNOW, it’s between 35.6 and 86° F and the test should be kept within this range. But if the test is stored outside the temperature range for a relatively short period of time – for a couple of hours up to a day or two – it will be fine to use, and it’s important is that test and its components be used at room temperature.

Are these at-home tests covered by insurance?

BinaxNOW is FSA and HSA eligible, but be sure to contact your health insurance provider to determine reimbursement eligibility. Beginning January 15, most people with a health plan are able to purchase an at-home test at no cost either through reimbursement or free of charge through their insurance. To learn more about this program, visit here or contact your insurance provider.

How do I know what day my BinaxNOW Self Test expires?

For the BinaxNOW COVID-19 Self Test, please reference the expiration date printed on the back of the box, next to the hourglass symbol, as the expiration date for your tests.

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Posted

2023-01-23

Abbott

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Abbott, BinaxNOW COVID-19 Ag Card Home Test