EUA AbtDX BNAgselftest Ifu
EUA AbtDX BNAgselftest Ifu
EUA AbtDX BNAgselftest Ifu
INTENDED USE
The BinaxNOW™ COVID-19 Antigen Self Test is a lateral flow immunoassay intended for the
qualitative detection of nucleocapsid protein antigen from SARS-CoV-2.
This test is authorized for non-prescription home use with self-collected anterior nasal (nares)
swab samples from individuals aged 15 years or older with symptoms of COVID-19 within the first
seven days of symptom onset. This test is also authorized for non-prescription home use with
adult collected anterior nasal (nares) swab samples from individuals aged two years or older with
symptoms of COVID-19 within the first seven days of symptom onset.
This test is also authorized for non-prescription home use with self-collected anterior nasal
(nares) swab samples from individuals aged 15 years or older, or adult collected anterior nasal
(nares) swab samples from individuals aged two years or older, with or without symptoms or other
epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 24
hours (and no more than 48 hours) between tests.
The BinaxNOW COVID-19 Antigen Self 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 anterior nasal (nares) swabs during the acute phase of infection. Positive
results indicate the presence of viral antigens, but clinical correlation with past medical 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. Individuals who test positive with the BinaxNOW™ COVID-19
Antigen Self Test should self-isolate and seek follow-up care with their physician or healthcare
provider as additional testing may be necessary.
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 an individual’s recent exposures, history and the presence of clinical signs and
symptoms consistent with COVID-19.
For serial testing programs, additional confirmatory testing with a molecular test for negative
results may be necessary, if there is a high likelihood of COVID-19, such as, an individual with a
close contact with COVID-19 or with suspected exposure to COVID-19 or in communities with
high prevalence of infection. Additional confirmatory testing with a molecular test for positive
results may also be necessary, if there is a low likelihood of COVID-19, such as in individuals
without known exposures to COVID-19 or residing in communities with low prevalence of
infection.
Individuals who test negative and continue to experience COVID-like symptoms of fever, cough
and/or shortness of breath may still have SARS-CoV-2 infection and should seek follow up care
from their healthcare provider.
Individuals should report their test result through the NAVICA app and provide all results
obtained with this product to their healthcare provider in order to receive appropriate medical
care. All 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.
The BinaxNOW COVID-19 Antigen Self Test is intended for non-prescription self-use and/or, as
applicable for an adult lay user testing another person aged 2 years or older in a non-laboratory
setting. The BinaxNOW COVID-19 Antigen Self Test is only for use under the Food and Drug
Administration’s Emergency Use Authorization.
The BinaxNOW COVID-19 Antigen Self Test is a rapid lateral flow immunoassay for the
qualitative detection of SARS-CoV-2 directly from anterior nasal swabs, without viral transport
media. The BinaxNOW COVID-19 Antigen Self Test kit contains all components required to carry
out an assay for SARS-CoV-2.
To perform the test, an anterior nasal swab specimen is collected by 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.
BinaxNOW COVID-19 Antigen Self Test instructions for use are provided as a paper copy within
the test kit, available digitally via website link (www.binaxnow-selftest.abbott) or digitally via the
NAVICA app downloaded to a compatible smart phone. Compatible smart phone includes Apple
iPhone running Operation System (iOS): latest major version and two prior major versions
(iPhone running iOS v12 or later), and Android Phones: latest major version and two prior major
versions (Android phone running Android OS v9 or later).
PRECAUTIONS
Positive Result
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.
Negative Result
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.
For serial testing programs, additional confirmatory testing with a molecular test for negative
results may be necessary, if there is a high likelihood of COVID-19, such as, an individual with a
close contact with COVID-19 or with suspected exposure to COVID-19 or in communities with
high prevalence of infection. Additional confirmatory testing with a molecular test for positive
results may also be necessary, if there is a low likelihood of COVID-19, such as in individuals
without known exposures to COVID-19 or residing in communities with low prevalence of
infection.
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 Antigen Self 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 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 Antigen Self Test
and may cause false negative results.
• Negative results are presumptive, 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 from patients without symptoms or other
epidemiological reasons to suspect COVID-19 infection or for serial screening, when tested
twice over three days with at least 24 hours (but no more than 48 hours) between tests has
not been determined, a study to support use will be completed.
• Testing for asymptomatic individuals should be performed at least twice over three days, with
at least twenty-four hours and no more than 48 hours between tests. You may need to
purchase additional tests to perform this serial (repeat) testing.
• There is a higher chance of false negative results with antigen tests than with laboratory-based
molecular tests. This means that there is a higher chance this test will give you a negative
result when you have a COVID-19.
• Serial testing (i.e., testing every day or every other day) is more likely to detect COVID-19,
especially when you do not have any symptoms.
• If the differentiation of specific SARS viruses and strains is needed, additional testing, in
consultation with state or local public health departments, is required.
• The performance of this test was established based on the evaluation of a limited number of
clinical specimens collected in November 2020. The clinical performance has not been
established in all circulating variants but is anticipated to be reflective of the prevalent
variants in circulation at the time and location of the clinical evaluation. Performance at the
time of testing may vary depending on the variants circulating, including newly emerging
strains of SARS-CoV-2 and their prevalence, which change over time.
PERFORMANCE CHARACTERISTICS
CLINICAL PERFORMANCE
Clinical performance characteristics of BinaxNOW COVID-19 Antigen Self 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 Antigen Self 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 Antigen Self 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 Antigen Self 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 Antigen Self 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 Antigen Self Test Performance within 7 days of symptom
onset against the Comparator Method
BinaxNOW COVID-19 Comparator Method
Ag 2 Card Home Test 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% - 98.9%)
Negative Agreement: 28/28 100.0% (95% CI: 87.7% - 100.0%)
*1 sample generated an invalid BinaxNOW COVID-19 Ag 2 Card result (0.1% invalid rate)
The performance of this test has not yet been clinically validated for use in patients without signs
and symptoms of respiratory infection or for serial screening applications, and performance may
differ in these populations.
Performance of BinaxNOW COVID-19 Antigen Self 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 Antigen Self 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.
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:
Cumulative
Days Since Cumulative BinaxNOW
95 % Confidence
Symptom RT-PCR COVID-19 PPA
Interval
Onset Positive (+) Antigen Self Test
Positive (+)
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 Antigen Self 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 Antigen Self Test LOD in natural nasal swab matrix was confirmed
140.6 TCID 50 /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 Antigen Self Test 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 Effect
No 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 Antigen Self
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
Antigen Self Test at the concentrations listed below and were found not to affect test performance.
Usability Study
Abbott conducted a study to evaluate whether a home user can follow instructions and
successfully perform the test steps for the BinaxNOW COVID-19 Antigen Self Test, including nasal
swab collection at home, and correctly interpreting the results.
100 home users, including individuals (n=50) and caregivers (n=50), participated in the study.
Each individual or caregiver pair participated in a 60-minute session with a single proctor. The
usability evaluation session included one simulated use of the BinaxNOW COVID-19 Antigen Self
Test and opportunities to provide feedback.
92% (92 out of 100) home users produced a valid result (all negative) and 8 participants produced
an invalid result.
100% (99 out of 99) of the home (individual and caregiver) participants correctly understood that
failure to follow the test steps correctly would potentially lead to an invalid or inaccurate result or
would require another test or consultation with a healthcare provider. (One participant was
inadvertently not asked this question by the moderator during the session).
SYMBOLS
This symbol indicates that the product is for single use only. It is not to be re-used.
This symbol indicates that you should consult the instructions for use.
This symbol indicates the name and location of the product manufacturer.
This symbol indicates that the total number of tests provided in the kit box
US
+ 1 833 637 1594 [email protected]