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ANALYTICAL PERFORMANCE
Limit of Detection (Analytical Sensitivity)
BinaxNOW COVID-19 Antigen Self Test limit of detection (LOD) was determined by evaluating
dierent 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.
Limit of Detection (LoD) Study Results
Concentration
TCID
50
/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 Antigen Self 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
50
/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
50
/mL
Human metapneumovirus (hMPV) 1.0 x 10
5
TCID
50
/mL
Rhinovirus 1.0 x 10
5
PFU/mL
Enterovirus/Coxsackievirus B4 1.0 x 10
5
TCID
50
/mL
Human coronavirus OC43 1.0 x 10
5
TCID
50
/mL
Human coronavirus 229E 1.0 x 10
5
TCID
50
/mL
Human coronavirus NL63 1.0 x 10
5
TCID
50
/mL
Human parainfluenza virus 1 1.0 x 10
5
TCID
50
/mL
Human parainfluenza virus 2 1.0 x 10
5
TCID
50
/mL
Human parainfluenza virus 3 1.0 x 10
5
TCID
50
/mL
Human parainfluenza virus 4 1.0 x 10
5
TCID
50
/mL
Influenza A 1.0 x 10
5
TCID
50
/mL
Influenza B 1.0 x 10
5
TCID
50
/mL
Respiratory Syncytial Virus A 1.0 x 10
5
PFU/mL
Bacteria
Bordetella pertussis 1.0 x 10
6
cells/mL
Chlamydia pneumoniae 1.0 x 10
6
IFU/mL
Haemophilus influenzae 1.0 x 10
6
cells/mL
Legionella pnuemophila 1.0 x 10
6
cells/mL
Mycoplasma pneumoniae 1.0 x 10
6
U/mL
Streptococcus pneumoniae 1.0 x 10
6
cells/mL
Streptococcus pyogenes (groupA) 1.0 x 10
6
cells/mL
Mycobacterium tuberculosis 1.0 x 10
6
cells/mL
Staphylococcus aureus 1.0 x 10
6
org/mL
Staphylococcus epidermidis 1.0 x 10
6
org/mL
Pooled human nasal wash N/A
Yeast Candida albicans 1.0 x 10
6
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 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 Eect
No high dose hook effect was observed when tested with up to a concentration of
1.6 x 10
5
TCID
50
/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.
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,
Lua 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 Mupirocin1 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.
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 that the product has a temperature limitation.
This symbol indicates the name and location of the product manufacturer.
This symbol indicates the product’s catalog number.
IVD
For In Vitro Diagnostic Use.
This symbol indicates that the total number of tests provided in the kit box.
TECHNICAL SUPPORT ADVICE LINE
US
Abbott Diagnostics Scarborough, Inc.
10 Southgate Road
Scarborough, Maine 04074 USA
www.binaxnow-selftest.abbott
© 2021 Abbott. All rights reserved.
All trademarks referenced are trademarks of either the Abbott group of companies
ortheirrespective owners.
IN195151 Rev. 1 2021/04
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