For Rapid Detection of SARS-CoV-2 | FDA EUA | IVD Use | RX Only | MPN 195-000 | CPT Code: 87811
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The BinaxNOW™ COVID-19 Ag Card 40 Pack Box (195-000) is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs from individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset.
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.
Negative results should be treated as presumptive, 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.
The BinaxNOW™ COVID-19 Ag Card is intended for use by medical professionals or trained operators who are proficient in performing rapid lateral flow tests. BinaxNOW™ COVID-19 Ag Card is only for use under the Food and Drug Administration’s EUA.
The contents below are per a box (40 Tests):
Test Cards (40): A cardboard, book-shaped hinged test card containing the test strip
Extraction Reagent (1): Bottle containing 7.5 mL of extraction reagent
Nasal Swabs (40): Sterile swabs for use with BinaxNOW COVID-19 Ag Card test
Positive Control Swab (1) : Non-infectious recombinant SARS-CoV-2 nucleocapsid antigen dried onto a swab
Negative Control Swab: The use of a sterile patient swab ensures appropriate negative results are obtained
Product Insert (1)
Procedure Card (1)
BINAXNOW COVID-19 AG CARD (PN 195-000) – INSTRUCTIONS FOR USE
Please note that all Peach Medical shipments do not require signature upon delivery. Since most test kits should be stored between 35.6 and 86 degrees F range, we strongly recommend that you track your order and anticipate its delivery. However, 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 as long as the test and it’s components are used at room temperature. Peach Medical is not responsible if the test kits are left outside in extreme temperatures for longer than the recommended time frame after delivery.
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Clinical performance characteristics of BinaxNOW™ COVID-19 Ag Card were evaluated in a multisite prospective study in the U.S in which patients were sequentially enrolled and tested. A total of ten (10) investigational sites throughout the U.S. participated in the study. Testing was performed by operators with no laboratory experience and who are representative of the intended users at CLIA waived testing sites. In this study, testing was conducted by sixty-two (62) intended users. To be enrolled in the study, patients had to be presenting at the participating study centers with suspected COVID-19. Patients who presented within 7 days of symptom onset were included in the initial primary analysis. Two nasal swabs were collected from patients and tested using the BinaxNOW™ COVID-19 Ag Card at all study sites. 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.
At all sites, one nasal swab was tested directly in the BinaxNOW™ COVID-19 Ag Card test according to product instructions and the other swab was eluted in viral transport media (VTM).
Swabs were randomly assigned to testing with the BinaxNOW or RT-PCR testing and were tested by minimally trained operators who were blinded to the RT-PCR test result. All sites shipped the VTM sample to a central testing laboratory for RT-PCR.
External control testing, using BinaxNOW™ COVID-19 Ag Card Positive and Negative Controls, was performed prior to sample testing each day, at all study sites.
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™ COVID19 Ag Card
Positive Agreement: 99/117 84.6% (95% CI: 76.8% - 90.6%)
Negative Agreement: 338/343 98.5% (95% CI: 96.6% - 99.5%)
Patient demographics (gender and age) are available for the 460 samples used in the analysis of patients with symptom onset within the previous seven (7) days. The table below shows the positive results broken down by age of the patient:
Age Comparator Method
Total # Positive Prevalence
< 5 years 0 - -
6 to 21 years 17 3 17.6%
22 to 59 years 312 79 25.3%
60 years 131 35 25.4%
Patient demographics, time elapsed since onset of symptoms for all patients enrolled, are patients with symptom onset greater than seven days should be interpreted with caution, as the sensitivity of the assay decreases over time.
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