Detects
FAST
The Nano-Check™ COVID-19 Antigen Test is a lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 in direct nasopharyngeal swab specimens collected from individuals who are suspected of COVID-19 by their healthcare provider within the first five (5) days of symptoms onset or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests.
All Reagents
Included
Reagents and Materials Included:
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20 Test devices in sealed aluminum foil pouch with desiccant
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20 Reagent tubes with extraction buffer (0.3 mL)
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20 Sample collection swabs
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1 Positive control swab
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1 Negative control swab
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1 Instructions for Use/ Quick Reference Instruction
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fifteen
minutes
Test results are interpreted at 15-20 minutes visually. The presence of
two pinkish red colored lines in the control line “C” and test line “Ag”
indicates COVID-19 positive. The presence of one colored line in the
control line “C” indicates COVID-19 negative. The control line (C)
must be present in the test window for self-procedure validation control.
This colored control band always appears at the control line position (C)
in valid test result.
12 volt DC Input
For Included AC Power Adapter
What Are the Steps to Complete the Test?
Steps:​
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1. Collect specimen
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2. Remove cap and insert swab into Reagent tube
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3. Swirl and plunge swab up and down while squeezing tube for 15 seconds
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4. Remove swab while squeezing tube and close dropper tip onto Reagent tube
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5. Hold tube vertically and dispense two drops into sample well
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6. Read results at 15 minutes
Emergency Use Authorization by the FDA
In the USA, this product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories; use by laboratories certified under the CLIA, 42 U.S.C. §263a, that meet requirements to perform moderate complexity, high complexity, or waived tests. This product is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. In the USA, the emergency use of 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 the virus that causes 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 the authorization is revoked sooner.
