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Nano-Check TM COVID-19 Antigen Test

The Nano-CheckTM COVID-19 Antigen Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from 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.

Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high or waived complexity 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.

  • For use under emergency use authorization (EUA) only
  • For in vitro diagnostic use
  • For prescription use only
  • For use with kit provided nasopharyngeal swab
  • Lateral flow assay
  • Detect SARS-CoV-2 nucleocapsid protein antigen
  • Rapid results within 15-20 minutes

Clinical performance

Positive Agreement: 90.32%
Negative Agreement: 100.0%

Interpretation

Do not interpret the test past after 20 minutes.

Positive

Appearance of pinkish red colored bands at both the control line and the test line indicates positive result. The colored test line depending on the concentration of SARS-CoV-2 virus in the test specimen will appear. The line in the control region (C) is the control line, which is used to indicate proper performance of the device. The color intensity of the test lines may be weaker or stronger than that of the control line.

Negative

A single pinkish red colored band at the control line without visual test line is a negative result. Negative result does not indicate the absolute absence of SARS-CoV-2 virus in specimen or rule out COVID-19; it only indicates that the specimen does not contain the virus concentration at above the detection limit of the level. Note: Negative results should be treated as presumptive and may be confirmed with a molecular assay, if necessary, for patient management.

Invalid

If no lines are seen or no colored line appears in the control region(C), the test result is invalid. If the invalid result is obtained during initial testing, the assay should be repeated with a new test device

Nasopharyngeal Swab Sample Procedure

1. To collect the nasopharyngeal swab sample, tilt the patient’s head back 70 degrees. Carefully insert the swab into the nostril that presents the most secretion under visual inspection. Slowly insert the swab parallel to the palate until resistance is encountered, or the distance is equivalent to that from the ear to the nostril of the patient. Rotate the swab several times, leave the swab in place for several seconds to absorb secretions and then remove it from the nasopharynx.
2. Remove the cap
3. Insert the swab into the reagent tube
4. Swirl and plunge the swab for 15 sec while squeezing the tube. Swirl and plunge the swab up and down in the extraction buffer while squeezing the sides of the tube for 15 seconds
5. Remove the swab while squeezing the sides of the tube to the swab head for extracting the maximum amount of liquid from the swab. Properly discard the swab.
6. Firmly close the dropper tip onto the Reagent tube containing the sample
7. With the processed Reagent Tube hold vertically, squeeze gently to dispense 2 drops of the sample into the sample well of the test device.
8. Read the results at 15 minutes visually. Do not read result more than 20 minutes after the sample application

Order information

Catalog No. Product Name Package
ND-MD8147 Nano-CheckTM COVID-19 Antigen Test 20 Tests/Box

Link for downloading documents

259 Prospect Plains Road, Building K. Cranbury, NJ 08512
Tel: 609-409-3300, 1+855+297+7877     Fax: 609-409-3377     E-mail: Info@nanoditech.com
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