Healgen COVID-19 Antigen Rapid Test Cassette (Nasal Swab)

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  • Product Information
  • Package Contents
  • Test Procedure
  • Approvals & Clinical Studies

Coronavirus Ag Rapid Test

COVID-19 Overview

The novel coronaviruses belong to the B genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in new cases.

Antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Rapid diagnosis of SARS-CoV-2 infection will help healthcare professionals to treat patients and control the disease more efficiently and effectively.

Product Information

The Coronavirus Ag Rapid Test Cassette (Swab) is an in vitro immunochromatographic assay for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in
nasopharyngeal (NP) swab specimens directly or after the swabs have been added to viral transport media from individuals who are suspected of COVID-19 by their healthcare
provider. It is intended to aid in the rapid diagnosis of SARS-CoV-2 infections. The Coronavirus Ag Rapid Test Cassette (Swab) does not differentiate between SARS-CoV and
SARS-CoV-2.

Benefits

• Rapid testing for SARS-CoV-2 antigen within 15 minutes
• Facilitates patient treatment decisions quickly
• Simple, time-saving procedure
• All necessary reagents provided & no equipment needed
• High sensitivity and specificity

Warning : This test has not been reviewed by the FDA. Negative results do not rule out SARS-CoV-2 infection, particularly those who have been in contact with the virus. Follow up testing with a molecular diagnostic test should be considered to rule out infection in these individuals.

Use of this test is limited to laboratories certified to perform high complexity testing, including testing at point-of-care when the site is covered by the laboratory's CLIA certificate of high-complexity testing.

This test is not for home-use or at-home specimen collection.

What Comes In The Box?

Package Contents:

  • 20 Test Cassettes
  • 20 Sterile Swabs
  • 20 Extraction Tubes and Dropper Tips
  • 1 Workstation
  • 1 Buffer
  • 1 Package Insert