HEALGEN Coronavirus Antigen Rapid Test

HEALGEN
Coronavirus Ag Rapid Test

COVID-19 Overview

The novel coronaviruses belong to the  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 a few 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

THIS PRODUCT IS NOT FOR SALE IN THE U.S.

THIS PRODUCT IS NOT FOR SALE IN THE U.S.

Specification

Contents

• 20 Test cassettes • 20 Sterile swabs
• 20 Extraction tubes and dropper tips
• 1 Workstation • 1 Buffer • 1 Package insert

Performance Characteristics

The Coronavirus Ag Rapid Test Cassette (Swab) has been evaluated with specimens obtained from patients. A commercialized molecular assay was used as the reference method. The results show that the Coronavirus Ag Rapid Test Cassette (Swab) has a high overall relative accuracy.

Relative Sensitivity: 86.7%
Relative Specificity: 100%
Accuracy: 96.3%

THIS PRODUCT IS NOT FOR SALE IN THE U.S.

HEALGEN FACT SHEET

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