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RAPID ANTIGEN
The Ultimate POC Test With Reliable Results Within Minutes
STAGE 2: RAPID DIAGNOSTICS
Principle of the Test
The Coronavirus Ag Rapid Test Cassette (Swab) is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect nucleocapsid protein from SARS-CoV-2 in nasopharyngeal (NP) swab.
The test strip is composed of the following parts: namely sample pad, reagent pad, reaction membrane, and absorbing pad. The reagent pad contains the colloidal-gold conjugated with the monoclonal antibodies against the nucleocapsid protein of SARS-CoV-2; the reaction membrane contains the secondary antibodies for nucleocapsid protein of SARS-CoV-2. The whole strip is fixed inside a plastic device.
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
PCR versus POC Tests
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.
Many physicians like to confirm when a patient is positive from the antigen (serology) test. Historically, most physicians have used the nasal swab PCR test (collect the specimen and send to a lab).
The compliant is the time it takes to receive results (lately, that has been 7-14 days). Rapid Antigen Test Instead of sending the nasal swab specimen to a lab and wait 7-14 days for results, we have the Healgen Rapid Antigen Test Kit available which produces results in 15 minutes! The antigen test detects the presence of the nucleocapsid protein—which is part of the SARS-CoV-2 virus that is the cause of COVID19. This is a point-of-care test.
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%