JusChek SARS-CoV-2 Antigen Rapid Tests (Nasal Swab) (INCP-502H) TGA Approved
Juschek SARS-CoV-2 Antigen Rapid Tests (Nasal Swab) (INCP-502H)
The SARS-CoV-2 Antigen Rapid Test (Nasal Swab) is a lateral flow chromatographic immunoassay single-use test kit intended to qualitative detect the SARS-CoV-2 that causes COVID-19 with self-collected nasal swab specimen.
- Clinical Sensitivity: High sensitivity
- Date Approved: 31 December 2021
USE
- The SARS-CoV-2 Antigen Rapid Test (Nasal Swab) is intended for use in symptomatic individuals meeting the case definition for COVID-19 within the first 7 days of symptom onset.
- Results are for the detection of SARS-CoV-2 Nucleocapsid protein Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection.
- Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status.
- Positive results are indicative of the presence of SARS-CoV-2. Individuals who test positive should self-isolate and seek additional care from their healthcare provider.
- Positive results do not rule out bacterial infection or co-infection with other viruses.
- Negative results do not preclude SARS-CoV-2 infection. Individuals who test negative and continue to experience COVID-like symptoms should seek to follow up care from their healthcare provider.
- Obtains a preliminary result only, an aid diagnosis of COVID-19, for the final confirmation should be based on clinical diagnostic results.
- Intended to be as a self-test for
home and workplace ( offices, for sporting events,workshops,schools, all purpose.)
Pack Contents
- Test cassette
- Package insert
- Sterile swab
- Extraction buffer
- Biosafety bag