ALL TEST COVID-19 Rapid Antigen Test Single kit (Oral Fluid)

Description

INTENDED USE

The COVID-19 Rapid Antigen Test (oral) is a single-use test kit intended to detect the novel coronavirus SARSCoV-2 that causes COVID-19 in human oral fluid. This test is designed for home use with self-collected oral fluid samples from symptomatic individuals who are suspected of being infected with COVID-19 within the first 7 days of symptom onset.
The COVID-19 Rapid Antigen  Test (oral) obtain a preliminary result only, the final confirmation should be based on clinical diagnostic results.
The COVID-19  Rapid Antigen Test (oral) is intended to be used by laypersons as a self-test for home and workplace (in offices, for sporting events, airports, schools, etc.)

SUMMARY

The novel coronaviruses belong to the β 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 diarrhoea are found in a few cases.

PRINCIPLE

The COVID-19 Rapid Antigen  Test (Oral Fluid) is a qualitative membrane-based immunoassay for the detection of SARSCoV-2 Antigens in human oral fluid specimen.

REAGENTS

The test device contains anti-SARS-CoV-2 antibodies.

WARNING

1. Read the entire package insert prior to performing test.
2. For self-testing in vitro diagnostic use only.
3. The test is for one time use only, do not reuse the test. Do not use after expiration date.
4. Do not eat, drink or smoke in the area where the specimens or kits are handled.
5. Do not drink the buffer in the kit. Carefully handle the buffer and avoid it contacting skin or eyes, rinse with plenty of running water immediately if contact occurs.
6. Do not use test if pouch is damaged.
7. Wash hands thoroughly before and after handling.
8. If the result is preliminary positive, share your test result with your healthcare provider and carefully follow your local COVID guidelines/requirements.
9. Test for children and young people should be used with an adult.
10.The used test should be discarded according to local regulations.

STORAGE

Store the test at 35.6-86°F (2-30°C). Do not open the pouch until ready for use. DO NOT FREEZE

ITEMS PROVIDED

Test device Buffer Package insert Biosafety Bag Collection device (Funnel, tube and tube tip)

 

• Negative Rapid Antigen test results do not exclude infection with SARS-CoV-2 (COVID-19); and
• Positive test results or symptomatic persons require immediate confirmatory testing using a polymerase chain reaction (PCR) test.
• Follow current government health messaging regarding polymerase chain reaction (PCR) testing requirements in your relevant State or Territory. https://www.health.gov.au/health-alerts/covid-19/testing
• Negative test results do not exclude infection with COVID-19 (so face masks, social distancing and good hygiene practice must be maintained)