‧ This product is made in Singapore and clinically tested with the assistance of Health Gene Limited, a laboratory accredited by the Government Department of Health, and it is confirmed that the ARISTA Novel Coronavirus (COVID-19) Antigen Test Stick product fully complies with EU standards
‧ Unlike the use of blood-dropping antibody test, which is only effective for detection seven to ten days after infection, this antigen test (Antigen Test) is especially for early infection (two to three days) Virus test (COVID-19 Early Detection) and there are no symptoms. Can be effectively tested, so it is very suitable for people or helpers who need to work outside
‧ Add an extra layer of protection for family members and yourself, effectively reducing the risk of invisible patients spreading the virus inside and outside
The ARISTA™ Antigen Rapid Test is a highly scalable testing solution:
Accurate: with overall consistency results exceeding 95% when compared to RT-PCR testing
Affordable: as low as 10% of the cost of RT-PCR testing
Approved: CE marking in conformity with In-Vitro Diagnostic Devices Directive 98/79/EC
Easy: even possible for home use
Fast: results available onsite in 15 minutes
Portable: the entire test is supplied in a hand-sized pack with no additional equipment required
Sample collection method: deep throat sputum as the preferred method; or throat and tonsil (oropharyngeal) swab as an alternative method if sputum cannot be produced
Test kit contents: disposable swab (one); dropper tube (one); diluent vial (one); sputum dish (one); test cassette (one)
Storage conditions: 2 to 30°C away from direct sunlight; use within 12 months from date of manufacture
Conducting the Test
1. Insert the swab stick into the dropper tube and rinse it in the solution for 30 seconds with a turning motion
2. Remove the swab stick and dispose safely
3. Replace the purple screw top onto the dropper tube and shake vigorously
4. Remove the white screw cap from the tip of the dropper tube
5. Add 5 drops of sample into the test cassette well labelled “S”
6. Wait 15 to 20 minutes
7. Read and record your result
8. Dispose all materials in a plastic bag and wash your hands thoroughly
The product should be stored at 2-30°C, away from direct sunlight
Unused test cassettes must be stored in the foil pack
1. This product can only be used to detect the N-protein antigen of the SARS-CoV-2 in human deep throat sputum, oropharyngeal, nasopharyngeal and nasal swab specimens.
2. The test results should only be interpreted by the instruction above. A negative test result does not rule out the possibility of infection with SARS-CoV-2. Other tests, including the nucleic acid test, are recommended.
3. Test performance was evaluated using the procedure provided in this instruction only and has not been validated by large-scale clinical samples.
4. A positive test result does not rule out co-infection with other pathogens.
5. Results read after 30 minutes are invalid.
Warnings and Precautions
1. For in vitro diagnostic use.
2. Nasopharyngeal swab specimen should only be performed by trained professionals.
3. Follow standard precautions when using the product and handling specimens.
4. Follow this “Instructions for Use” for optimal performance of this test.
5. Only open the foil pack immediately before use. Do not use if it is damaged, unintentionally opened prior to use or has been exposed to environmental conditions outside of those specified.
6. Do not use the product beyond the expiration date printed on the foil pack.
7. Do not reuse any components.
8. Do not use the swab other than the one provided in the package.
9. Inappropriate sample collection, storage or transportation may yield incorrect test results.
10. Viral Transport Media (VTM) includes a pre-diluted processing which may affect the specimen’s stability and test result; extracted specimens for PCR tests cannot be used with this cassette.