Artron COVID-19 Antigen Test is a rapid and convenient immunochromatographic assay for the qualitative detection of COVID-19 antigen (viral nucleoprotein) from nasopharyngeal swab obtained from patient with signs and symptoms of respiratory infection. The device is designed to aid in the rapid diagnosis of COVID-19 Virus infection.
Box of 25 individually packaged test kits.
The Artron COVID-19 antigen rapid test device instantly identifies the presence of the SARS-CoV-2 nucleoprotein in a simple nasal swabbed specimen.
Authorized for Professional Use
The Artron Antigen test kit has been authorized by Health Canada (IO 327866) for lab-based and point of care testing.
Performance Data
Nasopharyngeal Collection
97.22% Sensitivity
99.72% Specificity
Sensitivity, as measured by the positive percentage agreement (PPA), is the percentage of positive persons (that have COVID-19) that will test positive.
Specificity, as measured by the negative percentage agreement (NPA), is the percentage of negative persons (that don’t have COVID-19) that will test negative.
PACKAGE CONTENTS
• Pouch contents: Test Cassette, Desiccant
• Extraction Buffer Bottle (includes 12 ml extraction buffer) (two per box, 6ml per bottle)
• Reagent Tube with Cap
• Sterilized Nasopharyngeal/Nasal Swab (IFU Attached Separately)
• Test Instruction
MATERIALS REQUIRED (BUT NOT PROVIDED)
• Pipette
• Clock or timer
• Latex gloves
WARNINGS AND PRECAUTIONS
• For in vitro diagnostic use only.
• Do not reuse.
• Do not use if the pouch seal or its packaging is compromised.
• Do not use after the expiration date shown on the pouch.
• Do not mix and interchange different specimens.
• Wear protective clothing such as laboratory coats, disposable gloves and eye protection while handling potentially infectious materials or performing the assay.
• Wash hands thoroughly after finishing the tests.
Do not eat, drink or smoke in the area where the specimens or kits are being handled. Clean up spills thoroughly with appropriate disinfectants.
Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout testing procedures.
Dispose of all specimens and used devices in a proper bio-hazard container. The handling and disposal of the hazardous materials should follow local, national or regional regulations. Keep out of children’s reach.
Intended Use
Artron COVID-19 Antigen Test is a rapid and convenient immunochromatographic assay for the qualitative detection of COVID-19 antigen (viral nucleoprotein) from nasopharyngeal/nasal swab obtained from patient with signs and symptoms of respiratory infection. This test is for administration by healthcare workers and labs only, as an aid to early diagnosis of SARS-CoV-2 infection in patient with clinical symptoms of SARS-CoV-2 infection. It provides only an initial screening test result. This product is strictly for medical professional use only and not intended for personal use. The result of this test should not be the sole basis for the diagnosis and the test results should be confirmed by Real-Time Reverse Transcriptase (RT)-PCR Diagnostic kit. The test is intended for professional and laboratory use.
