COVID-19 Antigen Test (POCT) Nasopharyngeal Swab
Catalog Number: A03-50-422PNP1 (1/box)/ A03-50-422PNP5 (5/box)/ A03-50-422PNP25 (25/box)
INTENDED USE:
Artron COVID-19 Test is a rapid lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in self-collected anterior nasal (nares) swab samples obtained from individuals aged 14 years or older or adults collected nasal swab specimens from individuals aged two years or older. This test is intended for individuals suspected of COVID-19 within the first seven days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests.
DESCRIPTION:
Artron COVID-19 Test is an antigen-capture immunochromatographic assay, that detects the presence of SARS-CoV-2 nucleocapsid protein in nasal swab specimens. SARS-CoV-2 specific antibody and a control antibody are immobilized onto a membrane support as two distinct lines-Test lines (T) and Control line(C) and combined with colloidal gold-monoclonal antibody against SARS-CoV-2 antigen deposited on the conjugate pad to construct a test strip. When the swab sample migrates in the test strip, SARS-CoV-2 nucleocapsid protein binds to anti-SARS-CoV-2 nucleocapsid protein antibody-gold conjugate, forming an immune complex. The immune complex is then captured by the test line on the nitrocellulose membrane as it migrates through the strip, forming a visible pink or purple line, indicating a positive result. If SARS-CoV-2 is absent in the, sample, no pink or purple line will appear in the test line, indicating a negative result.
To serve as an internal process control, a control band has been designed. This control line should always be seen after the test is completed. The absence of a control line in the control region is an indication of an invalid result.
SAMPLE TYPE:
Time to Results:
20 mins
Analytical Sensitivity:
1.0 x 10 3TCID50 /mL
Analytical Specificity:
No cross reactions observed from tested analytes or other interfering substances
Interference:
No interference from common biological and chemical analytes
Diagnostic Sensitivity:
91.27%
Diagnostic Specificity:
100%
Accuracy:
98.16%
Precision
The precision was determined by replicate assays of both positive and negative samples with devices from three different production lots. The resultant data indicated no appreciable between lot variation when testing both positive and negative samples across three different lots.
Storage condition:
Store at 2-30°C, avoid direct sunlight and freezing.
Shelf life:
24 months
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WARNINGS AND PRECAUTIONS
- For in vitro diagnostic use only.
- The test is designed only for the detection of nasal swab specimens.
- This test is only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.
- All kit components are single-use items. Do not use it with multiple specimens. Do not reuse the test cassette.
- Do not use if the pouch seal or the packaging is compromised.
- Do not use it after the expiry date shown on the pouch.
- Do not mix and interchange different specimens.
- The swabs in the kit are approved for use with Artron COVID-19 Antigen home Test. Do not use other swabs.
- Do not touch the swab tip when handling the swab specimen.
- Complete the test within 1 hour after the reagent is opened.
- INVALID RESULTS can occur when an insufficient drop of sample is added to the test cassette.
- To ensure delivery of adequate volume, hold the vial vertically, 1⁄2 inch above the swab well, and add drops slowly.
- Wash hands thoroughly before and after finishing testing.
- Do not eat, drink, or smoke in the area where the specimens or kits are being handled.
- Clean up spills thoroughly with appropriate disinfectants.
- Dispose of kit components and patient samples in household trash.
- Keep out of children’s reach.
- If the extraction buffer contacts the skin or eye, flush with copious amounts of water.