The Coronavirus Ag Rapid Test Cassette （Swab） is an in vitro immunochromatographic assay for the qualitative detection of nucleocapsid rotein antigen from SARS-CoV-2 in nasopharyngeal （NP） swab specimens directly or after the swabs have been added to viral transport media from individuals who are suspected of COVID-19 by their healthcare provider.
It is intended to aid in the rapid diagnosis of SARS-CoV-2 infections. The Coronavirus Ag Rapid Test Cassette （Swab） does not differentiate between SARS-CoV and SARS-CoV-2. The Coronavirus Ag Rapid Test Cassette （Swab） is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect nucleocapsid protein from SARS-CoV-2 in nasopharyngeal （NP） swab.
The test strip is composed of the following parts: namely sample pad, reagent pad, reaction membrane, and absorbing pad. The reagent pad contains the colloidal-gold conjugated with the monoclonal antibodies against the nucleocapsid protein of SARS-CoV-2; the reaction membrane contains the secondary antibodies for nucleocapsid protein of SARS-CoV-2. The whole strip is fixed inside a plastic device. When the sample is added into the sample well, conjugates dried in the reagent pad are dissolved and migrate along with the sample.
If SARS-CoV-2 antigen presents in the sample, a complex formed between the anti-SARS-2 conjugate and the virus will be captured by the specific anti-SARS-2 monoclonal antibodies coated on the test line region （T.
Absence of the T line suggests a negative result. To serve as a procedural control, a red line will always appear in the control line region （C） indicating that proper volume of sample has been added and membrane wicking has occurred.
1.For in vitro diagnostic use only.
2.The test device should remain in the sealed pouch until use.
3.Do not use kit past its expiration date.
4.Swabs, tubes and test devices are for single use only.
5.The extraction buffer contains a solution with a preservative （0.09% sodium azide）. If solution comes in contact with the skin or eyes, flush with ample volumes of water.
6.Solutions that contain sodium azide may react explosively with lead or copper plumbing. Use large quantities of water to flush discarded solutions down a sink.
7.Do not interchange or mix components from different kit lots.
8.When collecting a nasopharyngeal swab sample, use the Nasopharyngeal Swab supplied in the kit.
9.To obtain accurate results, do not use visually bloody or overly viscous samples.
10.Wear suitable protective clothing, gloves, and eye/face protection when handling the contents of this kit.
11.Humidity and temperature can adversely affect results.
12.Used testing materials should be discarded in accordance with local regulations.
*To be administered by medical professionals only