OnSite COVID-19 Ag Self-Test, 2T/KIT

General description:
OnSite COVID-19 Antigen Self-Test 2T/KIT

Intended use:
The OnSite COVID-19 Ag Self -Test is a single-use lateral flow immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigens in nasal swab specimens from individuals suspected of COVID-19, within the first seven days of the onset of symptoms. This product is intended to be used for self-use and/or for adults over the age of 18 in a non-laboratory setting, or by children ages 12 and up with adult supervision. For in-vitro diagnostic use only.”

Technical specifications:
·Assay Technology: Lateral flow chromatographic immunoassay.
·Kit size: 2 Test/KIT.
·Specimen type: Nasal Swab specimen.
·Time to result: 15 minutes.
·Clinical sensitivity: 91.2%
·Clinical specificity:‫ ‬‫ ‬99.6%.
·Does not differentiate between SARS-CoV and SARS-CoV-2

Manufacturer product reference: CTK Biotech, Inc, R0182CST-2T.

Kit Components:
2x Buffer and nozzle pouch.
2x Cassette pouch.
2x Swab.
2x Waste bag.
2x IFU.

Items required, but not supplied:
A mirror, tissues, a way to time for test results, and soap and water or hand sanitizer.

Shelf life:
12 months from manufacturing date.

Storage & transportation condition:
The kit should be stored in a dry place at 2 ̊C to 30 ̊C away from direct sunlight.

Packaging & labelling:
Primary packaging: All contents of OnSite COVID-19 Ag Self-Test 2Test/KIT.
Secondary packaging: One Kit OnSite COVID-19 Ag Self-Test 2Test/KIT.

Weight & volume:
Estimated weight: 0.065kg
Estimated volume: 135mmx80mmx30mm.