Sure Status COVID-19Ag CardTest, kit/25T

General description:
Sure Status COVID-19 Antigen Card Test is a lateral flowimmunochromatographic assay for the qualitative detection ofnucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal (NP) swabspecimens directly collected from individuals who are suspected ofCOVID-19 by their healthcare provider. Sure Status COVID-19 Antigen CardTest is for in vitro diagnostic use and intended as an aid to detectionof nucleocapsid protein antigen in patient with clinical symptoms ofSARS-CoV-2 infection.

Technical specifications:
Technology: Lateral flow immunochromatographic test
Format: Cassette, 25 tests
Sample type: Nasopharyngeal swab
Analytical sensitivity: Limit of detection (LOD) in naturalnasopharyngeal swab matrix was confirmed as 22.4 TCID50/swab
Analytical specificity: No cross-reactivity or interference was seenwith 16 viruses, 13 micro-organisms and 2 negative matrixes
Clinical sensitivity: 94.16%
Clinical specificity: 100%
Manufacturer product reference: Premier Medical Corporation Pvt.
Ltd., SS03P25

Items supplied with:
·25 x Test device pouch containing: test device and desiccant
·25 x Nasopharyngeal swab
·25 x Reaction buffer vial with nozzle
·3 x Extraction Buffer Bottle (3 ml)
·1 x IFU

Items required, but not supplied:
New pair of disposable gloves & facemask, Permanent marker pen, Timer,PPE Kits and Biohazardous waste container

Shelf life:
24 months from the date of manufacturing; do not use beyond its expirydate.

Weight & volume:
Estimated weight: 0.33kg
Estimated volume: 0.00202m3

Storage & transportation condition:
Must be stored at 4 – 30°C. Do not freeze the kit. The kit is sensitiveto humidity and heat. Do not store the kit at temperatures above 30°Cand in humid conditions.

Packaging & labelling:
Primary packaging: All contents of Sure Status COVID-19 Antigen CardTest, kit of 25 tests
Secondary packaging: One kit Sure Status COVID-19 Antigen Card Test,kit/25 tests

General recommendations:
·Read the instructions carefully before performing the test, anydeviation will invalidate the test results.
·Do not re-use the test kit.
·Do not use the test kit if the pouch is damaged or the seal isbroken.
·Do not use the extraction buffer bottle from different lot.
·Wear personal protective equipment, such as gloves and lab coats whenhandling kit reagents. Wash hands thoroughly after the tests are done.

Useful link:
https://extranet.who.int/pqweb/sites/default/files/documents/eul_0590_010_00_Sure%20StatusCOVID-19_Antigen_Card_Test_ifu.pdf