Xpert Xpress CE-IVD SARS-CoV-2 kit/10T

General description:
The Xpert Xpress SARS-CoV-2 test is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal swab, nasal swab, or nasal wash/aspirate specimen collected from individuals who are suspected of COVID-19 infection.

Technical specifications:
Technology: Qualitative detection of nucleic acid
Kit size: 10 tests
Sample type: Nasopharyngeal swab, nasal swab, or nasal wash
Clinical sensitivity: 100%
Clinical specificity: 100%

Manufacturer product reference: Cepheid, XPRSARS-COV2-10

Items supplied with:
1)10 x Xpert Xpress SARS-CoV-2 Cartridges with Integrated Reaction Tubes
•Bead 1, Bead 2, and Bead 3 (freeze-dried), 1 of each per cartridge
•Lysis Reagent, 1.5mL per cartridge
•Binding Reagent, 1.5mL per cartridge
•Elution Reagent, 3.0mL per cartridge
2)12 x Disposable Transfer Pipettes
3)1 x CD
•Assay Definition File (ADF)
•Instructions to import ADF into GeneXpert software
4)Flyer
•Directions to locate the Product Insert on www.cepheid.com

Items required, but not supplied:
·Instruments:
-GeneXpert Dx or GeneXpert Infinity systems (catalog number varies by configuration): GeneXpert instrument, computer, barcode scanner, operator manual
-For GeneXpert Dx System: GeneXpert Dx software version 4.7b or higher
-For GeneXpert Infinity-80 and Infinity-48s systems: Xpertise software version 6.4b or higher
·Other important items:
-Sample Collection Kit for Viruses (Cepheid P/N SWAB/B-100, SWAB/F-100).
-Nylon flocked swab (Copan P/N 502CS01, 503CS01) or equivalent
-Viral transport medium, 3 mL (Copan P/N 330C) or equivalent.
-0.85% (w/v) saline, 3mL.

Shelf life:
12 months upon manufacure

Weight & volume:
Estimated weight: 0.8kg
Estimated volume: 2.69dm3

Storage & transportation condition:
Must be stored at 2-28°C

Packaging & labelling:
Primary packaging: All contents of Xpert Xpress CE-IVD SARS-CoV-2, kit of 10 tests
Secondary packaging: One kit Xpert Xpress CE-IVD SARS-CoV-2, kit/10 tests

Material safety data sheet information (MSDS):
Safety Data Sheets (SDS) are available at www.cepheidinternational.com under the SUPPORT tab.