Xpert Xpress CE-IVD CoV-2 plus, kit/10

General description:
The Xpert Xpress CoV-2 plus test is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal swab or anterior nasal swab specimen obtained from individuals meeting COVID-19 clinical and/or epidemiological criteria, as well as individuals without symptoms or other reasons to suspect COVID-19 infection. Results are for the identification of SARS-CoV-2 RNA.
The Xpert Xpress CoV-2 plus test is intended to be performed by trained users in both laboratory and near patient testing settings.

Technical specifications:
Kit size: 10 tests
Sample type: Nasopharyngeal swab, nasal swab, or nasal wash/aspirate specimens
Clinical sensitivity: 100%
Clinical specificity: 100%

Manufacturer product reference: Cepheid AB, XP3SARS-COV2-10 (Regulatory version: CE)

Items supplied with:
·10 x Xpert Xpress CoV-2 plus Cartridges with Integrated Reaction Tubes
·10-12 x Disposable Transfer Pipettes
·2 x Quick Reference Instructions
·1 x Flyer

Items required, but not supplied:
·Instruments:
-GeneXpert Dx System or GeneXpert Infinity System (catalogue number varies by configuration): GeneXpert instrument, computer, barcode scanner, and 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) (Copan P/N 305C, 346C) or equivalent
-Nylon flocked swab (Copan P/N 502CS01, 503CS01) or equivalent
-3 mL Viral transport medium
-0.85–0.9% (w/v) saline, 3mL

Shelf life:
12 months upon manufacture.

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 CoV-2 plus, kit of 10 tests
Secondary packaging: One kit Xpert Xpress CE-IVD CoV-2 plus, kit/10 tests