Xpert Ebola Assay, Kit/10

General description:
The Xpert Ebola Assay is a real time reverse transcription polymerase chain reaction (RT-PCR) test intended for the qualitative detection of RNA from the Ebola Zaire virus (detected in the West Africa outbreak in 2014) in EDT venous whole blood, peripheral blood from finger-stick, or buccal swab from individuals with signs and symptoms of Ebola Virus Disease (EVD) in conjunction with epidemiological risk factors.

Results are for the presumptive identification of Ebola Zaire virus. The definitive identification of Ebola Zaire virus infection requires additional testing and confirmation procedures in consultation with public health or other authorities for whom reporting is required. Only clinical laboratory personnel who have received specific training on the use of the Xpert Ebola Assay on the GeneXpert Instrument Systems can perform this test.

Technical specifications:
The 95% limit of detection of the assay was found to be 82.0 RNA copies/reaction, 95% CI 39.7 to 3193.6 copies/reaction.
Format: RT-PCR

Manufacture product reference: Cepheid AB, GXEBOLA-10

Items supplied with:
·GeneXpert Ebola Assay Cartridges with integrated reaction tubes, 10
-Bead 1, Bead 2, and Bead 3 (freeze-dried) 1 of each per cartridge, 1 of each per cartridge
-Rinse Reagent 0.5 mL per cartridge, 0.5ml per cartridge
-Elution Reagent 2.0 mL per cartridge, 2.0ml per cartridge
-Binding Reagent, 2.0ml per cartridge
·Ebola Sample Reagent Bag (Sample Reagent), 1 per kit
-Lysis Reagent (Guanidinium Thiocyanate), 10 x 2.5ml per bottle
·Disposable 1ml transfer pipettes, 10
·CD, 1
·IFU, 1

Items required, but not supplied:
GeneXpert Dx System or GeneXpert Infinity Systems, printer, disposable swabs (# SWAB/E-50), vortex, chlorine bleach.

Shelf life:
GeneXpert Ebola Assay Cartridges – 12 months
Ebola Sample Reagent Bag (Sample Reagent) – 12 months

Storage & transportation condition:
GeneXpert Ebola Assay Cartridges: 2 – 28 °C
Ebola Sample Reagent Bag (Sample Reagent): 2 – 28 °C

Useful links:
https://www.who. int/diagnostics_laboratory/procurement/190624_eae_0443_070_00_pqpr_expert_ebola_cepheid.pdf