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(mb GeneXpert) TEST SARS-CoV-2 cartridge, XPRSARS-COV2-10

https://msf.oodin.sh/cat/product/80589
NST ELAEMBIT113

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Single use
A single-use device, also referred to as a disposable device, is intended for use on one patient during a single procedure. It is not intended to be reprocessed (i.e., cleaned and disinfected or sterilized).
CE marking: declaration that the product meets EU standards for health, safety, and environmental protection. The CE marking indicates that the product may be sold freely in any part of the European Economic Area, regardless of its country of origin.
12
Shelf life = length of time a product can remain active and effective. Short shelf life = shelf life = < 24 months
PMFE
The order of this product needs to be justified and is only acceptable under certain conditions.
CT25
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)

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(mb GeneXpert) TEST SARS-CoV-2 plus cartridge

There is currently no SARS-COV-2 test available as an MSF standard. It is possible to order the test as a nonstandard item only after validation by the medical director of your respective operational center.

CAUTION

This test (= 1 cartridge) is worded and codified by unit to make the order easier, but is always packaged in kit of 10.

Definition

The Xpert SARS-CoV-2 plus assay runs on the GeneXpert System .

The Xpert Xpress SARS-CoV-2 test is a rapid, real-time RT-PCR test intended for the
qualitative detection of RNA from the SARS-CoV-2 in upper respiratory specimens (i.e., nasopharyngeal, oropharyngeal, nasal, or mid-turbinate swab or nasal wash/ aspirate) collected from individuals suspected of SARS-COV-2.

Specifications

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Material

The Xpert Xpress SARS-CoV-2 kit contains sufficient reagents to process 10 specimens or quality control samples.

Components

1 kit = 10 tests for specimens or quality control samples

  • 10 cartridges
  • 12 transfer pipettes
  • 1 CD
  • 1 flyer

Technical specifications

  • Test principle: Real Time PCR
  • Targets: nucleocapsid gene (N2) and envelope protein gene (E) and RNA-dependent RNA polymerase gene (RdRP)
  • Specimen: nasopharyngeal, nasal, mid-turbinate, or oropharyngeal swabs and nasal wash/aspirates
  • Transport medium: 3ml VTM or UTM
  • Test time: approximately 30 minutes
  • Hands-on time: < 1 minute

Instructions for use

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Precautions for Use

Do not open a cartridge until you are ready to perform testing.

Storage

  • Store between 2-28°C
  • Shelf life: 12 months
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of the total shelf life

Waste management

Substance with hazardous characteristics. Please contact your watsan referent for advice on proper disposal.

Detailed hazard and precautionary information can be found in the safety data sheet (SDS).

Signal Word

Warning

H302Harmful if swallowed
H320Causes eye irritation
H313May be harmful in contact with skin
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