(mb GeneXpert) TEST SARS-CoV-2 plus, XP3SARS-COV2-10
Valid Article
OC subscriptions: included in supply or field order tools (e.g. UniField)
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SC subscriptions: included in supply or field tools
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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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SARS-CoV-2 plus test cartridge
There is currently no SARS-COV-2 test available as an MSF standard. It is possible to order the test as a non standard 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 plus test is a rapid, real-time RT-PCR test intended for the qualitative detection of viral RNA from the SARS-CoV-2 in upper respiratory specimens collected from individuals suspected of SARS-CoV-2.
Specifications
Material
Contains Guanidine Thiocyanate
Components
1 kit = 10 tests for specimens or quality control samples
- 10 cartridges
- Bead 1, bead 2 and bead 3 (freeze-dried) - 1 of each per cartridge
- Lysis reagent (guinidinium Thiocyanate) - 1.0 ml per cartridge
- Binding reagent - 1.0 ml per cartridge
- Elution reagent - 2.0 ml per cartridge
- Wash reagent - 0.5 ml per cartridge
- 10 to 12 transfer pipettes
- 1 flyer
- 2 quick reference instructions (for use with GeneXpert Xpress System)
Technical specifications
- Test principle: Real-time RT-PCR
- Targets: nucleocapsid gene (N2) and envelope protein gene (E) and RNA-dependent RNA polymerase gene (RdRP)
- Specimen: nasopharyngeal, anterior nasal swabs
- Transport medium: 3ml VTM or UTM
- Test time: approximately 30 minutes
- Hands-on time: < 1 minute
- Reagent: clear colourless liquid
Packaging & Labelling
Kit of 10 cartridges
Transport Dangerous Goods
- UN3265
- Special provision: A3, A803
- Hazard class 8
- Packing group III
- Proper shipping name: Corrosive liquid, acidic organic, n.o.s (Guanidine thiocyanate)
To be Ordered Separately
- Nylon flocked swab
- Viral transport medium, 3ml
- 0.85-0.9% (w/v) saline, 3 ml
- Sample collection kit for viruses
Instructions for use
Precautions for Use
- Do not open a cartridge until you are ready to perform testing
- Do not use a cartridge that is wet or has leaked
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).
Classification EC Regulation N° 1272/2008
- Skin corrosion/irritation, Category 1c, H314
- Serious eye damae/eye irritation, Category 1, H318
Signal Word
Danger
| H314 | Causes severe skin burns and eye damage. |
| P260 | Do not breathe dust/fume/gas/mist/vapours/spray. |
| P280 | Wear protective gloves/protective clothing/eye protection/face protection |
| P310 | Immediately call a POISON CENTER or doctor/physician. |
| P321 | Specific treatment (see ... on this label) |
| P303 + P361 + P353 | IF ON SKIN (or hair): Remove/Take off immediately all contaminated clothing. |
| P305 + P351 + P338 | IF IN EYES: rinse cautiously with water for several minutes. If the victim wears contact lenses, remove them if possible. Keep rinsing |
Validated by OCBA laboratory referent - Laurence Flevaud - January 2026