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TUBERCULOSIS TEST, TB Ag MPT64, 1 test (Bioline-08FK50)

https://medicalguidelines.msf.org/en/node/1063
https://unicat.msf.org/cat/product/19111
STD SSDTTUBTSD25

Valid Article

Former Code(s): DDGTTUBT1--
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.
18
Shelf life = length of time a product can remain active and effective. Short shelf life = shelf life = < 24 months
W0105090199 - Bacteriology - rt & poc - other
European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. EMDN is characterised by its alphanumeric structure that is established in a seven-level hierarchical tree.
P
The order of this product needs to be justified and is only acceptable under certain conditions.
CT30
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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TUBERCULOSIS Ag MPT64 TEST (Bioline)

Reserved for TB culture programmes.

CAUTION

This test is worded and codified by unit to make the order easier, but it is always packaged in kit of 25 tests.

Definition

Rapid immunochromatographic lateral flow test used for identification of Mycobacterium tuberculosis complex ON CULTURE MEDIA!

Principle of Niacin Test

Sandwich type assay where monoclonal anti-MPT64 are immobilized on nitrocellulose membrane. Binding between the captured antigen and antibody-colloidal gold conjugate produce red-purple band on the test pad. No test band is sign of no MPT64.

Specifications

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Components

  • 25 individually packed tests
  • 1 bottle of extraction buffer
  • Package insert

Technical specifications

  • Lateral flow test
  • Rapid test (± 15 minutes) in 2 to 4 steps (depending of liquid or solid cultures)
  • Test performance according manufacturer:
    • Sensitivity: 98.6%
    • Specificity: 100%
  • Detection limit : 105 CFU/mL

Packaging & Labelling

Kit of 25 tests

To be Ordered Separately

Sterile transfer pipettes

Instructions for use

Use only from non–contaminated cultures.

The test can be directly used with liquid cultures.

To use the test with solid medium, prepare the suspension according to test procedure.

Test results must be interpreted together with morphological observation of mycobacterial growth, and if necessary with PNB results.

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Precautions for Use

All the samples must be considered as infectious. Take the necessary safety precautions when handling a sample. Autoclave the test before disposal.

Storage

  • Store between 2°C and 30º C
  • Do not freeze
  • Protect from sunlight and humidity
  • Shelf life: 18 months
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of the total shelf life
  • Not to be used beyond expiry date.

Waste management

Incinerate the tests and the used materials.

MSF requirements

Rapid test used on culture growth to distinguish Mycobacterium tuberculosis from atypical mycobacteria

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