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TUBERCULIN, 5 TU/0.1ml, multidose, 1 dose, vial.

https://medicalguidelines.msf.org/en/viewport/TUB/english/tuberculosis-20321086.html1083.html
https://unicat.msf.org/cat/product/24242
STD DVACDTUB5T-

Valid Article

Former Code(s): -X DDGTTUBP5-- DDGTZBE0202 DDGTZNL0176 ELAEVLHT003 DDGTTUBT003
The product is supplied (and stored) sterile, it must remain sterile until its use. Sterile = state of being free from all living microorganisms.
19.1 - Diagnostic agents
Classification of the medicines in groups and subgroups according to their therapeutic use. The classification used by MSF is based on the WHO Model List of Essential Medicines.
V04CF01
Anatomical Therapeutic Chemical Classification according to WHOCC
0208
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)
https://unicat.msf.org/web/image/product.template/573039/image_1920?unique=f81555d

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TUBERCULIN 5 TU/0.1 ml

CAUTION

This test is worded and codified by unit (= 1 dose) to make the order easier.

Full Name

Synonym: Mantoux-test

Therapeutic Action

Tuberculin purified protein derivative (Mantoux)

Biologic diagnostic agent

Indications

Skin test used as an aid in screening for infection by a tuberculous bacillus or as a pre or post-vaccination check for the BCG vaccine.

This test is used to diagnose tuberculosis infection :

  • in children in countries with high-prevalence, particularly those in close contact with contagious cases, provided that a chest X-ray can be performed.
  • in international staff who have already been tested, in order to detect a tuberculin conversion indicating a recent infection and to propose preventive treatment (after ruling out active tuberculosis).

Instructions for use

Multidose vial.

One dose (0.1 ml) is equivalent to 5 TU (Tuberculin Units) and contains 0.04 µg of tuberculin

Method of administration

Must be given by intradermal injection in the inner forearm.

Use a 1 ml graduated 1/100 syringe and a Luer needle 26G, brown, ID.

Evaluation of the reaction and interpretation

  • The intradermal injection may cause an induration at the injection site, often accompanied by erythema. Only the induration is measured for test interpretation.
  • The induration is measured transversely using a flexible ruler 48-72 hours post-injection by a trained healthcare professional.
  • An induration of ≥ 5 mm is considered as a positive test result, which indicates infection with Mycobacterium tuberculosis. A phlyctenular reaction is considered highly positive.
  • Induration and erythema typically will decrease after 4 days and disappear within 28 days.
  • Results should be interpreted within the medical context, considering risk assessment and potentially complemented by radiography or other diagnostic evaluations.

Orders are always done in number of doses and not in number of vials!

Image

Precautions for Use

Performing the test within 6 to 8 weeks of exposure to Mycobacterium tuberculosis may result in a false-negative result.

The test should not be used as a stand-alone tool for diagnosis of active tuberculosis disease. Risk assessment, radiography, and other diagnostic evaluations should also be considered for subjects suspected of having active tuberculosis.

Storage

  • Keep refrigerated between 2ºC and 8ºC. - Protect from sunlight
  • Do not freeze.
  • After opening, use the product within 28 days.

(Cf Introduction: Thermosensitive products)