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

https://medicalguidelines.msf.org/en/node/1083
https://unicat.msf.org/cat/product/24242
STD DVACDTUB5T-

Valid Article

Former Code(s): DDGTTUBP5-- DDGTZNL0176 DDGTTUBT003 DDGTZBE0202 ELAEVLHT003
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)

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TUBERCULIN 5 TU/0.1 ml

CAUTION

This test is worded and codified by unit to make the order easier, but it is always packaged in vial of 15 doses.

Full Name

Synonym: Mantoux-test

Therapeutic Action

Purified tuberculin protein derivative

Biologic diagnostic agent

Indications

Testing for a tuberculin hypersensitivity reaction

Screening for tuberculosis bacilli infection

Pre- or post-vaccination test of the BCG vaccine

This test is used to diagnose tuberculosis infection :

  • in children in high-prevalence countries, and especially in the close vicinity of 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 a preventive treatment (after elimination of active tuberculosis).

Instructions for use

Specifications:

  • Recommended dose: 0.1 ml = 5 TU (Tuberculin Units) = 0.04 µg tuberculin
  • Positive threshold: 6 mm
  • Good concordance of induration diameters with the tuberculin reference OMS-RT23
  • Sensitivity in comparison with OMS-RT23: 95.4%
  • Specificity in comparison with OMS-RT23: 95.7%

Method of administration

Must be given by intradermal injection on the anterior face of the forearm.

Use a 1 ml graduated 1/100 syringe and a needle Luer 26 G (0.45 x 13 mm), brown, ID.

Evaluation of the test

The result should be evaluated approximately 3 days (72 hrs) after the injection. It should always be interpreted in the medical context.

The reaction to the test is an induration, usually accompanied by erythema.

Only the induration is used for the interpretation of the test (any erythema is disregarded). The clearly palpable induration should be measured in millimetres (mm) in its widest diameter (with a transparent flexible ruler).

The reaction is considered positive if the diameter of the induration is 6 mm or greater. A phlyctenular reaction is considered highly positive.

Precautions for Use

Immediate erythematous reaction may occur at the injection site. Vesiculation, ulceration or necrosis may appear in highly sensitive persons.

Storage

  • Keep refrigerated between 2ºC and 8ºC. - Protect from sunlight
  • Do not freeze.
  • After opening, use the vial within 24 hrs.

(Cf Introduction: Thermosensitive products)