Tuberculin Purified Protein Derivative


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Tuberculin Purified Protein Derivative
Accession Number
Biologic Classification
Protein Based Therapies
Other protein based therapies

Tuberculin Purified Protein Derivative (PPD) is a sterile aqueous solution of a purified protein fraction for intradermal administration as an aid in the diagnosis of tuberculosis. The diagnostic test is commonly referred to as the Mantoux test which serves to minimize the risk of transmission of infection with Mycobacterium tuberculosis through early diagnosis and appropriate therapeutic intervention. The purified protein fraction is isolated from culture media filtrates of a human strain of Mycobacterium tuberculosis. It is included in the World Health Organization's List of Essential Medicines.

Protein chemical formula
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Protein average weight
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  • Mycobacterium tuberculosis purified protein derivative
  • Purified protein derivative of tuberculin
  • Tuberculin PPD
  • Tuberculin, purified protein derivative
  • Tuberculin,purified protein derivative
  • Tuberculina PPD
  • Tuberculinum
Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing End
AplisolInjection5 [iU]/0.1mLIntradermalPar Pharmaceutical2008-04-25Not applicableUs
AplisolInjection5 [iU]/0.1mLIntradermalTYA Pharmaceuticals2014-04-25Not applicableUs
AplisolInjection5 [iU]/0.1mLIntradermalA-S Medication Solutions2008-04-25Not applicableUs
AplisolInjection5 [iU]/0.1mLIntradermalRemedy Repack2018-03-06Not applicableUs
Tuberculin PPD (mantoux)Liquid1 tubIntradermalAventis Pasteur Limited1975-12-312001-07-19Canada
Tuberculin PPD (mantoux)Liquid250 tubIntradermalAventis Pasteur Limited1975-12-312001-07-19Canada
TubersolInjection, solution5 [iU]/0.1mLIntradermalSanofi Pasteur Inc.1956-08-15Not applicableUs
TubersolInjection, solution5 [iU]/0.1mLIntradermalA-S Medication Solutions1956-08-15Not applicableUs
TubersolSolution5 tubIntradermalSanofi Pasteur Limited1975-12-31Not applicableCanada
TubersolInjection, solution5 [iU]/0.1mLIntradermalPhysicians Total Care, Inc.1956-08-152013-06-30Us
Additional Data Available
  • Application Number
    Application Number

    A unique ID assigned by the FDA when a product is submitted for approval by the labeller.

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  • Product Code
    Product Code

    A governmentally-recognized ID which uniquely identifies the product within its regulatory market.

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CAS number
Not Available



Indicated as a diagnostic agent in Mantoux Test used to detect infection with Mycobacterium tuberculosis.

Associated Conditions

It is intradermally administered to facilitate detection of active tuberculosis caused by Mycobacterium tuberculosis. Tuberculin PPD is an inactivated purified protein fraction obtained from human strain of Mycobacterium tuberculosisand antigen that induces a delayed hypersensitivity response after few hours following administration. When the person has already acquired the tuberculin antigen, the immune response is stimulated to produce antigen-specific T cells that circulate in the bloodstream for up to several months and years. Clinically, a delayed hypersensitivity reaction to tuberculin is a manifestation of previous infection with M tuberculosis or a variety of non-tuberculosis bacteria. In most cases sensitization is induced by natural mycobacterial infection or by vaccination with BCG Vaccine. The antigen causes, pain, edema and infiltration of immune cells in the injection area.

Mechanism of action

When exposed to M. tuberculosis antigen, the sensitization initiates in the regional lymph nodes where T lymphocytes proliferate in response to the antigenic stimulus to give rise to specifically sensitized lymphocytes which may exist in the circulation up to many years. Antigen is presented to T cells by being ingested by antigen presenting cells (APC), which then present it on their surface to lymphocytes in combination with various MHC molecules once they reach local lymph nodes 4. Tuberculin PPD most likely interacts with toll-like receptor 2 expressed on APCs that initiates an inflammatory response. Subsequent restimulation of these sensitized lymphocytes with the same or a similar antigen, such as the intradermal injection of tuberculin PPD, evokes a local reaction mediated by these cells. This reaction is referred to as a delayed-type hypersensitivity response that includes vasodilation, edema, and the infiltration of lymphocytes, basophils, monocytes, and neutrophils into the site of antigen injection. The sensitized antigen-specific T lymphocytes proliferate and release lymphokines, which mediate the accumulation of other cells at the site 5. In vitro studies show that Tuberculin PPD promotes the upregulation of vascular endothelial growth factor (VEGF) expression in T lymphocytes through major histocompatibility (MHC) class II interaction with CD4+ T lymphocyte interaction 3. The reactions are evident after 5-6 hours following administration.

AToll-like receptor 2
Additional Data Available
Adverse Effects

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Volume of distribution
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Protein binding
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Route of elimination
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Half life
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Some adverse effects at the injection site include pain, discomfort, pyrexia, and erythema, rash, hemorrhage, hematoma and rarely ulcer and necrosis. Other unwanted effects include severe hypersensitivity reactions, dyspnea, generalized rash and syncope.

Affected organisms
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Pharmacogenomic Effects/ADRs
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Drug Interactions
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Food Interactions
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General References
  1. Yang H, Kruh-Garcia NA, Dobos KM: Purified protein derivatives of tuberculin--past, present, and future. FEMS Immunol Med Microbiol. 2012 Dec;66(3):273-80. doi: 10.1111/j.1574-695X.2012.01002.x. Epub 2012 Aug 1. [PubMed:22762692]
  2. Prasad TS, Verma R, Kumar S, Nirujogi RS, Sathe GJ, Madugundu AK, Sharma J, Puttamallesh VN, Ganjiwale A, Myneedu VP, Chatterjee A, Pandey A, Harsha H, Narayana J: Proteomic analysis of purified protein derivative of Mycobacterium tuberculosis. Clin Proteomics. 2013 Jul 19;10(1):8. doi: 10.1186/1559-0275-10-8. [PubMed:23870090]
  3. Matsuyama W, Kubota R, Hashiguchi T, Momi H, Kawabata M, Nakagawa M, Arimura K, Osame M: Purified protein derivative of tuberculin upregulates the expression of vascular endothelial growth factor in T lymphocytes in vitro. Immunology. 2002 May;106(1):96-101. [PubMed:11972637]
  4. 6. (2012). In Rang and Dale's Pharmacology (7th ed., pp. 82-84). Edinburgh: Elsevier/Churchill Livingstone. [ISBN:978-0-7020-3471-8]
  5. Tubersol (Tuberculin Purified Protein Derivative) product information [Link]
  6. World Health Organization Model List of Essential Medicines (19th List) [Link]
External Links
PubChem Substance
AHFS Codes
  • 04:00.00 — Antihistamine Drugs
  • 36:84.00 — Tuberculosis
FDA label
Download (138 KB)
Download (59 KB)

Clinical Trials

Clinical Trials
2CompletedDiagnosticHansen's Disease1
2CompletedDiagnosticTuberculosis Infection1
Not AvailableActive Not RecruitingBasic ScienceAtopic Dermatitis (AD)1
Not AvailableCompletedScreeningHuman Immunodeficiency Virus (HIV) Infections / Tuberculosis Infection1


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Dosage forms
InjectionIntradermal5 [iU]/0.1mL
LiquidIntradermal1 tub
LiquidIntradermal250 tub
Injection, solutionIntradermal5 [iU]/0.1mL
SolutionIntradermal5 tub
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Experimental Properties
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Organic Compounds
Super Class
Organic Acids
Carboxylic Acids and Derivatives
Sub Class
Amino Acids, Peptides, and Analogues
Direct Parent
Alternative Parents
Not Available
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Molecular Framework
Not Available
External Descriptors
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Pharmacological action
General Function
Triacyl lipopeptide binding
Specific Function
Cooperates with LY96 to mediate the innate immune response to bacterial lipoproteins and other microbial cell wall components. Cooperates with TLR1 or TLR6 to mediate the innate immune response to ...
Gene Name
Uniprot ID
Uniprot Name
Toll-like receptor 2
Molecular Weight
89836.575 Da
  1. Biyikli OO, Baysak A, Ece G, Oz AT, Ozhan MH, Berdeli A: Role of Toll-Like Receptors in Tuberculosis Infection. Jundishapur J Microbiol. 2016 Sep 14;9(10):e20224. eCollection 2016 Oct. [PubMed:27942355]
  2. Strapagiel D, Kasztalska K, Druszczynska M, Kowalewicz-Kulbat M, Vrba A, Matusiak A, Chmiela M, Rudnicka W: Monocyte response receptors in BCG driven delayed type hypersensitivity to tuberculin. Folia Histochem Cytobiol. 2008;46(3):353-9. doi: 10.2478/v10042-008-0044-1. [PubMed:19056540]

Drug created on May 24, 2016 16:49 / Updated on August 24, 2019 06:47