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Aplisol (Tuberculin) - Summary



Aplisol (tuberculin PPD, diluted) is a sterile aqueous solution of a purified protein fraction for intradermal administration as an aid in the diagnosis of tuberculosis. The solution is stabilized with polysorbate (Tween) 80, buffered with potassium and sodium phosphates and contains approximately 0.35% phenol as a preservative. This product is ready for immediate use without further dilution. The purified protein fraction is isolated from culture media filtrates of a human strain of Mycobacterium tuberculosis by the method of F.B. Seibert.1,2 Tuberculin PPD, diluted, is prepared from Tuberculin PPD Powder Master Lot 154616 which is clinically bioequivalent in potency to the standard PPD-S* (5 TU** per 0.1mL) of the U.S. Public Health Service, National Centers for Disease Control. This product is made from a single master lot (No. 154616) to eliminate lot to lot variation inherent in manufacturing. The potency of each lot of tuberculin PPD, diluted is determined in sensitized guinea pigs.

Tuberculin PPD is indicated as an aid in the detection of infection with Mycobacterium tuberculosis. The standard tuberculin test employs the intradermal (Mantoux) test using a 5 TU dose of tuberculin PPD.7 The 0.1 mL test dose of Aplisol (tuberculin PPD, diluted) is equivalent to the 5 TU dose which has been clinically utilized and standardized with PPD-S. Tuberculin skin testing is not contraindicated for persons who have been vaccinated with BCG and the skin-test results of such persons are used to support or exclude the diagnosis of M. tuberculosis infections.4 HIV infection is a strong risk factor for the development of TB disease in persons having TB infection. All HIV-infected persons should receive a PPD-tuberculin skin test.3

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Media Articles Related to Aplisol (Tuberculin)

Electronic reminders can help tuberculosis patients stay on medication
Source: IT / Internet / E-mail News From Medical News Today [2015.09.15]
Reminders to take medication, delivered to patients via an electronic pillbox, may be able to improve adherence to tuberculosis (TB) treatment.

Effects of MVA85A vaccine on tuberculosis challenge in animals: systematic review
Source: Veterinary News From Medical News Today [2015.09.09]
A new systematic review of animal studies testing a vaccine for tuberculosis raises questions about whether the studies provided sufficient evidence to move into trials of children.

Is Tuberculosis (TB) Contagious?
Source: MedicineNet Tuberculosis Skin Test (PPD Skin Test) Specialty [2015.08.24]
Title: Is Tuberculosis (TB) Contagious?
Category: Diseases and Conditions
Created: 8/24/2015 12:00:00 AM
Last Editorial Review: 8/24/2015 12:00:00 AM

Tuberculosis (TB)
Source: MedicineNet isoniazid, INH Specialty [2014.12.08]
Title: Tuberculosis (TB)
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 12/8/2014 12:00:00 AM

HIV patients should be included in early clinical trials of anti-TB drugs
Source: Clinical Trials / Drug Trials News From Medical News Today [2015.09.28]
Tuberculosis is the number one cause of death in HIV-infected patients in Africa and a leading cause of death in this population worldwide, yet the majority of these patients are excluded from the...

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Published Studies Related to Aplisol (Tuberculin)

Effect of micronutrient deficiency on QuantiFERON-TB Gold In-Tube test and tuberculin skin test in diagnosis of childhood intrathoracic tuberculosis. [2014]
CONCLUSION: Micronutrient status, especially serum levels of zinc, may influence

The comparative performance of the single intradermal comparative tuberculin test in Irish cattle, using tuberculin PPD combinations from different manufacturers. [2011.07.05]
Ireland currently obtains its avian and bovine tuberculin purified protein derivatives (PPDs) from a single source... In this study, the precision of the guinea pig bio-assay to assess tuberculin potency was low and therefore Ireland should maintain its practice of periodically assessing potency in naturally infected cattle, even though this is not currently required under WHO, OIE or EU Regulations.

Tuberculin skin-test reactions are unaffected by the severity of hyperendemic intestinal helminth infections and co-infections. [2010.08]
The tuberculin skin test (TST) quantifies cell-mediated immunity to tuberculosis antigens. Helminths suppress cell-mediated immunity, so we studied the effect of helminth infection and deworming on the TST in a randomized, double-blind, placebo-controlled study in an indigenous Amazon community (N = 195)...

Interpreting tuberculin skin tests in a population with a high prevalence of HIV, tuberculosis, and nonspecific tuberculin sensitivity. [2010.05.01]
Understanding the epidemiology and clinical course of tuberculosis is hampered by the absence of a perfect test for latent tuberculosis infection. The tuberculin skin test (TST) is widely used but suffers poor specificity in those receiving the bacille Calmette-Guerin vaccine and poor sensitivity in individuals with human immunodeficiency virus (HIV) infections...

The effect of tuberculin testing on the development of cell-mediated immune responses during Mycobacterium bovis infection. [2006.11.15]
Protection against tuberculosis (TB) is associated with Th1-type cell-mediated immunity (CMI).

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Clinical Trials Related to Aplisol (Tuberculin)

Dose Study of Tuberculin Purified Protein Derivative (JHP/Dose) [Recruiting]
Dose comparison study of tuberculin purified protein derivative (PPD)Aplisol with the standard tuberculin purified derivative (PPD-S2).

Equivalence Study of Specificity of PPD [Not yet recruiting]

Safety Study Investigating if Concomitant Injections of C-Tb and 2 T.U Tuberculin Affect Induration Responses [Completed]
A new, more specific skin test to detect tuberculosis has been developed by Statens Serum Institut in Denmark. The new skin test is named C-Tb and like the current Tuberculin a positive test result will show as redness and/or induration at the injection site, while a negative test will leave no reactions. The aim of this study is to address if the size of induration and the sensitivity of C-Tb is influenced by concomitant injections of C-Tb and Tuberculin. Furthermore, the intention is to evaluate the safety of C-Tb when injected alone or concomitantly with Tuberculin.

Equivalence Study of Tuberculin Purified Protein Derivative in Comparison With a Reference Standard (PPD-S2) [Not yet recruiting]

A Trial in Subjects Suspected to Have Tuberculosis, Comparing the Diagnostic Performance of C-Tb to QuantiFERON�, in Combination With a Safety Assessment of C-Tb Versus Tuberculin PPD RT23 SSI [Completed]
Tuberculosis (TB) continues to be one of the most serious bacterial infections worldwide and therefore new improved diagnostic tests are needed to help doctors in diagnosing TB. The new skin test is named C-Tb. Like the current tuberculin skin test, PPD, the C-Tb test is injected just under the skin and will, when positive, show redness and/or swelling at the injection site while a negative test will leave no reactions. The investigators hope that this new C-Tb skin test will be more precise (specific) than the PPD test, as the PPD test e. g. may show a reaction if the person tested is BCG vaccinated. The aim of this trial is to test the C-Tb skin test in volunteers suspected of having TB disease. With focus on age, HIV status and CD4 count the following analyses are done (in an overall perspective):

- To compare the C-Tb test to a blood test, the QuantiFERON test.

- To compare the C-Tb test to the PPD test that is currently being used.

- To assess the safety of the C-Tb test.

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Reports of Suspected Aplisol (Tuberculin) Side Effects

Injection Site Erythema (3)Erythema Multiforme (3)Gait Disturbance (3)Application Site Reaction (2)Chest Pain (2)Injection Site Reaction (2)Rash Papular (2)Injection Site Pruritus (2)Hypersensitivity (1)Injection Site Urticaria (1)more >>

Page last updated: 2015-09-28

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