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Aplisol (Tuberculin) - Summary

 
 



APLISOL 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.

Tuberculin PPD is recommended by the American Lung Association as an aid in the detection of infection with Mycobacterium tuberculosis. The standard tuberculin test recommended 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 recommended as clinically established 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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NEWS HIGHLIGHTS

Media Articles Related to Aplisol (Tuberculin)

Tuberculosis (TB)
Source: MedicineNet Amyloidosis 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

Tuberculosis (TB) Treatment and Vaccine
Source: MedicineNet isoniazid, INH Specialty [2014.10.30]
Title: Tuberculosis (TB) Treatment and Vaccine
Category: Doctor's & Expert's views on Symptoms
Created: 10/30/2014 12:00:00 AM
Last Editorial Review: 10/30/2014 12:00:00 AM

What Are the Symptoms and Signs of Tuberculosis (TB)?
Source: MedicineNet Tuberculosis Skin Test (PPD Skin Test) Specialty [2014.01.15]
Title: What Are the Symptoms and Signs of Tuberculosis (TB)?
Category: Doctor's & Expert's views on Symptoms
Created: 10/29/2014 12:00:00 AM
Last Editorial Review: 1/15/2014 12:00:00 AM

Provision of antiretroviral therapy for HIV-positive TB patients - 19 countries, sub-Saharan Africa, 2009-2013
Source: HIV / AIDS News From Medical News Today [2014.11.28]
All HIV-positive tuberculosis (TB) patients should receive antiretroviral therapy, which reduces the incidence of HIV-associated TB and reduces mortality among HIV-positive TB patients.

New database shows global increases in infection outbreaks, unique diseases rising since 1980
Source: Flu / Cold / SARS News From Medical News Today [2014.10.30]
Enterovirus. Tuberculosis. Cholera. Measles. Various strains of the flu and hepatitis.

more news >>

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).

more studies >>

Clinical Trials Related to Aplisol (Tuberculin)

A Contact Tracing Trial Comparing the Diagnostic Performance of C-Tb to QuantiFERON�-TB, in Combination With a Safety Assessment of C-Tb Versus Tuberculin PPD RT23 SSI [Recruiting]
Tuberculosis (TB) continues to be the most important bacterial infection worldwide and therefore new improved diagnostic tests are needed to help doctors in diagnosing TB.

We are investigating a new skin test 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 aim of this trial is to test the C-Tb skin test in volunteers. The volunteers are divided into four groups:

- Negative control group: Must have no history of exposure to a person with tuberculosis

disease.

- Occasional contact: Must be in contact with a person with tuberculosis disease between

6 hours/week and 6 hours/day

- Close contact: Must be in close contact with a person with tuberculosis disease for

more than 6 hours/day for at least five days

- Positive control group: Must have a confirmed tuberculosis disease within the last 3

years.

The goals of this clinical trial are:

- 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.

Safety Study Investigating if Concomitant Injections of C-Tb and 2 T.U Tuberculin Affect Induration Responses [Not yet recruiting]
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.

Optimization of Tuberculosis Intradermal Skin Test [Recruiting]
The only test available for in vivo diagnosis of tuberculosis is the intradermal injection of tuberculin according to the Mantoux method (also named tuberculosis skin test or PPD skin test).

The tuberculin skin test is based on a delayed-type hypersensitivity skin reaction However, this test needs to be performed by trained personnel, presents problem of reproducibility, and its interpretation is not well standardized (measure in millimeters of skin induration 48 to 72 hours after the PPD skin test).

The new generation BD micro needle used in this study should solve the technical difficulties; intradermal administration of tuberculin could then be made by any personnel.

A non-invasive and objective instrumental method of reading the test will be also tested .

Two-Stage Tuberculin (PPD) Skin Testing in Individuals With Human Immunodeficiency Virus (HIV) Infection [Active, not recruiting]
To quantitate in an HIV-infected population the percentage of patients demonstrating the "booster" phenomenon (attainment of a positive response to a second tuberculin purified protein derivative skin test when the first skin test was negative); to determine the relationship between the booster phenomenon and CD4-positive lymphocyte cell counts; to detect any relationship between the booster phenomenon and HIV exposure category.

The accuracy of skin testing to detect Mycobacterium tuberculosis (MTb) infection is dependent upon the host's ability to mount a delayed-type hypersensitivity (DTH) reaction; however, the DTH response may be impaired or absent in patients with impaired cell-mediated immunity, a classic characteristic of HIV infection. Patients in whom immunity is diminished, but not absent, may test negative the first time a purified protein derivative skin test for MTb is administered, but if the same skin test is repeated, a positive DTH response may then be elicited. This occurrence is known as the "booster" phenomenon.

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 [Recruiting]
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 being infected with TB.

The reasons for these tests are the following:

- 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.

more trials >>

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: 2014-12-08

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