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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)

The Unintentional Punishment: Time In Prison Should Not Lead To Infection With HIV Or Tuberculosis
Source: Alcohol / Addiction / Illegal Drugs News From Medical News Today [2009.10.30]
At any given time, over two million people are imprisoned in penal institutions in Europe. Prisons are extremely high-risk environments for the transmission of infectious diseases because of a high number of risk factors, such as overcrowding, poor nutrition, limited access to health care, continued illicit drug use and unsafe injecting practices, unprotected sex and tattooing.

Chao Center Donates Medications To Combat Multidrug-Resistant Tuberculosis
Source: MRSA / Drug Resistance News From Medical News Today [2009.09.25]
The Chao Center for Industrial Pharmacy & Contract Manufacturing officials announced that they will donate about 1,800 bottles of a medication to help fight multidrug-resistant tuberculosis (MDR-TB) to Cambodia and Ethiopia. The Chao Center, which is based in the Purdue Research Park, produces and manufactures drugs in smaller quantities that can't be produced in a cost-effective way by larger pharmaceutical companies.

Arthritis Drug Raises Risk of Tuberculosis
Source: MedicineNet Ankylosing Spondylitis Specialty [2009.07.10]
Title: Arthritis Drug Raises Risk of Tuberculosis
Category: Health News
Created: 7/10/2009 7:00:00 AM
Last Editorial Review: 7/10/2009

Tuberculosis
Source: MedicineNet Erythema Nodosum Specialty [2008.01.17]
Title: Tuberculosis
Category: Diseases and Conditions
Created: 12/31/1997
Last Editorial Review: 1/17/2008

Extensively Drug-Resistant Tuberculosis (XDR TB)
Source: MedicineNet ICU Psychosis Specialty [2007.05.30]
Title: Extensively Drug-Resistant Tuberculosis (XDR TB)
Category: Diseases and Conditions
Created: 5/30/2007
Last Editorial Review: 5/30/2007

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Published Studies Related to Aplisol (Tuberculin)

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).

The effect of Johne's vaccination on tuberculin testing in farmed red deer (Cervus elaphus). [2005.08]
AIM: To assess the degree of interference with bovine tuberculin testing in farmed red deer that vaccination of young deer with an oil-adjuvanted vs aqueous formulation of live attenuated Mycobacterium paratuberculosis Strain 316F vaccines would be likely to cause, and to compare immunological responses between vaccine formulations... CONCLUSIONS: Vaccination of farmed deer with an oil-adjuvanted Johne's vaccine has the potential to cause significant interference with routine tuberculin skin testing. The cross-reactivity should decline with time and the CCT should be able to clear MCT-positives, but there is a risk of false-positives to the blood test for tuberculosis (BTB), due to high persistent levels of antibody. The CCT could be used as a primary skin test in vaccinated deer on some farms. The Aqueous Ptb caused fewer problems with skin testing and produced significantly less bovine antibody than the Oil-adjuvant Ptb, but stimulated persistent cell-mediated immune responses that may provide some protection against Johne's disease.

BCG scar and positive tuberculin reaction associated with reduced child mortality in West Africa. A non-specific beneficial effect of BCG? [2003.06.20]
Previous studies have suggested that the bacille Calmette-Guerin (BCG) vaccine may have a non-specific beneficial effect on childhood survival in areas with high mortality. We examined whether BCG-vaccinated children with a BCG scar or a positive tuberculin reaction had better survival than children without such reactions...

Effect of zinc on the tuberculin response of children exposed to adults with smear-positive tuberculosis. [2002.12]
The tuberculin test (PPD) is used frequently in the diagnosis of tuberculosis. PPD, however, relies on an intact cell-mediated immunity and infected children often have false negative results... Zinc supplementation could work by correcting asymptomatic or marginal zinc deficiencies or as a non-specific booster of immunological mechanisms (whether or not there is a deficiency).

BCG vaccination among West African infants is associated with less anergy to tuberculin and diphtheria-tetanus antigens. [2001.11.12]
To examine risk factors for anergy, delayed-type hypersensitivity was assessed among 884 infants participating in a vaccine trial in Guinea-Bissau. The infants were skin-tested at 7.5 months of age with a panel of seven intradermal antigens.

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Clinical Trials Related to Aplisol (Tuberculin)

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.

Local Anesthesia and Tuberculin Skin Test in Infants and Children [Not yet recruiting]
The use of local anaesthesia efficiently reduces pain due to needle puncture. However, when tuberculin skin test is performed it is the skin reaction to tuberculin injection that is studied. It is a quantitative skin reaction measured in millimiters. From the study of literature it is not known whether local anaesthetic modify skin reaction to tuberculin. Therefore, before recommending the use local anaesthesia for tuberculin intradermal injection we have to rule out a potential effect of local anaesthetic on the result of the test. This is particularly important in children, since there are more sensitive to pain than adults

Comparison of Quantiferon-TB Gold Assay With Tuberculin Skin Testing in Patients With Chronic Liver Disease [Completed]
The purpose of the study is to estimate the usefulness of the QuantiFERON®-TB Gold test for the diagnosis of latent tuberculosis infection in liver transplant candidates by correlating the test results with risk factors for LTBI

Use TST and QFT-RD1 Test to Monitor the Tuberculous Infection in Patients, Close Contact People and Health Care Workers [Recruiting]
Tuberculosis is still the most common infectious disease in Taiwan. The infants in Taiwan

have been vaccinated at birth with BCG - Tokyo 171 strain since 1951. The BCG vaccination

rate is 97% among first grade students in a recent national survey. Even with such a high BCG vaccination coverage, Taiwan still has a relatively high TB incidence rate. In 2004, there were totally 16,784 newly diagnosed TB cases and the annual incidence was 74. 11 per 100,000 population nationally. Nearly 70% of the incidence cases were men and 30. 4% were women. The mean age of incidence cases was 57. 8 years old (median=63). 8,440(50. 29%) patients were elderly than 65 years old. The elderly men did not receive the BCG vaccination and were the most important group to develop newly diagnosed tuberculosis and a special issue for the national TB control program in Taiwan.

The tuberculin skin test (TST) is the only widely available method for detecting whether people have an immunologic reactivity to mycobacterial antigens and identified as latent tuberculosis infection (LTBI). Targeted tuberculin testing for latent TB infection is a very important strategy to identify subjects with high risk to develop tuberculosis including those who have recent infection with Mycobacterium tuberculosis or have clinical conditions that associated with an increased risk for progression of LTBI to active TB but the sensitivity was lower in elderly patients.

Quantiferon-TB gold test (QFT-RD1) is a new diagnostic test for latent tuberculosis and a valuable alternative to skin testing. This whole-blood assay measures the production of IFN-  in whole blood upon stimulation by ESAT-6 and CFP-10 and allows distinction of latent M. tuberculosis infection from BCG-induced reactivity. ESAT-6 and CFP-10 are deleted from BCG Region 1 (RD1), not present in most nontuberculous mycobacteria and are highly specific indicators of M. tuberculosis infection. Thus, the aim of this study was to estimate the specificity and sensitivity of a whole blood IFN-γassay employing CFP-10 and ESAT-6, for the detection of M. tuberculosis infection in a clustered high risk elderly population.

Changhwa Veterans Home is a government-expense veterans home with totally 519 residents in 2004. The inhabitants were all elderly people and lived in groups. , They did not receive BCG vaccination and were the high risk group to develop endemic TB infection. The annual TB incidence rate over there was 3,500 per 100,000 population.

Quantiferon-TB Gold in the Assessment of Latent TB in Patients Candidate to Treatment or Treated With TNFα Antagonists [Recruiting]
The purpose of this study is to evaluate the value of Quantiferon-TB Gold (QFT-G) assay in the screening for latent tuberculosis infection (LTBI) in rheumatologic patients due to start or on treatment with TNFα antagonists. The results of QFT-G will be compared to tuberculin skin testing (TST) and correlated to clinical and demographic data. The study hypothesis is that the inclusion of QTF-G in the screening strategy will allow a more accurate assessment of LTBI infection.

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Page last updated: 2009-10-30

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