1 What is Aplisol?

Brand: Aplisol, Tubersol

Generic: Tuberculin

Aplisol is used in Mantoux tuberculin test (also called a PPD skin test) to aid diagnosis of tuberculosis (TB) infection in persons at increased risk of developing active disease. This skin test is usually indicated when symptoms, screening, or testing, such as a chest x-ray, show that a person may have TB.

Tuberculosis is a highly contagious disease, usually of the lungs, caused by the bacteria Mycobacterium tuberculosis, which spreads by breathing in the air exhaled by an infected person.

The World Health Organization (WHO) estimates that TB is second only to HIV and AIDS as the greatest global killer. However, the causative organism can remain inactive in your body for years.

It can become active in immunocompromised state and produce symptoms such as fever, coughing, weight loss, and night sweats. Following TB infection, your body becomes extra sensitive to certain elements of the bacteria, such as the purified protein derivative (PPD).

That’s why; this tuberculin skin test is carried out to check whether you have ever been exposed to tuberculosis (TB) infection with Mycobacterium tuberculosis or not.

A tuberculin skin test is done by putting a measured amount of TB protein (i.e. tuberculin PPD) under the top layer of the skin on your inner forearm. Later, the area will be examined to see if you have had a strong reaction to the test.

If a reaction is seen at and around the place of injection or puncture within 48-72 hours reveals that the test is positive. If the test is given using an injection, this reaction is usually a hard, raised area with clear margins.

If the test is given using the puncture devices, the reaction is usually a swollen area at the puncture site. The amount of reaction/swelling may be different for children, people with HIV, the elderly, and others at high risk.

This medicine is to be given only by or under the supervision of a healthcare professional. This product is available in the following dosage form:

  • Solution

2 What to Know Before Using

Before using Aplisol, you must know all about the risks and complications associated with it. The accessibility of this diagnostic procedure is usually chosen by a doctor with the active participation of the patient.

There are some important factors such as drug interactions, the presence of any metabolic impairment, history of hypersensitivity reaction, pregnancy, lactation etc. which may affect the use of this test.

Sometimes the presence of other health disorders may alter the result of this skin test and even may cause serious toxic effects. If you have had any allergic reactions to any medicine then you must tell your doctor about that.

This diagnostic test is contraindicated in those who have had a severe reaction (e.g. necrosis, blistering, or anaphylactic shock) to a previous tuberculin skin test.

Make sure you inform your doctor if you have any other medical problems, especially:

  • Documented active tuberculosis or a clear history of treatment for TB infection
  • Extensive burns or eczema (skin disease)
  • HIV infection or AIDS
  • History of organ transplant
  • Impaired immune system—should not be given to patients with these conditions.

Because of drug-drug interactions, certain medicines should not be used while you are undergoing this tuberculin test. It is always recommended to consult with your doctor if you are in need of some other medications or even any over-the-counter medicine for another health problem in order to avoid unwanted toxic effects.

Besides, the followings should be kept in mind:

  • Reactivity to the test may be depressed or suppressed in persons who are receiving corticosteroids or immunosuppressive agents.
  • Reactivity to tuberculin may be temporarily depressed by certain live virus vaccines (measles, mumps, rubella, oral polio, yellow fever, and varicella).
  • If a parenteral live attenuated virus vaccine has been administered recently, tuberculin testing should be delayed for > 1 month after vaccination.

Animal reproduction studies have shown an adverse effect, and there are no adequate and well-controlled studies in pregnant women. Thus, this test should be used during pregnancy only if clearly needed.

Besides, caution should be exercised when used in lactating women because studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

3 Proper Usage

Proper usage of Aplisol requires strict adherence to your doctor’s orders. A nurse or other trained healthcare provider will give you this medicine in a hospital or clinic. This medicine is injected into the skin on your inner forearm. 

The injection site will be examined by the healthcare professional within 2 or 3 days after receiving tuberculin to check at the way your skin has reacted to the medicine.

Your skin may become red and swollen in the area where the medicine was given. However, general instructions are listed below:

Tuberculin is indicated for intradermal injection only. If subcutaneous injection occurs, the test cannot be interpreted.

The preferred site of the test is the volar aspect of the forearm. The areas with visible veins and red/swollen skin should be avoided.

The administration skin site should be cleaned with a suitable germicide and the site should be allowed to dry prior to injection of the TB antigen.

Five (5) tuberculin units (TU) per test dose of 0.1 mL is the standard strength used for intradermal tuberculin testing.

The test dose should be administered by slow intradermal injection using a syringe fitted with a short, one-quarter to one-half inch, 26 or 27 gauge needle.

Caution should be exercised to insert the point of the needle into the most superficial layers of the skin with the needle bevel pointing upward.

If the intradermal injection is performed properly, a definite pale bleb will rise at the needle point, about 10 mm (3/8”) in diameter. This bleb will disperse within minutes.

In the event of an improperly performed injection (i.e. no bleb formed), the test should be repeated immediately at another site, at least 2 inches from the first site and the second injection site must be marked by a circle as an indication that this is the site to be read.

The skin test should be read by a trained health professional 48 to 72 hours after administration. Skin test sensitivity is indicated by induration only; redness should not be measured.

Tuberculin reactivity may indicate latent infection, prior infection and/or disease with M. tuberculosis and does not necessarily indicate the presence of active tuberculosis. Persons showing positive tuberculin reactions should be considered positive by current public health guidelines and referred for further medical evaluation.

The significance of induration measurements in diagnosing latent TB infection must be considered in terms of the patient's history and the risk of developing active TB disease. Additionally, causes of false-positive and/or false-negative result should be considered before interpretation of the result of the tuberculin test.

False-positive tuberculin reactions can occur in individuals who have been infected with other mycobacteria, including vaccination with BCG. However, a diagnosis of M. tuberculosis infection and the use of preventive therapy should be considered for any BCG-vaccinated person who has a positive reaction, especially if the person has been, or is, at increased risk of acquiring TB infection.

Impaired or attenuated cell-mediated immunity (CMI) can potentially cause a false-negative tuberculin reaction. Many factors have been reported to cause a decreased ability to respond to the tuberculin test in the presence of tuberculous infection including viral infections (e.g. measles, mumps, chickenpox and HIV), live virus vaccinations (e.g. measles, mumps, rubella, oral polio and yellow fever), overwhelming tuberculosis, other bacterial infections, leukemia, sarcoidosis, fungal infections, metabolic derangements, low protein states, diseases affecting lymphoid organs, drugs (corticosteroids and many other immunosuppressive agents), and malignancy or stress.

4 Precautions to Take

Before using Aplisol, there are some precautions you must take. Firstly, you should know the possible outcomes of this diagnostic test. You should not delay visiting your healthcare provider to check tuberculin reactivity.

Additionally, the following guidelines should be maintained throughout the diagnostic procedure to prevent unwanted complications:

Allergic reactions, including anaphylaxis, may occur following the use of this drug even in persons with no prior history of hypersensitivity to the product components. Epinephrine injection and other appropriate agents used for the control of immediate allergic reactions must be immediately available.

Syncope (fainting) can occur in association with receiving this test. It may occur with other symptoms such as lightheadedness, muscle weakness, or seizures. Thus, procedures should be in place to avoid falling injury and to restore cerebral perfusion.

False-positive tuberculin skin test reaction may occur in some patients. This may occur if you have received a vaccine against tuberculosis i.e. BCG vaccine or if you have been exposed to other mycobacteria.

Screening should be completed as early as possible after HIV-infection because the test results in HIV-infected individuals are less reliable as CD4 counts decline.

You should make sure your doctor knows if you are using a medicine that weakens your immune system, such as a steroid or cancer treatment.

A tuberculin skin test should be deferred for patients with major viral infections or live-virus vaccination in the past month. These vaccines include measles, mumps, rubella, oral polio, yellow fever, and varicella.
If tuberculin testing will be conducted at regular intervals, for instance among health-care workers or prison workers, two-step testing should be performed as a baseline to avoid interpreting a booster effect as a tuberculin conversion.

The tuberculin solution should be inspected for extraneous particulate matter and/or discoloration before use. If these conditions exist, the product must not be used.

5 Potential Side Effects

As with many medications, there are several potential side effects associated with Aplisol. These side effects usually go away since your body adjusts to this purified protein derivative.

Your healthcare professional may advise you about the ways how to prevent or reduce those unwanted side effects.

Sometimes you may need to consult with the doctor if you notice any of the following toxic effects:

  • Pain, discomfort, or itching at the injection site
  • Redness or rash at the injection site
  • Bleeding at the injection site
  • Blistering, crusting or scabbing at the injection site
  • Cough
  • Deep, dark purple bruise, or scar at the injection site
  • Dizziness
  • Fainting
  • Fever
  • Formation of a hard lump at the injection site
  • Fast or irregular heartbeat
  • Hives
  • Labored breathing
  • Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • Unusual tiredness or weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.