Understanding Aplisol:
The Essential Guide to Tuberculin Testing
Tuberculosis, often called TB, is an infectious disease that affects the lungs. It is caused by the bacterium Mycobacterium tuberculosis and is associated with extreme cough, chest pain, fever, and weight loss. According to the Centers for Disease Control and Prevention (CDC), in the year 2023, nearly 9,615 tuberculosis cases have been reported in the US. If left undiagnosed and untreated, tuberculosis can become fatal. Therefore, a simple tuberculin test like Aplisol should be taken if you have a prolonged chest infection.
In this article, we will dive into the composition, uses, as well as side effects of Aplisol in addition to some of its available brands.
What is Aplisol?
Aplisol is a brand of tuberculin purified protein derivative (PPD) which is used to conduct an in vivo (inside the body) test for the diagnosis of tuberculosis (TB). The product comes in multi-dose vials and has been approved by the Food and Drug Administration (FDA).
Composition
The Aplisol tuberculin PPD test is composed of a sterile aqueous solution that contains purified protein fraction as its active ingredient. These proteins are isolated from lab cultures of the human strains of Mycobacterium tuberculosis.
For the purpose of stabilization, polysorbate 80 (also called Tween 80) is added to the mixture. Potassium and sodium phosphates are also added to the mixture as buffering agents while a small amount of phenol (0.25%) is added as a preservative.
How to Conduct Tuberculosis Test Using Aplisol?
To conduct the tuberculosis test using Aplisol, the following procedure needs to be kept in mind:
1. Select the Site of the Injection
Select a suitable area for the intradermal Aplisol injection. Ideally, the injection should be administered at the dorsal or volar surface of the forearm which is about 4 inches below the elbow.
2. Inspect the Site
Make sure that the site of injection is free from any lesions. The injection must also be given away from the veins as an intradermal (into the skin) administration is required instead of intravenous (into the veins).
3. Clean the Area
The selected site for the administration of Aplisol injection should be cleaned using a 70% alcohol solution. This will help wipe out all the germs.
4. Fill the Injection
The next step is to fill the Aplisol into a tuberculin syringe. For this purpose, use a 0.5 or 1.0 ml syringe which is attached to a 27 gauge needle (1/4 to ½”). The diaphragm of the vial-stopper must also be cleaned with 70% alcohol.
5. Fill the Syringe
Insert the needle into the vial through the stopper diaphragm. Fill the syringe up to 1 ml. Make sure that there are no air bubbles in the syringe.
6. Administer the Injection
Insert the needle intradermally into the superficial layers of the skin. The bevel of the needle should be pointed upward. During injection, a pale bled of about 6 to 10 mm in size appears at the site of injection. This bleb automatically disappears within a few minutes as the solution is distributed within the skin. Therefore, there is no need to use any dressing material.
If there is blood on the skin once it is withdrawn, apply a gauze pad on the site of injection and dab to remove the blood. Do not press the area as this may interfere with the test results.
Interpretation of Results
Both the conduction of the tuberculin skin test (Mantoux reaction) as well as the interpretation of its results should be done only by a trained healthcare professional. The results can be interpreted in the following ways:
- If you have a Mycobacterium infection, then the skin around the site of injection should swell within 24 to 48 hours of Aplisol administration.
- The size of this swollen area called bump or induration determines whether you have TB or not.
- Your healthcare professional will measure the size of the induration. For this purpose, perpendicular measurement is done between the elbow and the hand.
The following table summarizes the sizes of the induration as well as what they indicate:
Size of Aplisol Test Induration | Result |
Less than 5 mm (millimeters) | Negative |
At least 5 mm | Positive if the patient: Has been in contact with a TB patient recently Has previously suffered from TB Has HIV Has had an organ transplant Is taking immunosuppressants |
At least 10 mm | Positive if the patient: Is below the age of 4 Uses injected drugs Live in a high-risk environment Has migrated from a high-risk country in the past 5 years Works in a healthcare facility i.e. a hospital or a clinic |
15 mm or more | Positive |
Side Effects of Aplisol
The Aplisol test has been associated with certain side effects in some patients. These primarily include the anaphylactic reaction which can happen within 24 hours of exposure. It is associated with:
- Rash
- Urticaria (the itchy patches on the skin that get transformed into reddish swollen welts)
- Pruritis (itching)
- Edema (fluid buildup in the body parts which then appear swollen)
- Angioedema (swelling under the skin surface which appears as welts or hives)
There are some other side effects that can occur and in fact, do occur in a few people but there isn’t enough data to check how often their occurrence happens. These are labeled as ‘Incidence not known’ and include the following:
- Cough
- Dizziness
- Fever
- Weakness
- Extreme tiredness
- Appearance of hives at the injection site
- Blisters or scabs on the site of injection
- Itching
- Pain and redness
- Labored breathing
- Wheezing
- Purplish bruise on the site of injection
In case of any of these side effects, contact your healthcare provider immediately.
Contraindications
Despite being a safe tuberculosis diagnostic option for many patients, the Aplisol test is not for everyone. Therefore, the test should not be performed on individuals who suffer from any of the following conditions:
- Aplisol test is not suitable in case of a known allergy or hypersensitivity to its components.
- People who suffer from ulceration, vesiculation, or necrosis at the site of injection upon previous exposure should never be administered with Aplisol.
Caution
Before administration, each Aplisol tuberculin PPD vial should be visually inspected. In case of the presence of any particulate matter or any kind of discoloration, the product is not fit for administration and should be discarded immediately.
Vials that have been in use for more than 30 days should also be discarded due to the risk of possible oxidation of their contents. Do not keep the Aplisol vials in the freezer.
Frequently Asked Questions
The following section covers some of the frequently asked questions about Aplisol:
1. What if bleb is not formed upon the Aplisol injection administration?
If the bled did not form during the test, there is a risk that the injection has been administered subcutaneously instead of intradermally. In such a case, there is a need to administer the injection once again. For this purpose, an area on the skin needs to be chosen again which should be at least 5 cm away from the previous site of injection.
2. Does the color of the induration indicate tuberculosis?
No, the size of the induration determines whether a patient has the disease or not. The color of the induration does not indicate anything although it may change over time.
3. Can an Aplisol test conducted during pregnancy?
The safety of Aplisol is yet to be evaluated in pregnant women. It has been categorized in Pregnancy Category C which indicates that the product has not been studied in pregnant women. However, the animal studies conducted on it have indicated risk to the baby.
Therefore, it is recommended to use Aplisol in pregnant women only if the benefits outweigh the risks. Otherwise, exposure could be fetotoxic i.e. dangerous to the fetus.
4. Is Aplisol cancer-causing?
The present studies conducted on Aplisol have not indicated its carcinogenic or cancer-causing risk. However, there is a lack of long-term studies in this regard.
5. Does Aplisol affect fertility?
No reliable and long-term studies have been conducted to check the effects of Aplisol on fertility. Therefore, there is a need to design new studies that could address whether Aplisol causes impaired fertility.
Aplisol Tuberculin Purified Protein Derivative at Health Supply 770: Features and Specifications
Aplisol is a diagnostic product that contains tuberculin protein. When injected intradermally, the test solution helps in the detection of tuberculosis infection. It is one of the easiest ways to detect tuberculosis as test results can be obtained within 24 to 48 hours. Some of these Aplisol products are also available at Health Supply 770 and have been detailed below along with their features and purchase links:
Par Sterile Prod 42023010401 PPD Aplisol, VL 5TU/0.1 ml 1 ml (10 TEST/VL) JHPPHM
Product Details
Par Sterile Prod 42023010401 PPD Aplisol is a product of JHP Pharmaceuticals. It is a tuberculin-purified protein derivative that is employed for the detection of tuberculosis. The product is to be used via the intradermal route. Being free from latex, Aplisol is safe for people will sensitivities.
Each pack of Par Sterile Prod 42023010401 PPD Aplisol contains 10 test vials. These need to be stored at a temperature of 2 to 8°C (36 to 46°F). In addition, the product is also sensitive to light so must be stored away from places where direct sun exposure is possible.
As per usage instructions, the vials that are in use for more than 30 days should be discarded as the risk of oxidation as well as degradation of the drug is possible. As a result, the product may not be as effective as it should be as such chemical changes affect potency. The product also needs to be diluted before use.
Par Sterile Prod 42023010405 PPD Aplisol, VL 5TU/0.1 ml 5 ml (50 TEST/VL) JHPPHM
Product Details
Par Sterile Prod 42023010405 PPD Aplisol has the same features and uses as the above-mentioned product. This particular product contains 50 test vials per pack.
*Note: The prices mentioned in the article are taken from the Health Supply 770 website. These may vary over time.
The above-mentioned Aplisol products, along with many other medical supplies, can be ordered from Health Supply 770, a reliable name when it comes to medical products. They have a 30-day money-back guarantee and provide your products to you in the shortest possible time. Click the link given in the article to check out the wide range of instruments and devices for the diagnosis and management of tuberculosis infection.
Bottom Line
Tuberculosis is a disease which is caused by the bacterium M. tuberculosis. As the infection is contagious, it gets transmitted from one person to another even after a one-time exposure. Therefore, an early diagnosis is important so that the disease can be controlled from spreading further.
Aplisol test is a tuberculin protein-based skin test in which the derived protein content is administered intradermally into the skin. The results of the test can be seen within 24 to 48 hours and have been associated with the formation of an induration on the skin.
Considering its importance, Aplisol test vials should be stocked up in healthcare facilities and testing centers. For purchasing top-quality Aplisol as well as other medical products, reliable vendors like Health Supply 770 should be approached. They ensure the provision of quality products along with satisfactory services.
References
https://www.cdc.gov/mmwr/volumes/73/wr/mm7312a4.htm
PhD Scholar (Pharmaceutics), MPhil (Pharmaceutics), Pharm D, B. Sc.
Uzma Zafar is a dedicated and highly motivated pharmaceutical professional currently pursuing her PhD in Pharmaceutics at the Punjab University College of Pharmacy, University of the Punjab. With a comprehensive academic and research background, Uzma has consistently excelled in her studies, securing first division throughout her educational journey.
Uzma’s passion for the pharmaceutical field is evident from her active engagement during her Doctor of Pharmacy (Pharm.D) program, where she not only mastered industrial techniques and clinical case studies but also delved into marketing strategies and management skills.