Aplisol Tuberculin TB Skin Test (Mantoux Test)

Aplisol is a sterile intradermal diagnostic antigen used to detect Mycobacterium tuberculosis infection. It contains purified protein derivative (PPD) from M. tuberculosis (prepared by the Seibert method) at a standardized potency of 5 tuberculin units (TU) per 0.1 mL. Aplisol is indicated as an aid in diagnosing tuberculosis infection (latent or active). It is not a vaccine or treatment, but a skin test antigen. The solution is ready-to-use (no dilution needed) and contains a phenol preservative.

Aplisol Tuberculin PPD Skin Test Features:

• Highest Accuracy for TB Testing: Contains purified protein derivative (PPD) with 5 Tuberculin Units (TU) per 0.1 mL for standard, CDC-recommended Mantoux tuberculin skin testing.
• FDA Approved & Clinician Trusted: Aplisol is manufactured under strict sterile conditions, ensuring safety and reliability for mass screening and routine testing purposes.
• Bulk 5mL Vial – 50 Doses: Cost-effective, convenient packaging meets high-volume screening needs in healthcare, laboratory, and workplace environments.
• Sterile, Non-Pyrogenic Solution: Reduces risk of patient reactions and provides consistent testing results.
• Rapid, Easy Administration: Administers easily with a single intradermal injection; results can be evaluated within 48 – 72 hours for fast, actionable TB detection.
• Broad Applications: Essential for entry/annual screening of healthcare workers, students, correctional facilities, immigrants, and close contacts of TB patients.

Administration (Mantoux Method)

The standard Mantoux technique is used with Aplisol. A trained healthcare provider performs the test as follows.

1. Inject 0.1 mL intradermally (5 TU): Using a 27-gauge needle, inject 0.1 mL of Aplisol into the volar (inner) surface of the forearm, about 4″ below the elbow. A small pale wheal (6–10 mm) should appear if done correctly.
2. Reading the site (48–72 hours): The injection site is examined 48 to 72 hours later by a trained reader. Measure only the diameter of induration (the firm, raised area) in millimeters; do not measure redness (erythema). If no induration is palpable, record “0 mm.” If only erythema (redness) is present without induration, the test is considered negative (often indicating too-deep injection). If an improper dose was given or the test invalid (no wheal), the test should be repeated at a new site..

Administration tips: Use a new sterile syringe/needle per patient and clean the site with alcohol before injection. Ensure the full 0.1 mL (5 TU) is delivered intradermally; more than 30 minutes elapsing before testing can reduce potency. Pregnancy is not a contraindication; tuberculin testing is considered safe and valid during pregnancy.

Interpreting Results

• Positive reaction: An induration ≥5 mm is considered positive in high-risk individuals (e.g. HIV-positive, recent TB contacts, immunosuppressed). An induration ≥10 mm is positive in people with moderate risk (e.g. immigrants from high-TB countries, injection drug users, certain medical conditions, children <5). An induration ≥15 mm is positive in people with no known risk factors. (These cutoffs follow current CDC guidelines.)
• Negative reaction: An induration <5 mm is typically negative in low-risk people. However, false negatives can occur in immunocompromised persons or very recent infections (it takes 2–8 weeks post-infection for a positive PPD to develop).

Each result must be interpreted in context. For example, a BCG-vaccinated person with a positive reaction should be evaluated as if not vaccinated (since BCG effects wane over time). Likewise, repeat “two-step” testing (two PPD tests 1–3 weeks apart) may be used in periodic screening to distinguish a boosted reaction from a new infection.

Side Effects and Reactions

Local reactions are common: pain, redness, swelling at injection site. A strongly positive test can cause blistering, ulceration, or necrosis at the site, sometimes leading to a scar. These are not infections but inflammatory responses. Apply cold packs or topical steroids for comfort if needed.

Systemic allergic reactions are very rare but possible: rash, urticaria, angioedema, and even anaphylaxis have been reported. If any sign of severe allergy occurs, seek medical help immediately. Note: because of the preservative phenol, some people may have mild sensitivity.

Product Specifications

• Brand: Aplisol
• Manufacturer: Par Sterile Products LLC
• Type: Tuberculin PPD Purified Protein Derivative
• Concentration: 5 TU / 0.1 mL (standard Mantoux test)
• Vial Size: 5 mL multi-dose vial (approx. 50 tests/vial)
• Sterility: Sterile, non-pyrogenic
• Administration: Intradermal injection (usually forearm site)
• Indications: TB screening, latent tuberculosis infection (LTBI) detection, annual health and occupational screenings
• Storage: Refrigerated (2-8°C)

Best Uses & Clinical Applications

• Public Health & School TB Screening: Rapid, accurate TB detection for students, teachers, and staff members.
• Occupational Health & Hospital Employee Testing: Ensure compliance and protect staff with CDC-recommended annual screening.
• Community Clinics & Prisons: Screen high-risk populations for latent and active tuberculosis.
• Immigration & Visa Health Examinations: Essential for regulatory compliance in immigration processes.
• Close Contact Risk Assessment: Quickly assess TB exposure and infection among known contacts of TB-positive patients.

Key Benefits

• CDC-recommended concentration for maximum test sensitivity
• Bulk 50-dose vial for efficient high-volume testing
• Reduces risk of false positives and patient reactions
• Ensures safe, sterile intradermal administration
• Supports public health, compliance, and occupational safety standards

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Brand: Par Sterile Products LLC
NDC: 42023-0104-05
UPC: 342023104052
Type: Multiple Dose Vial

Aplisol PPD (5 TU) is a tuberculosis skin test antigen given intradermally. A 0.1 mL injection yields 5 TU, the standard test dose. After injection, induration is measured at 48–72 hours. The size of induration (not redness) determines the likelihood of TB infection, with risk-based cutoffs (e.g. ≥5 mm in high-risk persons, ≥10 mm in moderate risk, ≥15 mm otherwise). Use caution in those with prior severe reactions (do not test again), and remember that BCG vaccination or non-tuberculous mycobacteria can affect results. Store Aplisol refrigerated (2–8 °C), discard vials after 30 days of use, and always have trained personnel administer and read the test.

Disclaimer: This information is for educational purposes only. For personal medical advice (e.g. reading your own test, treatment of TB infection), consult a qualified healthcare provider.

Buy Aplisol Tuberculin PPD Skin Test today for the #1 FDA-approved, physician-trusted TB screening solution and keep your facility compliant and protected!