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Tubersol Tuberculin Purified Protein Derivative 1 mL (10 Tests) (Rx) *Refrigerated

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Tubersol Tuberculin Purified Protein Derivative

Tubersol by Sanofi is the gold standard for accurate, reliable, and safe screening of latent and active tuberculosis (TB) infection. This FDA-approved, sterile, Tween-stabilized Tuberculin Purified Protein Derivative (PPD) solution is preferred by clinics, hospitals, occupational health, and public health facilities for the Mantoux tuberculin skin test (TST) procedure. With rigorous manufacturing and globally trusted performance, Tubersol simplifies TB screening for healthcare professionals and ensures the best results for patient monitoring and outbreak control.

Tubersol Tuberculin Purified Protein Derivative (PPD) (Mantoux) 1 mL (10 Tests) Tween Stabilized Solution is the trusted choice for healthcare professionals worldwide in the detection of latent or active tuberculosis (TB) infection. This highly purified PPD solution is specifically designed for the renowned Mantoux tuberculin skin test (TST). Each vial contains 1 mL of stabilized solution (equal to 10 tests), ensuring consistency, accuracy, and reliability in TB screening programs for hospitals, laboratories, public health agencies, and clinics.

How Tubersol Works

Tubersol is administered intradermally via the Mantoux technique. The purified protein derivative (PPD) stimulates a delayed-type hypersensitivity (DTH) immune response in individuals sensitized to Mycobacterium tuberculosis. Read the induration region at the site 48-72 hours post-injection for accurate TB diagnosis.

Tubersol Tuberculin Purified Protein Derivative (Mantoux) is used for conducting the Mantoux tuberculin skin test, which helps diagnose latent tuberculosis infection. This solution is administered intradermally to assess the body’s immune response to the TB antigen. A critical tool in public health, it aids in identifying individuals who have been exposed to Mycobacterium tuberculosis. The solution is stabilized with Tween, ensuring consistent results for accurate TB screening and management.

Interpretation of Results

  • Positive TST: Indicates TB infection (active or latent); follow up with chest x-ray and/or clinical assessment.
  • Negative TST: Typically rules out TB infection; consider patient history, risk factors, and immunocompromised status.
  • Full Manufacturer’s Instructions Provided

Tubersol Tuberculin Purified Protein Derivative (Mantoux) 1 mL
Quantity: 10 Tests per vial
Formulation: Tween Stabilized Solution
Method: Mantoux method – intradermal injection
Intended Use: Detection of latent tuberculosis infection
Application: Used by healthcare professionals for skin test diagnosis
Dosage and Administration: Follow healthcare guidelines for dosage and administration for conducting the Mantoux test
Storage Conditions: Store refrigerated between 2°C and 8°C (35°F to 46°F); do not freeze
Stability: Ensure the solution is clear and free from particulate matter before use
Precautions: For professional use only; read the package insert for full instructions and safety information before use

Order Tubersol Tuberculin PPD (Mantoux) 1 mL (10 Tests) by Sanofi Today!

NDC: 49281-0752-21 | UPC: 349281752216 Fast Shipping | 100% Authentic | Bulk Discounts Available

Ensure TB safety for your facility, workforce, or patient population with the leading tuberculin PPD test from Sanofi. For the best accuracy, reliability, and clinical value—choose Tubersol for your tuberculosis testing needs.

Uses & Applications

Tubersol Tuberculin PPD Solution is indicated for:

  • Screening and diagnosis of tuberculosis infection (latent and active TB)
  • Routine testing of healthcare workers, students, correctional facility residents, and employees in high-risk settings
  • Contact tracing and TB surveillance during public health outbreaks
  • Immigration, school, and occupational health compliance
  • Baseline & serial TB testing for medical, dental, and laboratory staff

Benefits & Features

  • Highly Sensitive & Reliable: Considered the international standard for TB skin testing
  • Consistent & Reproducible Results: Purified protein derivative ensures uniform immune response interpretation
  • Tween Stabilized Solution: Enhanced stability, prevents protein aggregation, and ensures test accuracy
  • Preservative-Free, Sterile, Pyrogen-Free: Reduces risk of allergic reaction and site irritation
  • Economical 10 Test Vial: Efficient for group screenings, clinics, and occupational health programs
  • Convenient 1 mL Vial: Each vial contains 10 doses (0.1 mL per test)
  • FDA-Approved, Trusted Manufacturer: Expertly produced by Sanofi with rigorous quality standards

Specifications

Attribute Details
Generic Name Tuberculin Purified Protein Derivative (PPD)
Brand Name Tubersol
Strength 5 TU (tuberculin units) per 0.1 mL
Form Injectable Solution, Tween Stabilized
Volume 1 mL multi-dose vial (10 tests/vial)
NDC 49281-0752-21
UPC 349281752216
Administration Route Intradermal (forearm)
Storage 2°C–8°C (Refrigerate, DO NOT FREEZE)
Manufacturer Sanofi Pasteur

Instructions on How to Use (Mantoux TB Skin Test Procedure)

  1. Prepare the site:

    • Select the volar surface of the forearm, 2–4 inches below the elbow.
    • Cleanse with alcohol and let dry.
  2. Draw up the dose:

    • Using a tuberculin syringe, withdraw 0.1 mL (5 TU) of Tubersol solution.
  3. Administer the Injection:

    • Stretch the skin taut.
    • Insert the needle, bevel up, just below the skin surface (intradermal).
    • Inject slowly to form a pale, discrete wheal (6–10 mm diameter).
  4. Do not cover or massage site.

  5. Record the location, date, and time of administration.

Dosage & Administration

  • For adults and children:
    • 0.1 mL (5 TU) administered intradermally in the forearm.
  • Reading Results:
    • Test site should be evaluated by a healthcare professional in 48-72 hours.
    • Measure induration (not erythema) transversely to the long axis of the forearm.
  • Interpretation:
    • Positive threshold depends on risk factors and patient population (e.g.,>5 mm,>10 mm,>15 mm).

Always use a new, sterile syringe and needle for each patient.

Drug Interactions

  • Live Virus Vaccines: Measles, mumps, rubella can temporarily suppress response to PPD – if MMR given, delay TB test by 4–6 weeks.
  • Immunosuppressive Drugs & Corticosteroids: May reduce skin reactivity and cause false-negative results.
  • Acute Viral Illness or Recent Vaccination: May diminish test response; schedule test appropriately.
  • History of Severe Allergies or Immunodeficiency: Consult provider.

Communicate all medications and recent vaccinations to your healthcare provider prior to testing.

Side Effects & Warnings

Common Side Effects

  • Mild redness, itching, or swelling at injection site
  • Transient mild pain at administration point

Serious Adverse Reactions

  • Severe allergic reaction (anaphylaxis, urticaria): Extremely rare
  • Ulceration or necrosis at injection site (rare in hypersensitive individuals or improper administration)
  • Vesiculation or blistering at site (very rare)
  • Fever or generalized skin reaction (rare)

Warnings & Precautions

  • Do not use for IV, IM, or subcutaneous administration—intracutaneous only.
  • Store refrigerated at 2–8°C; do not freeze.
  • Not for use in patients with known PPD hypersensitivity or previous severe TB test reactions.
  • False negative possible in immunosuppressed, malnourished, or acutely ill patients.
  • Not a substitute for clinical evaluation or other TB diagnostics.