What Is CANDIN®?

CANDIN^®(Candida albicansSkin Test Antigen to Assess Cellular Hypersensitivity)is prepared and extracted from cultures of key strains of the yeast Candida albicansgrown in a chemically-defined media. The potency is controlled by clinical testing in normal subjects with pre-determined enrollment criteria. It is packaged as a sterile, ready-to-use aqueous solution in a multi-dose vial (10 tests/vial).

How Does CANDIN® Work?

The antigens present in CANDIN® elicit a response of the cellular immunity system when injected intradermally. The response, known as delayed-type hypersensitivity (DTH), demonstrates cellular immunity to Candidaand the ability of the cellular immune system to produce DTH. Not all people with intact cellular immunity react to Candidaextracts, so the response to CANDIN^®is not 100%. Clinical studies have shown about 80% of subjects without immunocompromised status produce a positive (>5mm) response to CANDIN.

How Is CANDIN Administered?

CANDIN is used according to the Mantoux Method. It is administered by an intradermal injection of 0.1 mL (cc) to the volar surface of the forearm or outer aspect of the upper arm. Caution must be exercised to avoid subcutaneous or intravenous injections. The injection site is evaluated by a trained health care professional approximately 48 hours after injection. The site is evaluated for the diameter of observed induration (swelling). A positive response to CANDIN^®is an area of induration of ≥5 mm.

CANDIN is intended for use by physicians who are experienced in the intradermal administration of a skin test antigen. Systemic reactions can occur with skin test antigens and in certain individuals these reactions may be life threatening or cause death. Patients should be observed for at least 20 minutes following the administration of a skin test. Emergency measures as well as personnel trained in their use should be immediately available in the event of a life-threatening reaction.”

This is not all of the information needed for dosage and administration of CANDIN^®. See Full Prescribing Information. For additional information, see Mantoux Method.

How Can CANDIN Aid Tuberculin Skin Testing?

The tuberculin skin test (TST) is a standard method of determining whether a person is infected with Mycobacterium tuberculosis. The TST is performed by injecting 0.1 mL of tuberculin purified protein derivative (PPD) into the inner surface of the forearm by intradermal injection. Some persons may not react to TST even though they are infected with M. tuberculosis. The reasons for these false-negative reactions may include the following:

• Cutaneous anergy (anergy is the inability to react to skin tests because of a weakened immune system due to disease, medications, or altered immune status)
• Recent TB infection (within 8-10 weeks of exposure)
• Very old TB infection (many years)
• Very young age (less than 6 months old)
• Recent live-virus vaccination (e.g., measles and smallpox)
• Overwhelming TB disease
• Some viral illnesses (e.g., measles and chicken pox)
• Incorrect method of TST administration
• Incorrect interpretation of TST reaction

Anergic patients may not react properly to TSTs. Concurrent testing with CANDIN^®can help assess a patient’s state of anergy,contributing to interpretation of TST. For more information, see Tuberculin Skin Testing.

What is Anergy?

Anergy, in regard to skin testing, is a state of altered cellular immune function that prevents the body from developing a DTH response. Anergy can arise from a variety of causes:

• Active Infection
• Immunosuppressive disease such as HIV
• Cancer
• Organ transplantation
• Inflammatory diseases such as Crohn’s disease, rheumatoid arthritis, and psoriasis
• Immunosuppressive drugs such as prednisone, methotrexate, or biologics such as TNF-a inhibitors (e.g., infliximab, adalimumab, etc.)
• Predisposing genetic conditions