Introduction

Antigen preparation derived from culture filtrate and cells of Candida albicans.

Uses for Candida Albicans Skin Test Antigen

Cellular Hypersensitivity

Used as a recall antigen for detecting cell-mediated hypersensitivity to Candida albicans.

May be used to evaluate the cellular immune response in patients suspected of having reduced cellular hypersensitivity.

Some individuals with normal cellular immunity may not be hypersensitive to Candida; therefore, concurrent use of other licensed cell-mediated hypersensitivity skin test antigens is recommended.

HIV infection can modify the delayed-type hypersensitivity (DTH) response to tuberculin; therefore, it is advised to test HIV-infected patients at high risk of tuberculosis with antigens in addition to tuberculin.

Do not use to diagnose or treat Type 1 allergy to Candida albicans.

Candida Albicans Skin Test Antigen Dosage and Administration

General

Patient Monitoring

• Observe patients for at least 20 minutes following administration of the skin test.

Dispensing and Administration Precautions

• Systemic reactions can occur with skin test antigens and in certain individuals these reactions may be life-threatening or fatal. Emergency measures, equipment, and personnel including epinephrine and oxygen should be immediately available when administering candida albicans skin test antigen.

• The expected response is a local area of inflammation at the site of the skin test. The reaction is usually dime to quarter size reaching maximum diameter between 24 and 48 hours. Larger accelerated reactions can occur, which may require treatment with local cold compresses and anti-inflammatory medication.

Administration

Administer intradermally; do not inject IV. Take care to avoid injection into a blood vessel.

Administer intradermal injections into volar surface of forearm or outer aspect of upper arm. Must administer as superficially as possible causing a distinct, sharply defined bleb. An unreliable reaction may result if the product is injected sub-Q.

Clean skin with 70% alcohol before applying the skin test.

Dosage

Adults

Cellular Hypersensitivity

Intradermal Injection

Dose used to assess cellular hypersensitivity is 0.1 mL.

Time required for the induration response to reach maximum intensity varies. The reaction usually begins within 24 hours and peaks between 24 and 48 hours.

Read the skin test at 48 hours by visually inspecting the test site and palpating the indurated area. An induration ≥5 mm is considered to be a positive delayed-type hypersensitivity (DTH) reaction.

Contraindications

• Previous unacceptable adverse reaction (e.g., extreme hypersensitivity or allergy) to the antigen contained in candida albicans skin test antigen or to a similar product.

Warnings/Precautions

Warnings

Serious Adverse Reactions

Larger reactions other than the expected local response may occur following administration of skin test. (See Boxed Warning.)

Life-threatening or fatal systemic reactions may occur. Report serious adverse reactions to the manufacturer or FDA.

Administration Precautions

Candida albicans skin test antigen must be injected intradermally as superficially as possible, causing a distinct, sharply defined bleb at the skin test site. An unreliable reaction may result if the product is injected sub-Q. Must not administer IV; take care to avoid injecting into a blood vessel.

Use a separate sterile syringe and needle for each patient to prevent transmission of infectious agents. Dispose of needles properly and do not recap.

Ensure that facilities, equipment, and medication (epinephrine, oxygen) necessary to treat potential adverse effects are readily available.

Do not administer IV. (see Boxed Warning.)

Local and Systemic Reactions

As with all skin test antigens, local and systemic allergic reactions can occur.

Local reactions include swelling, pruritus, and vesiculation. Necrosis and ulceration not observed, but theoretically possible. Local reactions may be treated with a cold compress and topical steroids. Severe local reactions (e.g., rash, vesiculation, bullae, dermal exfoliation, cellulitis) are possible in highly allergic persons; may require additional measures as appropriate.

In individuals with a bleeding tendency, trauma from the skin test may cause bruising and nonspecific induration.

Local immediate hypersensitivity reactions may occur. Such reactions are characterized by edematous hive surrounded by a zone of erythema and observed approximately 15–20 minutes after intradermal injection.

Systemic reactions not observed, but possible. Systemic reactions usually occur within 30 minutes after injection of antigen and may include the following symptoms: sneezing, coughing, itching, shortness of breath, abdominal cramps, vomiting, diarrhea, tachycardia, hypotension, and respiratory failure in severe cases.

Systemic allergic reactions (e.g., anaphylaxis) must be immediately treated with epinephrine HCl 1:1,000. Additional measures may be required, depending on severity.

Specific Populations

Pregnancy

Not known whether candida albicans skin test antigen can cause fetal harm or affect reproductive capacity. Animal reproduction studies not conducted. Use in pregnant women only if clearly needed.

Lactation

Not known whether candida albicans skin test antigen is excreted in human milk. Exercise caution when administering to a nursing woman.

Pediatric Use

Safety and effectiveness not established in children. However, the skin test has been used in pediatric patients for assessing cellular immunity.

Geriatric Use

Not adequately studied in geriatic patients; however, such patients may have a diminished response since the aging process is known to alter cell-mediated immunity.

Common Adverse Effects

Immediate hypersensitivity local reactions can include itching, swelling, pain, and blistering at the test site occurring 15-20 minutes after administration. Necrosis is possible.

Systemic reactions not observed; however, all foreign antigens have the remote possibility of causing Type 1 anaphylaxis and even death when injected intradermally.

General

Patient Monitoring

• Observe patients for at least 20 minutes following administration of the skin test.

Dispensing and Administration Precautions

• Systemic reactions can occur with skin test antigens and in certain individuals these reactions may be life-threatening or fatal. Emergency measures, equipment, and personnel including epinephrine and oxygen should be immediately available when administering candida albicans skin test antigen.

• The expected response is a local area of inflammation at the site of the skin test. The reaction is usually dime to quarter size reaching maximum diameter between 24 and 48 hours. Larger accelerated reactions can occur, which may require treatment with local cold compresses and anti-inflammatory medication.

Administration

Administer intradermally; do not inject IV. Take care to avoid injection into a blood vessel.

Administer intradermal injections into volar surface of forearm or outer aspect of upper arm. Must administer as superficially as possible causing a distinct, sharply defined bleb. An unreliable reaction may result if the product is injected sub-Q.

Clean skin with 70% alcohol before applying the skin test.

Dosage

Adults

Cellular Hypersensitivity

Intradermal Injection

Dose used to assess cellular hypersensitivity is 0.1 mL.

Time required for the induration response to reach maximum intensity varies. The reaction usually begins within 24 hours and peaks between 24 and 48 hours.

Read the skin test at 48 hours by visually inspecting the test site and palpating the indurated area. An induration ≥5 mm is considered to be a positive delayed-type hypersensitivity (DTH) reaction.

Corticosteroids and Immunosuppressive Drugs

Pharmacologic doses of corticosteroids may suppress the DTH skin test response after 2 weeks of therapy. Response usually returns to pretreatment level within several weeks after steroid therapy is discontinued.

Beta-blocking Drugs

Patients receiving beta-blocking drugs may not respond to usual doses of epinephrine, in the event that epinephrine is required to control an adverse allergic reaction.