Candida albicans Skin Test Antigen for Cellular Hypersensitivity (CANDIN) is a clear, colorless, sterile solution with a pH of 8.0 - 8.5.
Candin® is the only FDA licensed DTH skin test antigen made from Candida albicans. It is potency standardized by DTH skin testing in humans. The Delayed Type Hypersensitivity (DTH) test is used routinely to screen patients' immunocompetence. This simple, cost-effective in vivo method provides information to guide the interpretation of tuberculin skin tests as well as an overview of anergy in patients.
The product is indicated in the assessment of immune responsiveness in clinical situations involving the cellular immune system.
Intact cell-mediated immunity (CMI) requires a complex interaction between lymphocytes, macrophages and cytokines. Various immune disorders and disease processes can alter the CMI response. These include congenital immunodeficiencies, acquired immunodeficiencies, cancer, malnutrition and viral and fungal diseases.
A positive DTH response to Candin® indicates that the CMI is functioning properly. Candin® is frequently used as a control for tuberculin skin testing to rule out anergy as a possible factor in persons who are skin-test negative to tuberculin.
Contains: Candida antigen in buffered saline with 0.03% albumin, USP, 8 ppm polysorbate 80 and phenol 0.4% w/v as a preservative.
IMPORTANT SAFETY INFORMATION FOR CANDIN®:
WARNING: The expected response to CANDIN® 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.
Systemic reactions can occur with skin test antigens and in certain individuals these reactions may be life-threatening or cause death. Emergency measures and personnel trained in their use should be immediately available. Patients should be observed for at least 2 minutes following the administration of a skin test.
CANDIN® should never be given intravenously.
Contraindication: CANDIN® should not be used after a previous unacceptable adverse reaction to this antigen or to a similar product, i.e., extreme hypersensitivity/allergy.
Warnings and Precautions: The antigen must be injected intradermally. Do not inject intravenously. As has been observed with other unstandardized antigens used for DTH skin testing, it is possible that some patients may have exquisite immediate hypersensitivity to CANDIN®.
Physicians using this product must have facilities, equipment and medication necessary to treat potential side effects. Epinephrine and oxygen must be immediately available in the event of a serious systemic response.
Candin® is a clear colorless sterile solution with a ph of 8.0-8.5. It comes in a 1 ml multi-dose vial to be administered in ten 0.1 ml doses and should be stored at 2-8° Celsius (35.6 - 46.4° F).
The manufacturer has conducted shipping and stability studies that indicate Candin® is stable for up to one week at 40° C (104° F). However, stability of the product stored afterwards has not been established. Therefore, the manufacturer does not recommend storage or use of the product after it is exposed to conditions outside 2-8° Celsius (35.6 - 46.4° F).
Important Note: This product requires refrigeration immediately upon arrival. During warmer months, we do ship ice packs with this product to provide extra protection during air transit; however, please note the ice packs are not intended to stay frozen during transit and will have melted upon arrival. This is not an indication of spoiled product. Refrigerate product immediately upon arrival. During the winter months, ice packs are not included (to avoid freezing) but the product still requires refrigeration upon arrival. Due to the sensitive storage and transport status of this item, we do not recommend international shipment.
This product is temperature sensitive to hot and extreme cold. During periods of heat or cold, we require this product to be shipped by air service only (Next Day or Second Day) and we do not ship this product over a weekend to further reduce any risk of temperature exposure.
|Manufacturer Sales Restrictions||Cannot ship to: SC, ID, VT, KS|
|Freezable||Freeze / Unusable / Req|
|State Sales Restrictions||Ship to physicians licensed in these states only: CT, GA, HI, IA, IL, KS, KY, MA, NM, NC, NY, OH, PA, PR, RI, SC, TX|
|Country of Origin||United States|
|Manufacturer Item Number||59584-138-01|
|Hazardous Shipping Restrictions||Not Hazardous|
|Country Sales Restrictions||Ships to the United States Only|
|Refrigeration Required||Yes, Overnight Shipment Only|