No

Diagnostic Agent

Detection of nonresponsiveness to antigens by means of delayed hypersensitivity skin testing

C

Infected or inflamed skin, known hypersensitivity to skin test antigens; do not apply at sites involving acneiform, infected or inflamed skin; although severe systemic reactions are rare to diphtheria and tetanus antigens, persons known to have a history of systemic reactions should be tested with this test only after the test heads containing these antigens have been removed

Epinephrine should be available is case of severe reactions. Safety and effectiveness in children <17 years of age have not been established; discard applicator after use, do not reuse.

1% to 10%: Local: Irritation

Decreased effect: Drugs or procedures that suppress immunity such as corticosteroids, chemotherapeutic agents, antilymphocyte globulin and irradiation, may possibly cause a loss of reactivity

Keep in refrigerator at 2°C to 8°C (35°F to 46°F)

Select only test sites that permit sufficient surface area and subcutaneous tissue to allow adequate penetration of all eight points, avoid hairy areas. Press loaded unit into the skin with sufficient pressure to puncture the skin and allow adequate penetration of all points, maintain firm contact for at least 5 seconds, during application the device should not be "rocked" back and forth and side to side without removing any of the test heads from the skin sites.

1. The puncture marks of the nine tines on each of the eight test heads

2. An imprint of the circular platform surrounding each test head

3. Residual antigen and glycerin at each of the eight sites

If any of the above three criteria are not fully followed, the test results may not be reliable.

Reading should be done in good light, read the test sites at both 24 and 48 hours, the largest reaction recorded from the two readings at each test site should be used. If two readings are not possible, a single 48 hour is recommended. A positive reaction from any of the seven delayed hypersensitivity skin test antigens is induration greater than or equal to 2 mm providing there is no induration at the negative control site. The size of the induration reactions with this test may be smaller than those obtained with other intradermal procedures.

No information available to require special precautions

No effects or complications reported

Patients should be informed of the types of test site reactions that may be expected

Patients should be informed of the types of test site reactions that may be expected. Remove tests from refrigeration approximately 1 hour before use; select only test sites that permit sufficient surface area and subcutaneous tissue to allow adequate penetration of all points on all eight test heads; avoid hairy areas when possible because interpretation of reactions will be more difficult

Individual carton containing one preloaded skin test antigen for cellular hypersensitivity