Histamine Positive Skin Test Control (Page 2 of 2)

Interpretation

The patient’s response is based on the size of: erythema (degree of redness) and/or size of wheal (smooth, slightly elevated area) which appear after 10 minutes.

For percutaneous testing, different devices and/or techniques influence the size of the reaction. Therefore, it is important to refer to the device manufacturer’s or distributor’s instructions when grading reactions.

For prick, puncture and scratch testing, histamine base 1 mg/mL (Histamine Phosphate 2.75 mg/mL) should be used to give a positive reaction. In a large population, the NHANES II survey reports a mean diameter (average of length and width) wheal of 4.4 mm ± 1.65 mm (± standard deviation) and a mean erythema of 18.4 mm ± 8.55 mm (± standard deviation) when using 25 gauge B-D needle by prick puncture (Pepys) technique.7 All positive reactions should be interpreted against an appropriate negative control.

For Intradermal Skin Testing

Histamine base 0.1 mg/mL (Histamine Phosphate 0.275 mg/mL) or 0.01 mg/mL should be used to give a reaction. (Refer to Interpretation Section.)

Intracutaneously (Intradermal) Test Techniques

  1. The skin should be cleansed with alcohol and air dried.
  2. A sterile one milliliter tuberculin syringe with 26 or 27 gauge needle should be used. A single sterile syringe should be used for each solution to assure sterility. Only the histamine base 0.1 mg/mL (Histamine Phosphate, 0.275 mg/mL) or greater dilution solution should be used.
  3. The histamine base skin test solution should be injected at the same site with the other skin test allergens, either on the patient’s back or on the arm. The patient should be placed in a comfortable position before the testing is begun.
  4. The skin is held tense and the needle is inserted almost parallel to the skin, bevel side up, far enough to cover the beveled portion. Slowly inject 0.01 mL or 0.02 mL, making a small bleb approximately 3 mm — 5 mm in diameter.
  5. The test should be read in 15 minutes.

Interpretation

The patient’s response is based on the size of: erythema (degree of redness) and/or size of wheal (smooth, slightly elevated area) which appear after 10 minutes.

For intradermal skin testing, histamine base 0.1 mg/mL (Histamine Phosphate 0.275 mg/mL) or 0.01 mg/mL should be used to give a positive reaction. The available 0.1 mg/mL concentration must be diluted ten-fold to achieve this dose. All positive reactions should be interpreted against an appropriate negative control. In two successive years of testing, the Committee on Standardization of the American College of Allergy reported positive reactions at histamine base doses of 0.01 mg/mL and higher. Mean sum of wheal diameters was approximately 14 mm ± 4.8 mm and sum of erythema diameter was approximately 52 mm ± 21.6 mm following 0.01 mL intradermal doses of 0.01 mg/mL histamine base. When 0.01 mL of 0.1 mg/mL histamine base was injected, the sum of cross-diameters of wheal ranged from 15-20 mm and the sum of cross-diameters of erythema ranged from 60-80 mm.8


HOW SUPPLIED

Multidose vials containing 5 mL histamine base, 1 mg/mL (Histamine Phosphate 2.75 mg/mL) in Glycerin 50% (v/v) for prick, puncture, or scratch testing. Multidose vials containing 5 mL histamine base, 0.1 mg/mL (Histamine Phosphate 0.275 mg/mL) in aqueous solution for intradermal testing. Store at 2° — 8°C.

REFERENCES

  1. Bousquet, J.: In vivo methods for the study of allergy: skin test, techniques, and interpretation. In Allergy Principles and Practice, 3rd Edition, Middleton, et al eds., C.V. Mosby, St. Louis, MO, 1988.
  2. Skassa-Brociek, W., et al: Skin test reactivity to histamine from infancy to old age. J. Allergy Clin. Immunol. 80:711, 1987.
  3. Menardo, J.L., et al: Skin test reactivity in infancy. J. Allergy Clin. Immunol. 75:646, 1985.
  4. Van Asperen, P.P., et al: Skin test reactivity and clinical allergen sensitivity in infancy. J. Allergy Clin. Immunol. 73:381, 1984.
  5. Matheson, A., et al: Reactivity of the skin of the newborn infant. Pediatrics 10:181, 1952.
  6. Stevenson, D.D., et al: Development of IgE in newborn human infants. J. Allergy 48:61, 1971.
  7. National Center for Health Statistics, P.J. Gergen and P.C. Turkeltaub: Percutaneous immediate hypersensitivity to eight allergens, United States, 1976-80. Vital and Health Statistics. Series 11, No. 235. DHHS Pub. No. (PHS) 86-1685. Public Health Service. Washington. U.S. Government Printing Office, July 1986.
  8. Committee on Standardization. Report of the Committee on Standardization: 1. A method of evaluating skin test response. Ann. Allergy 29:30-34, 1971.

Revision: October 2008

© Alk-Abello, Inc., 2008 No. 107K

Distributed in Canada by:
ALK-Abelló Pharmaceuticals, Inc.
#35-151 Brunel Road
Mississauga, Ontario
Canada L4Z 2H6

PRINCIPAL DISPLAY PANEL

POSITIVE SKIN TEST CONTROL-HISTAMINE
5mL sterile multiple dose vial
FOR INTRADERMAL TESTING ONLY
HISTATROL® HISTAMINE BASE 0.1 mg/mL

PRINCIPAL DISPLAY PANEL
POSITIVE SKIN TEST CONTROL-HISTAMINE
5mL sterile multiple dose vial
FOR INTRADERMAL TESTING ONLY
HISTATROL®
HISTAMINE BASE 0.1 mg/mL
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

POSITIVE SKIN TEST CONTROL-HISTAMINE
5mL sterile multiple dose vial
FOR PERCUTANEOUS TESTING ONLY
HISTATROL® HISTAMINE BASE 1 mg/mL

PRINCIPAL DISPLAY PANEL
POSITIVE SKIN TEST CONTROL-HISTAMINE
5mL sterile multiple dose vial
FOR PERCUTANEOUS TESTING ONLY
HISTATROL®
HISTAMINE BASE 1 mg/mL
(click image for full-size original)

HISTAMINE POSITIVE SKIN TEST CONTROL histamine phosphate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0268-0248
Route of Administration INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HISTAMINE PHOSPHATE (HISTAMINE) HISTAMINE 0.275 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL 0.004 mL in 1 mL
HYDROCHLORIC ACID
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0268-0248-05 5 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103754 10/23/1989
HISTAMINE POSITIVE SKIN TEST CONTROL histamine phosphate solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0268-0247
Route of Administration PERCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HISTAMINE PHOSPHATE (HISTAMINE) HISTAMINE 2.75 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL 0.004 mL in 1 mL
HYDROCHLORIC ACID
SODIUM HYDROXIDE
GLYCERIN 0.5 mL in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0268-0247-05 5 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103754 10/23/1989
Labeler — ALK-Abello, Inc. (809998847)

Revised: 08/2020 ALK-Abello, Inc.

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