Mumps Skin Test Antigen (Monograph)

Drug class: Mumps
- Skin Test Antigen
- Cell-mediated Immunity Function
- Immunity Function, Cell-mediated
VA class: DX300

Medically reviewed by Drugs.com on Dec 23, 2024. Written by ASHP.

Introduction

Mumps skin test antigen is an aqueous suspension of inactivated mumps virus.

Uses for Mumps Skin Test Antigen

Mumps skin test antigen is used in conjunction with other antigens (e.g., candida, coccidioidin, histoplasmin, trichophyton, tuberculin) to assess the status of cell-mediated immunity, especially in malnourished patients, surgical patients, or patients with cancer. Because the cell-mediated response to these antigens depends on previous exposure to or infection with them, only those antigens to which the patient has probably been exposed in the past should be used. These skin test antigens are used as screening tests and can only indicate the presence or absence of cell-mediated immunity. In vitro tests (e.g., lymphocyte stimulation, assays for T and B cells) are necessary to diagnose specific immunologic disorders.

Because a substantial proportion of healthy individuals demonstrate a delayed-hypersensitivity reaction to mumps skin test antigen, it is one of several antigens currently recommended by the US Centers for Disease Control and Prevention (CDC) for use in assessing cell-mediated (delayed-type hypersensitivity) anergy in selected individuals with human immunodeficiency virus (HIV) infection and in others who are at risk of anergy and tuberculosis. Although evaluation of cell-mediated immunity in all HIV-seropositive individuals, whether symptomatic or asymptomatic, as well as other individuals at risk, at the time of tuberculin skin testing previously was recommended, the CDC no longer recommends routine anergy testing because of current information on variability and lack of reproducibility of anergy test methods, variation in the absolute risk of tuberculosis among different anergic groups, and the lack of demonstrated efficacy of a preventive therapy program in anergic, HIV-infected groups. Instead, the CDC and other experts state that there may be selected situations in which evaluation of anergy may assist in guiding individual decisions about preventive therapy (e.g., in individuals with insignificant reactions to tuberculin from populations at high risk for Mycobacterium tuberculosis infection). The CDC states that if the results of anergy skin testing are used to evaluate latent M. tuberculosis infection and make decisions about preventive therapy, the results of such anergy testing should be supplemented by information about the individual’s risk of exposure to and infection with M. tuberculosis; technical expertise, feasibility, and cost also may be important factors in choosing which test(s) to employ.

Mumps skin test antigen is not indicated for the immunization, diagnosis, or treatment of mumps virus infection.

Mumps Skin Test Antigen Dosage and Administration

Administration

Mumps skin test antigen is administered only by intradermal injection into the flexor surface of the forearm (Mantoux method). If the injection is inadvertently made subcutaneously, no reaction or an unreliable reaction may occur. A scrupulously clean syringe and needle must be used in the administration of mumps skin test antigen; a separate syringe and needle should be used for each patient. The syringe used for mumps skin test antigen should not be used for any other material.

Dosage

When mumps skin test antigen is used in conjunction with other antigens to assess the status of cell-mediated immunity, a battery of at least 4 different antigens to which the patient has probably been exposed in the past usually is used. For assessment of cell-mediated immunity as an aid to interpretation of tuberculin skin tests in selected individuals with human immunodeficiency virus (HIV) infection and in others who are at risk of anergy and tuberculosis, the US Centers for Disease Control and Prevention (CDC) currently recommend that the mumps skin test antigen labeled by FDA for assessment of cell-mediated immunity be used in conjunction with the candida skin-test antigen labeled for this purpose, in addition to tuberculin (PPD). The antigens are administered intradermally 5–10 cm apart on the forearm. The usual dose of mumps skin test antigen is 0.1 mL.

Interpretation

The reaction site should be examined in 48–72 hours.

When mumps skin test antigen is used in conjunction with other skin test antigens, an induration reaction at the mumps skin test antigen site measuring 5 mm or more (with or without erythema) usually is considered a positive reaction. A positive reaction to one or more antigens may indicate the presence of cell-mediated immunity. If there is no response to 4 or more antigens, the individual generally is considered to be anergic. While an induration reaction measuring 5 mm or more conventionally has been used for intrepreting a Mantoux-method skin test as positive, attempts to assess cell-mediated immunity in HIV-infected individuals have been made using smaller cutoff diameters (e.g., 3 mm, 2 mm, 1 mm, or “any induration”). In addition to validity concerns, the use of smaller cutoff diameters for induration reactions is subject to technical difficulties and has not improved predictive value; therefore, the CDC continues to recommend the use of a 5-mm cutoff diameter for assessing induration reactions with Mantoux-method anergy skin tests.

Cautions for Mumps Skin Test Antigen

Local Effects

Local tenderness, pruritus, vesiculation, and rash may occur at the injection site following administration of mumps skin test antigen. During a severe delayed-hypersensitivity reaction to the antigen, tissue sloughing, necrosis, abscess formation, and/or regional lymphadenopathy may also occur. Excessive dosage of mumps skin test antigen may produce severe erythema and induration followed by necrosis and ulceration.

Systemic Effects

Adverse systemic effects of mumps skin test antigen may include nausea, anorexia, headache, unsteadiness, and drowsiness. Diaphoresis, sensation of warmth, and lymphadenopathy may also occur.

Precautions and Contraindications

Individuals who are hypersensitive to avian protein may have a severe reaction to mumps skin test antigen. Therefore, mumps skin test antigen is contraindicated in patients who have a history of hypersensitivity, especially anaphylactic reactions, to eggs or egg products. The possibility of allergic reactions to thimerosal, which is present in the commercially available mumps skin test antigen, should be considered, and the skin test antigen is contraindicated in individuals with a known sensitivity to the preservative. Epinephrine should be available for immediate use whenever mumps skin test antigen is administered in case an anaphylactic reaction occurs.

Safety and efficacy of mumps skin test antigen in young adults who have been immunized with mumps virus vaccine live have not been established.

Although neurologic complications such as encephalopathies and peripheral nervous system lesions have not been reported to date with mumps skin test antigen, these complications have been reported following the administration of other biologicals.

Pediatric Precautions

Safety and efficacy of mumps skin test antigen in children have not been established.

Pregnancy and Fertility

Pregnancy

Animal reproduction studies have not been performed to date with mumps skin test antigen. It is not known whether the antigen can cause fetal harm when administered to pregnant women or whether administration during pregnancy can affect later growth, development, and functional maturation of the child. Mumps skin test antigen should be used during pregnancy only when clearly needed.

Fertility

It is not known if mumps skin test antigen affects fertility.

Pharmacology

Recovery from clinical or subclinical mumps promotes immunity to mumps by inducing production of specific antibodies and, in addition, produces a skin hypersensitivity to mumps virus. Once an individual has become sensitized to mumps virus, intradermal administration of mumps skin test antigen evokes a delayed-hypersensitivity reaction at the site of administration if the cellular immune system is intact. Most individuals, except the very young, have had contact or infection with mumps virus and 67–90% of healthy individuals reportedly demonstrate a delayed-hypersensitivity reaction to mumps skin test antigen. The frequency of a positive reaction to the antigen is decreased in individuals with an impaired immune system. Some individuals who do not show evidence of a delayed-hypersensitivity reaction with other skin test antigens may have a positive reaction with mumps skin test antigen.

Chemistry and Stability

Chemistry

Mumps skin test antigen is a sterile, aqueous suspension of formaldehyde-inactivated mumps virus in 0.9% sodium chloride injection. The virus used in the production of mumps skin test antigen is propagated in the extraembryonic fluid of chick embryo and is concentrated and purified by differential centrifugation. The commercial preparation contains approximately 0.012 M glycine as a stabilizing agent and thimerosal 1:10,000 as a preservative.

Mumps skin test antigen meets standards established by the Center for Biologics Evaluation and Research of the US Food and Drug Administration. Each mL of mumps skin test antigen contains not less than 20 complement-fixing units. The potency of commercially available mumps skin test antigen is 40 complement-fixing units per mL. After shaking, the commercially available antigen is slightly opalescent.

Stability

Mumps skin test antigen should be stored at 2–8°C; freezing should be avoided.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

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