Tests

Investigations to avoid

immunoglobulin G (IgG) allergy testing

Recommendations
Rationale
Recommendations

Do not perform lgG tests in the evaluation of drug allergy.[49]

Rationale

IgG testing is unproven in this setting and can lead to inappropriate diagnosis and treatment.[49]

Tests to consider

blood (whole blood, plasma, serum) drug concentration

Test
Result
Test

Can be useful when the usual target blood (whole blood, plasma, or serum) concentration range of the suspected drug is known.

Result

concentration above the usual target range increases suspicion of drug-induced cause

serum tryptase concentration (anaphylaxis)

Test
Result
Test

The 2023 American Academy of Allergy, Asthma & Immunology practice parameter on anaphylaxis recommends taking one sample as soon as possible (ideally within 2 hours of symptom onset) and a second sample at a later time to establish the baseline value.[46]​ UK guidance recommends ideally taking 3 samples: one as soon as possible after starting emergency treatment, a second 1-2 hours (but no later than 4 hours) after symptom onset, and a third at least 24 hours later to establish the baseline value.[45]

An acute tryptase level that is elevated above the (laboratory-defined) upper limit of normal is supportive of a diagnosis of anaphylaxis, as is an acute level that shows significant elevation from the patient’s baseline tryptase level (even where the acute level is still within the normal range, i.e., an acute tryptase level in the normal range does not rule out anaphylaxis).[46]

Elevation of tryptase levels may also exist in non-anaphylactic conditions, such as systemic mastocytosis.

Result

elevated during the first few hours after an anaphylactic reaction, both IgE and non-IgE mediated, due to mast cell degranulation

complement pathway assay

Test
Result
Test

C4 measures should be taken during an attack in angioedema alone (no urticaria). If C4 is low, C1-esterase levels should be measured. Occasionally, C1-esterase function needs to be measured if the enzyme is not low but inactive.

C1 esterase levels can be low in hereditary angioedema and autoimmune disorders. C4 can be normal in bradykinin-mediated angioedema.

Result

low levels of C4 are a strong indication of complement pathway problems such as acquired or inherited deficiency of C1-esterase inhibitor

histology of lesion biopsy

Test
Result
Test

A sample of the lesion and the surrounding normal skin is taken.

Some drug-induced skin rashes have a characteristic histology, whereas others are indistinguishable from nondrug-induced forms.

Result

infiltration of eosinophilic polymorphonuclear leukocytes may suggest drug-induced lesion

CBC and differential

Test
Result
Test

Anemia, leukopenia, thrombocytopenia, and rarely pancytopenia can be caused by adverse drug effects, but eosinophilia can be a useful sign of drug allergy.

Result

CBC usually normal in drug-induced lupus; peripheral blood eosinophilia may suggest a drug allergy reaction

antihistone antibodies to single-stranded DNA (lupus-like syndrome)

Test
Result
Test

Systemic lupus erythematosus is associated with antibodies to double-stranded DNA; drug-induced lupus is associated with antihistone antibodies.

Result

drug-induced lupus is associated with antibodies to histones

skin tests (prick tests, intradermal tests, patch tests)

Test
Result
Test

Specialist advice should be sought. Skin tests can help identify a causative drug after an allergic reaction; mainly useful in contact dermatitis.

Skin tests may also be useful adjuncts for establishing causality and cross-reactivity for delayed hypersensitivity reactions.[42]​​ However, skin tests are limited by low sensitivity and thus results should be interpreted with caution, particularly in the setting of severe reactions given the imperfect negative predictive value. Due to the risk of relapse, skin tests for DRESS should be delayed for at least 6 months after the acute reaction and/or 1 month after discontinuation of corticosteroids.​​​[42]

Result

identification of causative drug after an allergic reaction

drug-specific IgE

Test
Result
Test

Specialist advice should be sought. Drug-specific IgE testing can be helpful, particularly in the case of negative skin tests or severe life-threatening reactions (e.g., anaphylactic reactions to beta-lactam antibiotics).[53]

However, do not perform a battery of nonspecific IgE tests.[49]

Result

positive drug-specific IgE results are strongly supportive of anaphylaxis on re-exposure to the drugs; however, false negative results are a common problem with this assay. Test results should only be interpreted in conjunction with patient history and clinical findings

Emerging tests

basophil activation test

Test
Result
Test

Can be helpful, particularly in the case of negative skin tests or severe life-threatening reactions (e.g., anaphylactic reactions to beta-lactam antibiotics). Specialist advice should be sought. Remains largely a research tool at present.

Result

drug-induced basophil activation; test results should only be interpreted in conjunction with patient history and clinical findings

lymphocyte proliferation assay (LPA/LTT)

Test
Result
Test

Can be helpful, particularly in the case of negative skin tests or severe life-threatening reactions (e.g., anaphylactic reactions to beta-lactam antibiotics). Specialist advice should be sought. Remains largely a research tool at present.

Result

drug-induced in vitro proliferation of T cells with a stimulation index greater than 2 is widely regarded as a useful cut-off threshold for determining positive test results. The test results should only be interpreted in conjunction with patient history and clinical findings

enzyme-linked immunospot assay (ELISPOT test)

Test
Result
Test

Can be helpful, particularly in the case of negative skin tests or severe life-threatening reactions (e.g., anaphylactic reactions to beta-lactam antibiotics). Specialist advice should be sought. Remains largely a research tool at present.

Result

drug-induced cytokine detection above background cytokine release is the minimum threshold for positive test results; test results should only be interpreted in conjunction with patient history and clinical findings

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