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Radioallergosorbent test
Radioallergosorbent test
Radioallergosorbent test
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Radioallergosorbent test
MeSHD011852
LOINC13834-7

A radioallergosorbent test (RAST) is a blood test using radioimmunoassay test to detect specific IgE antibodies in order to determine the substances a subject is allergic to. This is different from a skin allergy test, which determines allergy by the reaction of a person's skin to different substances.[citation needed]

Medical uses

[edit]

The two most commonly used methods of confirming allergen sensitization are skin testing and allergy blood testing. Both methods are recommended by the NIH guidelines and have similar diagnostic value in terms of sensitivity and specificity.[1][2]

Advantages of the allergy blood test range from: excellent reproducibility across the full measuring range of the calibration curve, it has very high specificity as it binds to allergen specific IgE, and extremely sensitive too, when compared with skin prick testing. In general, this method of blood testing (in-vitro, out of body) vs skin-prick testing (in-vivo, in body) has a major advantage: it is not always necessary to remove the patient from an antihistamine medication regimen, and if the skin conditions (such as eczema) are so widespread that allergy skin testing cannot be done. Allergy blood tests, such as ImmunoCAP, are performed without procedure variations, and the results are of excellent standardization.[3]

Adults and children of any age can take an allergy blood test. For babies and very young children, a single needle stick for allergy blood testing is often more gentle than several skin tests. However, skin testing techniques have improved. Most skin testing does not involve needles and typically skin testing results in minimal patient discomfort.[citation needed]

Drawbacks to RAST and ImmunoCAP techniques do exist. Compared to skin testing, ImmunoCAP and other RAST techniques take longer to perform and are less cost effective.[4] Several studies have also found these tests to be less sensitive than skin testing for the detection of clinically relevant allergies.[5] False positive results may be obtained due to cross-reactivity of homologous proteins or by cross-reactive carbohydrate determinants (CCDs).[6]

In the NIH food guidelines issued in December 2010 it was stated that "The predictive values associated with clinical evidence of allergy for ImmunoCAP cannot be applied to other test methods."[7] With over 4000 scientific articles using ImmunoCAP and showing its clinical value, ImmunoCAP is perceived as "Gold standard" for in vitro IgE testing[8][9]

Method

[edit]

The RAST is a radioimmunoassay test to detect specific IgE antibodies to suspected or known allergens for the purpose of guiding a diagnosis about allergy.[10][11] IgE is the antibody associated with Type I allergic response: for example, if a person exhibits a high level of IgE directed against pollen, the test may indicate the person is allergic to pollen (or pollen-like) proteins. A person who has outgrown an allergy may still have a positive IgE years after exposure.[citation needed]

The suspected allergen is bound to an insoluble material and the patient's serum is added. If the serum contains antibodies to the allergen, those antibodies will bind to the allergen. Radiolabeled anti-human IgE antibody is added where it binds to those IgE antibodies already bound to the insoluble material. The unbound anti-human IgE antibodies are washed away. The amount of radioactivity is proportional to the serum IgE for the allergen.[12]

RASTs are often used to test for allergies when:

  • a physician advises against the discontinuation of medications that can interfere with test results or cause medical complications;
  • a patient has severe skin conditions such as widespread eczema or
  • a patient has such a high sensitivity level to suspected allergens that any administration of those allergens might result in potentially serious side effects.

Scale

[edit]

The RAST is scored on a scale from 0 to 6:

RAST Rating IgE Level (kU/L) Comment
0 level < 0.35 Absent or undetectable allergen specific IgE
1 0.35 ≤ level < 0.70 Low level of allergen specific IgE
2 0.70 ≤ level < 3.50 Moderate level of allergen specific IgE
3 3.50 ≤ level < 17.50 High level of allergen specific IgE
4 17.50 ≤ level < 50.00 Very high level of allergen specific IgE
5 50.00 ≤ level < 100.00 Ultra high level of allergen specific IgE
6 level ≥ 100.00 Extremely high level of allergen specific IgE

History

[edit]

The market-leading RAST methodology was invented and marketed in 1974 by Pharmacia Diagnostics AB, Uppsala, Sweden, and the acronym RAST is actually a brand name. In 1989, Pharmacia Diagnostics AB replaced it with a superior test named the ImmunoCAP Specific IgE blood test, which literature may also describe as: CAP RAST, CAP FEIA (fluorenzymeimmunoassay), and Pharmacia CAP. A review of applicable quality assessment programs shows that this new test has replaced the original RAST in approximately 80% of the world's commercial clinical laboratories, where specific IgE testing is performed. The newest version, the ImmunoCAP Specific IgE 0–100, is the only specific IgE assay to receive FDA approval to quantitatively report to its detection limit of 0.1kU/L. This clearance is based on the CLSI/NCCLS-17A Limits of Detection and Limits of Quantitation, October 2004 guideline.[citation needed]The guidelines for diagnosis and management of food allergy issues by the National Institute of Health state that:

In 2010 the United States National Institute of Allergy and Infectious Diseases recommended that the RAST measurements of specific immunoglobulin E for the diagnosis of allergy be abandoned in favor of testing with more sensitive fluorescence enzyme-labeled assays.[13]

See also

[edit]

References

[edit]
[edit]
Revisions and contributorsEdit on WikipediaRead on Wikipedia

Radioallergosorbent test

View on Grokipedia
from Grokipedia
The radioallergosorbent test (RAST) is an blood test that employs to quantify specific (IgE) antibodies against suspected allergens, aiding in the diagnosis of reactions such as , hay fever, and other atopic conditions. Developed in 1967 by Lars Wide, Hans Bennich, and S.G.O. Johansson, it represented a pioneering method for detecting allergen-specific IgE without relying on invasive skin testing. The test's name derives from its use of a radiolabeled anti-IgE antibody to measure bound IgE through radioactivity detection, providing a quantitative score that correlates with severity. Although the original RAST used radioactive labeling and has been largely supplanted by safer, non-radioactive methods since the , its principles underpin modern specific IgE testing. RAST has evolved into non-radioactive variants like the fluoroenzymoimmunoassay (FEIA) used in ImmunoCAP systems, which offer improved , with multiplex options allowing simultaneous testing of dozens of components. Despite these advancements, the term "RAST" persists colloquially for any specific IgE , though it is not interchangeable with modern assays due to differences in and performance. Modern specific IgE s, evolving from RAST, are valuable in diagnostics (as of 2025), particularly for patients unable to undergo testing, guiding and avoidance strategies while avoiding the risks of testing.

Introduction and Background

Definition and Purpose

The radioallergosorbent test (RAST) is an that quantifies serum levels of allergen-specific (IgE) antibodies through techniques, where allergens are bound to a solid phase and detected via radiolabeled anti-IgE antibodies. This blood-based method provides a non-invasive means to assess IgE-mediated immune responses without exposing patients to potential allergens directly. The primary purpose of the RAST is to diagnose IgE-mediated allergic sensitivities, particularly reactions, in individuals who cannot undergo skin prick testing due to conditions such as extensive dermatoses (e.g., severe eczema), ongoing or therapy, or in very young infants where skin tests may be impractical or unreliable. It serves as a reliable alternative to in vivo skin tests, enabling the identification of triggers that provoke immediate allergic responses like , urticaria, or respiratory symptoms. By measuring specific IgE, the test aids clinicians in confirming allergy diagnoses and guiding avoidance strategies or . Developed as a complement to skin prick tests, the RAST and modern specific IgE assays derived from it can evaluate sensitivities to over 1,000 distinct allergens, encompassing categories such as foods (e.g., peanuts, shellfish), inhalants (e.g., pollen, dust mites), venoms (e.g., bee stings), and drugs (e.g., penicillin). This broad applicability makes it valuable for pinpointing culprits in complex allergic profiles, though results must always be interpreted alongside clinical history to avoid overdiagnosis.

Underlying Principle

The radioallergosorbent test (RAST) operates on the principle of to detect and quantify allergen-specific (IgE) antibodies in patient serum. Allergens are covalently coupled to a solid-phase matrix, typically cyanogen bromide-activated paper discs or particles, which serves as an insoluble support to immobilize the allergens and facilitate separation of bound from unbound components. Patient serum is then incubated with this allergosorbent, allowing specific IgE antibodies to bind to their corresponding allergens through antigen-antibody interactions. Unbound serum components are removed by washing, after which radiolabeled anti-IgE antibodies—commonly tagged with (¹²⁵I)—are added to bind to the captured IgE. The amount of radiolabeled anti-IgE bound to the complex is proportional to the concentration of specific IgE in the original serum sample, and is measured using a gamma counter to provide a quantitative readout. This assay leverages the high specificity of antigen-antibody binding, where IgE molecules selectively recognize and attach to their target allergens amid a complex mixture of serum proteins. The radiolabeling with ¹²⁵I enables sensitive detection of even low levels of IgE, as the gamma emissions from the can be precisely quantified without interference from biological matrices.

Methodology

Test Procedure

The radioallergosorbent test (RAST) begins with the collection of a sample from the patient, typically 5-10 mL, to obtain sufficient serum for analysis. No special patient preparation is required beyond avoiding potential interferents such as recent , which may alter IgE levels.90062-8/fulltext) The blood sample is allowed to clot at for 30-60 minutes, followed by at 1,000-2,000 × g for 10 minutes to separate the serum from cellular components. The resulting serum is then aliquoted and stored refrigerated or frozen until testing in a certified clinical . In the , the serum is incubated with an -coated solid phase, such as paper discs or , allowing specific IgE antibodies to bind to the immobilized ; this step typically lasts 2-24 hours at or overnight to ensure adequate binding. Unbound components, including non-specific IgE, are removed through multiple washing steps (3-4 times) with a , followed by at 1,000 × g for 10 minutes and aspiration of the supernatant. Next, a radiolabeled anti-IgE antibody, commonly iodinated with 125I, is added to the solid phase to bind the captured allergen-specific IgE, followed by a second of 1-18 hours. A final series of washes (typically 4 times) removes unbound radiolabeled antibody, and the bound is measured using a gamma counter to quantify the signal. Results are calculated by comparing the sample's to a standard curve generated from known concentrations of IgE, enabling determination of specific IgE levels.90378-7/fulltext) The entire process, performed in certified laboratories under strict quality controls, has a typical turnaround time of 1-2 weeks from sample receipt. Due to the use of radioactive materials like 125I, RAST procedures must adhere to regulations set by the U.S. (NRC), including proper handling, shielding, waste disposal, and personnel monitoring to ensure safety.

Preparation and Allergens

The preparation of serum samples for the radioallergosorbent test (RAST) begins with a standard to collect , typically in a serum separator tube, followed by to isolate the serum. , which imparts a pinkish or reddish tint to the serum due to erythrocyte rupture, and lipemia, caused by elevated lipid levels leading to turbidity, must be avoided as both can interfere with accuracy by affecting optical readings or binding. If the serum is not analyzed immediately, it should be separated from cells within 4 hours and stored at -20°C to maintain stability for up to several weeks, preventing degradation of IgE . Panel selection for RAST is guided by the patient's clinical history to identify suspected allergens, opting for targeted single-allergen tests or broader multiplex panels as needed, while avoiding indiscriminate screening that could lead to unnecessary results. Multiplex assays facilitate the simultaneous evaluation of multiple allergens from a single serum sample, enhancing efficiency for patients with potential polysensitization. Common allergen categories tested via RAST include aeroallergens such as pollens (e.g., short , grass) and dust mites (e.g., Dermatophagoides farinae, Dermatophagoides pteronyssinus), foods like , eggs, , and tree nuts, drugs such as penicillin, and haptens including components. These utilize standardized extracts from FDA-approved suppliers, with 19 officially standardized products available across categories like grasses, weeds, mites, cat dander, and venoms to ensure consistent potency and reliability. Although commercial assays offer panels with over 120 extracts and components, testing is restricted to clinically relevant ones to reduce false positives, which occur in 50% to 60% of cases when unrelated allergens are included due to . The approximate cost per in RAST or equivalent specific IgE testing ranges from $40 to $100, depending on the and panel complexity.

Interpretation and Results

Scoring Scale

The results of the radioallergosorbent test (RAST) are typically reported in quantitative units of kU/L (kilo units per liter) for allergen-specific IgE levels, calibrated against the (WHO) international standard for total IgE, where 1 kU/L aligns approximately with 1 international unit (IU) per liter or 2.4 ng/mL of IgE protein. These measurements provide a semi-quantitative assessment to guide the interpretation of allergic severity, with higher values indicating greater levels of specific IgE antibodies. To facilitate clinical reporting, RAST results are often classified into a semi-quantitative scale ranging from class 0 to class 6, based on predefined kU/L thresholds that correlate with the degree of positivity. The positive threshold is generally set at greater than 0.35 kU/L, though this may vary slightly depending on the specific tested. The following table summarizes the standard class system:
ClasskU/L RangeInterpretation
0< 0.35Negative
10.35–0.7Weak positive
20.7–3.5Positive
33.5–17.5Positive
417.5–52.5Strong positive
552.5–100Strong positive
6>100Very strong positive
Modern non-radioactive immunoassays, such as ImmunoCAP, which have largely replaced the original RAST, employ similar class-based scales and kU/L reporting but are calibrated equivalently to nanograms per milliliter (ng/mL) through the WHO standard, enabling direct comparisons across assay types (e.g., 1 kU/L ≈ 2.4 ng/mL).

Clinical Thresholds

The interpretation of radioallergosorbent test (RAST) results in a clinical context relies on established thresholds to identify , with a positive result generally defined as a specific IgE level exceeding 0.35 kU/L; however, this alone does not confirm clinical and must be with patient history and symptoms. RAST findings often with skin prick test wheal size, providing a quantitative measure of that supports diagnostic decisions, though the does not always predict the severity or presence of symptomatic . The test demonstrates sensitivity ranging from 70% to 90% and specificity from 80% to 95%, with performance varying by —higher for inhalants like and certain foods, but lower for venoms or drugs—making it a reliable adjunct to clinical evaluation when appropriately applied. A critical distinction in RAST interpretation is between (detected IgE presence) and true clinical , which requires corroboration through exposure history to avoid misdiagnosis; for instance, individuals may show positive results without adverse reactions. Serial RAST testing is valuable for monitoring responses to , as declining IgE levels over time can indicate treatment efficacy and guide adjustments. False positives may arise from between structurally similar allergens, such as pollen and apples, where IgE antibodies to one trigger reactivity to the other without primary . According to guidelines from the American Academy of Allergy, Asthma & Immunology (AAAAI), RAST results should always be integrated with a thorough patient history and for accurate , emphasizing that the test is limited to IgE-mediated conditions and unsuitable for non-IgE allergies like . These thresholds align with the class system used in RAST scoring, where levels above class 0 signify potential clinical relevance pending further assessment.

Clinical Applications

Diagnostic Uses

The radioallergosorbent test (RAST), which measures allergen-specific IgE antibodies in serum, plays a key role in diagnosing IgE-mediated allergies across various clinical scenarios. It is particularly valuable for identifying food allergies, such as those to , where elevated specific IgE levels help confirm in patients with a history of reactions, guiding dietary avoidance strategies to prevent . Similarly, RAST aids in diagnosing inhalant allergies that trigger , such as those to dust mites or , by detecting IgE responses that correlate with respiratory symptoms and inform environmental control measures or initiation. In cases of drug hypersensitivities, like penicillin reactions, and allergies from stings, RAST confirms IgE involvement when testing is contraindicated due to dermatological conditions or heightened risk. Its utility extends to , where it is preferred for young children unable to tolerate tests or those at risk of severe reactions during provocation, supporting decisions on desensitization protocols. Component-resolved diagnostics (CRD), an advanced variant of specific IgE testing akin to RAST, identifies IgE to individual allergenic proteins, enabling differentiation of true allergies from cross-reactive ones, such as profilins in multiple foods or s. RAST results are often integrated with total serum IgE levels to screen for , enhancing overall management by predicting the likelihood of multiple sensitizations. Studies demonstrate high concordance with oral food challenges in high-risk cases, with specific IgE levels at certain thresholds (e.g., ≥14 kIU/L for ) showing >95% positive predictive value for reactivity in foods like and eggs, thereby reducing the need for invasive confirmations while establishing clinical thresholds for reactivity. This evidence-based approach underscores RAST's role in tailoring personalized interventions, such as avoidance or .

Advantages and Limitations

The radioallergosorbent test (RAST) offers several advantages over traditional skin prick testing for diagnosing IgE-mediated allergies. Primarily, it is safe, posing no risk of systemic reactions such as , which makes it suitable for patients with a history of severe allergic responses or those at high risk during skin testing. Unlike skin tests, RAST results are unaffected by antihistamines, tricyclic antidepressants, or skin conditions like extensive , dermatographism, or , eliminating the need for medication withdrawal or patient preparation. Additionally, RAST provides quantitative measurements of specific IgE antibody levels, allowing for assessment of sensitization degree and broad screening across multiple allergens without patient discomfort. Despite these benefits, RAST has notable limitations compared to skin prick testing. It generally exhibits lower sensitivity, averaging 70-75% (with a range of less than 50% to over 90%), making it less effective at detecting allergies than skin prick tests, which achieve higher sensitivity around 85-95% for many allergens. This reduced sensitivity is particularly evident for certain allergens, such as fresh foods (e.g., apple, orange, or ), where skin prick tests with fresh extracts outperform RAST in confirming clinical reactivity. RAST also incurs higher costs, typically $200-500 for a panel of allergens, and requires processing, leading to longer turnaround times of several days versus immediate skin test results. Furthermore, as an outdated , RAST has been largely phased out in favor of non-radioactive methods like fluoroenzyme immunoassays due to regulatory concerns and improved alternatives, though its specificity remains comparable or sometimes higher than skin tests for select allergens like cat dander. It is not suitable for acute diagnosis, as results do not provide real-time information during symptomatic episodes.

History and Developments

Invention and Early Use

The Radioallergosorbent test (RAST) was developed in 1967 by a team at Diagnostics in , , led by researchers Lars Wide, Hans Bennich, and S.G.O. Johansson. This innovation built on the recent discovery of (IgE) in 1966-1967, addressing the need for a sensitive method to detect allergen-specific IgE antibodies in serum, which total IgE assays could not distinguish from non-allergic responses. The test employed principles, coupling allergens to a solid-phase matrix ( bromide-activated paper discs) to capture specific IgE, followed by radiolabeled anti-IgE detection. The foundational work was first published in 1967 in The Lancet, describing RAST as an in vitro diagnostic for allergy by quantifying IgE reaginic antibodies to common allergens like birch pollen, timothy grass, and house dust mite. Initial validation studies in the late 1960s and early 1970s compared RAST results to skin prick tests and clinical histories in atopic patients, demonstrating correlation rates of around 70-90% for inhalant allergens, though lower for foods due to assay sensitivity limits at the time. These efforts overcame key limitations of prior total IgE measurements, which lacked allergen specificity and could not guide targeted allergy management. Commercially introduced by in 1974 as Phadebas RAST, the test became widely available in the in the early following regulatory clearance, enabling widespread use. Early adoption occurred primarily in during the mid-1970s, with Swedish and other European clinics integrating it for pediatric and adult diagnostics, particularly for respiratory allergies. By the early , RAST gained significant traction in U.S. laboratories, supported by multicenter studies confirming its utility in confirming skin test findings for and patients, though it required specialized radioisotope handling.

Modern Evolutions and Alternatives

In the , the Radioallergosorbent test (RAST) underwent significant evolution with the development of non-radioactive alternatives to address safety concerns associated with the original radioactive method. The allergosorbent test (FAST), introduced as a non-isotopic , utilized detection for specific IgE measurement, offering comparable sensitivity to traditional RAST while reducing handling hazards and improving . Similarly, the ImmunoCAP , a fluoroenzyme , emerged in the early as a standardized platform for quantifying allergen-specific IgE, providing enhanced precision through its hydrophilic cellulose-based solid phase that minimized non-specific binding. These advancements marked a pivotal shift away from radioisotopes, with ImmunoCAP gaining widespread adoption for its reproducibility across laboratories. The ImmunoCAP assay was calibrated to the World Health Organization's international reference standard for total IgE (75/502) and became the recommended gold standard for singleplex specific IgE quantitation by the WHO in the early 2000s, ensuring consistent results and facilitating global comparisons in allergy diagnostics. This standardization addressed variability in earlier RAST variants, with studies demonstrating ImmunoCAP's superior inter-assay precision (coefficient of variation <10%) compared to older methods. By the 2020s, fluoroenzyme immunoassays like ImmunoCAP dominated clinical practice, comprising the majority of specific IgE testing in laboratories worldwide due to their automation and safety profile. Contemporary alternatives to RAST-based blood tests include skin prick tests (SPT), which remain the first-line diagnostic tool for IgE-mediated allergies owing to their rapidity (results in 15-20 minutes), low cost, and high sensitivity for inhalant and food allergens. (BAT), employing to measure allergen-induced or CD203c expression on , offer a functional assessment of IgE reactivity, particularly useful when skin or blood tests are inconclusive, as seen in lipid transfer protein allergies. Oral food challenges, considered the gold standard for confirming food allergies, involve supervised allergen ingestion to observe clinical reactions but are reserved for ambiguous cases due to risks of . Multiplex platforms represent another modern substitute, enabling simultaneous detection of IgE to over 100 components. The ImmunoCAP ISAC , for instance, uses a to profile specific IgE against molecular s, aiding in distinguishing true from , as validated in studies of patients. Similarly, the ALEX multiplex array assesses more than 170 components and 120 extracts, showing strong correlation with ISAC for diagnosis. The term "RAST" has evolved into a generic descriptor for any specific IgE , despite referring originally to the radioactive method, reflecting its outdated specificity in clinical parlance. Non-radioactive iterations have virtually eliminated risks, enhancing accessibility in routine settings. Ongoing research into for point-of-care testing includes nanoparticle-based biosensors, such as and quantum dot-enhanced lateral flow assays, which promise rapid, multiplexed IgE detection with sensitivities rivaling methods, as well as innovations like the Hoxb8 Activation Test (2024), which uses sensitized lab-grown mast cells for high-accuracy (95%) assessment of severity.

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