Head-to-Head Comparison Study Between Different FDA Registered Allergy Skin Test Applicators

QHSLab, Inc.

Status: Completed

Conditions: Hypersensitivity, Immediate; Ig-E Mediated Food; Allergy

Treatments: Device: AllerTest-10 Multi-Head Skin Test Device; Device: AllerTest-8 Multi-Head Skin Test Device; Device: Skintestor OMNI Multi-Head Skin Test Device; Device: Multi-Test II Multi-Head Skin Test Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT07400718

33-098

Details and patient eligibility

About

This clinical study, titled "Head-to-Head Comparison Study between Different FDA Registered Allergy Skin Test Applicators," aims to compare the reliability and clinical performance of three skin prick test (SPT) devices: Allertest™ Multiple Skin Test Applicator, Lincoln Multi-Test II, and Greer Skintestor OMNI Applicator. The primary objective is to evaluate the consistency and accuracy of these devices in allergy testing.

Full description

Background and Rationale:

Percutaneous allergy skin testing remains the gold standard diagnostic method for IgE-mediated allergic disease. Multiple-head skin prick test (SPT) devices enable simultaneous application of multiple allergens, improving testing efficiency while potentially reducing patient discomfort. However, significant inter-device variability exists among commercially available devices, with important implications for diagnostic accuracy and clinical interpretation.

Intra-device variability-inconsistent responses across individual test heads within a single device-represents a particularly concerning phenomenon that may lead to physician misinterpretation and potentially inappropriate treatment decisions. Such variability can be attributed to manufacturing factors including tooling mold precision, molding equipment quality, and process controls during production. Prior research has demonstrated that devices with lower finished product variability exhibit improved clinical performance characterized by reduced false-positive reactions to negative controls.

Study Design:

This prospective, single-visit, head-to-head device comparison study employed a paired design in which each participant served as their own control, receiving testing with two devices simultaneously-one device applied to each forearm. This within-subject design minimizes inter-individual variability and provides robust comparative data.

Participants were allocated into two comparison groups based on device head configuration: a 10-head device comparison (n=13) and an 8-head device comparison (n=17). Device assignment to right versus left forearm was randomized. Testing personnel were blinded to solution contents (histamine versus glycerin) during application, and a separate evaluator blinded to device assignment recorded wheal measurements.

Study Procedures:

All testing was performed by trained personnel in accordance with standard percutaneous skin testing protocols. Histamine dihydrochloride (1 mg/mL; ALK-Abello) served as the positive control and glycerin solution (ALK-Abello) served as the negative control. Devices were applied to the volar forearm surfaces with standardized pressure and technique. Test sites were maintained at least 2 cm apart to prevent cross-contamination between histamine and glycerin reactions.

Wheal measurements were obtained 15-20 minutes post-application using the mean diameter method (average of longest diameter and its perpendicular midpoint), consistent with established international guidelines. Pain assessment was performed immediately following device application.

Statistical Considerations:

Paired comparisons between devices were analyzed using Wilcoxon signed-rank tests for continuous variables and McNemar's test for dichotomous outcomes. Intra-device variability was quantified using the coefficient of variation (CV) calculated across test heads, with lower values indicating greater consistency. Exact binomial (Clopper-Pearson) confidence intervals were calculated for sensitivity and specificity estimates. Statistical significance was set at α=0.05 (two-sided).

Clinical Significance:

This study addresses an important knowledge gap regarding comparative clinical performance of multi-head allergy testing devices. Results provide evidence-based data to inform device selection decisions that may impact diagnostic accuracy, patient comfort, and reliability of allergen identification in clinical allergy practice.

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients will be entered into this study only if they meet all of the following criteria:

  1. Written and signed informed consent obtained before starting any protocol-specific procedures.
  2. Subjects willing to withhold antihistamines, Leukotriene antagonists and H2 antagonists for at least 1 week before testing to avoid masking the histamine reactions on the skin.
  3. Male or female between 18 to 60 65 years, inclusive.
  4. Ability to comply with the study procedures and visit schedule.

Exclusion criteria

• Patients will NOT be entered into this study if they meet any of the following criteria:

  1. Anaphylactic reaction (constitutional) after the previous skin test with the same allergen
  2. Acute fever
  3. Systemic disease with acute manifestation or decompensation
  4. Abnormal skin condition in the area to be tested (such as eczema sunburn condition after sunbathing)
  5. Pregnancy
  6. Presence of dermatographism, severe atopic dermatitis, or use of tricyclic antidepressants.
  7. Current use of beta-blockers
  8. Known hypersensitivity to any component of the test solutions (histamine or glycerin).
  9. Participation in another clinical study within 30 days before enrollment. Participation in another clinical study within 30 days before enrollment.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups

AllerTest Device

Experimental group

Description:

Participants receive percutaneous allergy skin testing using an AllerTest multi-head device (either AllerTest-10 or AllerTest-8, manufactured by MedScience Research Group, Inc., distributed by ALK Abello, Inc.). The device is applied to one randomized forearm with a standardized histamine positive control (10 mg/mL histamine base) and a glycerin negative control (50% glycerin in saline). Outcomes measured include procedural pain (VAS 0-10), histamine wheal size at 15 minutes, glycerin wheal size at 15 minutes, sensitivity (proportion of histamine sites ≥3 mm), specificity (proportion of glycerin sites \<3 mm), and intra-device variability (coefficient of variation across test heads).

Treatment:

Device: AllerTest-8 Multi-Head Skin Test Device

Device: AllerTest-10 Multi-Head Skin Test Device

Comparator Device

Active Comparator group

Description:

Participants receive percutaneous allergy skin testing using a comparator multi-head device (either Skintestor OMNI manufactured by Greer Laboratories, Inc., or Multi-Test II manufactured by Lincoln Diagnostics, Inc.). The device is applied simultaneously to the opposite forearm with identical standardized histamine positive control (10 mg/mL histamine base) and glycerin negative control (50% glycerin in saline). The same outcomes are measured to enable direct paired comparison: procedural pain (VAS 0-10), histamine wheal size at 15 minutes, glycerin wheal size at 15 minutes, sensitivity, specificity, and intra-device variability.

Treatment:

Device: Multi-Test II Multi-Head Skin Test Device

Device: Skintestor OMNI Multi-Head Skin Test Device