An interventional study of AllerTest-10 Multi-Head Skin Test Device and Skintestor OMNI Multi-Head Skin Test Device in Allergy, Hypersensitivity, Immediate and Ig-E Mediated Food, sponsored by QHSLab, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-12.
Sponsored by QHSLab, Inc. · Not applicable, Interventional, and Diagnostic
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.
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.
82 studies on the registry are indexed under Hypersensitivity, Immediate; 7 are open to participants now.
This study's enrollment of 30 is below the median of 70 across 66 interventional studies indexed under Hypersensitivity, Immediate.
Browse Hypersensitivity, Immediate studies →QHSLab, Inc. is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Compared within Hypersensitivity, Immediate, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hypersensitivity. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients will be entered into this study only if they meet all of the following criteria:
Exclusion Criteria:
Patients will NOT be entered into this study if they meet any of the following criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Device: AllerTest-10 Multi-Head Skin Test Device · Device: AllerTest-8 Multi-Head Skin Test Device
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.
Device: Skintestor OMNI Multi-Head Skin Test Device · Device: Multi-Test II Multi-Head Skin Test Device
FDA-cleared 10-head percutaneous skin test applicator manufactured by MedScience Research Group, Inc., distributed by ALK Abello, Inc. The device consists of 10 individual test heads arranged in a linear array, each with a standardized needle length designed to penetrate the epidermis without drawing blood. Applied with standardized pressure for simultaneous delivery of 10 test substances (histamine and glycerin controls in this study). Single-use, disposable device.
Also known as: AllerTest 10-head
FDA-cleared 10-head percutaneous skin test applicator manufactured by Greer Laboratories, Inc. The device consists of 10 individual test heads arranged in a linear array for simultaneous application of multiple allergens and controls. Applied with standardized pressure for delivery of histamine and glycerin controls in this study. Single-use, disposable device.
FDA-cleared 8-head percutaneous skin test applicator manufactured by Lincoln Diagnostics, Inc. The device consists of 8 individual test heads arranged in a linear array for simultaneous application of multiple allergens and controls. Applied with standardized pressure for delivery of histamine and glycerin controls in this study. Single-use, disposable device.
FDA-cleared 8-head percutaneous skin test applicator manufactured by MedScience Research Group, Inc., distributed by ALK Abello, Inc. The device consists of 8 individual test heads arranged in a linear array, each with a standardized needle length designed to penetrate the epidermis without drawing blood. Applied with standardized pressure for simultaneous delivery of 8 test substances (histamine and glycerin controls in this study). Single-use, disposable device.
Pain Assessment Using Visual Analog Scale (VAS)
Procedural pain assessed immediately after device application using a 0-10 Visual Analog Scale (VAS), where 0 represents no pain and 10 represents unspeakable pain. Lower scores indicate less pain and better tolerability.
Time frame: Immediately after device application (within 1 minute of skin test procedure)
Sensitivity (Histamine Positive Control Performance)
Proportion of histamine control sites producing wheal ≥3 mm diameter at 15 minutes post-application. A wheal of ≥3 mm is the standard threshold for a positive allergic reaction. Higher sensitivity indicates better device performance in reliably eliciting positive control responses. Calculated as: (number of histamine sites with wheal ≥3 mm) / (total number of histamine sites tested) × 100%.
Time frame: 15 minutes after device application
Specificity (Glycerin Negative Control Performance)
Proportion of glycerin control sites producing wheal \<3 mm diameter at 15 minutes post-application. Glycerin should not produce a wheal response; a result \<3 mm confirms appropriate negative control performance and absence of non-specific mechanical irritation. Higher specificity indicates better device performance. Calculated as: (number of glycerin sites with wheal \<3 mm) / (total number of glycerin sites tested) × 100%.
Time frame: 15 minutes after device application
Intra-Device Variability
Coefficient of variation (CV) of histamine wheal sizes across all test heads within each device, calculated as CV = (standard deviation / mean) × 100%. Lower CV values indicate greater consistency and precision across test heads within the same device. This measure reflects the reliability of allergen delivery across multiple heads of a single device application.
Time frame: 15 minutes after device application
Mean Histamine Wheal Size
Mean diameter (in millimeters) of wheals produced by histamine positive control across all test heads of each device. Wheal diameter measured using the mean diameter method (average of longest diameter and its perpendicular midpoint). Larger wheals indicate stronger positive control response.
Time frame: 15 minutes after device application
Mean Glycerin Wheal Size
Mean diameter (in millimeters) of wheals produced by glycerin negative control across all test heads of each device. Wheal diameter measured using the mean diameter method (average of longest diameter and its perpendicular midpoint). Smaller measurements (ideally 0 mm) indicate appropriate negative control performance with minimal non-specific irritation.
Time frame: 15 minutes after device application
Proportion of Subjects with Clinically Significant Pain
Proportion of participants experiencing more than mild pain, defined as a score greater than 4 on the Visual Analog Scale (VAS) for pain. The VAS ranges from 0 (no pain) to 10 (unspeakable pain), with higher scores indicating worse pain. A threshold of \>4 represents approximately 40% of the scale and indicates clinically meaningful discomfort. Lower percentages indicate better device tolerability across the study population. Reported as percentage with 95% exact binomial confidence intervals.
Time frame: Immediately after device application (within 1 minute of skin test procedure)
Plan to share: No
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