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

NCT07400718 | Completed FDA Device

• 1 other identifier: 33-098
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Allergy; Hypersensitivity, Immediate; Ig-E Mediated Food

Keywords

Allergy skin testing; Skin prick test; Multi-head skin test device; Device comparison; Diagnostic accuracy; Sensitivity and specificity; Intra-device variability

Outcome Measures

Primary Outcomes (3)

• 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.

  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%.

  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%.

  15 minutes after device application

Secondary Outcomes (4)

• Intra-Device Variability

  15 minutes after device application

• Mean Histamine Wheal Size

  15 minutes after device application

• Mean Glycerin Wheal Size

  15 minutes after device application

• Proportion of Subjects with Clinically Significant Pain

  Immediately after device application (within 1 minute of skin test procedure)

Study Arms (2)

AllerTest Device

EXPERIMENTAL

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

Comparator Device

ACTIVE COMPARATOR

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

Interventions

AllerTest-10 Multi-Head Skin Test Device 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

AllerTest Device

Skintestor OMNI Multi-Head Skin Test Device DEVICE

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.

Comparator Device

Multi-Test II Multi-Head Skin Test Device 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.

Comparator Device

AllerTest-8 Multi-Head Skin Test Device 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.

AllerTest Device

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients will be entered into this study only if they meet all of the following criteria:
• Written and signed informed consent obtained before starting any protocol-specific procedures.
• 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.
• Male or female between 18 to 60 65 years, inclusive.
• Ability to comply with the study procedures and visit schedule.

You may not qualify if:

• Patients will NOT be entered into this study if they meet any of the following criteria:
• Anaphylactic reaction (constitutional) after the previous skin test with the same allergen
• Acute fever
• Systemic disease with acute manifestation or decompensation
• Abnormal skin condition in the area to be tested (such as eczema sunburn condition after sunbathing)
• Pregnancy
• Presence of dermatographism, severe atopic dermatitis, or use of tricyclic antidepressants.
• Current use of beta-blockers
• Known hypersensitivity to any component of the test solutions (histamine or glycerin).
• Participation in another clinical study within 30 days before enrollment. Participation in another clinical study within 30 days before enrollment.

Sponsors & Collaborators

• QHSLab, Inc.: lead
• ALK-Abelló A/S: collaborator

Study Sites (1)

QHS Health center

Miami, Florida, 33155, United States

Location

Related Publications (5)

• Platts-Mills TA, Woodfolk JA. Rise in asthma cases. Science. 1997 Nov 7;278(5340):1001. doi: 10.1126/science.278.5340.997c. No abstract available.

  PMID: 9381194 RESULT

• Arbes SJ Jr, Gergen PJ, Elliott L, Zeldin DC. Prevalences of positive skin test responses to 10 common allergens in the US population: results from the third National Health and Nutrition Examination Survey. J Allergy Clin Immunol. 2005 Aug;116(2):377-83. doi: 10.1016/j.jaci.2005.05.017.

  PMID: 16083793 RESULT

• Cox L, Williams B, Sicherer S, Oppenheimer J, Sher L, Hamilton R, Golden D; American College of Allergy, Asthma and Immunology Test Task Force; American Academy of Allergy, Asthma and Immunology Specific IgE Test Task Force. Pearls and pitfalls of allergy diagnostic testing: report from the American College of Allergy, Asthma and Immunology/American Academy of Allergy, Asthma and Immunology Specific IgE Test Task Force. Ann Allergy Asthma Immunol. 2008 Dec;101(6):580-92.

  PMID: 19119701 RESULT

• Antunes J, Borrego L, Romeira A, Pinto P. Skin prick tests and allergy diagnosis. Allergol Immunopathol (Madr). 2009 May-Jun;37(3):155-64. doi: 10.1016/S0301-0546(09)71728-8. Epub 2009 Jul 23.

  PMID: 19769849 RESULT

• Bernstein IL, Li JT, Bernstein DI, Hamilton R, Spector SL, Tan R, Sicherer S, Golden DB, Khan DA, Nicklas RA, Portnoy JM, Blessing-Moore J, Cox L, Lang DM, Oppenheimer J, Randolph CC, Schuller DE, Tilles SA, Wallace DV, Levetin E, Weber R; American Academy of Allergy, Asthma and Immunology; American College of Allergy, Asthma and Immunology. Allergy diagnostic testing: an updated practice parameter. Ann Allergy Asthma Immunol. 2008 Mar;100(3 Suppl 3):S1-148. doi: 10.1016/s1081-1206(10)60305-5. No abstract available.

  PMID: 18431959 RESULT

Related Links

• Asthma and Allergy Foundation of America. CDC Fast Facts A-Z
• Chronic Conditions: A Challenge for the 21st Century
• United States Census Bureau

MeSH Terms

Conditions

Hypersensitivity; Hypersensitivity, Immediate

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study employed a paired comparison design with each participant serving as their own control. Participants were assigned to one of two device comparison groups: (1) 10-head device comparison (AllerTest-10 vs. Skintestor OMNI, n=13), or (2) 8-head device comparison (AllerTest-8 vs. Multi-Test II, n=17). Within each comparison group, both devices were applied simultaneously-one to each forearm-with randomized left/right assignment. Each device was loaded with standardized histamine positive control and glycerin negative control. This within-subject design eliminates inter-subject variability in skin reactivity, providing robust paired comparisons of device performance on pain perception, control accuracy (sensitivity/specificity), and intra-device consistency.

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 10, 2026
• Study Start: November 12, 2025
• Primary Completion: November 30, 2025
• Study Completion: January 30, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)