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

Part of paid clinical trials in Miami, Florida.

Sponsor
QHSLab, Inc.
Study ID
NCT07400718
Status
Completed

Conditions

  • Allergy
  • Hypersensitivity, Immediate
  • Ig-E Mediated Food

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

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.
  • 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.
  • 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.
  • 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.

Study Details

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.

Key Dates

Start date
Nov 12, 2025
Status verified
Feb 2026
Primary completion
Nov 30, 2025
Completion
Jan 30, 2026

Study Design

Enrollment
30 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: AllerTest Device
    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).
  • Active Comparator: Comparator 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.

Primary Outcome Measure

Pain Assessment Using Visual Analog Scale (VAS) [ Time Frame: Immediately after device application (within 1 minute of skin test procedure) ]

Locations (1)

FacilityCityStateZIPSite coordinators
QHS Health centerMiamiFlorida33155-

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By research site
QHS Health center· Miami, FL

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