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

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

Interventions

DEVICE

AllerTest-10 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.

DEVICE

Skintestor OMNI Multi-Head Skin Test 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.

DEVICE

Multi-Test II Multi-Head Skin Test 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.

DEVICE

AllerTest-8 Multi-Head Skin Test 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.

Sponsors & Collaborators

• ALK-Abelló A/S

  collaborator INDUSTRY

• QHSLab, Inc.

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-11-12

Primary Completion

2025-11-30

Completion

2026-01-30

FDA Device

Yes

Countries

• United States

Study Locations