The Clinical Applicability of the 'TIB' Olfactory Test Device

Validation of the Local Applicability of the 'TIB' Olfactory Test Device in the Era of COVID-19

The aim of this study was to evaluate the validity and test-retest reliability of the 'TIB' Olfactory Test Device, a new olfactory test tool developed by Top International Biotech, Taipei, and to determine its normative values. The olfactory function of 180 subjects was evaluated using both the traditional Chinese version of the University of Pennsylvania of Smell Identification Test (UPSIT-TC) and TIB. The subjects consisted of 60 healthy volunteers (normosmic group), 60 hyposmic patients, and 60 anosmic patients. The healthy volunteers were retested with the UPSIT-TC and TIB at an inter-test interval of at least 7 days. The cut-off scores of TIB among the different groups were determined by receiver operating characteristic curve.

Study Overview

• Status: Completed
• Conditions: Anosmia; Hyposmia
• Intervention / Treatment: Diagnostic test: 'TIB' Olfactory Test; Diagnostic test: Traditional Chinese version of the University of Pennsylvania of Smell Identification Test (UPSIT-TC)

• Study Type: Observational
• Enrollment (Actual): 180

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 407219
    • Taichung Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 59 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Normosmic group were from community. Hyposmic and anosmic patients were from out patient clinic department of Otorhinolaryngology.

Description

Inclusion Criteria:

• Normosmic group were self-reported absence of deficits in olfaction. Hyposmic patients were loss of olfactory function with a phenyl ethyl alcohol (PEA) odor detection threshold below -1. Anosmic patients were loss of olfactory function with a PEA threshold equal to -1.

Exclusion Criteria:

• History of sinonasal symptoms within a week before the test

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
hyposmic patients	Diagnostic test: 'TIB' Olfactory Test; A new smell identification test, 'TIB' Olfactory Test Device (Top International Biotech, Taipei) has been developed in Taiwan. It consists of 16 tests with an odorant embedded in fragrant microcapsules positioned on a strip. The examinee scratches the strip to release the odorant. The released odorant is sniffed and the examinee identifies the odorant by choosing a name from a set of 4 odor descriptors. This process is then repeated with the next odorant on the strip.; Diagnostic test: Traditional Chinese version of the University of Pennsylvania of Smell Identification Test (UPSIT-TC); The University of Pennsylvania Smell Identification Test (UPSIT), which was developed at the University of Pennsylvania, is one of the most reliable and the most widely used olfactory test.The test consists of four 10-odorant booklets. Each odorant is embedded in 10 to 50 µm urea-formaldehyde polymer microencapsules fixed in a proprietary binder and positioned on a brown strip which is located at the bottom of each page of the test booklet.4 When the examinee takes the test, each of the 40 odorants is released by scratching the strip with a pencil tip. The released odorant is sniffed and the examinee identifies the odorant by choosing a name from a set of 4 odor descriptors.
anosmic patients	Diagnostic test: 'TIB' Olfactory Test; A new smell identification test, 'TIB' Olfactory Test Device (Top International Biotech, Taipei) has been developed in Taiwan. It consists of 16 tests with an odorant embedded in fragrant microcapsules positioned on a strip. The examinee scratches the strip to release the odorant. The released odorant is sniffed and the examinee identifies the odorant by choosing a name from a set of 4 odor descriptors. This process is then repeated with the next odorant on the strip.; Diagnostic test: Traditional Chinese version of the University of Pennsylvania of Smell Identification Test (UPSIT-TC); The University of Pennsylvania Smell Identification Test (UPSIT), which was developed at the University of Pennsylvania, is one of the most reliable and the most widely used olfactory test.The test consists of four 10-odorant booklets. Each odorant is embedded in 10 to 50 µm urea-formaldehyde polymer microencapsules fixed in a proprietary binder and positioned on a brown strip which is located at the bottom of each page of the test booklet.4 When the examinee takes the test, each of the 40 odorants is released by scratching the strip with a pencil tip. The released odorant is sniffed and the examinee identifies the odorant by choosing a name from a set of 4 odor descriptors.
normosmic group	Diagnostic test: 'TIB' Olfactory Test; A new smell identification test, 'TIB' Olfactory Test Device (Top International Biotech, Taipei) has been developed in Taiwan. It consists of 16 tests with an odorant embedded in fragrant microcapsules positioned on a strip. The examinee scratches the strip to release the odorant. The released odorant is sniffed and the examinee identifies the odorant by choosing a name from a set of 4 odor descriptors. This process is then repeated with the next odorant on the strip.; Diagnostic test: Traditional Chinese version of the University of Pennsylvania of Smell Identification Test (UPSIT-TC); The University of Pennsylvania Smell Identification Test (UPSIT), which was developed at the University of Pennsylvania, is one of the most reliable and the most widely used olfactory test.The test consists of four 10-odorant booklets. Each odorant is embedded in 10 to 50 µm urea-formaldehyde polymer microencapsules fixed in a proprietary binder and positioned on a brown strip which is located at the bottom of each page of the test booklet.4 When the examinee takes the test, each of the 40 odorants is released by scratching the strip with a pencil tip. The released odorant is sniffed and the examinee identifies the odorant by choosing a name from a set of 4 odor descriptors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
validity of TIB olfactory test	Criterion validity: Correlation between UPSIT-TC and TIB olfactory test	30 minutes to 1 hour
Reliability of TIB olfactory test	Test-retest reliability	1 week

Collaborators and Investigators

• Sponsor: Taichung Veterans General Hospital
• Investigators: Study Director: Rong-San Jiang, M.D., Ph.D., Taichung Veterans General Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2020
• Primary Completion (ACTUAL): August 31, 2021
• Study Completion (ACTUAL): September 16, 2021

Study Registration Dates

• First Submitted: November 26, 2021
• First Submitted That Met QC Criteria: November 26, 2021
• First Posted (ACTUAL): December 9, 2021

Study Record Updates

• Last Update Posted (ACTUAL): December 9, 2021
• Last Update Submitted That Met QC Criteria: November 26, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Sensation Disorders; Olfaction Disorders; Anosmia
• Other Study ID Numbers: CE20329A#1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No