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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05152030
Enrollment
180
Registered
2021-12-09
Start date
2020-11-01
Completion date
2021-09-16
Last updated
2021-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anosmia, Hyposmia

Brief summary

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.

Interventions

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_TESTTraditional 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.

Sponsors

Taichung Veterans General Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 59 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
validity of TIB olfactory test30 minutes to 1 hourCriterion validity: Correlation between UPSIT-TC and TIB olfactory test
Reliability of TIB olfactory test1 weekTest-retest reliability

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026