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Multicenter Performance Study of TriQuik Invitro Diagnostic Device

NCT05293821 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2023-01-13

No results posted yet for this study

Summary

This prospective and historical clinical study is designed to test the performance of the Genlantis TriQuik test kit (Cassette). The primary goal is to establish the sensitivity and specificity (i.e. how accurate the test is) when compared to the same patient's medical history.

Previous tests were performed on serum and whole blood specimens. A total of 607 serum specimens1 were collected for evaluation and comparison of the performance of the TriQuik Hepatitis B Surface Antigen (HBsAg) Test with a licensed commercial HBsAg EIA. 84 of 85 positive serum samples testing by the licensed commercial HBsAg EIA were reactive with TriQuik HBsAg Test and 520 of 522 negative samples testing by the licensed commercial HBsAg EIA were tested negative with TriQuik HBsAg Test.

Conditions

  • To Demonstrate Clinical Performance of the TriQuik Invitro Diagnostic Device

Interventions

DIAGNOSTIC_TEST

TriQuik IVD

TriQuik Invitro Diagnostic Device Cassettes. TriQuik Invitro Diagnostic Device Cassettes.

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-30
Primary Completion
2023-10-31
Completion
2023-11-30
FDA Device
Yes

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05293821 on ClinicalTrials.gov