Multicenter Performance Study of TriQuik Invitro Diagnostic Device
A Multicenter Clinical Performance Study to Compare the Results Obtained From the TriQuik Invitro Diagnostic Device With Historical Medical Records From the Same Subject
1 other identifier
observational
200
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2023
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2022
CompletedFirst Posted
Study publicly available on registry
March 24, 2022
CompletedStudy Start
First participant enrolled
April 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2023
CompletedJanuary 13, 2023
March 1, 2022
6 months
March 15, 2022
January 11, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Standard performance criteria
Diagnostic Sensitivity, Diagnostic Specificity, Positive Predictive Value, Negative Predictive Value
<1 day
Study Arms (2)
Positive test subjects
documented medical history of HIV, HBV or HCV. A combination of 2 or 3 conditions is acceptable.
Control
no documented medical history of HIV, HBV or HCV and are considered normal.
Interventions
TriQuik Invitro Diagnostic Device Cassettes. TriQuik Invitro Diagnostic Device Cassettes.
Eligibility Criteria
Study patients are seen, recruited and consented from local clinics and physician offices.
You may qualify if:
- a documented medical history of HIV, HBV or HCV. A combination of 2 or 3 conditions is acceptable.
- HbsAg patients need to have a HbsAg on file \< 2 years.
- HIV and HCV patients only need one antibody test in their medical chart.
- no documented medical history of HIV, HBV or HCV and are considered normal.
- Male or female subjects, ages ≥18 years.
- Signed informed consent provided by an authorized subject representative (based on local Institutional Review Board (IRB)/ethics panel requirements).
You may not qualify if:
- Any other condition or prior therapy, which, in the opinion of the investigator, would make the subject unsuitable for this study.
- Participation in any phase of another clinical research study involving the evaluation of another investigational drug or device within 30 days before randomization.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genlantis Diagnosticslead
- Northwestern Universitycollaborator
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Scientific Officer
Study Record Dates
First Submitted
March 15, 2022
First Posted
March 24, 2022
Study Start
April 1, 2023
Primary Completion
October 1, 2023
Study Completion
November 1, 2023
Last Updated
January 13, 2023
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, CSR
- Time Frame
- Two months following completion of analysis
There will be a need to communicate the results of this clinical performance study to clinicians and/or public health institutions and regulatory bodies after the study. This is the case since these test results have an immediate health impact to the patient, patient's relatives and the public. The decision and the mechanism to report results to clinicians and public health institutions will be discussed with the local ethics committee prior to beginning the clinical performance study.