Multicenter Performance Study of TriQuik Invitro Diagnostic Device

January 11, 2023 updated by: Robert Zeiler, Genlantis Diagnostics

A Multicenter Clinical Performance Study to Compare the Results Obtained From the TriQuik Invitro Diagnostic Device With Historical Medical Records From the Same Subject

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Study Objective To demonstrate clinical performance of the TriQuik Invitro Diagnostic device.

Measurement Methodology Whole blood samples are collected by fingerstick. Samples should be tested immediately.

Using the supplied sample dropper, transfer specimen blood drop into the sample well. Wait 20-30 seconds. Add two drops of the supplied assay buffer (~90µL) to the same sample well Read result in 20 mins.

Primary end points will determine how accurate these tests are (p<=0.02) by analyzing for:

Diagnostic Sensitivity; TP / (TP + FN) The ability of the test to correctly identify those patients with the disease Diagnostic Specificity; TN / (TN + FP) The ability of the test to correctly identify those patients who are truly free of the specific disease Positive Predictive Value: TP / (TP+ FP) The probability that subjects with a positive test truly have the disease. Negative Predictive Value: TN / (FN + TN) The probability that subjects with a negative test truly don't have the disease.

An estimated 200 patients are to be enrolled as follows:

150 with 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.

50 with no documented medical history of HIV, HBV or HCV and are considered normal.

Male or female subjects, ages ≥18 years.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Study patients are seen, recruited and consented from local clinics and physician offices.

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

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.

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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Positive test subjects
documented medical history of HIV, HBV or HCV. A combination of 2 or 3 conditions is acceptable.
Diagnostic test: TriQuik IVD
TriQuik Invitro Diagnostic Device Cassettes. TriQuik Invitro Diagnostic Device Cassettes.
Control
no documented medical history of HIV, HBV or HCV and are considered normal.
Diagnostic test: TriQuik IVD
TriQuik Invitro Diagnostic Device Cassettes. TriQuik Invitro Diagnostic Device Cassettes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Standard performance criteria
Time Frame: <1 day
Diagnostic Sensitivity, Diagnostic Specificity, Positive Predictive Value, Negative Predictive Value
<1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genlantis Diagnostics

Collaborators

Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2023

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

November 1, 2023

Study Registration Dates

First Submitted

March 15, 2022

First Submitted That Met QC Criteria

March 23, 2022

First Posted (Actual)

March 24, 2022

Study Record Updates

Last Update Posted (Estimate)

January 13, 2023

Last Update Submitted That Met QC Criteria

January 11, 2023

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GENL-TQ 002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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.

IPD Sharing Time Frame

Two months following completion of analysis

IPD Sharing Supporting Information Type

  • Study Protocol
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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