To Demonstrate Clinical Performance of the TriQuik Invitro Diagnostic DeviceNCT05293821
Multicenter Performance Study of TriQuik Invitro Diagnostic Device
An observational study of To Demonstrate Clinical Performance of the TriQuik Invitro Diagnostic Device, run by Genlantis Diagnostics.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- To Demonstrate Clinical Performance of the TriQuik Invitro Diagnostic Device
- What is being tested?
- TriQuik IVD
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Apr 2023to Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Study patients are seen, recruited and consented from local clinics and physician offices.
Who may be able to join
- 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).
Who cannot join
- 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.
- -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Being tested
- TriQuik IVD
- Keywords
- TriQuik IVD, HIV, hepatitis B, hepatitis C
- Medical subject headings
- Hepatitis B, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriQuik IVDDiagnostic test
TriQuik Invitro Diagnostic Device Cassettes. TriQuik Invitro Diagnostic Device Cassettes.
| Study group | Role | What they receive |
|---|---|---|
| Positive test subjects | documented medical history of HIV, HBV or HCV. A combination of 2 or 3 conditions is acceptable. Receives: Diagnostic Test: TriQuik IVD | |
| Control | no documented medical history of HIV, HBV or HCV and are considered normal. Receives: Diagnostic Test: TriQuik IVD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standard performance criteria
Diagnostic Sensitivity, Diagnostic Specificity, Positive Predictive Value, Negative Predictive Value
Measured: <1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study startApr 2023 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Demonstrate Clinical Performance of the TriQuik Invitro Diagnostic DeviceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genlantis Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Northwestern University
- Responsible party
- Principal investigator, Robert Zeiler, Genlantis Diagnostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05293821
- Sponsor's protocol ID
- GENL-TQ 002
- Status last verified
- Mar 2022
- First submitted
- 15 Mar 2022
- Last updated
- 13 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Clinical Performance Study to Compare the Results Obtained From the TriQuik Invitro Diagnostic Device With Historical Medical Records From the Same Subject
- ClinicalTrials.gov ID
- NCT05293821
- Acronym / sponsor ID
- GENL-TQ 002
- Keywords
- TriQuik IVD, HIV, hepatitis B, hepatitis C
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Genlantis DiagnosticsIndustry (pharma, biotech, devices)
- Collaborators
- Northwestern University
- Study start
- Apr 2023 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 24 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive test subjects | – | Diagnostic Test: TriQuik IVDdocumented medical history of HIV, HBV or HCV. A combination of 2 or 3 conditions is acceptable. |
| Control | – | Diagnostic Test: TriQuik IVDno documented medical history of HIV, HBV or HCV and are considered normal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Study patients are seen, recruited and consented from local clinics and physician offices.
Key inclusion criteria (6 listed)
- a documented medical history of HIV, HBV or HCV. A combination of 2 or 3 conditions is acceptable.
- 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).
Key exclusion criteria (3 listed)
- 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.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TriQuik IVDTriQuik Invitro Diagnostic Device Cassettes. TriQuik Invitro Diagnostic Device Cassettes. | Diagnostic test | Control, Positive test subjects |
Primary outcome
Standard performance criteria
Time frame: <1 day
Diagnostic Sensitivity, Diagnostic Specificity, Positive Predictive Value, Negative Predictive Value
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of To Demonstrate Clinical Performance of the TriQuik Invitro Diagnostic Device, run by Genlantis Diagnostics.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert H Zeiler, PhD (7074779081, rhzeiler@auhs.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standard performance criteria (time frame: <1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2023.