Trial · NCT07904416
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
NCT07904416, Not applicable, Not yet recruiting, bioLytical Laboratories
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use. Trials, record NCT07904416. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07904416
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
- NCT number
- NCT07904416
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 388 participants, estimated
- Lead sponsor
- bioLytical Laboratories
- Conditions
- HCV Infection
- Interventions
- INSTI HCV Antibody Test
- First posted
- 2026-10-29
- Last updated
- 2026-10-29
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Performance Evaluation | 6 months | To establish the positive and negative percent agreement of INSTI HCV performed with fingerstick whole blood compared to a comparator test in the hands of untrained operators at CLIA Waived settings. HCV RNA PCR will be used to establish HCV infection status. |
| Secondary | Usability Evaluation | 6 months | Obtain general usability feedback regarding INSTI HCV. To qualify for an overall good assessment of usability (ie., acceptable use-related risks, user satisfaction and effectiveness) a usability assessment questionnaire will be used, the overall average score shall be \>3. The usability assessment will use a Likert scale of 1-5 (1-strongly disagree to 5-strongly agree). |
| Secondary | Contrived result interpretation evaluation | 6 months | Evaluate contrived result interpretation accuracy in the hands of untrained operators. Operators will interpret contrived results and record their interpretation in a contrived result interpretation questionnaire. Answers will be evaluated to determine the percentage of correctly interpreted results. Each test type (negative, strong positive, weak positive, and invalid test) must receive a point estimate of \>90% correct answers. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07904416
GET https://conductscience.org/api/trials/v1/NCT07904416/registered