HCV InfectionNCT07904403
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
A study testing INSTI HCV Antibody Test in people with HCV Infection, run by bioLytical Laboratories.
Trial summary
A multicenter prospective study to evaluate the clinical performance, usability, and contrived result interpretation of the INSTI® HCV Antibody Test (INSTI HCV) with fingerstick (FS) whole blood specimens from participants with signs or symptoms of hepatitis or participants at risk for hepatitis C infection, by… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HCV Infection
- What is being tested?
- INSTI HCV Antibody Test
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,660 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Operator/study staff must be able to obtain data to complete the participant's Enrollment Questionnaire
- Participant can provide a history of HCV treatment if applicable
- Participant is able and willing to give informed consent
- Participant is willing and able to provide the required fingerstick and venous whole blood samples
- Participant must meet at least one of the following categories:
- Having signs or symptoms of hepatitis, or
- Are at risk of HCV infection
Who cannot join
- Participant unwilling or unable to provide the required volume of fingerstick and venous whole blood
- Participant unwilling or unable to provide HCV treatment history, if applicable
- Participant is already enrolled and participating in another clinical study that would interfere with the study activities and/or data integrity
- Known bleeding disorder or any other medical condition that, in the opinion of the Investigator or Operator, contraindicates fingerstick or venipuncture procedures
- Any other conditions which, in the opinion of the Investigator or Operator, would make the participant unsuitable or unsafe for enrollment or could interfere with the completion of study assessments
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection by Trained Operators in the United States
A multicenter prospective study to evaluate the clinical performance, usability, and contrived result interpretation of the INSTI® HCV Antibody Test (INSTI HCV) with fingerstick (FS) whole blood specimens from participants with signs or symptoms of hepatitis or participants at risk for hepatitis C infection, by trained operators at point of care (POC) settings. POC settings are locations where medical diagnostic testing is performed at or near the site of patient care.
- Conditions
- HCV Infection
- Being tested
- INSTI HCV Antibody Test
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INSTI HCV Antibody TestDiagnostic test
The INSTI® HCV Antibody test is a manual, rapid, flow-through immunoassay for the detection of HCV-specific antibodies. It is intended for use as an aid in the diagnosis of HCV infection in adults over 18 years of age.
| Study group | Role | What they receive |
|---|---|---|
| At Risk for HCV infection | Other | Participants at risk of HCV infection must have at least one of the following:
* Participants with past or present IV Drug Use
* Participants on long-term hemodialysis
* Participants with HIV positive status
* Having received a blood transfusion or organ transplant prior to 1992
* Healthcare workers with known exposure to needle sticks of HCV-positive blood
* Participants with Chronic Hepatitis B Virus (HBV), Liver Cirrhosis, and/or hepatocellular carcinoma
* Recipients of blood or organs from a donor who tested HCV positive
* Being born to an HCV positive mother
* History of incarceration
* Participants who have unprotected vaginal, anal, or oral intercourse or multiple sexual partners
* Men who have sex with men (MSM) and who are sexually active with an infected person
* Participants sharing personal care items, such as toothbrushes, scissors, and razors
* Participants receiving Receives: Diagnostic Test: INSTI HCV Antibody Test |
| Signs or Symptoms of HCV Infection | Other | Participants with signs or symptoms correlated with hepatitis, such as:
• Jaundice (yellow discoloration of the skin and eyes)
Or, a combination of two or more generalized symptoms, such as:
* Ascites (accumulation of fluid and swelling of the abdominal cavity)
* Star-shaped vein pattern developing on the swollen belly
* Dark-colored urine
* Light-colored bowel movement
* Easy bruising and bleeding
* Abdominal and joint pain
* Nausea/vomiting
* Loss of appetite
* Diarrhea
* Fatigue
* Itching Receives: Diagnostic Test: INSTI HCV Antibody Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance Evaluation
The positive and negative percent agreement of INSTI HCV performed with fingerstick whole blood compared to a comparator test in the hands of trained operators when performed at POC settings. HCV RNA PCR will be used to establish HCV infection status.
Measured: 6 months
Secondary outcomes (2)
Usability Evaluation
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).
Measured: 6 months
Contrived result interpretation evaluation
Evaluate contrived result interpretation accuracy in the hands of trained operators in POC settings. 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCV InfectionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two patient groups will be targeted for enrollment: (1) patients at risk for hepatitis C virus (HCV) infection and (2) patients exhibiting signs and symptoms of hepatitis. Enrollment will occur across multiple study sites and is intended to reflect the expected distribution of participants encountered in real-world point-of-care settings. The estimated total sample size is approximately 1,660 participants, with a target of 602 HCV-antibody positives. Total enrollment will target approximately 80% at-risk population and 20% with signs and symptoms of hepatitis population. Actual enrollment distribution and HCV positivity rates may vary based on disease prevalence at participating sites.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,660 participants (estimated)
Sponsor and investigators
- Lead sponsor
- bioLytical Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07904403
- Sponsor's protocol ID
- CLS-008A
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection by Trained Operators in the United States
- ClinicalTrials.gov ID
- NCT07904403
- Acronym / sponsor ID
- CLS-008A
- Conditions
- HCV Infection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,660 participants (estimated)
- Lead sponsor
- bioLytical LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 29 Oct 2026 (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.
A multicenter prospective study to evaluate the clinical performance, usability, and contrived result interpretation of the INSTI® HCV Antibody Test (INSTI HCV) with fingerstick (FS) whole blood specimens from participants with signs or symptoms of hepatitis or participants at risk for hepatitis C infection, by trained operators at point of care (POC) settings. POC settings are locations where medical diagnostic testing is performed at or near the site of patient care.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two patient groups will be targeted for enrollment: (1) patients at risk for hepatitis C virus (HCV) infection and (2) patients exhibiting signs and symptoms of hepatitis. Enrollment will occur across multiple study sites and is intended to reflect the expected distribution of participants encountered in real-world point-of-care settings. The estimated total sample size is approximately 1,660 participants, with a target of 602 HCV-antibody positives. Total enrollment will target approximately 80% at-risk population and 20% with signs and symptoms of hepatitis population. Actual enrollment distribution and HCV positivity rates may vary based on disease prevalence at participating sites.
| Arm | Type | Receives |
|---|---|---|
| At Risk for HCV infection | Other | Diagnostic Test: INSTI HCV Antibody TestParticipants at risk of HCV infection must have at least one of the following: * Participants with past or present IV Drug Use * Participants on long-term hemodialysis * Participants with HIV positive status * Having received a blood transfusion or organ transplant prior to 1992 * Healthcare workers with known exposure to needle sticks of HCV-positive blood * Participants with Chronic Hepatitis B Virus (HBV), Liver Cirrhosis, and/or hepatocellular carcinoma * Recipients of blood or organs from a donor who tested HCV positive * Being born to an HCV positive mother * History of incarceration * Participants who have unprotected vaginal, anal, or oral intercourse or multiple sexual partners * Men who have sex with men (MSM) and who are sexually active with an infected person * Participants sharing personal care items, such as toothbrushes, scissors, and razors * Participants receiving |
| Signs or Symptoms of HCV Infection | Other | Diagnostic Test: INSTI HCV Antibody TestParticipants with signs or symptoms correlated with hepatitis, such as: • Jaundice (yellow discoloration of the skin and eyes) Or, a combination of two or more generalized symptoms, such as: * Ascites (accumulation of fluid and swelling of the abdominal cavity) * Star-shaped vein pattern developing on the swollen belly * Dark-colored urine * Light-colored bowel movement * Easy bruising and bleeding * Abdominal and joint pain * Nausea/vomiting * Loss of appetite * Diarrhea * Fatigue * Itching |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years of age or older
- Operator/study staff must be able to obtain data to complete the participant's Enrollment Questionnaire
- Participant can provide a history of HCV treatment if applicable
- Participant is able and willing to give informed consent
- Participant is willing and able to provide the required fingerstick and venous whole blood samples
Key exclusion criteria (5 listed)
- Participant unwilling or unable to provide the required volume of fingerstick and venous whole blood
- Participant unwilling or unable to provide HCV treatment history, if applicable
- Participant is already enrolled and participating in another clinical study that would interfere with the study activities and/or data integrity
- Known bleeding disorder or any other medical condition that, in the opinion of the Investigator or Operator, contraindicates fingerstick or venipuncture procedures
- Any other conditions which, in the opinion of the Investigator or Operator, would make the participant unsuitable or unsafe for enrollment or could interfere with the completion of study assessments
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 |
|---|---|---|
| INSTI HCV Antibody TestThe INSTI® HCV Antibody test is a manual, rapid, flow-through immunoassay for the detection of HCV-specific antibodies. It is intended for use as an aid in the diagnosis of HCV infection in adults over 18 years of age. | Diagnostic test | At Risk for HCV infection, Signs or Symptoms of HCV Infection |
Primary outcome
Performance Evaluation
Time frame: 6 months
The positive and negative percent agreement of INSTI HCV performed with fingerstick whole blood compared to a comparator test in the hands of trained operators when performed at POC settings. HCV RNA PCR will be used to establish HCV infection status.
2 secondary outcomes
Usability Evaluation
Time frame: 6 months
Contrived result interpretation evaluation
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing INSTI HCV Antibody Test in people with HCV Infection, run by bioLytical Laboratories.
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 8 inclusion and 5 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: opening soon, as of the sponsor's last update on 29 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ana Subramanian (16042046784, asubramanian@biolytical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance Evaluation (time frame: 6 months). 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 29 Oct 2026.