An interventional study of INSTI HCV Antibody Test in HCV Infection, sponsored by bioLytical Laboratories. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by bioLytical Laboratories · Not applicable, Interventional, and Screening
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 untrained operators at CLIA Waived settings.
Multicenter, adaptive prospective clinical performance study evaluating the performance, usability, and contrived result interpretation of the INSTI HCV test using FS whole blood specimens at CLIA-waived settings by untrained operators. The study will enroll participants at risk for HCV infection and participants presenting with signs and symptoms of hepatitis. Approximately, 388 participants are expected to be enrolled, with approximately 80% from the at-risk population and 20% from the symptomatic population. Each site will have at least three (3) untrained operators available to perform study testing. Enrolled participants are expected to complete all study-related procedures during a single study visit. INSTI HCV results will be compared to OraQuick HCV. Abbott ARCHITECT Anti-HCV or equivalent and HCV RNA PCR will be used for discrepant testing, and to establish HCV infection status, respectively. The study will also include assessments of usability and contrived result interpretation by untrained operators.
1,743 studies on the registry are indexed under Hepatitis C; 97 are open to participants now.
This study's planned enrollment of 388 is above the median of 72 across 1,223 interventional studies indexed under Hepatitis C.
Browse Hepatitis C studies →bioLytical Laboratories is the lead sponsor of 16 studies on the registry; 6 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participant must meet at least one of the following categories:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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, cancer, 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 tattoos and body piercings with unsterile equipment
Diagnostic Test: INSTI HCV Antibody Test
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 * Fever
Diagnostic Test: INSTI HCV Antibody 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.
Performance Evaluation
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.
Time frame: 6 months
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).
Time frame: 6 months
Contrived result interpretation evaluation
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.
Time frame: 6 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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