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| Name | Class |
|---|---|
| Aga Khan University | OTHER |
| Clinic 553 Karachi | UNKNOWN |
| Ezintsha Clinical Research Center | UNKNOWN |
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This is a prospective, multi-centre study designed to evaluate the usability of the Panbio™ HCV Self Test, when performed by untrained lay users in an observed study setting. The Panbio™ HCV Self Test detects antibodies to Hepatitis C Virus (HCV). The study validation will be conducted in accordance with the World Health Organisation's technical guidance on Hepatitis C rapid diagnostic tests for professional use and/or self-testing (TSS-16).
Hepatitis C is a liver disease caused by the hepatitis C virus. The virus can cause both acute and chronic disease, ranging in severity from a mild illness lasting a few weeks to a serious, lifelong illness. Globally, Hepatitis C virus infects around 71 million people per year, resulting in 700,000 deaths. The WHO estimates that only 21% of individuals chronically infected with HCV are diagnosed, and the WHO HCV targets include increasing the diagnoses to 90% by 2030. WHO guidelines, published in 2021, strongly recommend offering self-testing for HCV as an additional approach to HCV testing services.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Panbio™ HCV Self Test | Diagnostic Test | Rapid diagnostic test (self-test and professional) plus laboratory reference tests |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lay user / professional user test result concordance | To assess the concordance between the Panbio™ HCV Self Test, as performed by lay users based on self-collected finger-stick samples, and the Panbio™ HCV Self Test performed by a trained health care worker, who also will collect the finger-stick sample required for the test and perform the test. | 5 months |
| Lay user / laboratory test result concordance | To establish clinical performance (concordance with the reference test) for the Panbio™ HCV Self Test, as performed by lay users using finger-stick whole blood samples, when compared to reference testing using venous plasma samples. | 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Usability evaluation - lay user experience | To assess the usability of the Panbio™ HCV Self Test, as performed by lay users, based on a participant questionnaire evaluation by the lay user participant. The participant questionnaire includes questions to assess the lay users' experience when performing the test. Most questions have a Yes / No answer option, with free text possible. Some questions require a free text answer. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jocelyn Farge, MSc, MBA | Contact | +33666483563 | jocelyn.farge@abbott.com | |
| Camilla S Forssten, PhD | Contact | +447792902244 | camilla.forssten@abbott.com |
| Name | Affiliation | Role |
|---|---|---|
| Huma Qureshi, MD | Clinic 553 | Principal Investigator |
| Saeed Hamid, Pr | Aga Khan University | Principal Investigator |
| Mohammed Majam, BSc, MBA |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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Single group assessment
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The study staff member who interprets the lay user's result will be blinded to the lay user's reference test results and medical status. The study staff member who conducts the Panbio™ HCV Self Test for the lay user will also be blinded to the lay user's reference test results and medical status as well as the self-test results.
| 5 months |
| Usability evaluation - Self-test observer records | To assess the usability of the Panbio™ HCV Self Test, as performed by lay users based on a questionnaire evaluation by the study staff observer. In the observer questionnaire, particular attention will be paid to compliance regarding factors considered critical for the test, such as reading the IFU/ QRG and applying the correct test volume. The observer questionnaire is not reporting scores on a scale, but is recording observations regarding how the users complete each step. For each step, a question is asked whether the user conducted a certain procedure, and a Yes / No answer is requested, with Monitor Notes when applicable. | 5 months |
| Lay user / professional user results interpretation concordance | To assess the concordance between the self-test results (obtained by the self-tester) when interpreted by the lay user and by the observer. | 5 months |
| Ezintsha |
| Principal Investigator |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |