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| Name | Class |
|---|---|
| EPISTEM | UNKNOWN |
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The principal objective is to assess the diagnostic accuracy of the PoC assay (Genedrive, Epistem) to detect HCV RNA against the reference standard of commercial real-time polymerase chain reaction (RT-PCR) assay (RealTime HCV, Abbott) using stored heparinized plasma from patients with chronic hepatitis C and non-infected controls.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HCV patients | 228 HCV patients |
| |
| control | 189 controls |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HCV RNA detection with Genedrive assay | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of HCV RNA detection with PoC assay (Genedrive, Epistem) vs reference standard of commercial real-time polymerase chain reaction (RT-PCR) assay (RealTime HCV, Abbott). | Assess the diagnostic accuracy of the PoC assay (Genedrive, Epistem) to detect HCV RNA against the reference standard of commercial real-time polymerase chain reaction (RT-PCR) assay (RealTime HCV, Abbott) using stored heparinized plasma from patients with chronic hepatitis C and non-infected controls (with Genedrive channel acceptance set at 2 out of 3). | pre-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic algorithm optimization | To optimize the diagnostic algorithm (i.e., 1, 2, or 3 out of 3 channels; repeat testing or not) that gives the optimal balance between sensitivity and specificity for detection of HCV RNA. | Pre-treatment |
| Factors associated with false-positive of false-negative results |
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Inclusion Criteria:
Criteria for case
Criteria for control
Exclusion Criteria:
-
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Pre-treatment cohort: 228 HCV patients samples
Control samples : 189 controls
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29615488 | Derived | Llibre A, Shimakawa Y, Mottez E, Ainsworth S, Buivan TP, Firth R, Harrison E, Rosenberg AR, Meritet JF, Fontanet A, Castan P, Madejon A, Laverick M, Glass A, Viana R, Pol S, McClure CP, Irving WL, Miele G, Albert ML, Duffy D. Development and clinical validation of the Genedrive point-of-care test for qualitative detection of hepatitis C virus. Gut. 2018 Nov;67(11):2017-2024. doi: 10.1136/gutjnl-2017-315783. Epub 2018 Apr 3. |
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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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| HCV RNA detection with RealTime HCV | Device |
|
|
To identify factors associated with false-positive or false-negative results of the PoC assay. |
| Pre-treatment |
| Assess the inter-examiner reproducibility of the PoC assay. | Pre-treatment |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |