Evaluation of Dried Blood Spot for HCV RNA Testing

Hepatitis C, Chronic Clinical Trial

Official title:

Multicentre Clinical Trial to Assess the Performance of Centralized Assays for Hepatitis C Virus RNA Detection From Dried Blood Spot (DBS) Samples

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03896087
• Other study ID #: 8160-2/1
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: December 2020
• Source: Foundation for Innovative New Diagnostics, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

FIND is preparing a study to evaluate the performance, as measured by sensitivity and specificity, of four centralized assays for the detection of HCV RNA using capillary blood collected on dried blood spots (DBS) and plasma separation card (PSC).

Description:

Available data on the performance of HCV RNA assays from DBS samples are insufficient to introduce their use in clinical practice. Only a few studies have been performed on DBS stored at ambient temperature, while the majority had DBS samples refrigerated or frozen right after collection, which does not mimic real-life settings. Additionally, due to the lack of standardized procedures, DBS collection and elution protocols varied across different studies. A large multicentre diagnostic accuracy study using standardized DBS collection and elution protocols validated by test manufacturers is needed to inform national hepatitis programmes and international guideline development groups. Test manufacturers need clinical evaluation data to update their regulatory claims and include DBS as an alternative sample type.

FIND is preparing a trial to evaluate the performance, as measured by sensitivity and specificity, of four laboratory-based assays for detection of HCV RNA assays using capillary blood collected on DBS/PSC. This will be provisional on the manufacturers agreeing to participate, as well as committing to applying to stringent regulatory approval for DBS/PSC.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 942
• Est. completion date: December 1, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Three different population groups will be considered:

1. Individuals at risk of having HCV infection based on positive HCV serology test results

Inclusion criteria:

• Aged 18 years or older

• Able to understand the scope of the trial

• Provided written informed consent

• Documented positive result of HCV serology test

2. Individuals at risk of having HCV infection based on past and/or current exposure to risk factors

Inclusion criteria:

• Aged 18 years or older

• Able to understand the scope of the trial

• Provided written informed consent

• Past and/or current exposure to one of the high risk factors as defined by WHO and CDC guidelines (Appendix I)

3. Individuals diagnosed with chronic HCV infection who initiated or completed the anti-HCV treatment with direct acting antivirals (DAA) presenting at the clinical site for treatment monitoring or test of cure (i.e. sustained virological response)

Inclusion criteria:

• Aged 18 years or older

• Able to understand the scope of the trial

• Provided written informed consent

• Initiated on DAA treatment (regardless of type of DAA regimen) within 12 months prior to the enrolment to the trial

Exclusion criteria (for all trial populations):

• Previously enrolled in the trial

• Unwilling to provide required volume of fingerstick blood

• Unwilling to provide required volume of venous whole blood

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C
• Hepatitis C, Chronic

Intervention

Diagnostic Test:
• Abbott RealTime HCV assay from DBS
The trial intervention will consist of testing DBS, PSC and plasma samples obtained from trial participants using the centralised molecular assays for detection of HCV RNA. Results of testing DBS samples on the HCV assay will not be used to make any clinical decisions, and should not be communicated to study participants.
• HCV for use on the cobas® 6800/8800 Systems from PSC and DBS
The trial intervention will consist of testing DBS, PSC and plasma samples obtained from trial participants using the centralised molecular assays cobas® 6800/8800 Systems for detection of HCV RNA. Results of testing DBS samples on the HCV assay will not be used to make any clinical decisions, and should not be communicated to study participants.
• Aptima® HCV Quant Dx Assay from DBS
The trial intervention will consist of testing DBS, PSC and plasma samples obtained from trial participants using the centralised molecular assays Aptima® HCV Quant Dx Assay from DBS for detection of HCV RNA. Results of testing DBS samples on the HCV assay will not be used to make any clinical decisions, and should not be communicated to study participants.
• HCV for use on the cobas® 4800Systems from PSC and DBS
The trial intervention will consist of testing DBS, PSC and plasma samples obtained from trial participants using the centralised molecular assays cobas® 4800 for detection of HCV RNA. Results of testing DBS samples on the HCV assay will not be used to make any clinical decisions, and should not be communicated to study participants.

Locations

Country	Name	City	State
Australia	St Vincent's Institute of Medical Research National Serology Reference Laboratory	Victoria Park	Fitzroy
Cameroon	Centre Pasteur du Cameroun	Yaoundé	Yaounde
Georgia	National Centre for Disease Control	Tbilisi
Greece	Hellenic Scientific Society for the Study of AIDS and Sexually Transmitted Diseases	Athens
Rwanda	Rwanda Military Hospital	Kigali	Kanombe

Sponsors (2)

Lead Sponsor	Collaborator
Foundation for Innovative New Diagnostics, Switzerland	UNITAID

Countries where clinical trial is conducted

Australia,  Cameroon,  Georgia,  Greece,  Rwanda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Point estimates (with 95% confidence intervals) of sensitivity and specificity for each assay for HCV RNA detection from DBS and/or PSC specimens measured against Abbott RealTime HCV VL assay performed at the clinical site	Point estimates (with 95% confidence intervals) of sensitivity and specificity for each assay for HCV RNA detection from DBS and/or PSC specimens measured against Abbott RealTime HCV VL assay performed at the clinical site	day 1 - day 30
Primary	Evaluation of the correlation of HCV viral load level determined by each assay performed from DBS and/or PSC specimens with the HCV viral load level in plasma determined by Abbott RealTime HCV VL assay performed at the clinical site	Evaluation of the correlation of HCV viral load level determined by each assay performed	day 1 - day 30
Secondary	Point estimates (with 95% confidence intervals) of sensitivity and specificity for each assay for HCV RNA detection from DBS and/or PSC specimens measured against the performance of the same assay in plasma	Point estimates (with 95% confidence intervals) of sensitivity and specificity for each assay for HCV RNA detection from DBS and/or PSC specimens measured against the performance of the same assay in plasma	day 1 - day 30
Secondary	Evaluation of the correlation of HCV viral load level determined by each assay performed from DBS and/or PSC specimens with the HCV RNA level in plasma determined by the same assay	Evaluation of the correlation of HCV viral load level determined by each assay performed from DBS and/or PSC specimens with the HCV RNA level in plasma determined by the same assay	day 1 - day 30
Secondary	WHO technician's appraisal sheet completed by all operators performing investigational test	WHO technician's appraisal sheet completed by all operators performing investigational test	through study completion, an average of 1 year
Secondary	point estimates (with 95% confidence intervals) of sensitivity and specificity for each assay for HCV RNA detection in plasma measured against the performance of Roche cobas® 6800 HCV VL assay	For Central Laboratory only	day 7 - day 30
Secondary	evaluation of the correlation of HCV RNA levels in plasma determined by each assay with HCV RNA levels in plasma determined by Roche cobas® 6800 HCV VL assay	For Central Laboratory only	day 7 - day 30