Clinical trial NCT03896087: Evaluation of Dried Blood Spot for HCV RNA Testing
Official title: Multicentre Clinical Trial to Assess the Performance of Centralized Assays for Hepatitis C Virus RNA Detection From Dried Blood Spot (DBS) Samples
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis C, Chronic
Keywords: dried blood spots
plasma separation card
HCV RNA test
Lead sponsor: Foundation for Innovative New Diagnostics, Switzerland
Sponsor class: OTHER
Collaborators: name: UNITAID
First posted: 2019-03-29
Enrollment: 942
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

Brief 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: day 1 - day 30
measure: 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
timeFrame: day 1 - day 30
Secondary outcomes:
measure: 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
timeFrame: day 1 - day 30
measure: 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
timeFrame: day 1 - day 30
measure: WHO technician's appraisal sheet completed by all operators performing investigational test
timeFrame: through study completion, an average of 1 year
measure: 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
timeFrame: day 7 - day 30
measure: 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
timeFrame: day 7 - day 30
Other outcomes:
Locations:
city: Victoria Park
country: Australia
facility: St Vincent's Institute of Medical Research National Serology Reference Laboratory
state: Fitzroy
city: Yaoundé
country: Cameroon
facility: Centre Pasteur du Cameroun
state: Yaounde
city: Tbilisi
country: Georgia
facility: National Centre for Disease Control
city: Athens
country: Greece
facility: Hellenic Scientific Society for the Study of AIDS and Sexually Transmitted Diseases
city: Kigali
country: Rwanda
facility: Rwanda Military Hospital
state: Kanombe
Study officials:
affiliation: Foundation for Innovative New Diagnostics
name: Elena Ivanova, Ph.D.
role: STUDY_DIRECTOR
References: