Evaluation of Dried Blood Spot for HCV RNA Testing

Foundation for Innovative New Diagnostics (FIND)

Status: Completed

Conditions: Hepatitis C, Chronic

Treatments: Diagnostic Test: Aptima® HCV Quant Dx Assay from DBS; Diagnostic Test: HCV for use on the cobas® 6800/8800 Systems from PSC and DBS; Diagnostic Test: HCV for use on the cobas® 4800Systems from PSC and DBS; Diagnostic Test: Abbott RealTime HCV assay from DBS

Study type: Interventional

Funder types: Other

Identifiers

NCT03896087

8160-2/1

Details and patient eligibility

About

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).

Full 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.

Enrollment: 942 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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942 participants in 2 patient groups

clinical performance of the HCV DBS assay

Experimental group

Description:

The study will be conducted in different geographical regions and populations and is designed to meet requirements of the for assays (medical devices) used for the qualitative and quantitative detection of Hepatitis C RNA.

Treatment:

Diagnostic Test: HCV for use on the cobas® 4800Systems from PSC and DBS

Diagnostic Test: Aptima® HCV Quant Dx Assay from DBS

Diagnostic Test: HCV for use on the cobas® 6800/8800 Systems from PSC and DBS

Diagnostic Test: Abbott RealTime HCV assay from DBS

comparison PQ marked reference assay arm

Active Comparator group

Description:

Plasma specimens from the participants will be tested on Abbott RealTime HCV assay that is approved for HCV diagnostics use by countries' authorities.

Treatment:

Diagnostic Test: HCV for use on the cobas® 4800Systems from PSC and DBS

Diagnostic Test: Aptima® HCV Quant Dx Assay from DBS

Diagnostic Test: HCV for use on the cobas® 6800/8800 Systems from PSC and DBS

Diagnostic Test: Abbott RealTime HCV assay from DBS