Clinical trial NCT04317729: DBS Evaluation of Fujirebio INNOTEST® HCV Ab IV
Official title: Evaluation of Hepatitis C Virus Antibody Detection From Dried Blood Spots With the Fujirebio INNOTEST® HCV Ab IV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis C Virus Infection
Lead sponsor: Foundation for Innovative New Diagnostics, Switzerland
Sponsor class: OTHER
First posted: 2020-03-23
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this trial is to evaluate the performance of the Fujirebio INNOTEST® HCV Ab IV using simpler collection methods such as fingerstick and venous whole blood collection on dried blood spots (DBS). In order to assess performance in samples with high and low antibody titres, performance will be evaluated with undiluted samples of all trial participants and serial diluted samples for a subset of HCV antibody reactive samples. Serial dilution of reactive samples will provide further insights into the potential difference of sensitivity in samples collected on DBS versus plasma.

Results of this trial will also support the update of the regulatory claims to include DBS as an alternative sample type.

Detailed description: Access to Hepatitis C virus (HCV) screening in resource-limited settings should be enabled not only through the provision of point-of-care screening tests, but also through the possibility of collecting samples in decentralized settings One possible way of decentralizing sample collection is collecting dried blood spot (DBS) specimens, which can be easily transported to testing laboratories, not requiring any cold chain or complex sample transportation. DBS serology screening is complementary to established point-point-of care screening with rapid diagnostic tests, both methodologies being somewhat less cost-effective and less sensitive compared to lab-based methods but suitable for settings without sophisticated infrastructure.

To date, no HCV antibody serology test is formally evaluated for the use with DBS, however several studies on off-label use of DBS in serology screening assays, suggests that this sample type can serve as an alternative to plasma and serum. Fujirebio's enzyme immunoassay (EIA) INNOTEST® HCV Ab IV is CE marked and has received pre-qualification by the World Health Organization (WHO) for the use with venous plasma and serum, which require special equipment for sample collection, sample preparation and temperature controlled transportation.

Available data on the performance of HCV antibody detection from DBS samples are insufficient to introduce their use in clinical practice. Fujirebio is one of the few manufacturers who have an EIA test pre-qualified by the WHO for the use with plasma and serum to detect anti-HCV antibodies. A prospective diagnostic accuracy trial of the Fujirebio INNOTEST® HCV Ab IV assay in fWB and vWB collected on DBS, using EDTA plasma results obtained with the Fujirebio INNOTEST® HCV Ab IV assay as reference standard is needed to understand the relationship between results generated in plasma and WB samples collected on DBS. Furthermore, the data generated can be used by Fujirebio to update their regulatory claims and include DBS as an alternative sample type.

Eligibility criteria: Inclusion Criteria:

* Aged ≥18 years
* Provision of written informed consent
* Routine RDT reactive or non-reactive and recruitment target not yet met
* No history of HCV treatment

Exclusion Criteria:

* Unwilling to provide required volume of fingerstick blood and venous whole blood
* Participants already enrolled in the trial

Primary outcomes:
measure: Sensitivity and specificity of fingerstick whole blood DBS
timeFrame: 4 months
measure: Sensitivity and specificity of venous whole blood DBS
timeFrame: 4 months
Secondary outcomes:
measure: Degree of agreement of undiluted samples fWB and vWB
timeFrame: 4 months
measure: Degree of agreement of undiluted samples vWB and plasma
timeFrame: 4 months
measure: Degree of agreement of undiluted samples fWB and plasma
timeFrame: 4 months
measure: Degree of agreement of serial diluted samples fWB and vWB
timeFrame: 4 months
measure: Degree of agreement of serial diluted samples vWB and plasma
timeFrame: 4 months
measure: Degree of agreement of serial diluted samples fWB and plasma
timeFrame: 4 months
Other outcomes:
Locations:
city: Lviv
country: Ukraine
facility: Astar Medical Centre
city: Lviv
country: Ukraine
facility: Lviv Regional Public Health Centre
Study officials:
affiliation: Medical Centre Astar
name: Marta Vasylyev, MD
role: PRINCIPAL_INVESTIGATOR
References: