DBS Evaluation of Fujirebio INNOTEST® HCV Ab IV

2020-03-27 03:25:40 | BioPortfolio


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.


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.

Study Design


Hepatitis C Virus Infection


Fujirebio INNOTEST® HCV Ab IV assay


Astar Medical Centre




Foundation for Innovative New Diagnostics, Switzerland

Results (where available)

View Results


Published on BioPortfolio: 2020-03-27T03:25:40-0400

Clinical Trials [3473 Associated Clinical Trials listed on BioPortfolio]

Hepatitis B Virus Infection After Liver Transplantation in Children

China is a highly prevalent area of hepatitis B virus(HBV) infection, with at least 75 million hepatitis B virus carriers, and 80% of primary hepatocellular carcinoma (HCC) is associat...

Hepatitis D Virus Infection Among Hepatitis B Virus Surface Antigen Positive Individuals

Globally, about 248 million people are chronic HBV surface antigen carriers, and about 5% of them also had hepatitis delta virus (HDV) infection as well. The prevalence of HBsAg in Egypt i...

Associations, Outcomes and Genomics of GB Virus C, Hepatitis C Virus and Human Immunodeficiency Virus Infection

The purpose of this study is to examine the effect of GB virus C (GBV-C) on the natural history of chronic hepatitis C virus (HCV) infection in subjects co-infected with HIV and HCV. The o...

Hepatitis B Virus Infection in Immunized Children With HBsAg-positive Parents

Hepatitis B virus (HBV) infection is a major public health problem facing the world, with more than 2 billion people infected with HBV. There are more than 400 million chronic carriers, an...

Assessment of Biomarkers for Recurrent HCV Infection Post-liver Transplantation

The purpose of this study is to learn about how different immunosuppressant therapies impact on recurrent hepatitis C virus infection in the new liver after liver transplant. We will be ev...

PubMed Articles [12313 Associated PubMed Articles listed on BioPortfolio]

Hepatitis B virus reactivation sustained by a hepatitis B virus surface antigen immune-escape mutant isolate in a patient who was hepatitis B core antibody positive during treatment with sofosbuvir and velpatasvir for hepatitis C virus infection: a case report.

Although several cases of hepatitis B virus reactivation have been described in patients with a history of hepatitis B virus infection while undergoing treatment for hepatitis C virus infection with d...

Hepatitis A and Hepatitis B Vaccination Coverage Among Persons Who Inject Drugs and Have Evidence of Hepatitis C Infection.

Despite recommendations for vaccination against hepatitis A virus (HAV) and hepatitis B virus (HBV) for all adults at increased risk of infection, several US states have reported increases in HAV and ...

Hepatitis A virus infection in an HIV-positive man with previously confirmed immunity against hepatitis A virus.

A Japanese man with human immunodeficiency virus (HIV) was detected 9 years ago to have a positive titer for hepatitis A virus (HAV) immunoglobulin (Ig) G, without a history of HAV infection or vacci...

Hepatitis C Virus Infection in Pregnancy: An Update.

Parenteral transmission is the major route of hepatitis C virus transmission in adults; however, vertical transmission is most common in children. There are several factors that have been shown to be ...

Hepatitis B virus reactivation in kidney transplant patients with resolved hepatitis B virus infection: risk factors and the safety and efficacy of pre-emptive therapy.

Hepatitis B virus (HBV) reactivation is associated with complications and adverse outcomes in patients with clinically resolved HBV infection who are seronegative for hepatitis B surface antigen (HBs ...

Medical and Biotech [MESH] Definitions

A family of hepatotropic DNA viruses which contains double-stranded DNA genomes and causes hepatitis in humans and animals. There are two genera: AVIHEPADNAVIRUS and ORTHOHEPADNAVIRUS. Hepadnaviruses include HEPATITIS B VIRUS, duck hepatitis B virus (HEPATITIS B VIRUS, DUCK), heron hepatitis B virus, ground squirrel hepatitis virus, and woodchuck hepatitis B virus (HEPATITIS B VIRUS, WOODCHUCK).

INFLAMMATION of the LIVER in humans caused by HEPATITIS DELTA VIRUS, a defective RNA virus that can only infect HEPATITIS B patients. For its viral coating, hepatitis delta virus requires the HEPATITIS B SURFACE ANTIGENS produced by these patients. Hepatitis D can occur either concomitantly with (coinfection) or subsequent to (superinfection) hepatitis B infection. Similar to hepatitis B, it is primarily transmitted by parenteral exposure, such as transfusion of contaminated blood or blood products, but can also be transmitted via sexual or intimate personal contact.

INFLAMMATION of the LIVER in humans caused by HEPATITIS C VIRUS, a single-stranded RNA virus. Its incubation period is 30-90 days. Hepatitis C is transmitted primarily by contaminated blood parenterally, and is often associated with transfusion and intravenous drug abuse. However, in a significant number of cases, the source of hepatitis C infection is unknown.

A species in the genus HEPATOVIRUS containing one serotype and two strains: HUMAN HEPATITIS A VIRUS and Simian hepatitis A virus causing hepatitis in humans (HEPATITIS A) and primates, respectively.

INFLAMMATION of the LIVER in humans due to infection by VIRUSES. There are several significant types of human viral hepatitis with infection caused by enteric-transmission (HEPATITIS A; HEPATITIS E) or blood transfusion (HEPATITIS B; HEPATITIS C; and HEPATITIS D).

More From BioPortfolio on "DBS Evaluation of Fujirebio INNOTEST® HCV Ab IV"

Quick Search

Relevant Topics

An antibody is a protein produced by the body's immune system when it detects harmful substances, called antigens. Examples of antigens include microorganisms (such as bacteria, fungi, parasites, and viruses) and chemicals. Antibodies may be produc...

Blood is a specialized bodily fluid that delivers necessary substances to the body's cells (in animals) – such as nutrients and oxygen – and transports waste products away from those same cells.  In vertebrates, it is composed of blo...

Astroesophageal Reflux Disease (GERD) Barrett's Esophagus Celiac Disease Cholesterol Crohn's Disease Gastroenterology Hepatitis Hepatology Irritable Bowel Syndrome (IBS) Pancreatitis Peptic Ulcer Disease...

Searches Linking to this Trial