NCT04317729|Completed
DBS Evaluation of Fujirebio INNOTEST® HCV Ab IV
Evaluation of Hepatitis C Virus Antibody Detection From Dried Blood Spots With the Fujirebio INNOTEST® HCV Ab IV
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Evaluation of Hepatitis C Virus Antibody Detection From Dried Blood Spots With the Fujirebio INNOTEST® HCV Ab IV
Sponsor study identifier
interventional
300
1 country
2
Study Start
January 30, 2020
Actual (reported)Primary Completion
April 30, 2020
Actual (reported)Study Completion
May 31, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 31, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 19, 2019
Actual (reported)January 30, 2020
Actual (reported)March 23, 2020
Actual (reported)April 30, 2020
Actual (reported)May 31, 2020
Actual (reported)Sensitivity and specificity of fingerstick whole blood DBS
Point estimates of sensitivity and specificity (with 95% confidence intervals) of the Fujirebio INNOTEST® HCV Ab IV assay in fWB collected on DBS, using EDTA plasma results obtained with the Fujirebio INNOTEST® HCV Ab IV assay as reference standard
4 months
Sensitivity and specificity of venous whole blood DBS
Point estimates of sensitivity and specificity (with 95% confidence intervals) of the Fujirebio INNOTEST® HCV Ab IV assay in vWB collected on DBS, using EDTA plasma results obtained with the Fujirebio INNOTEST® HCV Ab IV assay as reference standard
4 months
Degree of agreement of undiluted samples fWB and vWB
4 months
Degree of agreement of undiluted samples vWB and plasma
4 months
Degree of agreement of undiluted samples fWB and plasma
4 months
Degree of agreement of serial diluted samples fWB and vWB
4 months
Degree of agreement of serial diluted samples vWB and plasma
4 months
Collection of whole blood via fingerstick and venipuncture
Enzyme Immunoassay
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Astar Medical Centre
Lviv, 79000, Ukraine
Lviv Regional Public Health Centre
Lviv, 79026, Ukraine
Marta Vasylyev, MD
Medical Centre Astar
300 participants (actual enrollment reported by the registry).
First Submitted
December 19, 2019
First Posted
March 23, 2020
Study Start
January 30, 2020
Actual (reported)Implementing HCV Treatment for High-risk Populations in Austin, Texas
Contact the study team to confirm eligibility.
Primary Completion
April 30, 2020
Actual (reported)Study Completion
May 31, 2020
Actual (reported)Last Updated
July 7, 2020
Record last verified: 2020-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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