Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06649396
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-17
Brief Title:
Determination of New Detection and Quantification Thresholds for Serological and Molecular Tests for Hepatitis Delta Virus HDV Using Capillary Blood on Blotting Paper DBS
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Determination of New Detection and Quantification Thresholds for Serological and Molecular Tests for Hepatitis Delta Virus HDV Using Capillary Blood on Blotting Paper DBS
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SACADE
Brief Summary:
The Delta hepatitis virus HDV is a satellite virus that requires the presence of hepatitis B virus HBV for infection Approximately 5 of HBV-infected individuals or about 12 million people globally are also carriers of HDV This dual infection significantly heightens the risk of liver damage and the progression to hepatocellular carcinoma HCC
Historically the diagnosis of HDV has been limited leading to an underestimation of its true prevalence both nationally and internationally Recent advancements in treatments for viral hepatitis and the introduction of new HDV-specific therapies have spurred increased interest in the virus prompting public health authorities to call for improved diagnostic and monitoring tools
Detection of HDV typically involves serological tests ELISACLIA on serum or plasma followed by viral load quantification using RT-qPCR if positive However laboratory access is often insufficient in many regions particularly affecting marginalized populations and high-endemic areas especially in low-resource countries New sample collection methods that help connect patients to expert laboratories are needed as shipping frozen biological samples can be complex and costly
In response Dried Blood Spot DBS sampling-where serum plasma or whole blood is dried on filter paper-has been adopted by numerous public health organizations as a simple cost-effective and non-infectious means of storage and transport DBS is already validated for diagnosing and monitoring infections such as HIV HBV and HCV
Given the unique biology of each virus specific studies are required to determine how using DBS affects detection and quantification thresholds for each laboratory technique The National Reference Center for Delta Hepatitis CNR-Delta commissioned by Public Health France has developed a DBS protocol for HDV based on available literature and prior studies regarding storage conditions and reconstitution solutions Two retrospective studies utilizing CNR collections have established new positivity thresholds for serology and detectionquantification in molecular biology for serumplasma and EDTA whole blood on DBS
To finalize this protocol further study of thresholds for capillary blood tests on DBS is essential Capillary blood obtained via finger prick could simplify the use of this tool reducing the need for specialised equipment and expertise and potentially allowing for self-sampling by patients
The current study aims to validate the DBS tool for HDV serological and molecular testing using capillary blood The hypothesis posits that geographical barriers to accessing hospitals and laboratories for HDV patients complicate the shipping of frozen plasma samples increasing costs Developing a serological screening and viral load testing technique from a drop of capillary blood on DBS paper could effectively link patients to specialized centers Since DBS is considered non-infectious it also mitigates administrative complications
By comparing results from paired samples-plasma the gold standard from EDTA whole blood and capillary blood on DBS-we aim to redefine detection and quantification thresholds for both methods Validating these new thresholds will allow the use of this tool while maintaining quality standards for diagnosing and monitoring active HDV infections
Historically the diagnosis of HDV has been limited leading to an underestimation of its true prevalence both nationally and internationally Recent advancements in treatments for viral hepatitis and the introduction of new HDV-specific therapies have spurred increased interest in the virus prompting public health authorities to call for improved diagnostic and monitoring tools
Detection of HDV typically involves serological tests ELISACLIA on serum or plasma followed by viral load quantification using RT-qPCR if positive However laboratory access is often insufficient in many regions particularly affecting marginalized populations and high-endemic areas especially in low-resource countries New sample collection methods that help connect patients to expert laboratories are needed as shipping frozen biological samples can be complex and costly
In response Dried Blood Spot DBS sampling-where serum plasma or whole blood is dried on filter paper-has been adopted by numerous public health organizations as a simple cost-effective and non-infectious means of storage and transport DBS is already validated for diagnosing and monitoring infections such as HIV HBV and HCV
Given the unique biology of each virus specific studies are required to determine how using DBS affects detection and quantification thresholds for each laboratory technique The National Reference Center for Delta Hepatitis CNR-Delta commissioned by Public Health France has developed a DBS protocol for HDV based on available literature and prior studies regarding storage conditions and reconstitution solutions Two retrospective studies utilizing CNR collections have established new positivity thresholds for serology and detectionquantification in molecular biology for serumplasma and EDTA whole blood on DBS
To finalize this protocol further study of thresholds for capillary blood tests on DBS is essential Capillary blood obtained via finger prick could simplify the use of this tool reducing the need for specialised equipment and expertise and potentially allowing for self-sampling by patients
The current study aims to validate the DBS tool for HDV serological and molecular testing using capillary blood The hypothesis posits that geographical barriers to accessing hospitals and laboratories for HDV patients complicate the shipping of frozen plasma samples increasing costs Developing a serological screening and viral load testing technique from a drop of capillary blood on DBS paper could effectively link patients to specialized centers Since DBS is considered non-infectious it also mitigates administrative complications
By comparing results from paired samples-plasma the gold standard from EDTA whole blood and capillary blood on DBS-we aim to redefine detection and quantification thresholds for both methods Validating these new thresholds will allow the use of this tool while maintaining quality standards for diagnosing and monitoring active HDV infections
Detailed Description:
The Delta hepatitis virus HDV is a satellite virus that requires the presence of hepatitis B virus HBV for infection Approximately 5 of HBV-infected individuals or about 12 million people globally are also carriers of HDV This dual infection significantly heightens the risk of liver damage and the progression to hepatocellular carcinoma HCC
Historically the diagnosis of HDV has been limited leading to an underestimation of its true prevalence both nationally and internationally Recent advancements in treatments for viral hepatitis and the introduction of new HDV-specific therapies have spurred increased interest in the virus prompting public health authorities to call for improved diagnostic and monitoring tools
Detection of HDV typically involves serological tests ELISACLIA on serum or plasma followed by viral load quantification using RT-qPCR if positive However laboratory access is often insufficient in many regions particularly affecting marginalized populations and high-endemic areas especially in low-resource countries New sample collection methods that help connect patients to expert laboratories are needed as shipping frozen biological samples can be complex and costly
In response Dried Blood Spot DBS sampling-where serum plasma or whole blood is dried on filter paper-has been adopted by numerous public health organizations as a simple cost-effective and non-infectious means of storage and transport DBS is already validated for diagnosing and monitoring infections such as HIV HBV and HCV
Given the unique biology of each virus specific studies are required to determine how using DBS affects detection and quantification thresholds for each laboratory technique The National Reference Center for Delta Hepatitis CNR-Delta commissioned by Public Health France has developed a DBS protocol for HDV based on available literature and prior studies regarding storage conditions and reconstitution solutions Two retrospective studies utilizing CNR collections have established new positivity thresholds for serology and detectionquantification in molecular biology for serumplasma and EDTA whole blood on DBS
To finalize this protocol further study of thresholds for capillary blood tests on DBS is essential Capillary blood obtained via finger prick could simplify the use of this tool reducing the need for specialised equipment and expertise and potentially allowing for self-sampling by patients
The current study aims to validate the DBS tool for HDV serological and molecular testing using capillary blood The hypothesis posits that geographical barriers to accessing hospitals and laboratories for HDV patients complicate the shipping of frozen plasma samples increasing costs Developing a serological screening and viral load testing technique from a drop of capillary blood on DBS paper could effectively link patients to specialized centers Since DBS is considered non-infectious it also mitigates administrative complications
By comparing results from paired samples-plasma the gold standard from EDTA whole blood and capillary blood on DBS-we aim to redefine detection and quantification thresholds for both methods Validating these new thresholds will allow the use of this tool while maintaining quality standards for diagnosing and monitoring active HDV infections
The benefits of the capillary blood on DBS protocol include
For patients Improved access to care regardless of geographic location and easier sampling self-sampling
For clinicians Simplified management and extended screening to hard-to-reach populations
For laboratories Reduced transportation costs and infectious risk
For the CNR The opportunity to study global prevalence with a simplified protocol
In summary the gold standard for diagnosing and monitoring HDV infection involves serology on serum or plasma testing for total anti-HDV antibodies followed by viral load quantification To assess whether tests from dried capillary blood can replace plasmaserum tests a comparative study is necessary where plasma samples and a drop of capillary blood are collected simultaneously from the same patient and tested in parallel This comparison will evaluate the sensitivity and specificity of the DBS tool using capillary blood and establish new detection and quantification thresholds for viral load on DBS
Historically the diagnosis of HDV has been limited leading to an underestimation of its true prevalence both nationally and internationally Recent advancements in treatments for viral hepatitis and the introduction of new HDV-specific therapies have spurred increased interest in the virus prompting public health authorities to call for improved diagnostic and monitoring tools
Detection of HDV typically involves serological tests ELISACLIA on serum or plasma followed by viral load quantification using RT-qPCR if positive However laboratory access is often insufficient in many regions particularly affecting marginalized populations and high-endemic areas especially in low-resource countries New sample collection methods that help connect patients to expert laboratories are needed as shipping frozen biological samples can be complex and costly
In response Dried Blood Spot DBS sampling-where serum plasma or whole blood is dried on filter paper-has been adopted by numerous public health organizations as a simple cost-effective and non-infectious means of storage and transport DBS is already validated for diagnosing and monitoring infections such as HIV HBV and HCV
Given the unique biology of each virus specific studies are required to determine how using DBS affects detection and quantification thresholds for each laboratory technique The National Reference Center for Delta Hepatitis CNR-Delta commissioned by Public Health France has developed a DBS protocol for HDV based on available literature and prior studies regarding storage conditions and reconstitution solutions Two retrospective studies utilizing CNR collections have established new positivity thresholds for serology and detectionquantification in molecular biology for serumplasma and EDTA whole blood on DBS
To finalize this protocol further study of thresholds for capillary blood tests on DBS is essential Capillary blood obtained via finger prick could simplify the use of this tool reducing the need for specialised equipment and expertise and potentially allowing for self-sampling by patients
The current study aims to validate the DBS tool for HDV serological and molecular testing using capillary blood The hypothesis posits that geographical barriers to accessing hospitals and laboratories for HDV patients complicate the shipping of frozen plasma samples increasing costs Developing a serological screening and viral load testing technique from a drop of capillary blood on DBS paper could effectively link patients to specialized centers Since DBS is considered non-infectious it also mitigates administrative complications
By comparing results from paired samples-plasma the gold standard from EDTA whole blood and capillary blood on DBS-we aim to redefine detection and quantification thresholds for both methods Validating these new thresholds will allow the use of this tool while maintaining quality standards for diagnosing and monitoring active HDV infections
The benefits of the capillary blood on DBS protocol include
For patients Improved access to care regardless of geographic location and easier sampling self-sampling
For clinicians Simplified management and extended screening to hard-to-reach populations
For laboratories Reduced transportation costs and infectious risk
For the CNR The opportunity to study global prevalence with a simplified protocol
In summary the gold standard for diagnosing and monitoring HDV infection involves serology on serum or plasma testing for total anti-HDV antibodies followed by viral load quantification To assess whether tests from dried capillary blood can replace plasmaserum tests a comparative study is necessary where plasma samples and a drop of capillary blood are collected simultaneously from the same patient and tested in parallel This comparison will evaluate the sensitivity and specificity of the DBS tool using capillary blood and establish new detection and quantification thresholds for viral load on DBS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None