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GenMark Diagnostics esensor® hcvg direct test and xt-8 system
Esensor® Hcvg Direct Test And Xt 8 System, supplied by GenMark Diagnostics, used in various techniques. Bioz Stars score: 90/100, based on 1 PubMed citations. ZERO BIAS - scores, article reviews, protocol conditions and more
https://www.bioz.com/product/esensor%C2%AE+hcvg+direct+test+and+xt-8+system/esensor+xt+8/pmc10306429__txd___9___e1504___s001-9-326-328
Average 90 stars, based on 1 article reviews
esensor® hcvg direct test and xt-8 system - by Bioz Stars, 2026-09
90/100 stars

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Transplantation Assay:

Article Title: The SHELTER Trial of Transplanting Hepatitis C Virus–Infected Lungs Into Uninfected Recipients
Article Snippet: Methods S1: Summary of IRB-approved changes to the protocol for the SHELTER trial Date of IRB approval Change Rationale 11/2018 • Lowering of minimum eligible age from 30 to 18 • Removal of exclusion criteria for pulmonary pressures over 30 • Young adult patients may benefit from more rapid access to lung transplantation and can be expected to provide informed consent • Redundancy of methods to identify liver disease including screening past medical history, checking LFTs, and FibroScan 05/2019 • Removal of restriction to donors with HCV genotype 1 or 4 • Addition of HCV genotype testing donor and/or recipient to choose correct antiviral therapy • Addition of Epclusa antiviral therapy for new HCV genotypes • In the event that donor is infected with HCV genotype for which study drug (elbasvir and grazoprevir) is not an approved treatment, then institution will apply to insurance for HCV therapy; institution will cover any HCV therapy costs to patients for first and second round HCV treatments • Removal of exclusion criteria for lung allocation score (LAS) • Removal of exclusion criteria of esophageal dysmotility and related sclerosis • Access to more HCV+ organs and removing the barrier of genotyping donor pre-transplant • Ensure patient safety when using organs of unknown genotype • Ensure patient safety when using organs of unknown genotype • Remove any potential burden from patient during critical time • Sicker patients may benefit from more rapid access to lung transplantation and LAS should not reduce probability of HCV cure • Esophageal dysmotility will not hinder our ability to deliver antiviral therapy through feeding tube, as needed 01/2020 • Increasing of maximum eligible age from 65 to 67 • Older patients may benefit from more rapid access to lung transplantation SDC Methods 2: Hepatitis C virus genotyping and quantification Hepatitis C virus genotyping As described previously, we developed a protocol for genotype testing during the organ allocation process. (36) We used the eSensor® HCVg Direct Test and XT-8 System (GenMark Diagnostics, Carlsbad, CA) to ascertain HCV genotypes for donors and subsequently for organ recipients.

Infection:

Article Title: The SHELTER Trial of Transplanting Hepatitis C Virus–Infected Lungs Into Uninfected Recipients
Article Snippet: Methods S1: Summary of IRB-approved changes to the protocol for the SHELTER trial Date of IRB approval Change Rationale 11/2018 • Lowering of minimum eligible age from 30 to 18 • Removal of exclusion criteria for pulmonary pressures over 30 • Young adult patients may benefit from more rapid access to lung transplantation and can be expected to provide informed consent • Redundancy of methods to identify liver disease including screening past medical history, checking LFTs, and FibroScan 05/2019 • Removal of restriction to donors with HCV genotype 1 or 4 • Addition of HCV genotype testing donor and/or recipient to choose correct antiviral therapy • Addition of Epclusa antiviral therapy for new HCV genotypes • In the event that donor is infected with HCV genotype for which study drug (elbasvir and grazoprevir) is not an approved treatment, then institution will apply to insurance for HCV therapy; institution will cover any HCV therapy costs to patients for first and second round HCV treatments • Removal of exclusion criteria for lung allocation score (LAS) • Removal of exclusion criteria of esophageal dysmotility and related sclerosis • Access to more HCV+ organs and removing the barrier of genotyping donor pre-transplant • Ensure patient safety when using organs of unknown genotype • Ensure patient safety when using organs of unknown genotype • Remove any potential burden from patient during critical time • Sicker patients may benefit from more rapid access to lung transplantation and LAS should not reduce probability of HCV cure • Esophageal dysmotility will not hinder our ability to deliver antiviral therapy through feeding tube, as needed 01/2020 • Increasing of maximum eligible age from 65 to 67 • Older patients may benefit from more rapid access to lung transplantation SDC Methods 2: Hepatitis C virus genotyping and quantification Hepatitis C virus genotyping As described previously, we developed a protocol for genotype testing during the organ allocation process. (36) We used the eSensor® HCVg Direct Test and XT-8 System (GenMark Diagnostics, Carlsbad, CA) to ascertain HCV genotypes for donors and subsequently for organ recipients.

Virus:

Article Title: The SHELTER Trial of Transplanting Hepatitis C Virus–Infected Lungs Into Uninfected Recipients
Article Snippet: Methods S1: Summary of IRB-approved changes to the protocol for the SHELTER trial Date of IRB approval Change Rationale 11/2018 • Lowering of minimum eligible age from 30 to 18 • Removal of exclusion criteria for pulmonary pressures over 30 • Young adult patients may benefit from more rapid access to lung transplantation and can be expected to provide informed consent • Redundancy of methods to identify liver disease including screening past medical history, checking LFTs, and FibroScan 05/2019 • Removal of restriction to donors with HCV genotype 1 or 4 • Addition of HCV genotype testing donor and/or recipient to choose correct antiviral therapy • Addition of Epclusa antiviral therapy for new HCV genotypes • In the event that donor is infected with HCV genotype for which study drug (elbasvir and grazoprevir) is not an approved treatment, then institution will apply to insurance for HCV therapy; institution will cover any HCV therapy costs to patients for first and second round HCV treatments • Removal of exclusion criteria for lung allocation score (LAS) • Removal of exclusion criteria of esophageal dysmotility and related sclerosis • Access to more HCV+ organs and removing the barrier of genotyping donor pre-transplant • Ensure patient safety when using organs of unknown genotype • Ensure patient safety when using organs of unknown genotype • Remove any potential burden from patient during critical time • Sicker patients may benefit from more rapid access to lung transplantation and LAS should not reduce probability of HCV cure • Esophageal dysmotility will not hinder our ability to deliver antiviral therapy through feeding tube, as needed 01/2020 • Increasing of maximum eligible age from 65 to 67 • Older patients may benefit from more rapid access to lung transplantation SDC Methods 2: Hepatitis C virus genotyping and quantification Hepatitis C virus genotyping As described previously, we developed a protocol for genotype testing during the organ allocation process. (36) We used the eSensor® HCVg Direct Test and XT-8 System (GenMark Diagnostics, Carlsbad, CA) to ascertain HCV genotypes for donors and subsequently for organ recipients.



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