Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06368466
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-06
First Post:
2024-04-10
Brief Title:
A Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis HBsAg Test at the Point-Of-Care Sites
Sponsor:
bioLytical Laboratories
Organization:
bioLytical Laboratories
Study Overview
Official Title:
A Prospective Cross-Sectional Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis HBsAg Test at the Point-Of-Care Sites
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A prospective cross-sectional study in which surgically non-invasive sample-taking is done only for the purpose of the study Capillary fingerstick whole blood and EDTA venipuncture whole blood are collected by a healthcare professional The collected samples of capillary and EDTA whole blood are tested on iStatis and EDTA whole blood sample will be processed to obtain serum and plasma samples to be tested on the iStatis An aliquot of the collected serum sample will be shipped to the central laboratory for confirmatory testing The results from iStatis HBsAg Test results will not be used for patient management decisions
Detailed Description:
From each enrolled patient a total of 2 different blood samples capillary and venous whole blood will be collected processed and categorized under the following categories
- Sample 1 50μL of Capillary fingerstick see section 862 Sample 2 16ml of Venous whole blood further extraction of serum and plasma samples see section 862 Sample 1 consisting of capillary fingerstick and Sample 2 venous whole blood sample will be tested on iStatis HBsAg Test on site according to the Test Procedure described in the Instructions for Use IFU supplied with the reagents Sample 2 containing of 1 EDTA and SST venous whole blood samples will be separately processed to obtain plasma and serum samples respectively and will be tested onsite on the iStatis An aliquot of the serum sample stored and frozen at -20ᵒC at the testing site will be transferred to the central laboratory to establish further reference testing Upon arrival of the sample it will undergo an initial test using DiaSorin Liaison XL Murex HBsAg Quant Assay REF 310250 following the IFU of this reference assay If the first run of the assay yields a non-reactiveNegative result it will be reported as such However if the sample is ReactivePositive in the first run of the assay testing it will be retested on the same assay in duplicate following the manufacturers instructions A final ReactivePositive result means that at least one of the duplicate repeat tests was reactive if neither of the duplicate repeat tests yields a reactive results the final report in the DiaSorin Liaison XL Murex HBsAg Quant Assay requires three tests to confirm Samples with a reportable ReactivePositive result in the DiaSorin Liaison XL Murex HBsAg Quant Assay will undergo further testing using DiaSorin Murex HBsAg Confirmatory assay REF 9F80-01 A ReactivePositive result in this test will confirm the presence of the relevant marker
- Sample 1 50μL of Capillary fingerstick see section 862 Sample 2 16ml of Venous whole blood further extraction of serum and plasma samples see section 862 Sample 1 consisting of capillary fingerstick and Sample 2 venous whole blood sample will be tested on iStatis HBsAg Test on site according to the Test Procedure described in the Instructions for Use IFU supplied with the reagents Sample 2 containing of 1 EDTA and SST venous whole blood samples will be separately processed to obtain plasma and serum samples respectively and will be tested onsite on the iStatis An aliquot of the serum sample stored and frozen at -20ᵒC at the testing site will be transferred to the central laboratory to establish further reference testing Upon arrival of the sample it will undergo an initial test using DiaSorin Liaison XL Murex HBsAg Quant Assay REF 310250 following the IFU of this reference assay If the first run of the assay yields a non-reactiveNegative result it will be reported as such However if the sample is ReactivePositive in the first run of the assay testing it will be retested on the same assay in duplicate following the manufacturers instructions A final ReactivePositive result means that at least one of the duplicate repeat tests was reactive if neither of the duplicate repeat tests yields a reactive results the final report in the DiaSorin Liaison XL Murex HBsAg Quant Assay requires three tests to confirm Samples with a reportable ReactivePositive result in the DiaSorin Liaison XL Murex HBsAg Quant Assay will undergo further testing using DiaSorin Murex HBsAg Confirmatory assay REF 9F80-01 A ReactivePositive result in this test will confirm the presence of the relevant marker
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None