NCT06289868

Access Anti-HAV and Access Anti-HAV IgM Assays EU Clinical Trial Protocol (HAV-EU-11-23)

Evaluation of the Access Anti-HAV and Access Anti-HAV IgM Assays As an Aid in the Diagnosis of HAV Infection, and for Detection of Anti-HAV After Vaccination: EU Clinical Trial Protocol

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,409 (actual)
• Sponsor: Beckman Coulter, Inc. · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the clinical performance supporting that intended purpose of the Access anti-HAV as an aid in the laboratory diagnosis of HAV infection and for detection of anti-HAV after vaccination and of the Access anti-HAV IgM assay as an aid in the laboratory diagnosis of acute or recent HAV infection, on the DxI 9000 Access Immunoassay Analyzer. This study will be used to obtain CE mark for both Access anti-HAV and anti- HAV IgM assays.

Detailed description

The objective of this study is to determine the diagnostic accuracy of Access anti-HAV and Access anti-HAV IgM assays on the DxI 9000 Access Immunoassay Analyzer, measured as clinical sensitivity and specificity. The testing will be performed using banked, de-identified, prospective and retrospective US leftover clinical samples, and fully-anonymized retrospective known anti-HAV IgM positive patient samples procured from sample vendors.

Conditions

• HAV

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Access anti-HAV and Access anti-HAV IgM on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays	Samples will be tested by comparing Access anti-HAV assay results to final anti-HAV sample status, and Access anti-HAV IgM results to final anti-HAV IgM status, according to respective instructions for use (IFU) or study guide, as applicable, to determine to determine non-reactive (NR), reactive (R), Negative, Positive or Equivocal (EQ). For evaluation of the clinical performance of Access anti-HAV assay, all clinical samples will be tested with the reference assays DiaSorin - LIAISON® Anti-HAV and SIEMENS Healthineers Atellica® IM Hepatitis A Total (aHAVT). For evaluation of the clinical performance of Access anti-HAV IgM assay, all clinical samples, except pre- and post-vaccinated patient samples, will be tested with the reference assays Abbott - ARCHITECT® HAVAb-IgM, DiaSorin - LIAISON® Anti-HAV IgM, and SIEMENS Healthineers Atellica IM® Hepatitis A IgM (aHAVM).
DIAGNOSTIC_TEST	Access anti-HAV on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays	All samples will be tested pre- and post-vaccination by comparing Access anti-HAV assay results to final anti-HAV status, according to respective instructions for use (IFU) or study guide, as applicable, to determine non-reactive (NR), initial reactivity, and repeat reactivity. For evaluation of the clinical performance of Access anti-HAV assay, all clinical samples will be tested with the reference assays DiaSorin - LIAISON® Anti-HAV and SIEMENS Healthineers Atellica® IM Hepatitis A Total (aHAVT).

Timeline

• Start date: 2024-02-27
• Primary completion: 2024-08-13
• Completion: 2024-08-29
• First posted: 2024-03-04
• Last updated: 2024-12-04

Locations

2 sites across 1 country: France