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Access Anti-HCV Assay European Union (EU) Clinical Trial Protocol (HCV-EU-10-18)

2021年7月12日 更新者：Beckman Coulter, Inc.

Evaluation of the Beckman Coulter Access Anti-HCV Assay as an Aid in the Diagnosis of HCV Infection: EU Clinical Trial Protocol

The objective of this study was the collection and testing of clinical samples to determine the clinical performance in terms of diagnostic accuracy measured by specificity and sensitivity of the Access anti-Hepatitis C Virus (anti-HCV) assay on the DxI 9000 Access Immunoassay Analyzer. The Design Input Document (DID) indicates performance requirements and minimum target enrollment numbers (based on those in the CTS) of blood donor, hospitalized patient and known HCV antibody (Ab) positive samples for novel anti-HCV assays. A secondary objective was to determine the false initial reactive rate (IRR) of the Access anti-HCV assay.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

The study involved a multicenter, prospective and retrospective collection of samples, and testing of samples with the investigational Access anti-HCV assay. Subject sample enrollment was targeted to be approximately 8,000 specimens including approximately 6,000 blood donors and 1,500 hospitalized individuals for the specificity populations and 500 confirmed HCV Ab positive patients for the sensitivity population, required by European Union's Common Technical Specification for clinical validation of in vitro diagnostic medical devices and marketing needs to align with competitor submissions. Retrospective collection included HCV Ab positive genotyped samples from existing vendor collections meeting all inclusion/exclusion criteria.

All samples collected were anonymized, leftover, remnant samples and therefore member state or Institutional Review Board/Independent Ethics Committee approval was not required. Diagnostic sensitivity and specificity were evaluated for sample antibody status determined by a CE-marked anti-HCV assay (Abbott ARCHITECT anti-HCV assay for hospitalized patient and positive samples or Abbott PRISM HCV assay for blood donor samples) and Immunoblot testing with FUJIREBIO INNO-LIA HCV Score, if necessary. HCV RNA Polymerase Chain Reaction (PCR) or genotyping was requested or was available on all Immunoblot positive samples for further characterization, but these results were not used to determine final antibody status.

A portion of hospitalized patient samples (target 700/1500) and the majority of positive HCV Ab samples were collected and stored frozen prior to testing. A targeted portion of 800 hospitalized patient samples, 30 known positive samples and all blood donor samples were collected and tested fresh. Fresh blood donor and fresh hospitalized patient samples were used to determine false Initial Reactive Rate (IRR).

研究の種類

観察的

入学 (実際)

7901

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • フランス
      • Bois-Guillaume、フランス、76232
        • Etablissement Français du Sang (EFS) Hauts-de-France - Normandie
      • Ivry-sur-Seine、フランス、94208
        • Eurofins Biomnis
      • Saint-Ouen-l'Aumône、フランス、95310
        • Cerba Xpert

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

なし

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

The test population includes :

  • 513 Known HCV Ab Positive Patients
  • 1533 Hospitalized patients
  • 5855 Unselected Blood donors

説明

Inclusion Criteria:

Anonymized or pseudo-anonymised leftover ethylenediaminetetraacetic acid (EDTA) plasma/serum samples from

  • Males or females
  • Aged ≥18 years of age

  • Belonging to one of the following enrollment groups

    • Unselected blood donor
    • Hospitalized patient from GI, hepatology, Internal Medicine or Infectious Disease services
    • Known HCV Ab positive (by Immunoblot) at different stages of disease
  • with at least 1.5 mL leftover sample (without genotype or PCR on same draw) OR
  • at least 0.8 mL leftover sample (with genotype or HCV PCR on same draw)

Exclusion Criteria:

  • Samples from subjects already included in the study

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
Known HCV Ab Positive Patients
leftover samples be tested with both reference anti-HCV assay and Access anti-HCV assay according to respective instructions for use (IFU) or study guide, as applicable, to determine non-reactive (NR), initial reactivity, and repeat reactivity. Reference assay will be Abbott Architect anti-HCV assay for positive samples.
診断テスト：Access HCV

All samples were tested with both reference anti-HCV assay and Access anti-HCV assay according to respective instructions for use (IFU) or study guide, as applicable, to determine non-reactive (NR), initial reactivity, and repeat reactivity. Reference assay was Abbott Architect anti-HCV assay. For blood donors, Abbott PRISM HCV was used as reference.

For the specificity cohorts (blood donor and hospitalized patient samples), all HCV Ab positive results will have supplemental confirmation testing with HCV Immunoblot for final HCV Ab status
Hospitalized Patients

leftover samples be tested with both reference anti-HCV assay and Access anti-HCV assay according to respective instructions for use (IFU) or study guide, as applicable, to determine non-reactive (NR), initial reactivity, and repeat reactivity. Reference assay will be Abbott Architect anti-HCV assay for hospitalized patient.

For the specificity cohorts (blood donor and hospitalized patient samples), all HCV Ab positive results will have supplemental confirmation testing with HCV Immunoblot for final HCV Ab status
診断テスト：Access HCV

All samples were tested with both reference anti-HCV assay and Access anti-HCV assay according to respective instructions for use (IFU) or study guide, as applicable, to determine non-reactive (NR), initial reactivity, and repeat reactivity. Reference assay was Abbott Architect anti-HCV assay. For blood donors, Abbott PRISM HCV was used as reference.

For the specificity cohorts (blood donor and hospitalized patient samples), all HCV Ab positive results will have supplemental confirmation testing with HCV Immunoblot for final HCV Ab status
Unselected Blood Donors

Leftover samples be tested with both reference anti-HCV assay and Access anti-HCV assay according to respective instructions for use (IFU) or study guide, as applicable, to determine non-reactive (NR), initial reactivity, and repeat reactivity. les. For blood donors, Abbott PRISM HCV will be used as reference.

For the specificity cohorts (blood donor and hospitalized patient samples), all HCV Ab positive results will have supplemental confirmation testing with HCV Immunoblot for final HCV Ab status.
診断テスト：Access HCV

All samples were tested with both reference anti-HCV assay and Access anti-HCV assay according to respective instructions for use (IFU) or study guide, as applicable, to determine non-reactive (NR), initial reactivity, and repeat reactivity. Reference assay was Abbott Architect anti-HCV assay. For blood donors, Abbott PRISM HCV was used as reference.

For the specificity cohorts (blood donor and hospitalized patient samples), all HCV Ab positive results will have supplemental confirmation testing with HCV Immunoblot for final HCV Ab status

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
sensitivity and specificity
時間枠：Baseline
sensitivity and specificity relative to the final patient HCV Ab status determined from reference HCV Ab assay and/or supplemental confirmation testing (HCV Ab result by immunoblot).
Baseline

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Beckman Coulter, Inc.

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2019年11月4日

一次修了 (実際)

2021年3月30日

研究の完了 (実際)

2021年3月30日

試験登録日

最初に提出

2021年7月12日

QC基準を満たした最初の提出物

2021年7月12日

最初の投稿 (実際)

2021年7月21日

学習記録の更新

投稿された最後の更新 (実際)

2021年7月21日

QC基準を満たした最後の更新が送信されました

2021年7月12日

最終確認日

2021年7月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • DC-TR18-0406

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

HCVの臨床試験

Access HCVの臨床試験

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スポンサーと協力者

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条件

まれな病気

薬物療法

ダイエットサプリメント

スポンサー/協力者

場所

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