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NCT06360757 | RECRUITING | SARS-CoV-2 Acute Respiratory Disease

Clinical Evaluation of the NeuMoDx SARS-CoV-2 Assay (COVID-19)
Sponsor:

QIAGEN Gaithersburg, Inc

Brief Summary:

A multicenter study, using prospectively collected, fresh (Category I) and frozen (Category II), residual/leftover nasopharyngeal (NP) swab in UTM/UVT specimens obtained from symptomatic individuals suspected of COVID-19 infection. This study will evaluate the NeuMoDx SARS-CoV-2 Assay's clinical performance on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems.

Condition or disease

SARS-CoV-2 Acute Respiratory Disease

Intervention/treatment

NeuMoDx SARS-CoV-2 Assay

Study Type : OBSERVATIONAL
Estimated Enrollment : 1432 participants
Official Title : Multi-Center Clinical Performance Evaluation of the NeuMoDx SARS-CoV-2 Assay on the NeuMoDx Molecular Systems
Actual Study Start Date : 2024-02-06
Estimated Primary Completion Date : 2024-09-01
Estimated Study Completion Date : 2024-09-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study:
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Any de-identified NP swab specimen in transport medium from a symptomatic individual suspected of COVID-19 at the time of collection.
  • 2. NP swab specimens obtained using a flexible mini-tip flocked swab and collected into 3mL Copan UTM \[Cat. No. 305C\] or BD UVT \[Cat. No. 220531\].
  • 3. Prospective specimens, fresh (Category I) shall be tested within
    • 1. (4) hours when held at room temperature, or
    • 2. (3) days when held at (2 to 8°C), with cold storage starting within (4) hours of collection.
    • 4. Minimum volume of ≥ 2mL.
    Exclusion Criteria
    • 1. Required information unable to be obtained from the associated medical chart.
    • 2. Specimens that remained on-board the NeuMoDx System for \> (8) hours prior to processing.
Clinical Evaluation of the NeuMoDx SARS-CoV-2 Assay (COVID-19)

Location Details

NCT06360757

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How to Participate

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Locations

RECRUITING

United Kingdom,

QIAGEN Gaithersburg, Inc

Manchester, United Kingdom, M130BH