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

March 14, 2025 updated by: QIAGEN Gaithersburg, Inc

Multi-Center Clinical Performance Evaluation of the NeuMoDx SARS-CoV-2 Assay on the NeuMoDx Molecular Systems

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

503

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Manchester, United Kingdom, M130BH
        • QIAGEN Gaithersburg, Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Symptomatic subjects suspected of COVID-19

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity as compared to the comparator method
Time Frame: Through study completion estimated 9 months
Sensitivity ≥ 95% with a lower bound of the two-sided 95% CI > 90%
Through study completion estimated 9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specificity
Time Frame: Through study completion estimated 9 months
Specificity ≥ 95% with a lower bound of the two-sided 95% CI > 90%
Through study completion estimated 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

QIAGEN Gaithersburg, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2024

Primary Completion (Actual)

July 24, 2024

Study Completion (Actual)

July 24, 2024

Study Registration Dates

First Submitted

April 2, 2024

First Submitted That Met QC Criteria

April 9, 2024

First Posted (Actual)

April 11, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 14, 2025

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DHF-21-2141-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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