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

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: SARS-CoV-2 Acute Respiratory Disease
• Intervention / Treatment: Diagnostic test: NeuMoDx SARS-CoV-2 Assay

• Study Type: Observational
• Enrollment (Actual): 503

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: QIAGEN Gaithersburg, Inc

Study record dates

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: Respiratory Tract Diseases; Respiration Disorders
• 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