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

Terminated

• Conditions: SARS-CoV-2 Acute Respiratory Disease

• Registration Number: NCT06360757
• Lead 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-06
• Status Verified: 2024-04
• Study First Submitted: 2024-04-02
• Study First Submitted QC: 2024-04-09
• Study First Posted: 2024-04-11
• Primary Completion: 2024-07-24
• Study Completion: 2024-07-24
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 503

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity as compared to the comparator method	Through study completion estimated 9 months	Sensitivity ≥ 95% with a lower bound of the two-sided 95% CI \> 90%

Secondary Outcome Measures

Name	Time	Method
Specificity	Through study completion estimated 9 months	Specificity ≥ 95% with a lower bound of the two-sided 95% CI \> 90%

Trial Locations

Locations (1)

QIAGEN Gaithersburg, Inc; 🇬🇧 Manchester, United Kingdom