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

NCT06360757 | Terminated

• 1 other identifier: DHF-21-2141-1
• Study Type: observational
• Target: 503
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV-2 Acute Respiratory Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Specificity

  Through study completion estimated 9 months

Interventions

NeuMoDx SARS-CoV-2 Assay DIAGNOSTIC_TEST

The NeuMoDx™ SARS-CoV-2 Assay is an automated, in vitro nucleic acid amplification test intended for the qualitative detection of SARS-CoV-2 RNA in nasopharyngeal (NP) swabs in transport medium obtained from symptomatic individuals suspected of COVID-19 infection. The NeuMoDx SARS-CoV-2 Assay as performed on the NeuMoDx™ 288 Molecular System and NeuMoDx™ 96 Molecular System incorporates automated RNA extraction to isolate target nucleic acids from the specimen and real-time reverse transcription PCR targeting two conserved regions of the SARS-CoV-2 genome.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Symptomatic subjects suspected of COVID-19

You may qualify if:

• Any de-identified NP swab specimen in transport medium from a symptomatic individual suspected of COVID-19 at the time of collection.
• NP swab specimens obtained using a flexible mini-tip flocked swab and collected into 3mL Copan UTM \[Cat. No. 305C\] or BD UVT \[Cat. No. 220531\].
• Prospective specimens, fresh (Category I) shall be tested within:
• (4) hours when held at room temperature, or
• (3) days when held at (2 to 8°C), with cold storage starting within (4) hours of collection.
• Minimum volume of ≥ 2mL.

You may not qualify if:

• Required information unable to be obtained from the associated medical chart.
• Specimens that remained on-board the NeuMoDx System for \> (8) hours prior to processing.

Sponsors & Collaborators

• QIAGEN Gaithersburg, Inc: lead

Study Sites (1)

QIAGEN Gaithersburg, Inc

Manchester, M130BH, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Nasopharyngeal swabs in UTM or UVT

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 11, 2024
• Study Start: February 6, 2024
• Primary Completion: July 24, 2024
• Study Completion: July 24, 2024
• Last Updated: March 18, 2025

Record last verified: 2024-04

Locations

GB (1)