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

SARS-CoV-2 Acute Respiratory Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06360757
• Other study ID #: DHF-21-2141-1
• Status: Recruiting
• Start date: February 6, 2024
• Est. completion date: September 1, 2024

Study information

• Verified date: April 2024
• Source: QIAGEN Gaithersburg, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1432
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Respiration Disorders
• Respiratory Tract Diseases
• SARS-CoV-2 Acute Respiratory Disease

Intervention

Diagnostic Test:
• NeuMoDx SARS-CoV-2 Assay
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.

Locations

Country	Name	City	State
United Kingdom	QIAGEN Gaithersburg, Inc	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
QIAGEN Gaithersburg, Inc

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Specificity	Specificity = 95% with a lower bound of the two-sided 95% CI > 90%	Through study completion estimated 9 months