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

QIAGEN Gaithersburg, Inc503 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

503

Conditions

SARS-CoV-2 Acute Respiratory Disease

Interventions

NeuMoDx SARS-CoV-2 AssayDIAGNOSTIC_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

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

QIAGEN Gaithersburg, Inc

Manchester, United Kingdom

Outcomes

Primary Outcomes

Sensitivity as compared to the comparator method

Sensitivity ≥ 95% with a lower bound of the two-sided 95% CI \> 90%

Time frame: Through study completion estimated 9 months

Secondary Outcomes

Specificity

Specificity ≥ 95% with a lower bound of the two-sided 95% CI \> 90%

Time frame: Through study completion estimated 9 months

Data from ClinicalTrials.gov

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