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

Qiagen

Status: Terminated

Conditions: SARS-CoV-2 Acute Respiratory Disease

Treatments: Diagnostic Test: NeuMoDx SARS-CoV-2 Assay

Study type: Observational

Funder types: Industry

Identifiers

NCT06360757

DHF-21-2141-1

Details and patient eligibility

About

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.

Enrollment: 503 patients

Sex: All

Volunteers: No Healthy Volunteers

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.