A multicenter study, using prospectively collected, fresh (Category I) and frozen(Category II), residual/leftover nasopharyngeal (NP) swab in UTM/UVT specimens obtainedfrom symptomatic individuals suspected of COVID-19 infection. This study will evaluatethe NeuMoDx SARS-CoV-2 Assay's clinical performance on the NeuMoDx 288 and NeuMoDx 96Molecular Systems.
Not Provided
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.
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.
QIAGEN Gaithersburg, Inc
Manchester, United Kingdom
Not Provided