DIACARTA QuantiVirus™ SARS-CoV-2 Multiplex Test Kit

DIACARTA QUANTIVIRUS™ SARS-COV-2 MULTIPLEX TEST KIT

The QuantiVirus™ SARS-CoV-2 Multiplex Test Kit is based on Real-Time PCR technology, developed for specific detection of SARS-CoV-2 (COVID-19) viral RNA extracted from nasopharyngeal swabs, oropharyngeal swabs, and sputum. The analytical sensitivity is 50 copies per mL of SARS-CoV-2 viral with a 95% confidence. The QuantiVirus™ SARS-CoV-2 Multiplex Test KitRanks among the top 10 kits in terms of low limit of detection (LoD).   LEARN MORE

 

PRODUCT SUMMARY SHEET
FDA EUA

FDA Emergency Use Authorization (EUA) Approved (submission#: 200575)

DETECTED GENE

Orf1ab 

HIGH THROUGHPUT

 93 samples (96-well plate) or 381 samples (384-well plate) per run

RESULTS TIME

Less than 2 hours from RNA extraction to results

Analytical sensitivity

50 copies per mL of viral RNA

Clinical sensitivity

100% agreement with real patient samples previously tested with another assay

Validated Machines

Thermo Fisher (ABI) QuantStudio 5, Thermo Fisher (ABI) 7500 Fast Dx, and Bio-Rad CFX 384

CE/IVD Marked

Yes

Category
QuantiVirus™ SARS-CoV-2 Multiplex Test Kit
Tags
PCR Test

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