DIACARTA QuantiVirus™ SARS-CoV-2 TEST KIT

DIACARTA QuantiVirus™ SARS-CoV-2 TEST KIT

The QuantiVirus™ SARS-CoV-2 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 100 copies per mL of SARS-CoV-2 viral with a 95% confidence.

FDA EUA APPROVED I CE/IVD MARKED I MEXICO COFEPRIS APPROVED

INDIA ICRM APPROVED I COLUMBIA INVIMA APPROVED

DOWNLOAD: PRODUCT BROCHURE

DOWNLOAD: FDA EUA LETTER

PURCHASE

FDA EUA

FDA Emergency Use Authorization (EUA) Approved (FDA EUA #: 200176)

DETECTED GENES

Orf1ab, N and E genes

HIGH THROUGHPUT

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

SAMPLE TYPE

Nasopharyngeal Swabs, Oropharyngeal Swabs and Sputum

Analytical sensitivity

100 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, Bio-Rad CFX 384, Roche Light Cycler 480 II