DIACARTA QuantiVirus™ REAL-TIME PCR SARS-CoV-2 Test Kit(3 genes)

Accurately detects Orf1ab, N and E genes with high throughput

***UPDATE 14 JAN 2021*** 

THIS TEST DETECTS ALL COVID-19 VARIANTS TO DATE

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 (saliva). The analytical sensitivity is 100 copies per mL of SARS-CoV-2 viral.

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

INDIA ICRM APPROVED    I    COLUMBIA INVIMA APPROVED

PRODUCT HIGHLIGHTS

• FDA Emergency Use Authorization (EUA) Approved #: 200176
• CE/IVD Marked
• Detects three genes: Orf1ab, N, and E genes
• High throughput: 93 samples (96-well plate)
• High throughput: 381 samples (384-well plate) per run
• Nasopharyngeal Swabs, Oropharyngeal Swabs, and Saliva
• Sample input: 2 – 5.5 µL per sample
• Specificity: Proven by in silico analysis as well as wet-lab testing
• Turnaround time: Less than 2 hours from RNA extraction to results

SENSITIVITY

• Analytical sensitivity: 100 copies per mL of viral RNA
• Clinical sensitivity: 100% agreement with real patient samples previously tested with another assay

PACK SIZE

24-reaction per kit, 48-reaction per kit, 480-reaction per kit

VALIDATED MACHINES

Thermo Fisher (ABI) QuantStudio 5, Thermo Fisher (ABI) 7500 Fast Dx, Bio-Rad CFX 384, Roche Light Cycler 480 II

KEY COMPONENTS

• One-step RT-qPCR master mix
• One set of primer/probes specific to the Orf1ab, N and E SARS-CoV-2 genomic regions and primers/probe for human RNase P gene
• A Positive Control (PC), Extraction Control (EC) and a No Template Control (NTC)

HIGH THROUGHPUT

• 93 samples (96-well plate)
• 381 samples (384-well plate) per run
• Detected Genes – Orf1ab, N, and E genes
• Ease of Use
• One sample in one qPCR reaction well (1 assay mix/per sample)