FDA EUA SARS-CoV-2 qPCR Test Kit
Accurately detects Orf1ab, N, and E genes with high throughput.
CE/IVD Marked Product
Research Service
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.
Looking for a testing service? Our CLIA lab is also available for the COVID-19 testing! Learn more >
Product Highlights
- FDA Emergency Use Authorization (EUA) Authorized (FDA EUA #: 200176)
- CE/IVD Marked
- Detects three 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
- 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
Validated Machines
Thermo Fisher (ABI) QuantStudio 5, Thermo Fisher (ABI) 7500 Fast Dx, Bio-Rad CFX 384, Roche Light Cycler 480 II
COVID-19 Hotline
Email: covid19support@diacarta.com
Phone #: +1 510-878-6662, option 4 (tech support)
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How Does the QuantiVirus™ SARS-CoV-2 Test Kit Work?
The assay is a multiplex rRT-PCR assay consisting of one reaction with primers and probes for the viral targets (Orf1ab, N and E genes) and internal control in one tube thus with increased assay throughput and ease of use and other advantages as a multiplex assay.
The Orf1ab, N, and E genes of the SARS-CoV-2 genome are targeted in the rRT-PCR assay. Primers and TaqMan probes designed for conserved regions of the SARS- CoV-2 virus genome allow specific amplification and detection of the viral RNA from all strains of SARS-CoV-2 from respiratory specimens. The Human RNase P gene is used as Internal control to monitor viral RNA extraction efficiency and assess amplifiable RNA in the samples to be tested.
Product Configuration
Kit 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)
Pack Size
24-reaction per kit, 48-reaction per kit, 480-reaction per kit
*This product configuration image only shows the 24-reaction and 48-reaction pack size. 480-reaction pack size has 7 vials.
High Throughput & Ease of Use
Detected Genes
Orf1ab, N and E genes
High Throughput
93 samples (96-well plate) or 381 samples (384-well plate) per run
Ease of Use
One sample in one qPCR reaction well (1 assay mix/per sample)
Turnaround Time is Less than 2 Hours from RNA Extraction to Results
Step 1
Extract RNA from patient sample and extraction control using Thermo Fisher PureLink viral RNA/DNA mini kit or Qiagen QIAamp® Viral RNA Mini Kit or equivalents
Step 2
Set up the assay reactions using primer/probe mixes and one-step RT-qPCR master mix. A positive (PC), NTC (NC) and extraction control (EC) must be included for every run
Step 3
Perform RT-qPCR using the Applied Biosystems™ QuantStudio 5, or 7500 Fast Dx, Bio-Rad CFX 384 or Roche LightCycler 480 II Real-Time PCR Instrument
Step 4
Data analysis
Step 5
Review results interpretation for patient samples
Ultra-Sensitivity
Analytical Sensitivty
100 copies per mL of viral RNA
Clinical Sensitivity
100% agreement with real patient samples previously tested with CDC assay and Abbott m2000 assay.
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Ordering Information
US Customer Ordering Information (FDA EUA Authorized)
Product Name: QuantiVirus™ SARS-CoV-2 Test Kit
24-Reaction Kit Catalog Number: DC-11-0007
48-Reaction Kit Catalog Number: DC-11-0008
480-Reaction Kit Catalog Number: DC-11-0009
The FDA EUA version and CE/IVD version have the same contents & configuration. Labelling is the only difference between the two versions.
Outside US Customer Ordering Information (CE/IVD Marked)
Product Name: QuantiVirus™ Real-Time PCR Coronavirus (SARS-CoV-2) Detection Test
24-Reaction Kit Catalog Number: DC-11-0005E
48-Reaction Kit Catalog Number: DC-11-0004E
480-Reaction Kit Catalog Number: DC-11-0006E
The FDA EUA version and CE/IVD version have the same contents & configuration. Labelling is the only difference between the two versions.
Resources
COVID-19 Total Solution
DiaCarta offers a COVID-19 total solution to support the fight against COVID-19, including the RT-PCR test kit, antibody IgG test kit, and CLIA lab service.
QuantiVirus™ SARS-CoV-2 Test Kit (RT-PCR Test - Detects 3 genes)
QuantiVirus™ SARS-CoV-2 Multiplex Test Kit (RT-PCR Test - Detects 1 gene)
QuantiVirus™ Anti-SARS-CoV-2 IgG Test Kit (Antibody Test - Research Use Only)
