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FDA EUA Approved & CE/IVD Marked

QuantiVirus™ SARS-CoV-2 Test Kit

 

Accurately detects Orf1ab, N and E genes with high throughput

 

GET a quoteBrowse COVID-19 Total Solution

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) Approved (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

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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)
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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

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Detected Genes

Orf1ab, N and E genes

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High Throughput

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

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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

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Analytical Sensitivty

100 copies per mL of viral RNA 

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Clinical Sensitivity

100% agreement with real patient samples previously tested with CDC assay and Abbott m2000 assay.

Sample IDAbbott m2000 CDC AssayDiaCarta's QuantiVirus™ Assay
ADetectedDetected at 1:100 dilutions
BDetectedDetected at 1:1000 dilutions
CNot DetectedNot DetectedNot Detected
DNot DetectedNot DetectedNot Detected
ENot DetectedNot DetectedNot Detected
FNot DetectedNot DetectedNot Detected
GNot DetectedNot DetectedNot Detected
HNot DetectedNot DetectedNot Detected
INot DetectedNot DetectedNot Detected
JDetectedDetected Detected
KDetectedDetected
LDetectedDetected
MDetectedDetected Detected
NNot DetectedNot DetectedNot Detected

 Ordering Information

US Customer Ordering Information (FDA EUA Approved)

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, antibody IgG test, CLIA lab service, sample collection kits, RNA control and more. 

QuantiVirus™ SARS-CoV-2 Test Kit (Detects 3 genes)

QuantiVirus™ SARS-CoV-2 Multiplex Test Kit (Detects 1 gene)

QuantiVirus™ Anti-SARS-CoV-2 IgG Test Kit (Antibody Test)

COVID-19 Clinical Laboratory Testing Service

Nasopharyngeal and Oropharyngeal Sampling Collection Kit 

Saliva Samplling Collection Kit for COVID-19

Need Help?

Call us: +1 (800) 878-6662

Email us: information@diacarta.com

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