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 sensitivity is 100 copies per mL of SARS-CoV-2 viral with a 95% confidence. The assay is highly specific without cross-reaction with different types of non-SARS-CoV-2 species tested. The clinical validation shows 96.7% sensitivity and 100% specificity.

Key Product Information

  • Filed for FDA Emergency Use Authorization (EUA)
  • CE-marked
  • Detects three genes, Orf1ab, N and E genes
  • Detects different SARS-CoV-2 virus strains
  • Detects as low as 1 copy per uL from patient samples
  • Less than 2 hours from RNA to results on most qPCR machines

Sample Type

Nasopharyngeal Swabs, Oropharyngeal Swabs and Sputum

Validated Machines

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

Pack Size

24 Reactions

48 Reactions

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Performance Characteristics of the QuantiVirus™ SARS-CoV-2 Test Kit

High Sensitivity

100 copies per mL of SARS-CoV-2 viral with a 95% confidence

Low Sample Volume

only 2 uL viral RNA sample

High Accuracy

Detection of three target genes for calling positive results

Wide Dynamic Range

Allowing detection of from 10 million copies to single copy analyte in linear range

Coronavirus (SARS-CoV-2) Detection Tests are Crucial

The global outbreak of novel coronavirus, SARS-CoV-2 (COVID-19), caused over 3000 people’s death and huge economic damage. The number is still increasing. Detecting the virus early is essential to contain the virus from infecting more people. However, in the United States, the unavailability of enough reliable detection kits in time has caused concerns and panic in the society.

*The numbers are calculated on March 9, 2020 by https://www.worldometers.info/coronavirus/

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Without the test, the general public does not know if they get the novel coronavirus or the regular flu virus as they share similar symptoms

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Without the test, the general public does not know if they carry the virus without symptoms and further infect their closed ones and others who have contact with them

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Without the test, the general public does not know if they carry the virus and miss the treatment window

To meet the unmet medical needs, DiaCarta has developed the QuantiVirus™ SARS-CoV-2 Test Kit to accurately detect the virus with high sensitivity using nasopharyngeal swabs, oropharyngeal swabs and sputum.

How Does the QuantiVirus™ SARS-CoV-2 Test Kit Work?

Figure 1. Amplicon Target on SARS-CoC-2 genome. E: envelope protein gene; M: membrane protein gene; N: nucleocapsid protein gene; ORF: open reading frame; RdRp: RNA-dependent RNA polymerase gene; S: spike protein gene.

The QuantiVirus™ SARS-CoV-2 Test Kit is a qRT-PCR assay for the qualitative detection of SARS-CoV-2 viral RNA.

Three genes of the SARS-CoV-2 including N, Orf1ab and E are targeted in the qRT-PCR assay and primers and Taqman probes are designed in the conserved region of the SARS- CoV-2 virus-specific genome region to allow sensitive and specific amplification and detection of the virus. The human RNase P gene is used as internal and extraction control to monitor viral RNA extraction efficacy and assess amplifiable RNA/DNA in the samples to be tested.

Assay Performance

The assay has a wide dynamic range as shown in the figure below: Amplification curve of 10 -fold serial dilution of templates showing the dynamic range.

The assay performance summary for QuantiVirus™ SARS- CoV-2 Test Kit

  • Intra-assay reproducibility: Coefficient of Variation (%): < 3%
  • Operator reproducibility: Coefficient of Variation (%): < 1.5%
  • Inter-instrument reproducibility: Coefficient of Variation (%): < 5%
  • Assay detection limit (LOD): 1 copy of virus RNA or 100 copies per ml sample

Clinical Evaluation (In Vitro Transcribed Viral RNA Spiking into Sputum)

Clinical evaluation of the QuantiVirus™ SARS-CoV-2 Test kit was conducted with contrived sputum specimens including 30 positive and 30 negative samples. 20 sputum samples were contrived with RNA (in vitro transcripts) templates at 2xLOD (2×5 copies/uL) and 10 sputum samples were contrived with different higher RNA  (500, 1000, 5000 and 10000 copies/uL). 30 specimen were contrived only with water as the negative control. The contrived clinical samples were tested blindly to generate the Positive Predictive Value (PPV), Negative Predictive Value (NPV) as a measurement of estimated Diagnostic Accuracy.

Data show that there is a 95% agreement with the spiking sample with 2X LOD (2×5 copies/uL), but one sample cannot be detectable. With higher concentration spiking samples (500, 1000, 5000 and 10000 copy/uL), 10 out of 10 samples were detectable. For negative control, Thirty samples were negative.

Table: Contrived clinical sample evaluation with in vitro transcribed RNA

The above table shows: 

  • Clinical Sensitivity = 96.7% (95% CI, 81.4%-99.8%)

  • Clinical Specificity = 100% (95% CI, 85.4%-100%)

  • Positive Predictive Value (PPV) = 100% (95% CI, 85.8%-100%

  • Negative Predictive Value (NPV) = 96.6% (95% CI, 80.9%-99.8%)

Streamlined Workflow for the QuantiVirus™ SARS-CoV-2 Test Kit

Step 1: Viral RNA Isolation and Quantification

Extract and isolate the RNA from samples including sputum and swabs. Using approved RNA quantification device to measure the concentration.

Step 2: Set Up qRT-PCR Assays

Following the instruction to setup the reactions on the PCR plates with master mix, primer/probe mixes, as well as controls and water.

Step 3: Amplification Setup

Enter the reaction amplification parameter and start the amplification.

Step 4: Data analysis

Determine the presence or absence of virus in the sample.

 Product Specifications and Order Information

US Customer Ordering Information (Filed for FDA EUA)

Product Name: QuantiVirus™ SARS-CoV-2 Test Kit

24-Reaction Kit Catalog Number: DC-11-0007
48-Reaction Kit Catalog Number: DC-11-0008

Outside US Customer Ordering Information (CE-Marked)

Product Name: QuantiVirus™ SARS-CoV-2 Test

Outside the US, this product is available for diagnostic use (CE-marked) and research use (RUO)

24-Reaction Kit Catalog Number: DC-11-0005E
48-Reaction Kit Catalog Number: DC-11-0004E

Sample Type

Nasopharyngeal Swabs, Oropharyngeal Swabs and Sputum

Instruments Validated

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

Detection Chemistry
TaqMan
Turnaround Time

~2 hours

Stability

Stable for 12 months at -25°C to -15°C

Resources

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Need Help?

Call us: +1 (800) 878-6662

Email us: information@diacarta.com

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