The QuantiVirus™ SARS-CoV-2 Multiplex Test Kit, following the launch of FDA EUA-approved QuantiVirus™ SARS-CoV-2 Test Kit, is a higher throughput test kit that is based on real-time Reverse-Transcription Polymerase Chain Reaction (RT-PCR) technology and is used for highly specific detection of SARS-CoV-2 (COVID-19) viral RNA extracted from saliva in addition to nasopharyngeal swabs, oropharyngeal, and sputum samples. The sensitivity reaches 50 copies per mL of SARS-CoV-2 viral load with a 95% confidence. Clinical validation of the assay shows 95% sensitivity and 100% specificity, with no cross-reaction to different types of non-SARS-CoV-2 species.

Validated for saliva samples, the newly developed QuantiVirus™ SARS-CoV-2 Multiplex Test Kit overcomes the detection barrier caused by the global shortage of the swabs for OP and NP sampling. With four reactions combined into one reaction, the new kit has increased the throughput significantly (see the comparison of the two kits below for detailed assay difference).

Key Product Information

  • High throughput: 93 samples (96-well plate) or 381 samples (384-well plate) per run
  • Detects as low as 50 copies of viral RNA /mL sample, enables early virus detection and diagnosis
  • Minimal sample input: as low as 2 μL sample needed
  • Easy saliva sampling in addition to NP, OP, and sputum
  • < 2 hours from RNA to results

Validated Machines

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

COVID-19 Hotline

Email: covid19support@diacarta.com

Phone #: +1 510-878-6662, option 4 (tech support) 

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

Easier sampling

Easy saliva sampling in addition to NP, OP, and sputum

Low Sample Volume

As low as 2 μL sample needed

High sensitivity

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

High throughput

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

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/

P

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

P

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

P

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.

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 Multiplex Test Kit

  • Intra-assay reproducibility: Coefficient of Variation (%): < 3%
  • Operator reproducibility: Coefficient of Variation (%): < 3%
  • Inter-instrument reproducibility: Coefficient of Variation (%): < 3%
  • Assay detection limit (LOD)50 copies per mL of SARS-CoV-2 viral with a 95% confidence

Clinical Evaluation 

Clinical evaluation of the QuantiVirus™ SARS-CoV-2 Multiplex Test Kit was conducted with contrived sputum specimens including 80 positive and 30 negative samples. Sputum samples were mixed with the lysis buffer from the extraction kit at 1:1 ratio before spiking in non-infectious viral particles. Sputum samples (20 samples) were contrived with non-infectious viral particles templates at 1X LoD (1×50 copies/mL), 20 samples at 2xLoD (2×50 copies/mL), 20 samples at 4xLoD (4×50 copies/mL) and 10 sputum samples were spiked with non-infectious virus at 6xLoD (300 copies/mL) and another 10 sputum samples were spiked at the concentration of 10xLoD (500 copies/mL). Viral RNA was extracted from spiked samples and tested blindly with the QuantiVirus™ SARS-CoV-2 RT-qPCR. Data show that there is 95% agreement with the spiked sample at 1xLoD (1×50 copies/mL), and 100% agreement at all other concentrations including 100 copies/mL(2xLoD) 200 copies/mL (4xLoD), 300 copies/mL (6xLoD) and 500 copies/mL. For negative control, all the 30 samples were tested negative.

Table: Contrived clinical sample evaluation with viral particles (ABI 7500 Fast Dx).

Third-Party Clinical Test Results

The third-party clinical test results demonstrated that DiaCarta’s QuantiVirus™ SARS-CoV-2 Test Kit shared the same testing results (100% match), compared with peer products, even at much lower sample concentration in some cases.

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

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

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

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 Dx or BioRad CXF 384 Real-Time PCR Instrument

Step 4

Data analysis and review results interpretation for patient samples

Comparison of QuantiVirus™ SARS-CoV-2 Test Kit and QuantiVirus™ SARS-CoV-2 Multiplex Test Kit

 QuantiVirus™ SARS-CoV-2 TestQuantiVirus™ SARS-CoV-2 Multiplex Test (Presented on the current web page)
Sample typesSputum, NP, OPSputum, NP, OP, and saliva
Ease of useOne sample in multiple qPCR reaction wells (4 assay mixes/per sample)One sample in one qPCR reaction well (1 assay mix/per sample
Throughput21 samples (96-well plate) or 93 samples (384-well plate) per run93 samples (96-well plate) or 381 samples (384-well plate) per run
SensitivityDetects as low as 100 copies of Viral RNA /mL sampleDetects as low as 50 copies of Viral RNA /mL sample
SpecificityProven by in silico analysis as well as wet lab testingProven by in silico analysis as well as wet lab testing
Sample input(2 - 5.5 µL)x4/per sample2 - 5.5 µL per sample
Validated instrumentValidated on ABI 7500 Fast Dx, ABI QuantStudio 5 and Bio-Rad CFX 384Validated on ABI 7500 Fast Dx, ABI QuantStudio 5 and Bio-Rad CFX 384
Turnaround timeLess than 2 hours from RNA extraction to resultsLess than 2 hours from RNA extraction to results
Detected genesOrf1ab, N and E genesOrf1ab
Registration statusCE/IVD Marked
FDA EUA Approved
CE/IVD Marked
FDA EUA Filed

 Product Specifications and Order Information

US Customer Ordering Information (FDA EUA Filed)

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

24-Reaction Kit Catalog Number: DC-11-0017
48-Reaction Kit Catalog Number: DC-11-0018
480-Reaction Kit Catalog Number: DC-11-0019

Outside US Customer Ordering Information (CE/IVD)

Product Name: QuantiVirus™ SARS-CoV-2 Multiplex Detection Test

Outside the US, this product is available for diagnostic use (CE/IVD) 

24-Reaction Kit Catalog Number: DC-11-0015E
48-Reaction Kit Catalog Number: DC-11-0014E
480-Reaction Kit Catalog Number: DC-11-0016E

Sample Type

Nasopharyngeal Swabs, Oropharyngeal Swabs, Sputum, and Saliva

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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Email us: information@diacarta.com

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