CE/IVD qPCR coronavirus test in 2 hours

CE/IVD qPCR coronavirus test in 2 hours


QuantVirus Real-Time PCR Coronavirus Test - Accurately detects positive subjects within 2 hours!

The QuantVirus Real-Time PCR Coronavirus (SARS-CoV-2) CE-IVD Detection Test is an in vitro diagnostic test based on Real-Time PCR technology, developed for specific detection of SARS-CoV-2 viral RNA extracted from nasopharyngeal swabs, oropharyngeal swabs and sputum from suspected patients infected with the novel coronavirus. The analytical sensitivity is 1 copy per reaction (100 copies/mL) of SARS-CoV-2 viral RNA with a 95% confidence. The assay is highly specific without cross-reaction with different types of non-SARS-CoV-2 species tested.

Key Product Information
  • CE-IVD cleared
  • Made in USA
  • Detects three genes, Orf1ab, N and E genes
  • Detects different SARS-CoV-2 virus strains
  • Detects as low as 1 copy of virus RNA
  • 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

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

The global outbreak of novel coronavirus, SARS-CoV2, 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/

  • 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
  • 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
  • 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 QuantVirus Real-Time PCR Coronavirus (SARS-CoV-2) Detection Test to accurately detect the virus with high sensitivity using nasopharyngeal swabs, oropharyngeal swabs and sputum from suspected subjects.

How Does the QuantiVirus Assay 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 QuantVirus Real-Time PCR Coronavirus (SARS-CoV-2) Detection Test is a qRT-PCR based in vitro diagnostic 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 Real-Time PCR Coronavirus (SARS- CoV-2) Detection Test:

  • Intra-assay reproducibility: Coefficient of Variation (%): < 3%
  • Operator reproducibility: Coefficient of Variation (%): < 2%
  • Inter-instrument reproducibility: Coefficient of Variation (%): < 6%
  • Assay detection limit (LOD): 1 copy of virus RNA or 100 copies per ml sample