Detection of COVID-19 Coronavirus
QuantiVirus™ SARS-CoV-2 Multiplex Test Kit from DiaCarta
The QuantiVirus™ SARS-CoV-2 Multiplex Test Kit is an enhanced throughput version of the FDA EUA-approved QuantiVirus™ SARS-CoV-2 Test Kit. Based on real-time Reverse-Transcription Polymerase Chain Reaction (RT-PCR) technology, it is highly specific for the detection of SARS-CoV-2 (COVID-19) viral RNA extracted from nasopharyngeal swabs, oropharyngeal, and sputum samples. The level of detection is 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.
The QuantiVirus™ SARS-CoV-2 Multiplex Test Kit combines four genes into one reaction well and increases throughput significantly to 93 samples in a 96 well plate or 381 samples in a 384 well plate (see the comparison of the two kits below for detailed assay difference).
For Emergency Use Authorization (EUA) only. For prescription use only. For in vitro diagnostic use.
Performance Characteristics of the QuantiVirus™ SARS-CoV-2 Multiplex Test Kit
EASIER SAMPLING
Sample Type: Nasopharyngeal Swabs, Oropharyngeal Swabs and Sputum
LOW SAMPLE VOLUME
As low as 2-5.5 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
Key Product Information
- FDA Emergency Use Authorization (EUA) Granted
- 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 2-5.5 μL sample needed
- <2 hours from RNA to results
Instruments Validated
Thermo Fisher (ABI) QuantStudio 5, Thermo Fisher (ABI) 7500 Fast Dx, and Bio-Rad CFX 384
Detection Chemistry
TaqMan
Turnaround Time
~2 hours
Stability
Stable for 12 months at -25°C to -15°C
COVID-19 Hotline
Email: [email protected]
Phone #: +1 510-878-6662, option 4 (tech support)
Other COVID-19 Related Products
Fastep® COVID-19 Antigen Home Test (FDA EUA Granted)
Clarity COVID-19 Antigen Rapid Test Cassette (FDA EUA Granted)
Sienna™ COVID-19 Antigen Rapid Test Cassette (FDA EUA Granted)
POC/Waived/Fingerstick Fastep® COVID-19 IgG/IgM Rapid Test Device by Assure Tech. (FDA EUA Granted)
Status™ COVID-19/Flu A&B Antigen Test (FDA EUA Granted)
Diazyme SARS-CoV-2 IgG and IgM Automated Antibody Test Kits for DZ-Lite 3000 Plus (FDA EUA Granted)
QuantiVirus™ SARS-CoV-2 Test Kit from DiaCarta (FDA EUA Granted)
QuantiVirus™ SARS-CoV-2 Multiplex Test Kit from DiaCarta (FDA EUA Granted)
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 (In Vitro Transcribed Viral RNA Spiking into Sputum)
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 ID | Abbott m2000 | CDC Assay | DiaCarta's QuantiVirus™ Assay |
|---|---|---|---|
| A | Detected | Detected at 1:100 dilutions | |
| B | Detected | Detected at 1:1000 dilutions | |
| C | Not Detected | Not Detected | Not Detected |
| D | Not Detected | Not Detected | Not Detected |
| E | Not Detected | Not Detected | Not Detected |
| F | Not Detected | Not Detected | Not Detected |
| G | Not Detected | Not Detected | Not Detected |
| H | Not Detected | Not Detected | Not Detected |
| I | Not Detected | Not Detected | Not Detected |
| J | Detected | Detected | Detected |
| K | Detected | Detected | |
| L | Detected | Detected | |
| M | Detected | Detected | Detected |
| N | Not Detected | Not Detected | Not 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
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/
- 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 QuantiVirus™ SARS-CoV-2 Test Kit to accurately detect the virus with high sensitivity using nasopharyngeal swabs, oropharyngeal swabs and sputum.
Comparison of QuantiVirus™ SARS-CoV-2 Test Kit and QuantiVirus™ SARS-CoV-2 Multiplex Test Kit
| QuantiVirus™ SARS-CoV-2 Test | QuantiVirus™ SARS-CoV-2 Multiplex Test (Presented on the current web page) | |
|---|---|---|
| Sample types | Sputum, NP, OP | Sputum, NP, OP |
| Ease of use | One sample in multiple qPCR reaction wells (4 assay mixes/per sample) | One sample in one qPCR reaction well (1 assay mix/per sample |
| Throughput | 21 samples (96-well plate) or 93 samples (384-well plate) per run | 93 samples (96-well plate) or 381 samples (384-well plate) per run |
| Sensitivity | Detects as low as 100 copies of Viral RNA /mL sample | Detects as low as 50 copies of Viral RNA /mL sample |
| Specificity | Proven by in silico analysis as well as wet lab testing | Proven by in silico analysis as well as wet lab testing |
| Sample input | (2 - 5.5 µL)x4/per sample | 2 - 5.5 µL per sample |
| Validated instrument | Validated on ABI 7500 Fast Dx, ABI QuantStudio 5 and Bio-Rad CFX 384 | Validated on ABI 7500 Fast Dx, ABI QuantStudio 5 and Bio-Rad CFX 384 |
| Turnaround time | Less than 2 hours from RNA extraction to results | Less than 2 hours from RNA extraction to results |
| Detected genes | Orf1ab, N and E genes | Orf1ab |
| Registration status | CE/IVD Marked FDA EUA Approved | CE/IVD Marked FDA EUA Filed |
Important Information
The QuantiVirus™ SARS-CoV-2 Test Kit and Quanti-Virus™ SARS-CoV-2 Multiplex Test Kit from DiaCarta have not been FDA cleared or approved; these tests have been authorized by FDA under an EUA for use by authorized laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, 42 U.S.C. §263a, to perform high complexity tests. These tests have been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. These tests are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Instructions for Use and Fact sheets for Healthcare Providers and Patients can be found at carolinachemistries.com.
