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SARS-CoV-2 Test Kit

Although many kits have entered the market recently, many of them suffer from low sensitivity and have misled the healthcare physicians. DiaCarta’s QuantiVirusTM Real-Time PCR Coronavirus (SARS-CoV-2) Test can accurately detect positive subjects within 2 hours, thereby providing great value to the current outbreak. This marketing data sheet is aimed to compare different PCR tests in the market for coronavirus detection tests.
Pack Size

SARS-CoV-2 Test Kit

Minimum Quantity

10,000 tests

DESCRIPTION: The QuantiVirus™ SARS-CoV-2 Test Kit is based on Real-Time PCR (RT-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. Clinical validation of the assay showed 96.7% sensitivity and a specificity of 100%, with no cross-reaction to different types of non-SARS-CoV-2 species.

  • High Sensitivity: 1 copy per uL from patient sample (2 copy per reaction)
  • 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

CE and FDA APPROVED

All certificates available upon LOI

TECHNICAL INFORMATION:

The results for the QuantiVirusTM SARS-CoV-2 Test Kit performance evaluation have been generated on ABI 7500 Fast Dx and ABI QuantStudio 5 qPCR instruments. Additional tests were performed on Bio-Rad CFX 384.

  • Whole Blood, Serum and Plasma Sample Types
  • Independent IgM and IgG Results
  • Validated by Hundreds of Clinical Samples
  • CFDA/NMPA Approved, CE Labeled

Standard Shipping Time: Expedited Delivery Available Box Size: Length: 12cm, Width: 13.5cm, Heigh: 13cm, 20pcs per box Carton Size: L: 62cm, W: 29.5cm, H: 28.5cm, 20 box/carton, 400pcs, 4.5kg

Analytical Sensitivity:

To determine the limit of detection (LOD) and analytical sensitivity of the kit, the studies were performed using serial dilutions of analyte and the LOD was determined to be the lowest concentration of template that could be reliably detected with 95%-100% confidence. The LOD was confirmed by testing 3-fold dilutions of in vitro transcribed RNA with 20 replicates of each dilution. The LOD was determined to be the lowest concentration (copies/uL) at which ≥95% (19/20) of the 20 replicates were tested as positive. Average Ct from 20 samples for N gene, ORF1ab and E gene were between Ct 32-36 with 95% CI. The data confirmed that the assay analytical sensitivity is 1-5 copies/uL. The assay amplification showed a wide dynamic range allowing detection from 10 million copies down to 1-5 copies of the analyte in the linear range.

Analytical Specificity:

The QuantiVirus™ SARS-CoV-2 Test Kit has been designed to detect all publicly available SARS-CoV-2 viral RNA sequences. At the same time, the primers and probes were designed in the SARS-CoV-2 virus specific genome region ensuring the specific detection of the SARS-CoV-2 virus. In silico analysis of the SARS-CoV-2 assay design showed that the assay can detect different SARS-CoV-2 virus strains and exhibited no cross reactivity with non-SARS-CoV-2 species.

Inter-Instrument Reproducibility and Operator Reproducibility:

Assay reactions were set up with three replicates and run on three different qPCR instruments including BioRad CFX 384, ABI QS5 and ABI 7500 Fast Dx. Coefficient of Variation (%): < 5%. The assay reactions were set up by two operators using the same lot of reagent and run on the same instrument. Coefficient of Variation (%): < 1.5%.

Clinical Evaluation:

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 2X LOD (2X100 copies/mL) and 10 sputum samples were contrived with different higher RNA concentration (500, 1000, 5000 and 10000 copies/uL). 30 specimens were contrived only with water as 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 shows that there is a 95% agreement with the spiking sample with 2X LOD (2×100 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, 30 samples were negative.

Table: Contrived Clinical Sample Evaluation with in vitro transcribed RNA

The left 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%)

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