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Rain8's New FDA/CE High Accuracy, High-Throughput Diagnostic Kit

Updated: Jul 4, 2020

Since the new coronavirus (SARS-CoV-2) outbreak started in Wuhan, China, over 3,300,724 people have been infected and more than 233,693 people have died of the infection. The virus has now infected people in over 212 countries.


Different from other coronaviruses that caused epidemics in the past, the SARS-CoV-2, which can be transmitted from one person to another without showing symptoms, leads to a pandemic according to the World Health Organization (WHO).


It is critical to detect the virus quickly and accurately so those who get infected can be effectively quarantined to prevent further infection.

*Calculated on April 30, 2020 by https://www.worldometers.info/coronavirus/


Huge Improvements

Following FDA EUA approval of DiaCarta's QuantiVirus SARS-CoV-2 Test, DiaCarta’s second COVID-19 detection test QuantiVirus SARS-2 Multiplex Test Kit allows saliva samples, improves throughput by three times and increases assay sensitivity by two times.


Nasal Swaps Not Needed

Nasal swabs have been in short globals supply. This kit supports the use of saliva samples to eliminate the need for nasal swabs and the patient discomfort associated with nasal swabs.


Eliminating patient test-reluctance can lead to more widespread testing.


Features and Advantages

  • High Sensitivity: Detects as low as 50 copies of viral RNA /mL sample, enables early virus detection and diagnosis

  • High Throughput: Up to 93 clinical samples can be tested on one 96-well plate; up to 381 clinical samples can be tested on one 384-well plate

  • High Specificity: Proven by in silico analysis as well as wet lab testing

  • Intended Sample Types: Easy sampling with saliva in addition to NP, OP, and sputum

  • Minimal Sample Input: As low as 2 µL sample needed

  • Ease of Use: Only one reaction mix needs to be set up per sample

  • Fast Turnaround Time: Only 2 hours from nucleic acid extraction to results

  • Flexibility: Assay validated on widely used qPCR instruments including ABI 7500 Fast Dx, ABI QuantStudio 5 and BioRad CFX 384

  • Precision: Coefficient of variation (CV) < 3%, allowing reproducible test results

Specifications

Sample Type: Nasopharyngeal Swabs, Oropharyngeal Swabs, Sputum and Saliva


Pack Size: 24 Reactions, 48 Reactions, 480 Reactions


Validated Machines:

  • Thermo Fisher (ABI) QuantStudio 5,

  • Thermo Fisher (ABI) 7500 Fast Dx,

  • Bio-Rad CFX 384

Turnaround Time: ~2 hours


Stability: Stable for 12 Months at -25 o C to -15 o C


Superb Analytical Sensitivity

To determine the Limit of Detection (LoD) and analytical sensitivity of the kit, studies were performed using serial dilutions of analyte and the LoD was determined to be the lowest concentration of template that could reliably be detected with 95% of all tested positive. The LOD was confirmed by testing 1xLoD of viral RNA with 20 replicates. The LoD was determined to be the lowest concentration (copies/ml) at which ≥95% (19/20) of the 20 replicates were tested as positive. The following data confirmed the assay detects as low as 50 copies of viral RNA /mL sample for ABI 7500 Fast Dx, enables early virus detection and diagnosis. Please refer to the product IFU for analytical sensitivity data on ABI QuantStudio 5 and Bio-Rad CFX 384.


Clinical Evaluation: 100% Agreement with Typical Samples

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 (1x50 copies/mL), 20 samples at 2xLoD (2x50 copies/mL), 20 samples at 4xLoD (4x50 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 (1x50 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.


Clinical Test Results Match CDC and Peer Products

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.


Instructions for Use (IFU)

Detailed instructions for use are included in the Product Information Sheet below.


Download the full Product Information Sheet below:


20200623A LIDIA-FDA CE-Diagnostic Test K
Download • 5.78MB


Contact

Contact us here: https://www.raineightsourcing.com/contact for more information about the contents of this article or how we may assist you with a custom product or service search to meet your business needs.

About

Rain8 Group, http://www.raineight.com/, has over 20 years experience in China market-entry and business development. Rain8 Sourcing, https://www.raineightsourcing.com/, has over 10 years experience in developing and managing supply chains in China. Rain8 Group and Rain8 Sourcing are wholly-owned subsidiaries of Precision Arrow Placement LLC, http://topranger.us/, a producer of wired and wireless cloud-based sensor networks operating over LoRa WAN for the industrial and agri-tech markets.

Partners

Rain8 partners with the Chinese central government and with influential Chinese industry organizations to achieve superior results for our clients including:

○ product quality,

product authenticity, and;

security of financial transactions.

Visit our partner, The Chinese Council for Promotion of International Trade (CCPIT) here: http://en.ccpit.org/info/index.html

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