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3DMed 2019-nCoV TEST

An Integrated Solution for SARS-­CoV-­2 Detection

Performance proven with hundred thousands of bona fide tests in China

The Challenges and Our Solutions

3DMed real world experience in China

The Challenges Our Solutions
Differential Diagnosis:
Since COVID-19 symptoms can be easily confused for other respiratory infections, diagnostics are urgently needed to distinguish SARS-CoV-2 from influenza A/B virus.
  1. Multi-target design to minimize misdetection.
  2. Inclusion of Flu A/B as targets to facilitate differentiation between COVID-19 and Flu A/B.
  3. No cross-reaction with SARS-CoV or MERS-CoV.
High Throughput:
With the rapid spread of COVID-19, conventional manual nucleic acid extraction can hardly support rapid high throughput testing.
  1. The ANDiS 350 Automated Nucleic Acid Extraction System increases daily throughput by 5-25 times.
 
ANDiS SARS-CoV-2 Detection Products
  ANDiS SARS-­CoV-­2 RT-qPCR Detection Kit ANDiS SARS-­CoV-­2 and Influenza A/B RT-­qPCR Detection Kit
Catalog Number 3103010031(100 tests) 3103010022 (100 tests)
3103010030 (200 tests)
SARS-CoV-2 Detection Yes Yes
FluA/B Detection No Yes
CE Yes Yes
FDA Under FDA EUA review Preparing
WHO Under WHO EUL review Preparing

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★ Global Performance Reports

1.Performance Report from Institute for Medical Research (IMR), Malaysia – Malaysia Reference Laboratory

Summary:
100% sensitivity and 100% specificity were observed in 15 known positive and 15 known negative specimens. Performance of this kit (3DMed 2019-nCoV RT-qPCR Detection Kit) is comparable with in house COVID-19 RT-PCR kit.

 

 

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2.Performance Report from Institute Pasteur (one of the most prestigious microbiology insititutes internationally), France

Summary:
The ANDiS SARS-CoV-2 and Influenza A&B RT-qPCR Detection Kit detects the viral RNA from SARS-CoV-2 to pool 9, the most diluted of the panel. The National Reference Center for Respiratory Infections Viruses (including influenza) considers ANDiS SARS-CoV-2 and Influenza A&B RT-qPCR Detection Kit to have an acceptable sensitivity for detection of SARS-CoV-2.

 

 

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3.Interpretation and Excerpts of Performance Report from Sullivan Nicolaides Pathology (a Sonic Health Laboratory), Australia

Summary:
ANDiS 350 Automated Nucleic Acids Extraction System (ANDiS Viral RNA Auto Extraction & Purification Kit) has comparable or even superior extraction efficiency to Thermofisher KingFisher Flex (MagMax kit).

 

 

Note:
Considering the theoretical Ct difference of -2 (due to the different loading and elution volumes between ANDiS and MagMax), the adjusted Ct difference between ANDiS and MagMax shows that RNA recovery rate of ANDiS is equal or even better than MagMax kits.

 

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4.Performance Report from Todos Medical, U.S.A.

Summary:
100% accuracy was observed in 33 confirmed positive and 30 confirmed negative samples, which are clinically derived specimens (CDS) obtained from ISpecimen Inc.

 

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5.Interpretation and Excerpts of Performance Report from National Institutes for Food And Drug Control, China

Summary:
Based on the results of LoD validation, the limit of detection (LoD) for ANDiS SARS-CoV-2 and Influenza A&B RT-qPCR Detection Kit is about 50 (100,000/2187=45.7) RNA copies/mL.

The known concentration of China National Reference material (Cultured virus in National Reference Panel for 2019-nCoV Nucleic Acids Detection Kit) was diluted to 10^5copies/mL with Nuclease Free water. A serial dilution (S1-S10) of the stock solution of 10^5copies/mL was built as follows.

 

 

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ANDiS SARS-CoV-2 RT-qPCR Detection Kit

Intended Use

Presumptive qualitative detection of SARS-CoV-2 (2019-nCoV) RNA in specimens from individuals suspected of COVID-19 by their healthcare providers.

Features and Performance
Multi-target

Multi-target: With the aim of minimizing false calling,primers and probes are designed to target sequences specific of SARS-CoV-2 (ORF1ab, N and E gene).

LoD=5 copies/reaction

SARS-CoV-2 could be present at very low viral titers in some specimens, especially those collected from patients with early infection. A viral detection assay with high sensitivity can significantly reduce false negative.

Inclusivity and specificity

The test covers 100% of the known SARS-CoV-2 sequences based on NCBI&GISAID database as of February 20, 2020. No cross-reaction was observed with other pathogens commonly found in respiratory specimens.

Multiple Controls:

A positive control and negative control are included in each run to ensure that the assay is working properly and to identify potential reagent contamination, respectively. An internal control is included in each reaction to monitor the whole testing process.

Real world clinical evaluation

RNA samples extracted from 111 clinical specimens were sent for SARS-CoV-2 testing using both next generation sequencing (NGS) and the ANDiS SARS-CoV-2 RT-qPCR Detection Kit. 100 out of 111 specimens finally met the requirement of quality control of NGS. The performance of the kit was evaluated against NGS.

* Read No. requirement: ≥3 positive reads
PPA=96% [49/(49+2) ]
NPA=100% [49/(49+0) ]

Performance Comparison of 3DMed vs. CDC 2019-nCoV Assay:

The performance of 3DMed 2019-nCoV RT-qPCR Detection Kit was tested in parallel with US CDC 2019-nCoV assay which has been approved by FDA EUA. A total of 40 oropharyngeal swabs were used in this evaluation. The PPA and NPA analysis demonstrated that the performance of the 3DMed kit appears comparable and demonstrated 100% agreement with US CDC 2019-nCoV assay.

Note: Four (4) inconclusive samples called by the CDC assay were not
included in the analysis
PPA = 100% x 20/(20+0) = 100%
NPA=100% x 16/(0+16) = 100%

ANDiS SARS-CoV-2 and Influenza A/B RT-qPCR Detection Kit

Intended Use

Intended for the presumptive qualitative detection of nucleic acid from the SARS - CoV-2, Influenza A and Influenza B virus in upper respiratory specimens (such as nasopharyngeal or oropharyngeal swabs).

Features and Performance
Multi-target

Multi-target: With the aim of minimizing false calling, primers and probes are designed to simultaneously target sequences specific of SARS-CoV-2, Flu A and Flu B virus in one signle assay.

LoD=5 copies/reaction

SARS-CoV-2 could be present at very low viral titers in some specimens, especially those collected from patients with early infection. A viral detection assay with high sensitivity can significantly reduce false negative.

Inclusivity and specificity

The test covers 100% of the known SARS-CoV-2 sequences based on NCBI&GISAID database as of February 20, 2020. No cross-reaction was observed with other pathogens commonly found in respiratory specimens.

Multiple Controls:

A positive control and negative control are included in each run to ensure that the assay is working properly and to identify potential reagent contamination, respectively. An internal control is included in each reaction to monitor the whole testing process.

Real world clinical evaluation

Real-world clinical evaluation: RNA samples extracted from 282 clinical specimens were sent for SARS-CoV-2 testing using both next generation sequencing (NGS) and the ANDiS SARS-CoV-2 and Influenza A/B RT-qPCR Detection Kit. The performance of the kit was evaluated against NGS.

*Read No. requirement:≥3 positive reads

ANDiS 350 Automated Nucleic Acid Extraction System

A simple, efficient and reliable solution for nucleic acid extraction

Features and Performance
Easy-­to-­use
  1. 7-­inch color touch screen, built-­in computer with Android OS;
  2. Pre-­loaded reagents & fully automated sample processing, minimal hands-on time;
  3. USB supported for system upgrade and program import.
Small-­in-­size
  1. Approximately 15.8'' X 15.8'' X 17.8'' in size, easily fits in any biosafety cabinet, easily transported.
Ultra-efficient and rapid
  1. >95% recovery rate of magnetic beads, ultra-­high extraction efficiency;
  2. Turnaround time of 30~60 minutes (reagent dependent) .
Robust and reliable
  1. Built-­in UV lamp for preventing contamination, <3% CV for technical replicates.
Readily Adaptable
  1. Compatible with different magnetic bead-based nucleic acid extraction reagents.
Memory for storing up to 500 programs
  1. Optimized protocols for each sample type;
  2. Easy and Flexible to establish a high throughout testing capacity.
Easy and flexible to establish a high throughout testing capacity

 

3 ANDiS 350 Instruments for RNA Extraction + 1-­2 qPCR Instrument + 3 Operators =Nearly 500 tests/6 hours

 

An Integrated Solution for SARS-CoV-2 Detection

Challenges of Viral RNA Detection

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3DMed Solution for 2019‐nCoV Detection:Easy and Fast

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3DMed’s integrated solution allows clients to define a SARS‐CoV-2 testing workflow with ease

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A Video Demonstrating Detection of SARS-CoV-2

Partnership in Global

News and Events about SARS-CoV-2 Detection

  •  
    2020-05-08

    3DMed Automated Nucleic Acid Extraction System Receives FDA Approval!

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  •  
    2020-03-27

    Why is nucleic acid testing the gold standard?

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  •  
    2020-03-26

    Todos Medical and 3DMed Enter Into Coronavirus

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  •  
    2020-03-26

    The 3DMed Coronavirus Detection Kit and Automated Nucleic Acid Extraction System has been successfully submitted to FDA EUA, and commercially sold in the United States!

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  •  
    2020-03-23

    3DMed SARS-Cov-2 Detection Kit Receives CE Mark

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01 IFU for 3DMed ANDiS SARS-CoV-2 and Influenza A&B RT-qPCR Detection Kit
Performance Evaluation of 3DMed 2019-nCoV RT-qPCR Detection Kit
DA for 3DMed 2019-nCoV RT-qPCR Detection Kit
DA for ANDiS SARS-CoV-2 and Influenza A&B RT-qPCR Detection Kit
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(To be updated)

contact us

400-0211-661
ivdsupport@3dmedcare.com