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What are some Approved COVID19 Test Kits?

  

7 novel coronavirus test kits from 6 companies approved

Rapid and accurate diagnosis of infectious diseases is a key factor in controlling disease outbreaks. As the number of people infected with the novel coronavirus (2019-nCoV) continues to increase, many in vitro diagnostic companies have launched new coronavirus detection kits, while many bio companies have joined the fray by offering test kits.

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Rapid and accurate diagnosis of infectious diseases is a key factor in controlling disease outbreaks. As the number of people infected with the novel coronavirus (2019-nCoV) continues to increase, many in vitro diagnostic companies have launched new coronavirus detection kits, while many bio companies have joined the fray by offering test kits.

 

In the early days of the Wuhan pneumonia outbreak, due to the small number of approved testing products, coupled with the restrictions on production and logistics during the Spring Festival, the new coronavirus testing kit appeared in the dilemma of "hard to find a box".

Today, as more testing products are approved, many companies invest a lot of manpower in production, and some companies even donate testing kits for free, which has greatly eased this dilemma. At the same time, the number of laboratories with testing qualifications is increasing, which has also accelerated the speed of sample testing.

 

Usually, a kit needs to go through multiple links such as research and development, production, and approval before it can be truly applied to patients, which takes about 2-3 years.

Coronavirus test kit infographics



In the face of the severe epidemic, the State Drug Administration has opened up a fast-track approval channel, shortening the process to about 5 days. 

So far, the Chinese State Food and Drug Administration has urgently approved 7 new coronavirus detection reagents. 

They are:

1. Shanghai Zhijiang Biotechnology Co., Ltd. – Novel Coronavirus 2019-nCoV Nucleic Acid Detection Kit (Fluorescent PCR Method)

2. Shanghai Jienuo Biotechnology Co., Ltd. – Novel Coronavirus 2019-nCoV Nucleic Acid Detection Kit (Fluorescent PCR Method)

3. BGI Biotechnology (Wuhan) Co., Ltd. – Novel Coronavirus 2019-nCoV Nucleic Acid Detection Kit (Fluorescent PCR Method)

4. BGI Biotechnology (Wuhan) Co., Ltd. – Novel Coronavirus 2019-nCoV Nucleic Acid Detection Kit (Combined Probe-Anchored Polymerization Sequencing) and Analysis Software

5. Sun Yat-Sen University Daan Gene Co., Ltd. – Novel Coronavirus 2019-nCoV Nucleic Acid Detection Kit (Fluorescent PCR Method)

6. Shengxiang Biotechnology Co., Ltd. – Novel Coronavirus 2019-nCoV Nucleic Acid Detection Kit (Fluorescent PCR Method)

7. Shanghai Berger Medical Technology Co., Ltd. – Novel Coronavirus 2019-nCoV Nucleic Acid Detection Kit (Fluorescent PCR Method)

 

In addition, a number of companies have also released the research and development progress of new coronavirus detection reagents.

 

What is Thermo Fisher Scientific Test Kit?

After the national emergency department announced the full sequence of the new virus particles, Thermo Fisher quickly responded and sorted out the relevant equipment and instruments for rapid detection of safety prevention and control, and sorted out a complete set of solutions to help decipher and prevent major epidemics. At the same time, Thermo Fisher quickly established a project team at the headquarters, and quickly invested in the development of suitable kits. 

The prototype product has been designed and finalized, and it is still in the clinical verification stage.

 

What is QIAGEN (Qiagen)?

With its leading expertise in viral nucleic acid extraction and subsequent detection and analysis, QIAGEN has developed a series of laboratory molecular detection technologies and products to achieve rapid and accurate detection and diagnosis of pathogens. 

It currently provides a complete set of solutions, including viral nucleic acid extraction, viral qualitative detection, Real-Time fluorescence quantitative PCR detection, and viral NGS analysis solutions.

In addition, QIAGEN is the first to release a sample preparation protocol for novel coronavirus in the digestive tract and environment.

 

What is Soworld Bio?

On January 13, 2020, based on fluorescent PCR technology, Shuoshi Bio developed a new coronavirus nucleic acid detection kit and a coronavirus universal nucleic acid detection kit.

It is reported that the new coronavirus detection reagent produced by the company is the first new coronavirus detection reagent qualified by the statutory inspection agency of Jiangsu Province.

As of January 28, it has been provided to about 350 CDCs and medical institutions in 29 provinces and cities. Reagents exceeded 500,000 copies.

 

What is Ed Bio?

On February 3, the first batch of 15,000 new coronavirus detection kits developed and produced by Aide Bio were officially packaged and sent to hospitals in Hubei, Shanghai, Guangdong, Shanxi and other places through cold chain logistics.

It is reported that Aide Bio currently has the capacity to produce 100,000 kits per week, and will continue to carry out mass production according to market demand. Aide Bio's new coronavirus detection kits will be donated directly to hospitals in need in a free form.

 

What is Parsono Bio?

Parsenor's novel coronavirus (ORF1ab/N gene) nucleic acid detection kit adopts the double fluorescent PCR method, which has advanced method and high detection reproducibility.

The high homology of the coronavirus ensures the specificity and sensitivity of the test; the test samples are suitable for a variety of different sample types in the upper and lower respiratory tracts, including throat swabs, nasal swabs, sputum, bronchial lavage fluid , bronchoalveolar lavage fluid, etc., can provide scientific and reliable detection support for clinical diagnosis in various situations.

 

What is Dark blue cloud creature?

Deep Blue Cloud Biotechnology and Beijing Micro Future Technology, based on the recommended regions of the National Center for Disease Control and Prevention and WHO, have developed ultra-sensitive digital PCR detection methods and rapid quantitative PCR detection methods for the four conserved sequences of the 2019 new coronavirus as detection targets.

At present, DeepBlue Cloud provides 5 sets of free trial Azure IRIS™ Real time PCR fluorescence quantitative system and free technical support services.

 

What is Perspective Life?

Vision Life has recently completed the development of new coronavirus nucleic acid detection products. This product adopts the cassette fluorescent PCR method, and all PCR extraction, preparation and amplification are completed in one cassette. 

The product can be randomly loaded, and can be tested immediately at the bedside or other open laboratories, and the results can be obtained after 1-1.5 hours. 

At present, the company is organizing personnel to carry out the clinical verification and registration application of the product.

 

What is Distant geneG?

Weiyuan Gene uses its own CRISPR pathogen diagnosis platform to design specific CRISPR detection sites and develop a "new coronavirus (2019-nCoV) nucleic acid detection kit (isothermal CRISPR method)". 

The gene editing tool innovative product CRISPR-nCoV has achieved high specificity, single-copy level sensitivity, and rapid 40-minute nucleic acid detection of the new coronavirus.




Author's Bio


Name: Gwynneth May

Educational Qualification: MBBS, MD (Medicine) Gold Medalist

Profession: Doctor

Experience: 16 Years of Work Experience as a Medical Practitioner

About Me


 

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