Coronavirus Diagnostic Test – COVID 19 Test Kits

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The laboratory diagnostic tests for coronavirus or COVID 19 includes molecular tests and serology tests. As per World Health Organization (WHO) and Centers for Disease Control and Prevention (CDC), laboratory testing for Middle East Respiratory Syndrome Coronavirus (MERS-CoV) is conducted by close cooperation between the central, state and local health departments.

Coronavirus Diagnostic Test

Diagnostic testing for coronavirus is undertaken using two different approaches, including, Whole Genome Sequencing and Real-Time Reverse Transcriptase PCR (RT-PCR). Sequencing was used in the early days of the outbreak for early documentation of this novel virus and is an instrument of viral discovery. Currently, nearly all diagnostic testing for CoV is done using RT-PCR.

Current testing methods are considered precise, but authorities have limited testing to central health agencies or a few credited laboratories, limiting the ability to quickly identify new cases. These situations are driving a commercial race to develop new COVID-19 tests involving the rapid collection and testing of suitable specimens from patients meeting the definition for COVID- 19.

Clinical and outbreak control should be guided by a laboratory expert where suspected cases must be vetted for the virus with Nucleic Acid Amplification Tests (NAAT), such as RT-PCR. The decision to test must come from clinical and epidemiological factors and linked to a calculation of the likelihood of infection. PCR testing can be considered in the assessment of persons who have had contact with a COVID- 19 case.

Specimen Collection

The process of specimen collection includes following steps:

1. Safety during specimen collection

Ensure that safe collection mechanisms are in use and that the workforce is trained for suitable specimen collection, storage, packaging, and transport. Specimens collected for investigations must be regarded as possibly infectious.

2. The specimen to be collected

Mostly respiratory material must be collected, either upper respiratory or lower respiratory specimens. Apart from this additional medical specimen may be collected as the virus had been seen in blood and stool.

3. Packaging and shipment of Clinical Specimen

Correct handling and its storage in 2-8 degrees Celsius is necessary. Transport of the specimen within national borders should comply with applicable national regulations. Internationally the UN Model Regulations and any other applicable regulations must be followed depending on the mode of transport.

Coronavirus Laboratory Testing

Labs carrying out the testing for the COVID-19 virus should follow strict biosafety practices. NAAT detects the unique sequence of the virus RNA such as real-time reverse-transcription polymerase chain reaction (RT-PCR) with confirmation to nucleic acid sequencing when necessary. The lab testing includes following steps:

1. Determining Confirmation

To consider a case as confirmed, the following needs to be ensured in countries where the virus is not prevalent. A positive NAAT result for at least two different targets on the genome, of which at least one target is likely more specific, or One positive NAAT result for the presence of beta coronavirus, and COVID- 19 is further recognized by sequencing the genome of the virus. For laboratories testing for countries where the virus was circulating, WHO advises testing results for the first 5 positive specimens, or, the first 10 negative specimens (collected from patients that fit the definition) by referring them to one of the WHO laboratories providing assenting testing. For national COVID-19 laboratories that need support with specimen shipment to one of the laboratories for testing confirmation, a WHO shipment fund is made available.

2. Serological testing

Serological surveys can help the investigation of an ongoing outbreak and retrospective assessment of. In cases where NAAT assays are negative and there is a strong epidemiological connection to COVID-19 infection, paired serum samples can support diagnosis once validated tests are accessible. Serum samples can be stored for these purposes.

3. Viral sequencing

In addition to providing confirmation of the presence of the virus, sequencing of a percentage of specimens from clinical cases is valuable to monitor for viral genome mutations that may affect the performance of medical countermeasures, including diagnostic tests. Virus genome sequencing can also inform molecular epidemiology studies.

4. Viral culture

Virus isolation is not recommended as a diagnostic procedure.

Coronavirus Diagnostic Test Kits

Various companies worldwide are manufacturing the coronavirus diagnostic test kits, including:

(a) GenMark Diagnostics, Inc.- ePlex Research Use Only (RUO) test kits is provided by GenMark and the company plans to use this information to support submission of an Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) for the ePlex SARS-CoV-2 test to address the virus.

(b)  BioFire Diagnostics – Film Array® Respiratory (RP & RP2) Panels, also known as the BioFire Respiratory Panels, are tests made to help clinicians quickly diagnose respiratory infections, which add up to a significant healthcare burden and present with nearly indistinguishable symptoms.

(c)  Cephied Inc.– This company as announced development of a test for the Coronavirus Strain (2019-nCoV). The test will be designed for use on any of its 23,000 GeneXpert Systems placed worldwide and is likely to deliver point-of-care results in about 30 minutes.

(d)  Meridian Biosciences creates a “Master Mix,” that works as the building blocks for rapid testing of the coronavirus. The kit tests RNA similar to how tests are done for influenza. The test kits, which are assembled in China after the Master Mix is shipped from Germany, can produce test results in 45 minutes to an hour.

Patent Protection

Excluding the public health emergency situation wherein the coronavirus is being considered as a pandemic, medical device companies generally opt for patent protection of their innovations. This helps the innovators to bear the costs associated with research and development efforts.

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Advocate Rahul Dev is a Patent Attorney & International Business Lawyer practicing Technology, Intellectual Property & Corporate Laws. He is reachable at rd (at) patentbusinesslawyer (dot) com & @rdpatentlawyer on Twitter.

Quoted in and contributed to 50+ national & international publications (Bloomberg, FirstPost, SwissInfo, Outlook Money, Yahoo News, Times of India, Economic Times, Business Standard, Quartz, Global Legal Post, International Bar Association, LawAsia, BioSpectrum Asia, Digital News Asia, e27, Leaders Speak, Entrepreneur India, VCCircle, AutoTech).

Regularly invited to speak at international & national platforms (conferences, TV channels, seminars, corporate trainings, government workshops) on technology, patents, business strategy, legal developments, leadership & management.

Working closely with patent attorneys along with international law firms with significant experience with lawyers in Asia Pacific providing services to clients in US and Europe. Flagship services include international patent and trademark filingspatent services in India and global patent consulting services.

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