As the pandemic rages, spreads, and mutates, the demands on biopharma for treatments and the infrastructure built for disease response are intensifying rapidly.
The standard technique used for SARS-CoV-2 detection is predominantly Real-Time PCR (RT-PCR), which is both reliable and accurate. However, it faces several obstacles in serving the mass testing initiatives of governments during a global crisis like COVID-19. RT-PCR requires both a technician and the necessary logistics to get the sample to and from the lab. However, in the case of a rapidly spreading and mutating virus, any alternative that minimizes labor requirements must be availed.
In recent months, several point-of-care (POC) tests have emerged around the world facilitating the quick and easy tracking of infections and inform people when they need to get treatment. A POC test is able to provide nearly immediate (3-15 minutes) feedback. But whether or not the testing device is accessible to the patient or the test still requires the mailing of samples to a lab will eventually determine the speed of POC obtained test results.
Point-of-Care: Technical Details
According to the FDA, the primary forms of POC tests are molecular, nucleic acid, serology, and antigen-based tests.
Molecular-based tests consist primarily of RT-PCR with a feature allowing for home sample collection. These tests, while still very similar to the original, do have the benefit of limiting contact between patient and lab and thereby reduce the likelihood of spreading the virus.
Nucleic acid-based tests work by detecting the RNA that makes up the genome of the SARS-CoV-2 virus while antigen-based are meant to detect surface proteins from the virus. Nucleic acid-based POC tests are incredibly specific but suffer from problems of false negatives due to the fragility of nucleic acids. Alternatively, there are POC tests that use proteins (antigen-antibody pairs) to detect viral presence.
These pairings are more robust (due to the natural function of antigen-antibody pairs) and so are more likely to survive being carried around by the average person and not being destroyed. This category of tests has the most EUA approvals for entirely home-based testing.
POC tests have a variety of means of displaying results. This can range from color change to a wide variety of electrical properties that shift due to the nucleic acid or protein interacting with the POC test.
So far, the FDA has granted EUAs to 32 nucleic acid-based diagnostic tests and 15 antigen-antibody-based tests to accompany the multiple hundreds of RT-PCR testing kits that have been granted authorization since the beginning of this pandemic. However, out of them, only four, all antigen-antibody tests are actually approved for effective use in the home without assistance from an approved lab. While being able to collect the sample at home is still beneficial, requiring a lab and qualified personnel to carry out the testing procedure limits the speed and convenience provided by POC tests. To ensure the efficacy of these tests, three have the ability to be used for serial screening (routine testing of asymptomatic individuals for SARS-CoV-2).
Table 1: POC Tests Authorized for Home Usage
Authorized settings of the POC tests include the following:
- H – Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.
- M – Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform moderate complexity tests.
- W – Patient care settings operating under a CLIA Certificate of Waiver.
- Home – At home, outside of a lab
While only four test kits out of hundreds have been approved for home use and completely avoid the need for the patient to get outside assistance the market is still churning out innovations for convenience and safety in viral testing.
Table 2: Recently Approved Tests
The Point-of-Care test market was estimated to grow to $40 billion by 2026 in 2019 before COVID-19. With the sudden need and incredible influx of working capital, the POC test market will likely grow to $40 billion long before 2026. Giving consumers the ability to quickly and easily self-diagnose and take precautionary measures is one of the best defenses against future pandemics. It is important to avoid crowded waiting rooms and contact with other sick people during a pandemic. POCs ensure that this can happen without reducing the number of testing and diagnosis.
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