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The evolution of healthcare in the era of COVID-19

During the last 20 years, the world has seen multiple viral outbreaks that include severe acute respiratory syndrome (SARS-CoV), Middle-East respiratory syndrome (MERS-CoV), Zika virus, Ebola virus, and the latest novel coronavirus (n-CoV). The ongoing pandemic of novel coronavirus disease 2019 (COVID-19) has created a worldwide threat to public health with striking short-term and long-term impacts on the healthcare ecosystem.

Since the last few decades, non-communicable diseases have been a predominant cause of burden over our healthcare system but of late SARS-CoV-2 has changed this equation in favor of infectious diseases. Importantly, the current pandemic has brought to trial many aspects of healthcare systems, especially their overall preparedness to cope with sudden intense surge in demand. The currently available public health surveillance programs and infrastructure appeared unable to support and handle the sudden upsurge and enduring pressures. It is a well-understood fact that we are going to live with SARS-CoV-2 for quite some time now. The whole scenario demands us to understand the importance of disease prevention, multi-disciplinary assessment at the initial presentation, remote care, precision medicine as an approach for disease treatment, transformation of healthcare from volume-based to value-based approach, substantial technological dependence, and decentralization of medical diagnostics to bring healthcare delivery closer to home.

COVID-19 in itself has been a dilemma because of arrant and confusing presentation of the disease. The patients include asymptomatic carriers, subjects with mild symptoms, and cases with fulminant disease characterized by sepsis and acute respiratory failure. The outbreak of COVID-19 on the now infamous Diamond Princess Cruise made us recognize the role of asymptomatic and pre-symptomatic subjects in the transmission of SARS-CoV-2. It also highlighted the fact that SARS-CoV-2 can be detected only by molecular assays (gold standard) and brought the focus on RT-PCR testing across the world. It brought to forefront the importance of laboratory testing and raised awareness about the significant role played by medical laboratories in diagnostic reasoning and management of suspected and confirmed cases of COVID-19 infection. Further evidence also pointed to the essential contribution these tests made in etiological diagnosis and epidemiological surveillance.

During the initial days, a significant challenge was the availability of accurate and approved testing solutions. According to a survey by American Society for Clinical Chemistry in the year 2020, around 70 percent of the labs were unable to procure necessary supplies to run their molecular labs. Moreover, around half of the respondent labs in the above survey failed in procuring the approved testing kits. In order to overcome this, the US in 2020 adopted an emergency use authorization (EUA) grants under FDA to expedite the development, validation, and deployment of diagnostics solutions during the COIVD-19 emergency. Indian molecular diagnostic market, which was primarily dependent on international players for their molecular diagnostics solutions, also struggled a bit during March-April, 2020, but subsequently evolved significantly in accordance with the changing scenario. The pandemic had raised an unexpected need for consolidated and innovative testing solutions from the local diagnostic players, and offered an opportunity to exhibit their capabilities. The indigenous players responded diligently to the market needs and to the clarion call of Atmanirbhar Bharat given by our honorable PM during the 2020 lockdown. Indian Council of Medical Research, which was given the important task of controlling and ramping-up the COVID-19 diagnostics capabilities of the country during this pandemic, also took the challenge head-on and started evaluating and approving the locally manufactured COVID-19 RT-PCR kits. Till today, they have tested approximately 374 RT-PCR kits and have approved approximately 168 companies for RT-PCR kits, which include a significant number of Indian manufacturers.

During such pandemics when public health warrants large scale testing, these significant steps taken by the government helped ease the pressure of procurement from international markets, and gave a boost to local manufacturing thus making the reagents available at a very competitive pricing. Easy access to accurate diagnostic tests with speed of reporting helped in effective screening and control of the spread of COVID-19 infection. The early introduction of rapid antigen cards was an additional tool in the fight against COVID-19. Use of rapid antigen card proved to be an advantage in screening as it did not need expertise and could be used in field testing as a point-of-care-testing tool. During the initial days of their introduction, the uncertainty of testing and poor perforce of these cards did become an issue. However subsequent lateral flow assays had an improved PPV of approximately 95 percent, but this warranted an authorization of correctly evaluated and validated methods in order to make best use of available resources during the pandemic.

COVID-19 has dramatically increased awareness about the role of laboratory medicine and in turn raised the public demand for tests that concern diagnosis, prognosis, monitoring, theronostics, precision medicine, and epidemiological surveillance. The current demand of market dynamics is a better amalgamation of different faculties of laboratory medicine. These inter-specialties collaborations would trigger the initiatives for newer, better, and innovative approaches for rapid and highly sensitive diagnosis of SAR-CoV-2. The introduction of digital droplet PCR, isothermal PCR, and CRISPR technologies is an indication that the need for more and better testing tools is being taken seriously. The new assays are being developed with a target to improve the overall accuracy and reduce false negativity. Some forms of isothermal PCR and CRISPR-Cas12a with RT-recombinase polymerase amplification (RT-RPA) reaction allows direct detection of SARS-CoV-2 from sample eliminating the need for RNA extraction and dedicated thermocycler. The initial data shows that these can prove to be excellent POCT devices as the PPV and NPV are 100 percent in comparison to conventional RT-PCR testing.

In addition to currently used RT-PCR, CLIA, ELISA, lateral flow assays, other technologies that are being extensively explored for COVID-19 diagnostics include Matrix assisted laser desorption/ionization time of flight mass spectrometry (MALDI-TOF-MS), RT-LAMP, Gas-Chromatography-ion-mobility spect, multiplexed nano material-based sensors. Innovation and interesting developments to diagnose COVID-19 are also taking into consideration the urgent need for sampling strategies that are non-invasive/less-invasive and painless. The use of saliva and exhaled breath concentrate is being actively pursued. Volatile organic compounds are the active targets of breath tests whereas saliva can be used as an alternate to nasopharangeal/oropharangeal swabs as it is non-invasive, entails no patient discomfort, cost-effective, easy collection, easy storage, easy shipping, and is suitable for children, disabled, and elderly individuals.

The COVID-19 pandemic has brought significant changes in the clinical practice and has called for a reality check for many aspects of healthcare delivery in times when months are being spent in safety of home and in-person clinical examinations are being cancelled in accordance with the rules imposed by the local governments from time to time. In the absence of face-to-face services, unfamiliar approaches, such as remote care, telemedicine services, and electronic diaries, which were predominantly used during emergencies and crisis, are now being widely used in large-scale screening of patients prior to their visit, triage assessment, in routine monitoring of patients at home, for remote clinical encounters, and to enable patients to receive supervised medical care by off-site experts. This system evolution is likely to continue in post-COVID-19 era.

With COVID-19, even the diagnostics in India is progressing from Tier-I to Tier-II and Tier-III cities. With this, there is a whole lot of rural population, which over time has developed a lot of expectations from the current healthcare system. Additionally, the growing list of corporates in diagnostics are getting desperate to increase their market share. This will force them to look for greener pastures that would move them into deep territories beyond the cities, with an additional challenge to utilize the available funds in an effective and efficient manner. The future of diagnostics would not be complete without the inclusion of precision medicine and artificial intelligence. AI is being currently successfully used in laboratory medicine for enabling the effective use of reagents and manpower. The smart system organizes the inventory and helps in avoiding unnecessary tests. Decentralization of diagnostics would be a focal point for healthcare delivery in the post-COVID-19 era. There would be unprecedented push and support for point-of-care testing as decentralized diagnostics would lead to improved patient outcomes and benefit the healthcare economy. Primary care network hubs, local care centers, paramedics, community clinics, mobile units, and many other point-of-care setups are the opportunities available to disrupt the conventional healthcare pathways. Of these mobile care unit is a model that can make diagnostics available to a large number of people, providing great convenience. The mobile units were being planned extensively to be used in rural health mission but of late a few of the state governments along with some private diagnostic players have collaborated for COVID-19 mobile testing units. The projects are being run successfully and aim to provide improved accessibility as well as prompt and localized diagnostic services during the COVID-19 pandemic.

Teaching often comes the hard way and COVID-19 crisis has given an opportunity to the healthcare sector to think a lot about, to explore innovative methods, to ignore all perceived boundaries, evolve to improve, and create new normal by virtue of change to provide personalized patient care!

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