Covid-19 Impact on Immunoassay in the Healthcare Industry
The coronavirus disease epidemic stresses the need for a simple and reliable test tool to identify and diagnose the target virus. Improved urgent need for the successful production of drugs and vaccines to curb COVID 19 spread is the advancement of the accelerated process, including immunoassay.
Impact of price: The need for a COVID 19 research immunoassay kit prompted the government of the country to lower the price of the tests in order for individuals with economic status to allow these tests to be carried out on their own. Some of the immunoassay kits have also been shipped from different parts of the world, but importations of test kits have also stopped due to a ban and a lockout across borders. In addition , the production of immunoassay kits has also prompted price cuts in the country itself.
Immunoassay procedures are available at government laboratories to diagnose viral antigen and associated immunoglobulin and this has contributed to a further decline in costs of kits. Two types of COVID detection tests have been validated, one molecular test and the other immunological test. However, because molecular diagnostic tests, for example PCR, can not be used to track the stage of development of the disease, immunological evaluations are very important. Sources are: The ICMR fee is USD (Indian Rupees 4 500) in private immunoassay laboratories. As a result, the price of immunoassays kits and associated goods will be lowered because of the COVID 19 pandemic while the sales of drugs will rise.
Impact on Demand It has been documented that RT-PCR-based viral RNA detection tests are commonly used for COVID-19 diagnosis but there is a great need for immunological assays to track disease progress and distinguish different stages. The findings of immunological studies play an significant role in the production of vaccines, which will again boost the market for immunoassay studies. Lateral immunoassay on the flow is one of the fast diagnostic tests used to detect viral antigens within 10-30 minutes. It is also an inexpensive test and does not require any trained staff to carry out the study. Both of these factors boost the need for immunoassay tests once again. ELISA test can also be used for viral portion detection. ELISA is compatible with various types of samples which increase their COVID 19 test demand. In addition it is ideal for identification of the point of treatment. In excessive use for COVID 19 diagnosis, luminescent immunoassay has been documented and manufacturers are also taking measures to meet such that demand. For example, Cai et al . developed an immunoassay of peptide-based magnetic chemiluminescence enzyme for COVID detection -19 In addition , rising COVID-19 prevalence all over the world is also responsible for growing demand for immunoassay kits.
Figure1: Number of Laboratory Confirmed COVID-19 Cases
P OS T COV ID -19 CH ALLE NG ES AND OPP ORT U NIT I ES IN -D EPT H REP O RT AV AILABLE H ERE
Supply Chain Impacts: Because of the persistent outbreak of COVID-19, multiple restrictions have been imposed by government bodies from many countries that include, among others, ban across the country's borders. Such limitations led to a shortage of immunoassay kits in the market. Although such lockdown Indian government has allowed the importation of some kits used to detect coronavirus immunoassay. Abbott Healthcare and Roche Diagnostics obtained clearance for the import of immunoassay kits according to the study published in May 2020. This approval requires the importation of immunoassay kits with chemiluminescent effect. This measure by the Indian government helped hold a continuous supply chain in the midst of COVID-19. This signifies that several strategic initiatives by different manufacturers in order to fight against novel coronavirus, fuel up the market growth. 
Presence of large number of Immunoassay kits are helping the doctors and scientist to get an optimal solution as per their need, which again led to increasing growth of the market
TABLE 1. DIFFERENT TYPES OF IMMUNOLOGICAL TESTS USED FOR DETECTION OF VIRAL ANTIBODIES FORMED AGAINST SARS- CoV-2 VIRUS Test Name
Test Type
Manufacturer
m2000 SARS-CoV-2 assay
chemiluminescent microparticle immunoassay
Abbott Laboratory
COVID-19 IgG/IgM LF
lateral flow immunoassay
Advagen Biotech
serum/plasma/whole blood
COVID-19 IgM/IgG rapid test
lateral flow immunoassay
BioMedomics
serum/plasma/whole blood
One-Step COVID-2019 test
lateral flow immunoassay
Celer Biotechnologia
serum/plasma/whole blood
qSARS-CoV-2 IgG/IgM rapid test
lateral flow immunoassay
Cellex Inc.
serum/plasma/whole blood
DEIASL019/020 SARS-CoV-2 IgG ELISA kit
ELISA
Creative Diagnostics
serum/plasma
CTK Biotech Inc. (USA)
serum/plasma/whole blood
OnSite COVID-19 IgG/IgM lateral flow immunoassay rapid test P OS T COV ID -19 AV AILABLE H ERE
CH ALLE NG ES
AND
O PP O RT U NIT I ES
Sample Sources
Core
IN -D EPT H
serum/plasma/whole blood
REP O RT
Depending on the data given in the table, there is a large range of products available to conduct immunoassays, this paves the way for manufacturers to gain more product profits, which will fuel business growth once more.
Standing Orders: Despite the COVID -19 outbreaks, the FDA and other regulatory bodies have relaxed various regulations associated with the launch of the immunoassay test kit due to the growing demand for rapid coronavirus detection tests. FDA is aware that many manufacturers are designing coronavirus immunoassay tests with the intention of submitting an Emergency Use Authorization (EUA) to FDA. When the need for such a test grows, FDA is not intended for fair testing of specimens, which consumes a lot of time. During this pandemic FDA ensures these test kits are distributed to all labs, hospital property, and other facilities that need it. In addition, FDA operates 24 * 7 to help laboratories and research creators, so that at this critical moment, the manufacturers can distribute immunoassay test kits throughout the different countries. The European Commission released a directive in April concerning medical devices used for coronavirus research. According to the directive launched in April when an assay meets all the criteria of the directive launched by the European Commission, there is no need for the manufacturer to obtain a CE mark for this assay.
Conclusion: The COVID 19 pandemic has led to an urgent need for coronavirus identification to advance the disease stage and create a novel vaccine that can be used with immunoassay kits to easily detect coronavirus-formed antibodies. This led to increased demand for immunoassay kits and boosted immunoassay market growth. Specific forms of bans have resulted in a shortage of drug supplies that are supposed to impede market development, but policy policies related to product import and investment by some authorities have helped manufacturers sustain the supply chain of immunoassay items. This is also expected to drive market growth by increasing the prevalence of COVID-19 and the availability of immunoassay products. In addition, regulatory authorities endorse authorisation for approval and emergency use of immunoassay products to help market players achieve a lucrative development.
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