COVID-19 Impact on Immunoassay in Healthcare Industry | DBMR

Posted by Rajesh on April 15th, 2021

COVID-19 Impact on Immunoassay in Healthcare Industry

The Coronavirus (COVID-19) pandemic is having a dramatic impact on the immunoassays as numbers of immunoassays have received approval for diagnostic use for COVID-19 pandemic, utilizing assays like ELISA and lateral flow. Currently, PCR and immunoassays are the only means for diagnosis of COVID-19 used by the healthcare professionals in order to detect the spread of Coronavirus across the globe.

Moreover, immunoassays demonstrate some distinct benefits over PCR. Antigens and antibodies are slightly more robust than RNA, rendering them less vulnerable to spoliation during transport and storage, thereby reducing the risk of false-negative outcomes. The quality in research is often improved by the reality that antigens and antibodies are found more consistently in sputum and blood samples. The virus has spread across all regions ranging from North America, Europe, Asia-Pacific, Middle East and Africa up to South America.

The COVID-19 has been declared as a pandemic by WHO due to its increased spread across the globe. After the declaration of the pandemic, various countries announced the complete lockdown such as the U.S., Germany, India, China among others in order to decrease its spread. The lockdown of countries aids in surging of use of immunoassays diagnostic kits in order to screen patients suffering from Coronavirus. According to the situation, the report of 5th August 2020 by WHO stated 18,354,342 cases of Corona has been reported globally and 696,147patients are dead due to the Coronavirus.


Exponential rise in globally occurring Coronavirus cases is increasing the demand for diagnostic kits for immunoassays. The reasons responsible for the growth in diagnostic demand include rising market appetite for serology-based rapid-test products, a favorable regulatory climate for drug creation and marketing, as well as a substantial rise in target patient population. Because of these factors, different market players were prompted to improve and enhance their current production and distribution capabilities and focus on upgrading and marketing of their product.

Immunoassay is the method of choice for the diagnosis of patient with Coronavirus as major point-of-care testing kits are based on antigen – antibody interaction or immunoassay based. Moreover, the pandemic has led to significant rise in demands for reagents used in immunoassay testing in the recent months, leading to shortages in reagents required for perform the key steps in the testing process such as buffers and test reagents among more.

Immunoassay-based kits manufacturers have taken huge initiatives to enhance patient access to Coronavirus diagnostic testing in laboratories, hospitals and other test sites around the globe to support patient care and improve human health.

The companies listed below developed serology testing based on immunoassay that gained Emergency Use Authorization from the U.S. FDA:

  • Abbott: SARS-CoV-2 IgG assay
  • Autobio Diagnostics Co.: Anti-SARS-CoV-2 Rapid Test
  • Bio-Rad Laboratories, Inc.: Platelia SARS-CoV-2 Total Ab Assay
  • Cellex: qSARS-CoV-2 IgG/IgM Rapid Test
  • Chembio Diagnostic Systems, Inc.: DPP COVID-19 IgM/IgG System
  • DiaSorin: LIAISON SARS-CoV-2 S1/S2 IgG
  • Healgen Scientific, LLC: COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)
  • Ortho Clinical Diagnostics: VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack; VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack Read more…

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