IVD market trends in Covid-19 pandemic

IVD Market Trends in Covid-19 Pandemic

Through our global presence and a customer network of more than 1,000 IVD companies, we at Medix Biochemica are in a unique position to monitor and experience global IVD market trends very closely in our business. During this exceptional year, we have seen faster changes in market demands than never before. We want to support the global diagnostics industry not only with essential raw materials but also with information and knowhow gained in the field. In this article, we want to share some of our recent learnings on the latest market trends.

All testing methods co-exist, with different roles to play in the healthcare systems

The first trend we observed in IVD during the early stages of the pandemic was the increased need for raw materials for serology testing, i.e. detection of patients’ antibodies against the SARS-CoV-2 virus. This market need is still evident, but the highest demand for serology testing has lately been moving away from acute healthcare settings to population-wide epidemiological studies, patient recovery monitoring, donor identification for convalescent plasma, and vaccine development 1, 2, 3. Product quality has become a major concern in serology testing, with FDA recently evoking the emergency use authorization (EUA) for certain COVID-19 antibody tests based on unsatisfactory clinical performance results 4. Serology test development thus continues very active around the world for high sensitivity and specificity, and result in reproducibility 5, 6. According to our experience, this will also emphasize the need for high purity raw materials, such as antigen proteins and detection antibodies, used in the tests.

For acute healthcare settings, viral RNA or antigen detection tests are recommended over antibody detection tests 7, 8, 9. Viral RNA is detected by reverse-transcriptase quantitative PCR, RT-qPCR, whereas viral antigens are detected by immunodiagnostic methods utilizing antibodies recognizing viral proteins. Currently, most tests on the market are based on RT-qPCR, as the design and synthesis of new primer sequences for PCR is a faster process than antibody development and optimization for immunodiagnostic tests 4. However, multiple immunodiagnostic testing workflows are widely adopted in hospitals and clinics globally, and those often offer a fast implementation path to adding new tests. Combined with their ease-of-use and short time-to-results, this creates a strong market need for immunodiagnostic SARS-CoV-2 antigen detection tests, and the first such tests have recently been approved by the FDA 4. Most immunodiagnostic testing platforms already host assays for the detection of influenza viruses, and based on feedback from our customers, we are now seeing a trend towards respiratory panel development in antigen detection: active development work is on-going to develop combination antigen tests for the combined detection of influenza A, influenza B, and SARS-CoV-2 viruses.

Other diagnostic tests that are not specific for SARS-CoV-2 can also be used in conjunction with the methods above to support assessing the disease status of COVID-19 patients. These are based on clinical manifestations and include hematology tests such as white blood cell counts, various metabolic panels, and tests for liver and kidney markers. Based on scientific literature and our feedback from IVD manufacturers, especially the inflammatory markers, such as C-reactive protein (CRP), serum amyloid A (SAA), interleukin-6 (IL-6), ferritin, procalcitonin (PCT), and lactate dehydrogenase (LDH), are actively being used to predict the risk of severe hyperinflammatory reaction in COVID-19 patients 10, 11. Cardiovascular biomarkers D-dimer and cardiac troponin are also very often assessed 11, 12. These play a significant role when healthcare professionals make decisions on the treatment and monitoring of patients with COVID-19.

References:

  1. Centers for Disease Control and Prevention (CDC), Interim Guidelines for COVID-19 Antibody Testing in Clinical and Public Health Settings, Updated Aug. 1, 2020. https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antibody-tests-guidelines.html. Accessed Aug. 31, 2020.
  2. Yang HS, Racine-Brzostek SE, Lee WT, et al., SARS-CoV-2 antibody characterization in emergency department, hospitalized and convalescent patients by two semi-quantitative immunoassays. Clin Chim Acta (2020) 509:117-125. doi:10.1016/j.cca.2020.06.004
  3. Folegatti PM, Ewer KJ, Aley PK, et al., Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial, The Lancet (2020) 396:467-478. https://doi.org/10.1016/S0140-6736(20)31604-4.
  4. U.S. Food and Drug Administration (FDA), Emergency Use Authorization (EUA) information, and list of all current EUAs https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization. Accessed Aug. 31, 2020.
  5. Dzimianski JV, Lorig-Roach N, O’Rourke SM, et al., Rapid and sensitive detection of SARS-CoV-2 antibodies by biolayer interferometry. medRxiv 2020.07.17.20156281; doi: https://doi.org/10.1101/2020.07.17.20156281. Accessed Aug. 31, 2020.
  6. Liu B, Li J, Tang X, et al., Development of a quantum-dot lateral flow immunoassay strip based portable fluorescence smart-phone system for ultrasensitive detection of IgM/IgG to SARS-CoV-2. medRxiv 2020.07.21.20159392; doi: https://doi.org/10.1101/2020.07.21.20159392. Accessed Aug. 31, 2020.
  7. Centers for Disease Control and Prevention (CDC), Overview of Testing for SARS-CoV-2 (COVID-19), Updated Aug. 24, 2020. https://www.cdc.gov/coronavirus/2019-ncov/hcp/testing-overview.html. Accessed Aug. 31, 2020.
  8. European Centre for Disease Prevention and Control (ECDC), Diagnostic testing and screening for SARS-CoV-2, https://www.ecdc.europa.eu/en/covid-19/latest-evidence/diagnostic-testing. Accessed Aug. 31, 2020.
  9. Wei P-F (Editor), Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 7), Chinese Medical Journal (2020) 133:1087-1095 doi: 10.1097/CM9.0000000000000819
  10. Manson JJ, Crooks C, Naja M, et al., COVID-19-associated hyperinflammation and escalation of patient care: a retrospective longitudinal cohort study, The Lancet Rheumatology, 2020 ISSN 2665-9913, https://doi.org/10.1016/S2665-9913(20)30275-7.
  11. Kermali M, Kaur Khalsa R, Pillai K, et l., The role of biomarkers in diagnosis of COVID-19 – A systematic review, Life Sciences (2020) 254: 117788. https://doi.org/10.1016/j.lfs.2020.117788.
  12. Yao Y, Cao J, Wang Q, et al., D-dimer as a biomarker for disease severity and mortality in COVID-19 patients: a case control study, J Intensive Care 8, 49 (2020). https://doi.org/10.1186/s40560-020-00466-z