SARS-CoV-2 In Vitro Diagnostic (IVD) Reagent Development Platform

The outbreak of a new coronavirus (SARS-CoV-2) is driving China’s urgent public health actions, as well as an international concern. Infection prevention and control through diagnostic testing and quarantine has become critical. Creative Biolabs offers an in vitro diagnostic (IVD) reagent development platform for improved detection and control of SARS-CoV-2.

Introduction to Coronaviruses and SARS-CoV-2

SARS-CoV-2 In Vitro Diagnostic (IVD) Reagent Development Platform

Coronaviruses (CoVs) are enveloped positive-sense RNA viruses, which are characterized by club-like spikes projecting from its surface. They are important pathogens capable of infecting respiratory, gastrointestinal, hepatic, and central nervous system of human, livestock, avian, and many wild animals. The possibility of CoVs transmission from animals to human has been proved since the outbreaks of the severe acute respiratory syndrome (SARS) in 2002 and the Middle East respiratory syndrome (MERS) in 2012, and more recently in December 2019–January 2020 of a novel Coronavirus (SARS-CoV-2).

SARS-CoV-2 is a new member of the genus Betacoronavirus. Its origins have traced back to the seafood wholesale market in Wuhan, China. Resulting from the human-to-human transmission, the number of cases of SARS-CoV-2 infections in China is rising dramatically and also worldwide. At present, SARS-CoV-2-specific therapies and vaccines are under development and the main treatments are supportive.

Increasing Need for SARS-CoV-2 Diagnostics

Early diagnosis is quite important for control of SARS-CoV-2 infection and life-saving. However, because SARS-CoV-2 is a newly discovered virus, the spectrum of the available diagnostic tools is tight. At present, the confirmation of SARS-CoV-2–infected pneumonia is based on both (fever or respiratory) symptoms, traveling and contact history, and laboratory testing. In the laboratory, SARS-CoV-2 can be detected in human clinical specimens by next-generation sequencing, real-time RT-PCR, cell culture, and electron microscopy. The current situation necessitates the development of diagnostic assays with good sensitivity and specificity for SARS-CoV-2.

SARS-CoV-2 IVD Reagent Development Platform

Reliable diagnostic kits on a large scale are increasingly needed. Creative Biolabs has established a SARS-CoV-2 IVD reagent development platform to aid companies and research institutes in the development of coronavirus reagents and assays. We offer support in:

1) SARS-CoV-2 IVD Antibody & Immunoassay Development Services

  • Production of antibodies/antigens that can be used for serological testing for SARS-CoV-2
  • Immunoassay design, development, validation, and manufacturing

2) Molecular Diagnostic Kit Development Services for Detection of SARS-CoV-2

  • Molecular diagnostic assay development using different technology platforms
  • Support in feasibility analysis, assay design, assay protocol establishment, validation, and kit production

Features of our Services

  • Years of experience in antibody/immunoassay development
  • Expertise in multiple molecular diagnostic technology platforms
  • Prompt response, ongoing communication, and regular updates
  • Services tailored to meet the exact needs of our valued clients

Please feel free to contact us to learn more about our services and platforms.


  1. Li, Q.; et al. Early Transmission Dynamics in Wuhan, China, of Novel Coronavirus–Infected Pneumonia. New England Journal of Medicine. 2020.
  2. Phan, T. Novel coronavirus: From discovery to clinical diagnostics. Infection, Genetics and Evolution. 2020: 104211.
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