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PCR Detection Kit Development Service

PCR Detection Kit Development Service

Leveraging the deep domain expertise of its IVD Kit developers, Creative Biogene has rapidly developed and manufactured nucleic acid-based detection kits for both local and international partners and clients. Creative Biogene offers full-cycle development services for in vitro diagnostic (IVD) kits and assays from sample preparation and sample matrix to data analysis that can be seamlessly adapted to your project requirements.

Among various disease fields, infectious diseases have the highest demand for detection kits. Infectious diseases are becoming increasingly difficult to manage. Now more than ever, clinical laboratories throughout the world desperately need access to molecular diagnostic tests that can be performed at scale. Rapid and accurate diagnostics can identify infected individuals and facilitate patient care, effective infection control measures, and contact tracing. Although the landscape of diagnostics is rapidly evolving, molecular diagnostics for the detection of nucleic acids of pathogens have become the basis for a range of assays aimed at detecting pathogens in clinical samples, in part due to their reliability, flexibility, and wide application.

A multiplex rRT-PCR assayFig.1 A multiplex rRT-PCR assay

With deep domain expertise and state-of-the-art facilities in molecular IVD assay development, we can develop and verify a working diagnostic assay in a timely manner for our clients.

Project Workflow of In vitro Diagnostic Kit Development

Step 1: Feasibility evaluation
Step 2: Designs and proposals
Step 3: Kit/assay development
Step 4: Validation
Step 5: Product/Project Transfer

The advantages of our outstanding quantitative RT-PCR kit development service:

  • Customizability
  • High quality
  • Consultative service
  • Profession

Turnaround Time of PCR Assay Development

In general, our turnaround time is 4-6 weeks depending on the scale of your project.

If you are interested in any of our services or have a specific assay you want to develop, please contact us and we would be happy to help. Our knowledgeable team will provide you with a highly competitive quote with realistic turnaround times. To know more about how our experienced team can facilitate your work, please feel free to contact us.

References:

  1. Tombuloglu, H., Sabit, H., Al-Khallaf, H. et al. Multiplex real-time RT-PCR method for the diagnosis of SARS-CoV-2 by targeting viral N, RdRP and human RP genes. Sci Rep 12, 2853 (2022).
  2. Anahtar, M. N. , Shaw, B. , Slater, D. , Byrne, E. H. , & Turbett, S. E. . Development of a qualitative real-time rt-pcr assay for the detection of sars-cov-2: a guide and case study in setting up an emergency-use, laboratory-developed molecular assay. medRxiv : the preprint server for health sciences, 2020.08.26.20157297.
* For research use only. Not intended for any clinical use.
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