Molecular Diagnostic Assay Development Services for Detection of SARS-CoV-2
The ongoing outbreak of the recently emerged novel coronavirus (SARS-CoV-2) poses a challenge for public health. Molecular diagnostic tools are in urgent need to help rapidly identify this novel CoV. As a well-known CRO company serving both the therapeutic and diagnostic industry, Creative Biolabs offers custom assay design, development, and manufacturing service to improve SARS-CoV-2 infection detection.
Full-genome sequence analysis of SARS-CoV-2 revealed that it belongs to betacoronavirus, but it is divergent from severe acute respiratory syndrome coronavirus (SARS-CoV) and Middle East respiratory syndrome coronavirus (MERS-CoV) that caused epidemics in the past. The SARS-CoV-2 together with the Bat SARS-like coronavirus forms a distinct lineage within the subgenus of the sarbecovirus. Infected individuals may present with cough, fever or lower respiratory infection such as bronchitis or pneumonia. No vaccine or specific treatment for the virus is available at this time, making it necessary to quickly identify infected patients to begin supportive care before the patient’s condition deteriorates. As it is characterized by human-to-human transmission, rapid identification can also minimize the spread of the disease.
Since the full gene sequence of SARS-CoV-2 has been obtained, various molecular technologies can be implemented to detect SARS-CoV-2 for early diagnosis. Centers for Disease Control and Prevention (CDC) has developed a new laboratory test kit for use in testing patient specimens for SARS-CoV-2 based on Real-Time Reverse Transcriptase (RT)-PCR technology. Moreover, based on experience in the diagnosis of other CoVs, other molecular diagnostic tools can also be used for diagnosis of the SARS-CoV-2 infection, including real-time reverse transcription PCR (rRT-PCR), reverse transcription loop-mediated isothermal amplification (RT-LAMP), as well as real-time RT-LAMP.
Creative Biolabs has a scientific team with a shared scientific background in infectious diseases and molecular technologies. We offer services to global clients in molecular diagnostics development for SARS-CoV-2 detection, focusing on multiple technologies. Our services cover the whole process ranging from the development and validation of molecular diagnostic test systems to the transfer into new ready-to-use kits for IVD purposes. We assist with primer and probe design, prototype testing, prototype optimization, stability studies and optimization, assay verification and validation.
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