SARS-CoV-2 is a positive-sense single-stranded RNA virus that enters host cells by binding to angiotensin-converting enzyme receptor 2 (ACE2) on a variety of mucosal cells, thus airway mucosa, oral mucosa, eyelids, and conjunctiva that are connected to the outside world are susceptible to exposure to infection. The SARS-CoV-2 genome has nearly 30,000 bases, so obtaining the genome sequence promptly is critical to the development of in vitro diagnostic (IVD) tools. GMP proteins are highly stable and pure proteins that have undergone stringent quality control and safety assessment, making them ideal raw materials for IVD reagents, further ensuring the accuracy and safety of IVDs and providing reliable diagnostic support for the prevention and control of SARS-CoV-2. Currently, IVD techniques involving SARS-CoV-2 mainly include nucleic acid diagnosis and immunodiagnosis.
Figure 1. SARS-CoV-2 serological testing. (Kevadiya B D, et al., 2021)
As the "gold standard" for the identification of new coronaviruses and the first IVD technique used for the identification of SARS-CoV-2, RT-PCR is very sensitive and can quantify low-copy-number viral RNA.
The reaction process is always maintained at a constant temperature, and rapid nucleic acid amplification is achieved by adding different active enzymes and specific primers. Compared with conventional RT-PCR, it is susceptible, rapid, and portable.
RT-LAMP technology has been developed as a rapid, cost-effective, and efficient molecular diagnostic method for SARS-CoV-2 detection. RT-LAMP combines loop-mediated isothermal amplification (LAMP) and reverse transcription to directly detect RNA, and when coupled with a pH indicator in the reaction mixture, the results can be obtained qualitatively by a color change.
Microarray technology is a rapid and high-throughput assay in which viral RNA is reverse transcribed to produce cDNA labeled with a specific probe, which hybridizes with solid-phase oligonucleotides immobilized on a microarray. Coronavirus RNA is detected through the detection of specific probes.
ELISA is a microtiter plate-based assay for the qualitative or quantitative detection of proteins, antibodies, hormones, etc. The time to obtain results is usually 1-5 hours. ELISA is characterized by multi-sample detection, low cost, high sensitivity, and specificity, and can be used for semi-quantitative testing.
CLIA combines susceptible chemiluminescent assay technology with highly specific immunoreaction, featuring quantification, high sensitivity, high specificity, easy operation, and a high degree of automation, and it can recognize all types of new coronavirus-specific antibodies, including IgG, IgM, IgA, etc. The immunoassay can be used for semi-quantitative detection of new coronavirus.
ICA is a qualitative detection method that combines immunotechnology and chromatography. Chromatography, represented by colloidal gold, is widely used in many fields of IVD as a rapid test strip and can be used to carry out immediate diagnosis.
FIA is an immunodiagnostic method that combines the specificity of immunological reaction and the sensitivity of fluorescence technology, which has the advantages of strong specificity, high sensitivity, and practicality.
Creative BioMart is committed to the IVD field and hopes to provide a range of high-quality GMP proteins and customized GMP protein services to research institutions around the world. Our products can be used in SARS-CoV-2 research to help you improve the accuracy and reliability of your diagnosis. If you are interested in our services or products, please contact us.
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