In order to control the epidemic and improve the efficiency of epidemic prevention and control, the home new coronavirus rapid test self-test has become an irreversible trend. This year, the country released the "Regional New Coronavirus Nucleic Acid Testing (New Coronavirus Rapid Test) Organization and Implementation Guide (Third Edition)" clearly launched the "antigen screening, nucleic acid diagnosis" surveillance model. It further strengthens the role of home self-testing in outbreak prevention and control.
In 2020, the U.S. FDA approved a new rapid nucleic acid test for home self-testing; subsequently, 2 new rapid nucleic acid tests were approved for home use in 2021. Unlike antigen testing, which detects pathogens, the New Crown Nucleic Acid Rapid Test detects the genetic material of viruses through the principles of translation, transcription, and reverse transcription, and is a highly sophisticated experiment that previously could only be performed in a laboratory.
New crown nucleic acid rapid test is highly accurate and is the "gold standard" for new crown virus detection, and these three new crown nucleic acid rapid test reagents are the first to realize the whole process of new crown self-test at home, which is a major technical breakthrough in the rapid detection of new crown nucleic acid at home.
It is reported that the approved three new crown nucleic acid rapid test home self-test products use the constant temperature amplification technology.
Nucleic acid constant temperature amplification technology refers to a constant temperature, by a specific enzyme action to complete the target nucleic acid amplification and related signal detection technology. After more than a decade of development, there are various isothermal amplification techniques used in the field of molecular diagnostics, among which the common nucleic acid thermostatic amplification techniques include loop-mediated thermostatic amplification (LAMP), nucleic acid sequence-dependent amplification (NASBA), incision and extension amplification reaction (NEAR), recombinase polymerase amplification (RPA), etc. Compared with PCR nucleic acid amplification technology, isothermal nucleic acid amplification does not require a thermal cycler and can quickly reach the temperature required for the experiment.
Although the new crown nucleic acid rapid test kit for home testing has the advantage of more accurate results than the antigen test, but the cost of the test is several times or even tens of times more than the antigen test. In addition, the home nucleic acid rapid test takes 30 minutes to an hour longer than the antigen, while the antigen test takes only 15 minutes or even less, therefore, in the home testing market, the nucleic acid rapid test products are not competitive.
Although with technical breakthroughs, market maturity, home self-test product development and registration rules perfect, China's home testing market has also been rapid development. However, before the cost of technology has been reduced, the home new crown nucleic acid rapid test is still not feasible.
At present, the home Nucleic Acid Rapid Test has not been widely implemented, but a kind of Nucleic Acid Rapid Test that is both efficient and accurate, which tends to be a just-in-time test (POCT) technology, is widely used in fever clinics, airport customs and other scenarios that require immediate results. Through the nucleic acid efficient amplification reagents and portable amplification instrument, the efficiency of the new crown nucleic acid rapid test is greatly improved, while replacing the shortcomings of large testing equipment adapted to multiple scenarios.
It is believed that in the future home new crown nucleic acid rapid test technology will be further improved and widely used, but for now, new crown nucleic acid rapid test is still the backbone of epidemic prevention and control!
