What does a home-based instrument look like for testing nucleic acids?
Officially unveiled today!
A few days ago, Li Weimin, president of West China Hospital of Sichuan University, introduced a portable and rapid nucleic acid detection card box independently developed by the West China team in an interview released by Sichuan. He mentioned that this card box was developed by the team of Professor Hu Wenchuang of West China Hospital through multidisciplinary medical and engineering cross-collaboration with the support of the Science and Technology Department of Sichuan Province. Through this lighter-sized small instrument, you can conduct nucleic acid testing at home, use the front nose swab to sample into the card box, gently press, without any auxiliary equipment, within 30 minutes to produce the test results, the card box "true face" originally looked like this!
The global pandemic has strong demand for nucleic acid self-test products
It is understood that since 2021, the new crown Delta strain, Omicron strain has been widely circulated around the world, the nucleic acid testing infrastructure of medical institutions and third-party laboratories has been overwhelmed, and the new crown pneumonia virus self-test products have been used on a large scale in foreign countries, such as low-cost antigen colloidal gold test strips have been widely used for home self-examination screening, as a supplementary means for nucleic acid detection (the gold standard for new crown diagnosis). However, this kind of antigen test strip belongs to the antigen self-test product, the sensitivity is not good, the positive detection rate is less than 60% (the Ct value of nucleic acid amplification is about 24), resulting in a high false negative rate in the detection process, it is easy to miss the diagnosis, so the nucleic acid self-test products with higher detection sensitivity are more expected by the industry.
Recently, the United States has successively listed several nucleic acid self-test products, such as Cue health, Lucira, Detect and other companies released products, the detection sensitivity is significantly better than the antigen test strip (nucleic acid amplification Of the Ct value is about 35), can be detected in the full cycle of virus infection and negative, but the sales price is expensive (a card box is more than 70 US dollars), it is difficult to popularize among the general public. In addition, the nucleic acid self-test products that have been released also have the risk of re-contamination of nucleic acid amplification products, interfering with the test results of others in the vicinity. There are also similar nucleic acid rapid detection products under development in China.
Results can be produced in less than 30 minutes! Huaxi R&D team developed a nucleic acid home detection card box
Professor Hu Wenchuang of the Precision Medicine Center of West China Hospital of Sichuan University, together with the team of Professor Ying Binwu of the Department of Experimental Medicine, began research and development work in 2020. The R&D product uses microfluidic chip technology to break through the traditional mode of "instrument + reagent" in existing nucleic acid detection, and miniaturizes the reagents, amplification equipment and detection devices required for nucleic acid detection in a completely sealed card box to automatically complete the process, without the need for other auxiliary equipment, and also eliminates the contamination of nucleic acid products.
The all-in-one detection cartridge has several distinctive features on the basis of ensuring high detection sensitivity (the Ct value of nucleic acid amplification is about 35):
1, fast, within 30 minutes can produce results;
2, portability, to achieve one-handed mastery, with the use;
3. Safety, fully sealed system to avoid contamination of nucleic acid products;
4, easy to operate, completely without medical background people can also be easily used, a learning will be;
5, easy to judge, the indicator light quickly distinguished.
Compared with the antigen detection products on the market, the sensitivity and detection rate of this nucleic acid self-test product are significantly improved; compared with similar nucleic acid self-test products at home and abroad, it has certain advantages in terms of card box cost (a single detection box can be controlled at 100 yuan), ease of use, and safety of use (to prevent nucleic acid pollution).
Synchronous upload of data results can be realized, which is suitable for home testing, public place quick inspection, community screening, etc
"People without a medical background can also use it easily." According to reports, in the process of testing, in addition to using the front nasal swab sample into the card box ("sample in") after the sealing cap, there is no need for other operations, wait for about 30 minutes, and the card box indicator light displays the test result ("result out").
Rapid nucleic acid detection kit detection process
This integrated detection card box avoids open liquid operation, and does not require traditional nucleic acid amplification to be transferred between the separated equipment and laboratory, so it can be safely and conveniently operated outside the laboratory, and after the nucleic acid test results are produced, the technical can realize the synchronous upload of data results, which is suitable for home detection, public place rapid inspection, community screening and other application scenarios.
It is understood that the current product research and development work has been basically completed, and the next step will be to carry out multi-center clinical sample testing nationwide with the strong support of relevant departments. West China Hospital is applying for medical device registration certificates with relevant partners, and promoting industrial production with relevant cooperative enterprises.
Earlier, President Li Weimin said that this product is expected to be officially launched in the first half of 2022.
Friends, looking forward to it?
Trivia
Nucleic acid detection CT value refers to the real-time monitoring of how many cycles the fluorescence in the reaction tube has undergone to reach a predetermined threshold by RT-PCR technology. The higher the Ct value, the less DNA was originally present in the sample and the higher the sensitivity of the corresponding detection method. The difference in ct value is 1, and the difference in the number of original DNA is 2 times; the difference in ct value is 10, and the difference in the number of original DNA is about 1000 times.
Source: Sichuan Release