May 18, sponsored by Beijing Health Promotion Association and Shanghai Sidi Biomedical Technology Co., Ltd. The “Seminar on Hot Issues in Large-scale Nucleic Acid Screening for COVID-19 – Jianxian Thinking of ‘epidemic’ | Shanghai Station” (hereinafter referred to as the “Seminar”) was successfully held, and medical laboratory experts and scholars from all over the country gathered in the cloud to participate in the grand meeting.
Professor Ni Yuxing from Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine was invited to serve as the chairman of the seminar. Experts present at the meeting (in alphabetical order by surname): Prof. Wang Weiling from China National Accreditation Service for Conformity Assessment, Prof. Xiao Yanqun from Shanghai Clinical Laboratory Center, Prof. Wu Wenjuan from Oriental Hospital Affiliated to Tongji University in Shanghai, Second Affiliated Hospital of Naval Military Medical University (Shanghai Changzheng Hospital) Professor Zhou Lin, Dr. Meng Lingzhuo from Shanghai Sidi Biomedical Technology Co., Ltd.
Experts on Nucleic Acid Screening Hot Issues >
Opening speech by the chairman of the conference
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine In his opening speech, Prof. Ni Yuxing mentioned that since March this year, the Omicron variant has been surging, with strong contagiousness, rapid spread and high concealment, and has spread to many places across the country in a short period of time. The situation of epidemic prevention and control is severe and complicated. In the face of the new crown epidemic, my country has always adhered to the general policy of “dynamic clearing”. Nucleic acid detection is a powerful “weapon” for the prevention and control of the new crown epidemic, and it is also a strong support for the realization of “dynamic clearing”. How to quickly improve the efficiency of nucleic acid testing and strengthen laboratory quality management is an urgent problem that all testing institutions need to solve. I believe that all the inspectors at the meeting can combine their own practical experience and bring more effective solutions and strategies to jointly help the prevention and control of the epidemic.
Professor Wu Wenjuan, East Hospital Affiliated to Tongji University, Shanghai brought the theme sharing of “Enhancing the Efficiency of Nucleic Acid Testing Laboratories for Large-Scale Screening of the Novel Coronavirus”. She pointed out that under the situation of large-scale screening, in the process of “race” with the virus, it is necessary to act fast, and nucleic acid detection ability is the key to victory. At present, Beijing, Hangzhou, Wuhan, Shanghai and other places across the country have begun to implement normalized nucleic acid testing policies. In particular, Shandong Province clearly requires that the test results be issued and uploaded within 8 hours, which puts forward higher requirements for the efficiency of nucleic acid testing. How to improve the efficiency of nucleic acid testing is one of the biggest challenges faced by major testing institutions. Relying on his rich anti-epidemic experience, Professor Wu introduced a more economical and feasible solution for improving efficiency—optimizing the nucleic acid detection process, introducing an automated sample preprocessing system and automated pipetting equipment, and using faster detection reagents. The nucleic acid amplification process is one of the key links in the nucleic acid detection rate limit. Choosing a faster detection reagent can effectively shorten the reporting time without increasing laboratory operating costs, and will better meet the current epidemic prevention and control and normal conditions. dual requirements for nucleic acid detection.
Professor Xiao Yanqun from Shanghai Clinical Laboratory span> brought the theme sharing of “Indoor Quality Control in New Coronary Nucleic Acid Screening”. In the race against the epidemic, we not only require “fast” speed, but also “accurate” results, and focus on strengthening laboratory quality control to ensure accurate and reliable test results. In practice, it is recommended to select the positive quality control of pseudovirus type. Since pseudoviruses encapsulate RNA fragments in viral coat proteins, they have good stability, are easy to store, and are not easy to cause laboratory contamination. At the same time, they can be effectively used for monitoring Nucleic acid extraction, reverse transcription process and nucleic acid amplification and other experimental links. As one of the quality control substances, the exogenous internal standard is usually in the form of pseudovirus. The Ct value is relatively fixed and concentrated. If the Ct value of individual samples is high, it may indicate abnormality in the sample extraction process, such as low nucleic acid purity and inhibitor concentration. higher, resulting in lower amplification efficiency. Therefore, exogenous internal standards can sensitively monitor the process of sample nucleic acid extraction and amplification. Under the situation of large-scale nucleic acid screening, each testing institution needs to strengthen the daily indoor quality control of the laboratory, and regularly accept the national or provincial inspection quality control, which is a strong guarantee for the prevention and control of the epidemic.
Professor Wang Weiling, the chief reviewer of ISO15189 of China National Accreditation Service for Conformity Assessmentbrings a speech entitled Report on “ISO15189 Accreditation Requirements for Novel Coronavirus Nucleic Acid Testing Projects”. Professor Wang gave a detailed introduction to the ISO15189 accreditation system in the report, and the value of the laboratory after the testing project was recognized. Due to its particularity, in addition to the basic medical practice license and clinical gene amplification testing laboratory qualifications as a molecular diagnostic project, the application laboratory also needs to have the second-level pathogenic microorganism laboratory qualification. At the same time, Professor Wang also mentioned that the current new crown nucleic acid In the detection, it is difficult to use the extraction system, the amplification system and the sample preservation. When the non-supporting combination is used, clear guidance on how to confirm the performance of the detection system is given.
< img class="content_title" height="300" layout="responsive" sizes="(min-width: 320px) 320px, 100vw" src="https://mmbiz.qpic.cn/mmbiz_png/nkx18ibQgVwTibV5TuzHPwafvN13rGj1cZTicxBWJOm8ew1cvE3k1mMGFw9yuc9icenXXibm1dphgMpjOw4width4="600">Side Diagnostics Dr. Meng Lingzhuo made a keynote report on “Common Abnormal Results and Solutions for Mass Screening of New Coronary Nucleic Acids”. In the report, he I shared with you in detail the rich practical experience accumulated by Sidi Diagnostics in undertaking large-scale nucleic acid screening tasks. In large-scale screening, each testing institution needs to increase laboratory production capacity on the premise of ensuring quality and biosafety, and Nucleic acid detection capability is maximized. Abnormalities in each link of people, machines, materials, methods, and loops will affect the accuracy of the detection results. Therefore, Scientific and reasonable quality control is crucial, which can effectively monitor all aspects of the experimental process, investigate risks in a timely manner, and ensure accurate and reliable test results. In the normal use process of exogenous internal standard, the amplification curve has good homogeneity. If the internal standard amplification curve deviates and the amplification efficiency varies greatly, it may indicate that the corresponding sample may have poor nucleic acid extraction effect and amplification. inhibition, etc. The laboratory needs to analyze the characteristics of the abnormal curve, and conduct risk investigation from the aspects of instrument calibration, consumables quality, laboratory environment, personnel operation, etc., so as to ensure the authenticity and reliability of the test results.
Conference Discussion
Conference SummarySide Diagnosis Helps Improvement of new crown detection capabilities
Nucleic acid detection is the “gold standard” for judging new crown virus infection, especially in the face of Omic, which is highly contagious, fast-spreading, and highly concealed For Rong mutants, multiple rounds of large-scale nucleic acid testing is a powerful guarantee for timely detection of infected persons and the realization of “dynamic clearing”. The essence of “dynamic clearing” lies in “fast” and “accurate”, which runs faster than the virus and makes it faster. Nucleic acid testing includes sampling, transportation, cap opening and pipetting, nucleic acid extraction, PCR testing, and reporting. Among them, PCR testing is the most time-consuming and is one of the main speed-limiting steps in nucleic acid testing. Choosing higher sensitivity and faster detection reagents will help break the bottleneck of laboratory speed limit and improve the efficiency of nucleic acid detection.
The “New Coronavirus 2019-nCoV Nucleic Acid Detection Kit (Fluorescent PCR Method)” developed by Sidi Diagnostics was approved by the State Drug Administration on March 16, 2022 ( NMPA) approved and approved for listing. Through the optimization of reagent components, the kit shortens the reaction time of fluorescence quantitative PCR from 80-120 minutes, which is the usual time in the industry, to 30 minutes. In actual use, this reagent can achieve more sample detection volume per unit time with a fixed instrument configuration, especially when dealing with mass nucleic acid screening of large-scale populations, it can effectively alleviate the lack of detection capacity caused by the shortage of detection instruments, and the time for issuing reports. lag problem.
While improving the amplification speed, the reagent also maintains a high standard in terms of detection sensitivity, achieving an excellent level of 200 copies/mL, which can detect lower viruses Concentration of samples to reduce the risk of missed detection. The product has a validity period of up to 12 months, and can withstand repeated freezing and thawing within 10 times, and the experimental results are stable. In addition, based on bioinformatics analysis, this reagent can effectively detect mutant strains listed as special concern by WHO, including Omicron.
During the current round of the epidemic, the advantages of this reagent in rapidly improving the detection capacity of the new crown have been highly recognized by the cooperative units, and it has been used in more than 20 large third-party inspection institutions in Shanghai. The landing application has improved the daily testing capacity of testing institutions by 50-70% without increasing personnel and equipment, and has completed about 160 million nucleic acid screenings in Shanghai.
Meanwhile, Sidi Diagnostics has also launched a complete set of “one-stop” solutions for COVID-19 testing, including sample pre-processing systems, nucleic acid extraction systems, nucleic acid testing pipelines and cabin experiments Offices, etc., to help the national epidemic prevention and control.
Cover source: Xinhua News Agency
Edit: Ren Miles Reviewer: Xiao Ran