How to ensure the accuracy of nucleic acid detection results, and how to ensure the accuracy and safety of nucleic acid detection results.

How to ensure the accuracy of nucleic acid detection results?

In order to ensure the accuracy and reliability of nucleic acid detection results, we mainly take the following measures:

The first is to strictly control the qualification access. Strengthen the management of gene amplification testing laboratories, supervise the access of laboratories that carry out nucleic acid testing, strengthen the qualification examination of technicians, and constantly improve the access registration to ensure that the institutions and personnel entering meet the qualification requirements. At present, there are about1.3000 laboratories with nucleic acid detection qualification in COVID-19, and there are1.5300 technicians with nucleic acid detection qualification.

Second, strict inspection and quality control. While carrying out normal laboratory indoor quality control, we organize the National Clinical Laboratory Center to evaluate the laboratory indoor quality every month. At present, more than 38,000 laboratories have been evaluated, with a qualified rate of 99.4%. At the same time, in large-scale nucleic acid screening, a quality supervisor is stationed in each laboratory that undertakes the detection task to supervise and guide its detection work throughout the whole process to ensure the detection quality.

The third is to continuously optimize technical specifications. Two editions of "COVID-19 nucleic acid detection technology operating rules" have been formulated successively, and the whole process of technicians, single sample collection, mixed sample collection, sample management, laboratory testing and result reporting has been standardized. Innovative research and development of 5-step 1, 10, 20-step 1 mixed sampling detection technology, and the third edition of the organization implementation guide for nucleic acid detection has been updated.

The fourth is to strengthen the supervision of third-party testing institutions. Formulate and implement the Interim Measures for the Administration of Medical Laboratories and the Measures for the Administration of Large Nucleic Acid Testing Laboratories in COVID-19, and regularly publish the list of qualified institutions; For laboratories with false negative, false positive or even false test reports, strengthen supervision and deal with them according to the law and regulations, and will never tolerate them.

In the next step, the National Health and Wellness Commission will continue to strengthen the quality supervision of nucleic acid detection, and comprehensively use various methods such as "flight inspection", regular sampling inspection and publication of qualified laboratories to continuously improve the quality of nucleic acid detection and provide strong support for epidemic prevention and control.