Nucleic acid detection test agent composite group Registration Technical Review Guidelines (No. 65 of 2015) This guidelines are designed to guide the registration of the applicant's preparation and writing of nucleic acid testing agents for nucleic acid testing agents, and also provide reference information for the review of the technical review department. This guiding principle is the general requirement of nucleic acid detecting reagent for tuberculosis compound groups. Applicants should determine if the content is applicable, if not applicable, require specific intentions and corresponding scientific basis, and according to product Specific features enrich and refine the contents of the registration data. This guiding principle is to use guidance documents for applicants and reviewers, do not involve administrative matters such as registration approval, and do not act as regulations. If there is any other method that meets regulatory requirements, it is also possible to provide detailed research. Data and verification materials. This guidelines should be used under the premise of following relevant regulations. This guiding principle is in the current regulatory, standard system and current cognitive level. With the continuous improvement of regulations, standards, this guiding principle is also adjusted in time. First, range Tuberculosis is chronic infectious diseases caused by Nika Mycobacterium, Bull Tuberculosis, and African Mycobacterium, which can be tired and all organized by all organs, with tuberculosis. Among them, tuberculosis pathogens is mainly the bunge of Mycobacterium, bullocalypsenacrower. Niki myobacter pylori is mainly due to air, most people have no symptoms after infection of nucleus, called latent infections. The latent infection can last for decades, only 5% -10% of the latent infected people develop into active tuberculosis. In the bacterial test of tuberculosis, the bobacterium is usually divided into Mycobacterium Tuberculos Complex and Nontuberculos Mycobacteria, NTM. Nuclear Pyrocylla composite groups include M.Tuberculosis, cow tuberculosis (M. Bovis), M. Africanum, and M.Microti. In various in the complex group of tuberculosis compound groups, except for human pylorgi, other three kinds of bacteria can be caused by human disease and produce substantially the same clinical manifestations. Therefore, it is often used to identify the identification of tuberculosis complex groups without performing sub-horizontal identification. The nucleic acid detection reagent for tuberculosis assisted diagnosis is often used as a nucleic acid sequence common to tuberculosis complex group as a target. Detection. Nucleic acid detection is an important reference in the original diagnosis of tuberculosis. In 2009, the US Disease Control Prevention Center (CDC) updated the diagnosis and treatment of tuberculosis, the nucleic acid detection as auxiliary diagnosis method of tuberculosis, clearly: a nucleic acid detection of at least one respiratory sample should be performed on all suspected tuberculosis patients. my country's "Clinical Diagnosis and Treatment" - Tuberculosis Volume "is also clear: DNA detection of Mycobacterium tuberculosis can be used as a reference for tuberculosis diagnosis. Compared with other laboratory tests, the value of nucleic acid detection is that the value of nucleic acid detection is to quickly identify the complexion of the Nikiocarbium complex and non-tuberculosis, improve the diagnosis of positive tuberculosis of the smear; (2) Compare with the smear The sensitivity is high, and the detection rate of the coating negative pulmonary tuberculosis can be improved; (3) Fast operation is fast, and the correct medical treatment can be carried out early. Nucleic acid detection reagent refers to the nucleic acid detection test technique: using molecular biological detection techniques, such as polymerase chain reaction (PCR), etc., the nucleic acid sequences commonly used in a specific tuberculosis complex compound group are detected targets, phlegm, The tuberculous alveolar compound group in the bleeding alveolar, the reagent of body permeability detection, for the auxiliary diagnosis of tuberculosis. The technical requirements of this guiding principle are based on the fluorescence probe PCR method. For other molecular biological detection techniques, it may partially require incomplete applications or not fully comprehensively, and the applicant can perform in accordance with product characteristics. Revise or supplement other evaluations and verification, but need to explain the reasons for unwanted, and verify the scientific rationality of the alternative method. This guidelines apply to agents for detecting target nucleic acid sequences common to tuberculosis complex groups, for some reagents that are detected by target nucleic acid sequences with tuberculosis bacterium, may partially require incomplete application Or insufficient technical indicators described herein, applicants can revise or supplement other evaluations and verification according to product characteristics, but need to illustrate the reasons for unwanted, and verify the scientific rationality of alternative methods. This guiding principle applies to the expected use of tuberculosis assisted diagnosis, with sputum or bronchial alveolar lavage liquid as a nucleic acid testing agent for nucleic acid testing agents for sample types. For the same type of respiratory sample type, or the expected use is a nucleic acid testing agent for tuberculosis complex, which may be used, may partially require incomplete application or in full comprehension, the applicant can according to product characteristics Revise or supplement other evaluations and validates for unbalanced parts. This guiding principle applies to products for the first registration declaration and related licensing matters. Second, registration data requirements (1) Summary information Summary information mainly includes the expected use, product description, instructions on biological safety, summary evaluation of research results, and introduction of similar products at home and abroad. Among them, the introduction of similar products on the listings should focus on the main difference between the declaration reagent and the current market-approved similar products from the characteristics of the methodology, inspection principle, the minimum detection limit and the detected target nucleic acid sequence. If the measured object is a new target nucleic acid sequence, the clinical significance of nucleic acid sequences for detecting the target should be discussed in detail, ie the correlation with clinical applications (can be used for tuberculosis auxiliary diagnosis), and provides sufficient support information. Summary information should comply with the Administration of In Vitro Diagnostic Reagents (State Food
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