NMPA published Registration Guideline on Novel Coronavirus (Covid-19) Antigen/Antibody Detection Reagent on February 25, addressing the urgent needs of virus diagnostics. It is the second major regulation after theGuideline on Coronavirus Nucleic Acid Detection Reagentpublished on Feb 12.
As of March 1, national NMPA granted 14 Emergency Approvals to Coronavirus diagnostics including 10 employing the nucleic acid method and 4 utilizing antibodies. Among them, it only took 4 days for the first four reagents to go to market.
In a separate notice, NMPA explains the timeline of Emergency Approval which include Nucleic Acid Detection Reagent, Antibody Detection Regent and a wide range of medical supplies:
Class II Device
5-day technical review and 3-day administrative approval process
Class III Device
10-day technical review and 3-day administrative approval process
The Notice also require testing centers to begin test in 1 day after receiving your testing samples.
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Application Scope
The guideline is for registration of antigen/antibody detection reagents for in vitro qualitative testing. Testing sample can be obtained from serum, plasma, whole blood, throat swabs, alveolar lavage fluid, sputum, or other respiratory secretions.
Performance Evaluation
Specific research methods, experimental schemes, experimental data and statistical analysis shall be included in the material. The following shall be focused on:
Sample collection and processing
Detection limit
Verification of inclusivity of virus samples in different regions
Specificity analysis
IgM antibody detection reagent
Precision
Study on the hook effect
Reference product verification
Other matters needing attention (such as instrument’s performance evaluation)
Applicable sample types
Type Testing
Type testing shall be conducted at certified testing center; Testing report shall comply with PTR (product technical requirement); 3 batches of testing report shall be provided.
The product has no national reference material, so applicant’s reference material should be used for type testing.
Positive Test Results Determination
Determination material includes specific test protocols, population and subject sample selection, evaluation criteria, statistical analysis, research data, etc. The selection of the sample source used to establish the positive judgment value should take into account the influence of different geographical regions, different infection stages and physiological conditions. The sample type differences should be verified.
Main Raw Materials
The main raw materials include antigens, antibodies, quality control products, and reference materials. Relevant research materials such as selection and source of main raw materials, preparation process, quality standards should be provided.
If the main raw materials are self-made by the applicant, the detailed preparation process should be provided;
If the main raw materials are outsourced, information should be provided including: the basis for selecting the raw materials and comparative screening test data, the quality standards provided by the supplier, the factory inspection report. The supplier shall not be changed.
The applicant shall define the quality control standards for each major raw material:
Coronavirus-specific antigens and antibodies
Other main raw materials
Quality control kit and facility
Reference product
Production Processes and Reaction Systems
Stability
Stability study includes two main areas:
The reagent stability data: real-time stability,open-bottle stability, high-temperature accelerated stability, and transportation stability.
The sample stability: the validity period under two conditions of refrigeration and frozen.
Clinical Evidence
The clinical evaluation shall be conducted in at least three clinical trial institutions (including the CDCs at all levels); the test results from clinical case samples and similar products already on the market shall be compared with the intended reagent. It is recommended that the kits of multiple manufacturers be jointly verified in the same clinical trial institution. Following materials shall be provided:
Determination of clinical trial reference standard
Clinical trial population
Clinical trial sample types
Clinical trial sample size
Statistical analysis of clinical trial results
Format requirements for clinical evidence
To accelerate market introduction, clinical evaluation can be conducted after market approval. Also, TheReal-World Dataandoverseas clinical datacan be used for clinical evaluation.
Source from: “NMPA Guideline on Novel Coronavirus Antigen/Antibody Detection Reagent Issued”China Med Device, LLC , 6 March 20, https://chinameddevice.com/coronavirus-antigen-antibody-reagent/.
