After publishing the guideline on the Emergency Approval of Novel Coronavirus Nucleic Acid Detection Reagent on 12 January 2020, NMPA has approved so far, seven Nucleic Acid Detection Reagents in china. Some of them were approved in only four days before going to the market.
The guideline clarifies the requirements for performance and clinical evaluation, type testing, list raw materials and their quality control, manufacturing information, and stability data needed for the registration of nucleic acid detection reagents for in-vitro qualitative testing.
For these reagents, testing sample can be obtained from pharyngeal swab, nasopharyngeal swab, alveolar lavage fluid, sputum, respiratory tract lotion, aspirate, and other respiratory secretions.
NMPA Performance Evaluation:
Performance evaluation should include research methods, experimental schemes, experimental data and statistical analysis, and shall focus on the following:
- Nucleic acid (RNA) extraction / purification performance
- Lowest detection limit
- Verification of inclusiveness of virus samples in different regions
- Analytical specificity
- Provide verification information of enterprise reference products.
Type testing shall be conducted at certified testing center; and testing report shall comply with PTR (product technical requirement). Additionally, 3 batches of testing reports shall be provided.
Determination of Positive Test Results:
An explanation and rational for the determination of positive test results should be provided.
Main Raw Materials:
The main raw materials of the product include primers, probes, enzymes, dNTPs, nucleic acid isolation / purification components (if any). Rational for selecting the raw materials, the procedures for their quality testing and specifications should be provided.
Stability Study Data:
The stability data should be provided. It should include stability data on the declared reagent and stability data on the applicable sample as well.
The clinical evaluation shall be conducted in three or more clinical trial institutions (including the CDCs at all levels). Clinical data from clinical case samples should be compared to data obtained from similar approved products.