IVD

For the gene mutation detection reagent of tumor companion diagnosis (CDx), if the gene is known to have multiple mutation sites for the same companion diagnosis purpose (such as the same companion drug), the coverage of mutation sites shall be fully considered in combination with product risk benefit analysis in subsequent product design, and the detection range of sites shall not be arbitrarily reduced for the convenience of product evaluation. For example, when KRAS gene mutation is used for tumor companion diagnosis, because it is a negative companion diagnostic gene detection and related to adverse drug reactions, insufficient coverage of mutation sites may increase the risk of patients. 

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The analytical performance of in vitro diagnostic reagents includes multiple contents such as accuracy, precision, limit of detection and specificity. It is necessary to include the samples from different sources, types, concentrations and other characteristics according to the specific requirements for various performances, so as to fully evaluate various performances of product. Therefore, the re-use of samples shall be avoided as far as possible in the evaluation process of analytical performances.

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In clinical trials, when clinical samples of the type specified in the instructions for use (IFU) are tested, attention shall be paid to the conformity of technical contents such as sample collection, sample storage conditions, sample storage time, sample processing methods, etc. The claims in the test reagent IFU shall be supported by preclinical studies, and attention shall be paid to the requirements in the IFU of test reagent, reference reagent and recheck reagent.

For example, clinical trials of nucleic acid detection reagents should note that:

• Sample collection methods shall meet the requirements in the IFU;
• Sample storage time shall be within the claimed shelf life of samples;
• Clinical trials shall be performed using original samples, and extracted DNA or RNA nucleic acid shall not be regarded as original samples;
• The supporting nucleic acid extraction/purification reagent and sample storage solution (if applicable) shall be claimed in the IFU of the test reagent and reference reagent respectively;
• If the IFU of the product has requirements for the purity and concentration of extracted nucleic acid, they should meet the relevant requirements in the IFU of the product.

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Detection limit (LOD) is an important performance index of in vitro diagnostic reagents. Generally, three batches of reagents are used for LOD research. If the LOD results differ from batch to batch (generally there should be no significant difference), the maximum value or higher value shall be taken as the claimed LOD of the reagent to ensure that all batches of reagents meet the claim.

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If the packaging specification of in vitro diagnostic reagent changes, the difference of packaging specification before and after the change shall be described in detail. All relevant potential risks shall be identified according to the specific differences, and these risk factors shall be analyzed and verified. Some examples are as below:

if there are differences in the reaction form (such as poison detection products) and reaction film size (such as PCR amplification and hybridization products) of the packaging specification before and after the change, the analysis performance evaluation dossiers of the changed packaging specification shall be submitted.Before and after the change, the amount of packaging specifications and containers will change significantly, which will lead to the increase of evaporation loss and other risks. Therefore, it is necessary to consider whether the shelf life, stability and calibration frequency of the product will change.

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In the clinical trial dossiers of in vitro diagnostic reagents, the implementation plan of the clinical trial and the corresponding written comments of the ethics committee agreeing to carry out the clinical trial shall be submitted. Due to the change of clinical trial protocol, there may be multiple versions. The following principles should be noted when submitting application dossiers:

If the the clinical trial protocol changes before the formal implementation of the clinical trial, the clinical trial protocol of the final version shall be submitted, together with the written comments of the ethics committee corresponding to the version.If the clinical trial has started and the protocol is changed in the process, the clinical protocol before and after the change and its ethics documents shall be submitted together, and the reasons for the protocol change and its impact on the conducted clinical trial shall be clearly explained.It should be noted that before the clinical trial, the scientificity, rationality, feasibility and compliance of the protocol should be fully studied, the protocol should be formulated and strictly implemented. During the clinical trial, the protocol shall not be changed at will for unnecessary reasons.

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In the clinical trials of in vitro diagnostic reagents, all tests shall be completed by the institution undertaking the clinical trials. However, a third-party testing institution may be entrusted if all the following conditions are met:

The reference methods for laboratory testing are adopted for the comparison methods,These methods are not routine clinical testing technologies,Require special equipment, instruments and test conditions, andClinical trial institution do not have relevant testing conditions

The test results of the third party shall be recognized by the clinical trial institution. For example,tests for nucleic acid sequencing and GC-MS / MS test could meet the above conditions. However, if the comparison method is a routine clinical test method, such as general pathogen isolation and culture, micro broth dilution method (for in vitro antibiotic susceptibility test), although the test operation is complex and requires special laboratory conditions and testing technology, the test should still be completed by the clinical institution instead of a third-party laboratory. In order to ensure the quality of clinical trials, clinical institutions capable of undertaking relevant trials should be selected to carry out clinical trials. In the process of clinical trials, relevant trials should be strictly standardized, and the consistency eval

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