How long will it take for antigen testing products to enter clinical trials?

How long will it take for the clinical trial report of antigen saliva kit to produce results?

H65 1 135000

135 10308572 He CCC CE RoHS FCC

Evaluation report on clinical trial of COVID-19 kit

In order to cope with the current outbreak of novel coronavirus in the United States and enhance the detection ability of novel coronavirus, on February 29th, 2020, the FDA of the United States issued "Before the emergency use authorization (hereinafter referred to as EUA) of novel coronavirus (hereinafter referred to as coronavirus pneumonia-19) was issued, laboratories that have been certified to engage in high-complexity detection (HCT) were diagnosed and detected according to the Clinical Laboratory Improvement Amendment (CLIA).

Clinical evaluation:

Due to the lack of known positive samples, FDA recommends using synthetic samples for product performance verification. There shall be no less than 30 positive samples and no less than 30 negative samples. The positive sample can be purified RNA or inactivated virus added to the clinical sample matrix. At least 20 positive samples should be within the LoD concentration range of 1-2 times, and the rest should be within the detection range of the kit. It is required that at least 95% of the positive samples are positive in the LoD concentration range of 1-2 times, and the coincidence rate of the rest positive samples with all negative samples should be 100%.

How long does it take for the clinical trial of lvdr in vitro diagnostic reagent COVID-19 kit?

According to the age-based stratified serum epidemiological investigation scheme of coronavirus 20 19 (coronavirus pneumonia-19) published by WHO, if the test results of serum samples are positive or suspicious, antibodies need to be added. At present, all the COVID-19 antibody kits listed on the market have obtained CE certification and have been applied overseas, but there is no domestic approval for neutralizing antibody detection kits.

1, evaluation of vaccine development

The titer of protective antibody (neutralizing antibody) produced by immune reaction after vaccination directly determines the clinical efficacy of the vaccine. The detection of this antibody is just applied to the development and evaluation of vaccines.

In vitro diagnostic reagent/COVID-19 kit clinical trial process kit detection process

Determine the applicant's needs and sign the contract.

Write clinical data such as clinical trial scheme.

Select clinical hospitals and prepare clinical samples at the same time.

Ethical examination and approval, revision of clinical scheme and signing of clinical agreement.

Tracking and monitoring of test process

Collection and summary of clinical trial data

Write clinical trial report

Two kinds of products (virus nucleic acid, antibody and antigen detection) made a breakthrough, and COVID-19 virus (20 19-nCoV) nucleic acid diagnostic kit was developed, and now novel coronavirus IgM/IgG antibody detection reagent (colloidal gold method) was developed.

Writing of Clinical Trial Summary Report

According to the technical guidelines for clinical trials of in vitro diagnostic reagents, clinical trial reports should clearly and completely describe the overall design and key points of the trial, and coherently describe the implementation process, result analysis and conclusion of the whole clinical trial, including necessary basic data and statistical analysis methods. It is suggested that the following contents should be detailed in the clinical summary report.

Overall design and scheme description of clinical trials

This paper introduces the overall management of clinical trials, the selection of clinical trial institutions and the introduction of major clinical researchers.

Inclusion/exclusion criteria, expected number of cases in different groups and criteria.

Sample type, sample collection, processing and preservation, etc.

Statistical methods, statistical software and standards for evaluating statistical results.

Specific clinical trial

The name, batch number, expiration date and model of the reagent to be evaluated and the reference reagent.

Summarize the number of cases and population distribution in each research unit, and suggest giving the specific number and percentage in the form of list or chart.

Quality control, tester training, daily maintenance of instruments, instrument calibration, quality control operation, detection precision evaluation, quality control recovery rate (or measured value) and spot check results.