Entrusted by Xiamen Boson Biotech Co., Ltd. (“Boson”), The Catholic University of Korea Incheon ST. Mary’s Hospital carried out the clinical trials of the Rapid SARS-CoV-2 Antigen Test Card (“Evaluated Reagent”) manufactured by Boson.
The clinical diagnosis ability and the in-use safety and effectiveness of the Rapid SARS-CoV-2 Antigen Test Card manufactured by Xiamen Boson Biotech Co., Ltd. were evaluated based on comparison with RT-PCR method.
The clinical trials were carried out in strict accordance with the experiment plan. A total of 659 confirmed cases were used.
1.1.1 Background for Clinical Trial
COVID-19 is caused by infection with SARS-CoV-2 (Novel Coronavirus) with major clinical symptoms of fever, cough, and muscle fatigue. The incubation period is 1 to 14 days, mostly 3 to 7 days. A small number of patients can also exhibit nasal congestion, tears, sore throat, myalgia, diarrhea, and other symptoms. Critically ill patients often develop dyspnea and/or hypoxemia one week after disease onset, with severe cases rapidly
progressing into acute respiratory distress syndrome, septic shock, metabolic acidosis, coagulation disorder, and multiple organ failure. SARS-CoV-2 is an RNA virus belonging to the B-CoV lineage. It has a viral envelope, is round or oval in shape with approximately 60-140 nm in diameter, and is usually polymorphic.
1.1.2 Product Testing Principle and Methods
1. Testing Principle
Rapid SARS-CoV-2 Antigen Test Card is an immunochromatographic lateral flow device that employs the principle of double antibody sandwich method. Colloidal gold conjugated anti-SARS-CoV-2 antibodies are dry-immobilized on the test device. When the specimen is added, it migrates by capillary diffusion through the strip to re-hydrate the gold conjugate complexes. If present at or above the limit of detection, SARS-CoV-2
viral antigens will react with the gold conjugate complexes to form particles, which will continue to migrate along the strip until the Test Zone (T) where they are captured by the immobilized anti-SARS-CoV-2 antibodies to form a visible red line. If there are no SARS-CoV-2 viral antigens in the specimen, no red line will appear in the Test Zone (T). The gold conjugate complexes will continue to migrate alone until being captured by
immobilized antibody in the Control Zone (C) to form a red line, which indicates the validity of the test.
Read the instructions for use carefully before testing. Bring the kit components to room temperature and carry out the test under room temperature. Refer to the instructions for use for testing procedures.
1.1.3 Intended Use
Rapid SARS-CoV-2 Antigen Test Card is an immunochromatography based one step in vitro test. It is designed for the rapid qualitative determination of SARS-CoV-2 virus antigen in nasopharyngeal swabs from individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset. Rapid SARS-CoV-2 Antigen Test Card can not be used as the basis to diagnose or exclude SARS-CoV-2 Infection.
To evaluate the clinical diagnosis ability and the in-use safety and effectiveness of the Rapid SARS-CoV-2 Antigen Test Card manufactured by Xiamen Boson Biotech Co., Ltd.
1.3 Clinical Trial Management
1. Quality control of clinical test conditions and personnel: Before the clinical test is carried out, the department undertaking the clinical test shall check and confirm that the test equipment and instruments are running normally, the reagent is within the effective period and the storage conditions meet the requirements of the kit. Test personnel are trained and able to meet test requirements.
2. Quality control! during the clinical trial: This clinical trial adopted a blind controlled trial design, and the samples were blinded. Neither the sample tester nor the result observer knew about the blindness of the samples. It can effectively reduce the bias of test results and ensure the quality of clinical trials. The acquisition, preservation and test operation of samples shall be carried out in strict accordance with the program, and clinical supervisors shall be assigned to supervise the implementation of clinical trials.
3. Quality control of clinical trial results: control products are set to ensure the reliable quality of experimental results.
4. The main researcher should appoint experienced personnel in his department to carry out the experiment and judge the results.
5. The operation of clinical trials shall be carried out in strict accordance with standard operating procedures.
1.4 Experiment Design
1.4.1 Description of Overall Experiment Design and Plan
In this clinical trial, blind data analysis was adopted and the Rapid SARS-CoV-2 Antigen Test Card manufactured by Xiamen Boson Biotech Co., Ltd. was used to compare and study the detection results of the samples with the RT-PCR method. The specific test process is as follows: (TEST PROCESS IS AN IMAGE WITHIN THE PDF DOCUMENT.)
2. Selection of Clinical Trial Institutions
The clinical trials were conducted in The Catholic University of Korea Incheon ST. Mary’s Hospital. The hospital has the technical personnel and relevant experiences in clinical trial projects to ensure the successful implementation of the clinical trials.
3. Number of samples
Not less than 500 cases.
4. Sample type
Nasopharyngeal swab samples from the patients.
1.4.2 Testing Reagent
A. Evaluated Reagent
Reagent Name: Rapid SARS-CoV-2 Antigen Test Card
Manufacturer: Xiamen Boson Biotech Co., Ltd,
Packaging: 20 tests/kit
Storage: 4-300, sealed and stored in dry conditions
B. Comparator Method: RT-PCR method
Reagent Name: PowerChek™ 2019-nCoV Real-Time PCR Kit
Manufacturer: Kogene Biotech Co., Ltd.
1.4.4 Quality Control Methods
1. Adopt unified technical methods in the same laboratory. Evaluation should be performed by the same testing personnel in strict accordance with the reagent operation procedures.
2. Indoor quality control should be carried out for each test.
1.4.5 Statistical Analysis Methods
The sensitivity and confidence interval were calculated by comparing the detection results of Evaluated Reagent with RT-PCR.
1.5 Clinical Trial Results and Analysis
1.5.1 Sample distribution statistics
A total of 659 confirmed samples were used for the clinical trials.