CY-F006-AG25 Saliva Antigen Test Kit COVID-19 Nucleic Acid Test

CY-F006-AG25 Saliva Antigen Test Kit COVID-19 Nucleic Acid Test

COVID-19 Rapid Test Kit Antigen Rapid Test Kit Nucleic Acid Test Saliva Test

product description:

The COVID-19 Antigen Detection Kit (Transverse Chromatography) is an immunochromatographic method for the rapid, qualitative detection of SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab samples, either directly or after swab collection. 2 nucleocapsid protein antigens. Added to viral transmission media by individuals suspected of having COVID-19 by a healthcare provider, testing is limited to accredited laboratories that meet requirements to perform moderate, high, or exempt complexity testing. The test is authorized for use at the point of care (POC), which is an inpatient care setting operating on the basis of a certificate of exemption, certificate of compliance, or certificate of accreditation. This test is used to identify SARS-CoV-2 nucleocapsid antigens that are commonly detected in upper respiratory tract samples during the acute phase of infection. A positive result indicates the presence of viral antigens, but clinical correlation with the patient's medical history and other diagnostic information is necessary to determine infection status, and a positive result does not rule out bacterial infection or co-infection with other viruses.

Notice:

Negative results should be considered presumptive, do not exclude SARS-CoV-2 infection, and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in conjunction with the patient's recent exposure, medical history, and the presence of clinical signs and symptoms consistent with COVID-19, and confirmed by molecular analysis, if necessary, for patient management.

Product Description:

The COVID-19 Antigen Detection Kit (Lateral Chromatography) is intended for use by trained clinical laboratory personnel who have been specifically instructed and trained in in vitro diagnostic procedures and appropriate infection control procedure techniques, as well as in point-of-care settings Individuals with similar training.

Product Instructions:

Sample Collection and Preparation To prepare for testing:

Remove one extraction tube and one COVID-19 antigen detection kit (transverse chromatography) cartridge from the foil bag immediately before testing
Label test cartridges and extraction tubes for each sample to be tested. Place the labeled extraction tubes on the rack in the designated area of ​​the work area. See Figure 1.

Nasal swab specimen collection:

When collecting a nasal swab sample, carefully insert the swab (provided in the kit) into the nostril with the most secretion on visual inspection. With gentle rotation, push the swab until it encounters resistance at the level of the turbinate (approximately 2.0-2.5 cm or nearly 1 inch into the nostril). Roll the swab around the nose wall about 5 times and remove it from the nostril.

Sample Preparation:

Unscrew the cap of the sample extraction buffer bottle, squeeze the sample extraction buffer bottle, and add the sample extraction buffer to the extraction tube. (See Figure 2) Immediately after specimen collection, immerse the swab in the sample extraction buffer. (See Figure 3) To allow the extracted sample to fully penetrate the buffer of the swab, rotate the swab against the tube wall repeatedly for 10 seconds, then hold the tube with your fingers (the tube wall is semi-solid) and squeeze and wipe Several times, slowly remove the swab from the tube at the same time. (See Figure 4) The purpose of squeezing the swab against the tube wall is important because it keeps the liquid-containing specimen as much as possible in the tube. After removing the swab and discarding it in the biohazard waste container, tie the nozzle (provided in the kit) to the top of the extraction tube and gently shake the tube to thoroughly mix the liquid inside, see Figure 5.

Interpretation of results:

Positive Test Result: Visible color lines appear at both the "T" and "C" sites, or a darker color if the "T" site is tested.
Negative test result: Only the "C" reference is colored, the "T" position is blank.
Invalid result: If "C" is empty and no color is displayed, the test result is invalid and the sample needs to be re-tested.

Performance characteristics
Sensitivity: 96.15% (100/104), compared with nucleic acid amplification tests, confirmed positive cases.
Specificity: 99.78% (448/449), negative cases were also confirmed by nucleic acid amplification test.

Huachenyang Technology Co., Ltd. was established on June 2, 2008. The company has 3 major business segments. The business operation center is located in Yifang Center, Baoan District, Shenzhen, the R&D experiment center is located in Nanshan District, Shenzhen, and the manufacturing center is located in Baoan, Shenzhen. Xinqiao Street, District, the company covers an area of ​​15,000 square meters, with a registered capital of 50 million yuan and more than 300 employees. A national high-tech enterprise integrating R&D, production, and sales of medical device products.

Huachenyang Technology is committed to biological sample collection and preservation of medical products. It is a well-known professional manufacturer of medical sampling and preservation products. The company has 52 patents, of which 30 patents have been transformed into the market. Products are mainly used in genetic testing, biopharmaceuticals, large-scale A-level hospitals, entry-exit inspection and quarantine, diagnostic reagents, CDC, public security criminal investigation, forensic identification, and other medical institutions. The company has successively established good cooperative relations with more than 30 domestic universities, more than 50 national scientific research institutions, more than 200 tertiary hospitals, more than 600 disease prevention and control centers, and more than 1,000 third-party medical testing institutions for genetic testing.

The company's independent research and development products include disposable virus sampling tubes, disposable sampling swabs, medical cotton swabs, cell preservation solutions, saliva collection devices, transport medium, disposable samplers, disposable sampler, sample preservation solution, Nucleic acid extraction reagents, genetic testing reagents, and other products. The company's products have obtained China NMPA, EU CE, US FDA EUA, SGS, TUV, TGA, and ISO13485 certification qualifications, and have the exclusive right to use registered trademarks and sales rights for multinational products. The products are exported to Europe, America, Asia, the Middle East, and other 120 countries. It has won unanimous praise and recognition from customers.

Shenzhen Huachenyang Technology Co., Ltd. will adhere to the tenet of "inheriting innovation, winning with science and technology", adhering to the corporate culture of "quality first, truth-seeking and innovation, integrity and law-abiding, cooperation and win-win", and strive to create China's high-end biological sample collection and preservation medical products, casting The industry benchmark for microbial sample collection and preservation products!