Oropharyngeal Nasopharyngeal Rapid Diagnostic Test Kit Sampling Swab

Oropharyngeal Nasopharyngeal Rapid Diagnostic Test Kit Sampling Swab

COVID-19 Antigen Rapid Test Kit (1-Pack): Oropharyngeal/Nasopharyngeal Swab 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.
Application: For suspected patients with symptoms, mild or even asymptomatic symptoms, it can also be used to detect people who are in close contact with infected patients and isolate control personnel.

Product Usage:
This assay is used for the direct and qualitative detection of SARS-CoV-2 antigens in nasopharyngeal and oropharyngeal secretion specimens. Provides clinical results in 15 to 30 minutes, and visual interpretation of results requires no special equipment.

Technical features:
This reagent adopts the double antibody sandwich method, which can legally detect the novel coronavirus antigen in nasopharyngeal and oropharyngeal swabs. During the detection process, the gold-labeled anti-coronavirus monoclonal antibody on the labeling plate combines with the new coronavirus antigen in the sample to form a complex, and the reaction complex moves forward along the nitrocellulose membrane under the action of chromatography, and passes through the nitrocellulose The detection area (T) on the chip is pre-coated with anti-2019-nCoV monoclonal antibody, and finally a red reaction line is formed in the T area. If the 2019-nCoV antigen is not present in the sample, the red reaction line cannot be formed in the T zone. Regardless of whether the test sample contains 2019-nCoV antigen, a red reaction line will be formed in the quality control area (C).

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.



test program:
1. Please read the instructions carefully before testing.
2. Invert the specimen extraction tube and keep it upright. Squeeze the test tube, and add more than 3 drops of the sample solution (about 70-90 μL) into the test tube through the nozzle of the test tube.
3. Start the timer. Visually read results at 15 minutes. Do not interpret results after 30 minutes.

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!