Infections Disease Home Antigen Rapid Test Kit With CE FDA Certification

Product description: Antigen Rapid Test Kit

COVID-19 Ag Rapid Test is a lateral flow immunoassay intended for the qualitative detection of the Nucleocapsid antigen from SARS-CoV-2 in nasopharyngeal swabs from individuals who are suspected of SARS-COV-2 by their healthcare provider within the first 7 days of symptom onset, or for screening of individuals without symptoms, or other reasons to suspect SARS-COV-2 infection, if applicable.

Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.

Negative results should be treated as presumptive, and do not rule out 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 the context of a patient’s recent exposures, history, and the presence of clinical signs and symptoms consistent with COVID-19, and confirmed with a molecular assay, if necessary, for patient management.

Product usage:

This kit is used for vitro qualitative detection of coronavirus(Covid-19) in human pharyngeal or nasal secretions,sailva samples.

Used as a supplementary test indicator for suspected cases of new coronavirus nucleic acid test negative or used in conjunction with nucleic acid testing in the diagnosis of suspected cases

Main components:

The kit consists of test cards, sample buffer, and SWAB.
Test card: composed of aluminum foil bag, desiccant, test strip and plastic card. Test sheet consists of absorbent paper, nitrocellulose film, test pad, adhesive pad and rubber sheet. t line covering nitrocellulose film with 2019 nvvab (test line), c with goat-mouse polyclonal ab (quality management line) and 2019 nvvab. on the pad
Sample buffer: phosphate, sodium nitride, etc.

Test procedure:

• Remove the foil from the top of the extraction buffer tube
• Open the swab package at the stick end
• Gently insert the swab into the nostril and the tip of the swab should be inserted 1/2-3/4 inch away from the edge of the nostril
• Roll the swab along the mucous membrane inside the nostril 5 times,taking about 15 seconds to collect the speciman
• Insert the sampling swab into the sample buffer
• Swirl the tube for 30 seconds
• Rotate the swab 5 times while squeezing the tube
• Remove the swab while squeezing the tube
• Cover the emitter
• Add 2 drops to extract the treated sample to the loading well of the test card and then start the timer
• Leave at room temperature for 15 minutes before reading the results.The result will be invalid after 20 minutes

Detailed explanation of test results:

Product performance indicator:
The coronavirus(Covid-19) antigen detection kit was used to detect 60 positive cases with a sensitivity of 95% of 170 negative specimens tested with the Covid-19 antigen detectior kit,168 were negative,with a specificity of 99.1%