Antigen Detection Rapid Lateral Flow Test (latex bead-based) AIVD Biotech's Ag test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein (NP) antigen in direct nasal swabs from individuals suspected of infection. Description: This kit utilizes the principle of latex bead immunochromatography to qualitatively detect the Np antigen in human nasal swabs. Lateral flow immunochromatographic assay provides an easy workflow, short turnaround time, and rapid diagnosis of suspected patients. The test contains latex bead conjugate pad and a membrane strip pre-coated with antibodies specific to the antigen on the test lines (T). If novel NP antigen is present in the specimen, a visible band appears on the test lines (T) as antibody-antigen-antibody latex bead complex forms. The control line (C) is used for procedural control and should always appear if the test is performed correctly. This method does not require expensive medical instruments and consumables. Just take the specimen and add it to the sample well. If sample contains the antigen, it will interact with the latex bead-labeled anti- NP antibodies on the conjugate pad. Required components 1. A foil pouch with a desiccant and a single use test card, 1 piece 3. Sterile swab, 1 piece 3. Extraction buffer tube (1 ml), 1 tube. 4. Instructions for use, 1 piece. Storage conditions 1. Store at the dark place, room temperature 18~28C with low humidity. 2. After opening the foil bag, please use the test cassette within 30 mins. 3. Expiration period 12 month Specimen requirements: 1. Nasopharyngeal swab specimen. 2.Specimen should be tested as soon as possible upon collection. If the sample has to be stored, store the swab sample at room temperature for up to 1 hour or 2~8C for up to 4 hours prior to testing. Performance Characteristics A total of 365 samples from suspected patients were tested by the RT-qPCR test. Testing results are shown in the following table: PCR AIVD Antigen Rapid Test Kit Positive Negative Positive 59 8 Negative 6 292 Total: 65 300 Sensitivity: 90.7%; Specificity: 97.3%.