Lepu COVID-19 Antigen Rapid Test kit MSLRDT121

A rapid test for the qualitative detection of antigens to the novel coronavirus SARS-CoV-2 in human throat and nasal secretions, and saliva specimen.
For professional in vitro diagnostic use only.

Lepu COVID-19 Antigen Rapid Test kit MSLRDT121 PACKING SPECIFICATIONS
40 T/kit, 20 T/kit, 10 T/kit, 1 T/kit. 

Lepu COVID-19 Antigen Rapid Test kit MSLRDT121 INTENDED USE
The SARS-CoV-2 Antigen Rapid Test (COVID-19 Ag) is a rapid chromatographic immunoassay for the qualitative detection of novel coronavirus SARS-CoV-2 in human throat and nasal secretions, and saliva specimen.

Lepu COVID-19 Antigen Rapid Test kit MSLRDT121 PRINCIPLE
The SARS-CoV-2 Antigen Rapid Test is for detection of SARS-CoV-2 antigens. Anti-SARS-CoV-2 monoclonal antibodies are coated in the test line and conjugated with the colloidal gold. During testing, the specimen reacts with the anti-SARS-CoV-2 antibodies conjugate in the test strip.

The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with another Anti-SARS-CoV-2 monoclonal antibodies in the test region. The complex is captured and forming a colored line in the Test line region. 

Lepu COVID-19 Antigen Rapid Test kit MSLRDT121 contains anti-SARS-CoV-2 monoclonal antibodies conjugated particles and another anti-SARS-CoV-2 monoclonal antibodies are coated in the test line regions.

STORAGE AND STABILITY
The kit can be stored at room temperature or refrigerated (2-30°C). The Test Strip is stable through the expiration date printed on the sealed pouch. The Test Strip must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date. The stability of the kit under these storage conditions is 18 months

Lepu COVID-19 Antigen Rapid Test kit MSLRDT121SPECIMEN COLLECTION AND PREPARATION
The SARS-CoV-2 Antigen Rapid Test (COVID- 19 Ag) can be performed using throat secretions and nasal secretions.

Throat Secretions: Insert the sterile swab into the throat. Gently scrape the secretions around the wall of pharynx.  
Nasal Secretions: Insert the sterile swab into the deep nasal cavity. Gently rotate swab against wall of turbinate for several times. Make the swab wet as much as possible. 

Saliva: Take a specimen collection container. Make a “Kruuua” noise from the throat, to get out the saliva or sputum from the deep throat. Then spit saliva (about 1-2ml) into the container. Morning saliva is optimal for saliva collection. Do not brush the teeth, eat food or drink before collection the saliva specimen. 

Collect 0.5ml of assay buffer and place into a specimen collection tube. Insert the swab into the tube and squeeze the flexible tube to extrude the specimen from the head of the swab.

Make the specimen resolved in the assay buffer sufficiently. Add the crystal tip onto the specimen collection tube. If saliva specimen, suck the saliva from the container and place 5 drops (approx.200ul) of the saliva into the sample collection tube.