Covid SARS-CoV-2 Rapid Antigen3 Way Swab Hygisun Test Kits

The kit is used for the qualitative detection of SARS-CoV-2 in human nasal swab, throat swab or saliva in vitro. 

Why use SARS-CoV-2 Rapid 3 Way Swab Test Kits?

• Reliable, rapid chromatographic immunoassay for the qualitative detection of specific antigens of SARS-CoV-2 present in the nasopharynx or human saliva
• Obtain a quick result within 15-30 minutes
• No need for a follow-up appointment to discuss result
• Easy handling which does not require specific training
• No instrument required
• Allows immediate access to testing on site
• Age: Over 3 years old.
• Intended Operator: The trained medical or paramedical staff who have received professional medical knowledge, or Non-health care person, we can fully understand and understand the content identification and description.
• Environment: Hospitals and professional medical institutions and laboratories; Closed or semi-closed groups; include schools, nursing homes, cruise ships, prisons, workplaces and dormitories, or non-laboratory sites.
• Single-used. 
• Samples should be tested as soon as possible after collection. Saliva specimen can be stored in Extraction Solution for up to 24 hours at room temperature or 2° to 8°C. Do not freeze.
• The test should be operated at room temperature（15-30℃).
• Reference standard: BS EN 62366-1:2015 IEC 62366-1:2015
• Medical devices-Application of usability engineering to medical devices (IEC 62366:2007).

• This item is non-returnable.

Kit Components

1. Nasal swabs, Throat Swabs and Saliva 

• SARS-CoV-2 Antigen Test Card
• Extraction solution
• Swab
  
• Instructions for Use Kit components 

Materials required but not provided: 

• Timer 
• Tube rack for specimens
• Any necessary personal protective equipment
  

• Test Card should be used right after opening the pouch.

NOTE: Results are for the identification of SARS-CoV-2 nucleocapsid antigen.  The positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. The positive results do not rule out bacterial infection or co-infection with other viruses. 
The negative results 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. 

Wear suitable protective clothing, gloves, eye/face protection when handling the content of this Kit.