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SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method)-Saliva

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Category:COVID-19 Test

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SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method)-Saliva

This Detection kit is for in vitro qualitative detection of SARS-CoV-2 antigen in saliva samples. This test is intended for non-prescription home use self-testing with self-collected saliva samples from individuals aged 15 years or older who are suspected of COVID-19 or adult collected saliva samples from individuals under 15 years old who are suspected of COVID-19. 
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Introduction

Catalogue Number and Packing size
HWTS-RT062Q (1 test / kit)
HWTS-RT062W (5 tests / kit)
HWTS-RT062X (10 tests / kit)
HWTS-RT062R(20 tests / kit)

 

Intended use
This Detection kit is for in vitro qualitative detection of SARS-CoV-2 antigen in saliva samples. This test is intended for non-prescription home use self-testing with self-collected saliva samples from individuals aged 15 years or older who are suspected of COVID-19 or adult collected saliva samples from individuals under 15 years old who are suspected of COVID-19. 
Results are for the identification of SARS-CoV-2 Nucleocapsid Protein antigen. Antigen is generally detectable in anterior nasal swab during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation past medical history and other diagnostic information is necessary to determine infection status. Negative results cannot exclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results should be considered in the context of an individual’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.

 

Key Components

Materials required but not provided
• Clock, timer or stopwatch


Detection method
The Instruction for Use should be read and understood thoroughly before testing. Ensure all test components are at room temperature (18℃~26℃) before use.
Do not open items until instructed to do so:


Wash or sanitize your hands. Make sure they are dry before starting.



Perform the test

1. Take the test card to equilibrate to room temperature. Open the aluminum foil bag of the detection reagent card, take out the test card.    
2. Remove the test card cap.    
3. Place the exposed saliva sheet of the test card under the tongue in the mouth, make sure that the saliva sheet is close to the tongue, and place the test card horizontally.
Note: During the test process, gently place it in the mouth to allow saliva to be naturally absorbed into the saliva cotton sheet.    
4. It takes about 2 minutes for the purple liquid flows through the middle of the test card window (line C) and take out the test card, close the cap, and place the test card horizontally to react.    
5. Test result is interpreted visually between 15-20 minutes. Results should not be read after 20 minutes.    


Note:
1.When sampling, gently hold it in mouth and let saliva naturally adsorb on the absorbent pad.
2.Do not eat, drink,or smoke prior to the test for at least 30 minutes.
3.Any saliva specimen is approprate for testing but the saliva specimen cllected in the morning, before mouth rinsed, eating or drinking is recommended.

Key words:
COVID-19
Self Test
Saliva
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