SARS-CoV-2 SALIVA ANTIGEN TEST DEEPBLUE (1 UNIT)

Product Description:

The SARS-CoV-2 Saliva Antigen Test DEEPBLUE is a rapid and qualitative test for detecting the SARS-CoV-2 antigen using a saliva sample. This self-test is ideal for use at home, providing results in just 15 minutes without the need for professional assistance.

Main Features:

• Fast and Convenient Use: Detects the presence of SARS-CoV-2 antigen within 7 days after symptom onset.
• Saliva Test: Uses an oral swab to collect the sample, providing comfort and ease of use.
• Detection Method: Based on immunochromatography to identify the virus antigen in the saliva sample. A positive result is indicated by a fuchsia line in the test zone, while the absence of this line suggests a negative result.
• Quality Control: Includes a control line that must appear regardless of the test result.

Instructions for Use:

1. Preparation: Read the instructions carefully before conducting the test.
2. Sample Collection: Use the oral swab to collect saliva from the oral cavity and place it in the extraction tube. Mix well and leave the swab in the tube for 1 minute.
3. Test: Add 2 drops of the solution into the test well and read the result after 15-20 minutes.

Precautions:

• Minors under 18 should perform the test with adult assistance.
• Do not reuse or ingest the liquids in the kit.
• Do not use the kit if it is damaged or expired.
• Keep the kit between 2 and 30ºC, and handle samples with care.
• Use gloves and facial protection when handling samples.

Kit Contents:

• 1 Sterile Swab
• 1 Extraction Tube with Reagent
• 1 Collection Bag
• 1 Information Leaflet
• 1 Test Cassette

Sensitivity and Specificity:

• Sensitivity: 98.7%
• Specificity: 99.9%
• Accuracy: 98.8%

Restrictions:

• This kit is intended solely for the qualitative detection of SARS-CoV-2 antigen in saliva.
• Results should be assessed alongside other available clinical data.
• Improper storage or handling of samples may affect result accuracy.

Manufacturer:
Anhui Deepblue Medical Technology Co., Ltd.
4th Floor, D-1# Zone, Pearl Industrial Park, 106 Innovation Avenue, High-Tech Development Zone, 230088 Hefei, Anhui, China

Distributor:
Luxus Lebenswelt GmbH
Kochstr. 1, 47877 Willich, Germany

CE: 1434