Flu a/B Lateral Flow Antigen Rapid Diagnostic Test Kit Self Test

• Type: IVD Reagent
• Weight: 15kg
• Sensitivity: 97.62%
• Specificity: 98.73%
• Accuracy: 98.23%
• Lod: 10pg/Ml
• Model NO.: CG201A
• Package: 1test/5tests/25tests
• Certificates: CE/ISO13485/9001/FSC/White List
• Swab Matches: Nasal/Oral/Saliva Swab
• Results Available: Within 15minutes
• Testing Method: Colloidal Gold
• Testing Type: Antigen
• Working Efficiency: Fast
• Shelf Life: 18 Months
• Reagent: Prefilled in The Tube
• Delivery Time: Within 7 Days
• Transport Package: Carton
• Specification: 655mm*373mm*455mm
• Trademark: cas-envision
• Origin: China
• HS Code: 3002100090
• Production Capacity: 500000/Per Day

Product Description

 

Product Description:
1 Test/Kit; ; 5 Tests/Kit; 25 Tests/Kit;
Materials Provided:

	1 Test/kit	5 Tests/kit	25 Tests/kit
Foil bag(each contains 1 test cartridge and 1 desiccant pouch)	1	5	25
Extraction tube with Extraction solution	1	5	25
Samping swab	1	5	25
Biohazard bag	1	5	0
Instructions for Use	1	1	1
Qc card	0	0	1

Materials Required but not provided:
1. Tube rack for specimens
2. Timer
3. Any necessary personal protective equipment, such as protective gloves, medical mask, goggles, and lab coat.
STORAGE AND STABILITY:
1. Store at 2-30ºC;
2. The test cartridge should be used within 1 hour after taking out from the foiled pouch;
3. Keep away from sunlight, moisture, and heat;
4. The product batch number, production, and expiry date are printed on the outer packaging box Under the correct storage conditions, the items in the kit are stable until the expiration date.


Product Actual Photo:
Sensitivity and Specificity: The nasal swabs of 161 patients with nucleic acid positive and 185 subjects with nucleic acid negative were tested simultaneously using the product and PCR method to evaluate the sensitivity, specificity, and accuracy of the product; The NP swabs test results were compared with PCR, The sensitivity, specificity, and accuracy were calculated and the 95% confidence intervals were calculated respectively.