Nasopharyngeal/ Oropharyngeal/ Nasal Swab Antigen Rapid Test Cassette

• Type: Rapid Diagnosis Test
• Specimen: Nasopharyngeal/Oropharyngeal/Nasal Swab
• Box Specification: 1 Tests/Box
• Shelf Life: 24 Months
• Test Time: 15 Minutes
• Instrument Classification: Class III
• Model NO.: 610021101110
• Format: Cassette
• Quality Certification: CE
• Usage: Professional Use or Home Use
• Certificate: CE/ISO 13485
• OEM: Available
• Sensitivity: 97.6%
• Specificity: 98.4%
• Transport Package: Carton 57*38*37.5cm
• Specification: 160*70*18mm
• Trademark: Testsealabs
• Origin: China
• HS Code: 3822190020
• Production Capacity: 3000000/Day

Product Description

 

Product Description

Quality Certification	CE
Certificate	CE ISO 13485
Specimen	Nasopharyngeal/Oropharyngeal/Nasal swab
Instrument classification	Class Semiprofessional
	use and home use
Shelf life	24 Months
Accuracy	More than 99.0%
OEM	Available

Sensitivity	97.6%
Specificity	98.4%

Detailed Photos

 

Test Procedure

 

DIRECTIONS FOR USE
 

Allow the test, sample and buffer to reach room temperature 15-30°C (59-86°F)

before running.

1. Place the extraction tube in the Workstation.
 

2. Peel off the aluminum foil seal from the top of the extraction tube containing the

extraction tube containing the extraction buffer.

3. Have the nasopharyngeal, oropharyngeal or nasal swab carried out by a

medically trained person as described.

4. Place the swab in the extraction tube. Rotate the swab for about 10 seconds.

5. Remove the swab by rotating against the extraction vial while squeezing the sides

of the vial to release the liquid from the swab. properly discard the swab. while pressing

the head of the swab against the inside of the extraction tube to expel as much liquid

as possible from the swab.

6. Close the vial with the provided cap and push firmly onto the vial.

7. Mix thoroughly by flicking the bottom of the tube. Place 3 drops of the sample

vertically into the sample window of the test cassette. Read the result after 10-15

minutes. Read the result within 20 minutes. Otherwise, a repetition of the test is

recommended.

Company Profile

Hangzhou Testsea Biotechnology Co., LTD. is a national high-tech enterprise, is located in Hangzhou. Testsea has lots of researchers and workers who graduated from Zhejiang University and overseas. Testsea is specialized in the research, development, production and sales of raw materials for medical diagnosis and food safety testing. We have applied for 28 kinds of patents which cover medical diagnosis, food safety rapid testing, food enzymatic immunoassay and new enzyme preparation. Testsea provides perfect raw material solutions for scientific research institutions, enterprises, research institutes and other institutions globally. Testsea total business area is more than 56,000 square meters, including 2,000 square meters of GMP 100,000-level purification workshop, our company is strictly following ISO13485 and ISO9001 quality management system operation with research, production, quality control, finance, domestic sales and international sales, etc. Our products are well accepted by many users domestic and abroad. In addition, we establish a good business relationship with many domestic universities and in vitro diagnostic production enterprises, even with southeast Asia, Europe, Africa, Latin America, and other countries.

Testsea has a research and development team led by doctors and masters with professional workers and a well-equipment facility. The production capacity of recombinant antigens has reached 18g/month.

Testsea pursuit of "integrity, quality, responsibility" concept and adhere to the quality, the purpose of serving the society and constantly developing new high-quality diagnostic materials efforts.

Certifications