Testsealabs Neutralizing Antibody Rapid Test Cassette Results in 15 Minutes

• Type: Rapid Diagnosis Test
• Specimen: Whole Blood/Serum/Plasma
• Box Specification: 20 Tests/Box
• Shelf Life: 24 Months
• Test Time: 15 Minutes
• Instrument Classification: Class III
• Model NO.: 202205070120
• Format: Cassette
• Quality Certification: CE
• Usage: Professional Use or Home Use
• Certificate: CE ISO 13485
• OEM: Available
• Sensitivity: 97.3%
• Specificity: 100%
• Transport Package: Carton 47*43*34.5cm
• Specification: 205*150*65mm
• Trademark: Testsealabs
• Origin: China
• HS Code: 3822190020
• Production Capacity: 3000000/Day

Product Description

 

Product Description

Quality Certification	CE
Certificate	CE ISO 13485
Specimen	Whole blood/Serum/Plasma
Instrument classification	Class Semiprofessional
	use and home use
Shelf life	24 Months
Accuracy	More than 99.0%
OEM	Available

Sensitivity	97.3%
Specificity	100%

 

Detailed Photos

 

Test Procedure

 

DIRECTIONS FOR USE

1. Bring the pouch to room temperature before opening. Remove

the test device from the sealed pouch and use it as soon as

possible.
 

2. Place the test device on a clean and level surface.

For Serum or Plasma Specimens: Using the Micropipette,

transfer 10ul serum/plasma to the specimen well of the test

the device, then add 2 drops of buffer, and start the timer.

For Whole Blood (Venipuncture/Fingerstick) Specimens: Using

the provided disposable pipette, transfer 10ul whole blood to

the specimen well of the test device, then add 2 drops of buffer,

and start the timer. Note: we can also apply Specimens using a

micropipette.

3. Wait for the colored line(s) to appear. Read

results at 15 minutes. Do not interpret the result after 20 minutes.

 

INTERPRETATION OF RESULTS
 

Result 1:*The red colored line in the reference line region (C)

and reference line region(1) appears and a colored the line appears in the test line region(2 ). and the intensity of 2 lines is weaker than 1 line, The result is show Signal Inhibition between Less than 30%
 

Result 2:*The red colored line appears in the reference line region (C) and reference line region(1), a colored line appears in test line region(2).and and the intensity of 2 line is weaker than C line and strong than 1 line, The result is show Signal Inhibition between 30%-60%
 

Result 3:*The red colored line in the reference line region (C) and reference line region(1) appears and a red colored line appears in test line region (2 ) and the intensity of 2 line is strong than C line, The result is show Signal Inhibition between greater than 60%.
 

INVALID: There is no line appearing in the reference region C or reference region(1) Insufficient buffer volume or incorrect procedural techniques are the most likely reasons for control line failure.Review the procedure and repeat the procedure with a new test device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

 

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