Anti-H.Pylori Rapid Test Kits (CE)

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Port: Xiamen
Payment Terms: L/C,T/T
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Quick Details

Type:
Pathological Analysis Equipments
Brand Name:
InTec
Place of Origin:
Fujian China (Mainland)
Certificate:
CE
Quality Guaranty:
GMP&ISO 13485
Specimen:
Whole Blood/Serum/Plasma
Format:
Strip/Cassette
Storage Condition:
2-30℃
Shelf Life:
2 years

Packaging & Delivery

Packaging Detail: Cassette: 40Pcs /box, 30boxes/Carton Strips:50 Pcs /box, 30 boxes/Carton
Delivery Detail: Within 21 work days againest the payment

Specifications

Anti-H. Pylori rapid test kits
CE CERTIFICATE

Anti-H.Pylori Rapid Test Kits

CE CERTIFICATE

 

Intended use:
The Advanced quality rapid anti-H.pylori test is a colloidal gold enhanced. Rapd immunochromatographic assay for the quaitative detection of antibodies to H.pylori in human serum or plasma. This test is a screening test and all positive must be confirmed using an alternate test such as western blot. The test is intended for healthcare professional use only.

 

Features:

Format

Strip/Cassette

Specimen

Whole Blood/Serum/Plasma

Specificity

95%

Sensitivity

95.4%

Shelf life

2 years

Storage Condition

2-30°C

Reading Time

15- 20 minutes

Certification

CE

 

Sample collection and storage:
1. Serum

Use the standard venous phlebotomy procedure to collect a whole blood sample by a tube NOT containing any of the following anticoagulants: EDTA, heparin, or sodium citrate. Leave to settle for 30 minutes for blood coagulation and then centrifuge blood to get serum specimen of supernatant.

2. Plasma

Use the standard venous phlebotomy procedure to collect a whole blood sample by a tube containing any of the following anticoagulants: EDTA, heparin, or sodium citrate. And then centrifuge blood to get a plasma specimen.

Note:

1. If serum or plasma specimens are not tested immediately, they should be refrigerated at 2°C-8°C. For storage period longer than 7days, freezing is recommended. They should be brought to room temperature before testing.

2. Serum or plasma specimens containing a precipitate may yield inconsistent test result. Such specimens must be clarified before testing.

 

Performance Characteristics:

Sensitivity and Specificity

The accuracy of Rapid Anti-H.pylori test was evaluated in comparison to the results of widely recognized ELISA tests. Out of the 1148 samples, 1093 test results agreed with the ELISA result, while 55 samples gave different results.

 

The comparison study results gave a relative sensitivity of 94.88% (371/391), a relative specificity of 95.38% (722/757), and a total agreement of 95.21% [(371+722)/1148]. The results indicate that the results of the Rapid Anti-H.pylori Test testing clinical specimens generally conform to that of the reference ELISA kit, and it is suitable to apply to using as primary screening test.

 

 

 

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As one of the earliest Chinese IVD kit manufacturers, we were established in 1989. Our company is dedicated to serving health-care institutions, clinical laboratories, blood banks and other good quality products. With the technology originated from the United States, we manufacture a broad range of clinical diagnostic products, including EIA test kits/rapid test kits for infectious diseases, drug-of-abuse and pregnancy. We have launched a series of new product lines including blood glucose ... View detail

Basic Information

Product/Service (We Sell): Rapid Test Kit,Elisa Test Kit,Blood Grouping Kit  
Number of Employees: 501 - 1000 People  

Trade & Market

Main Markets: North America
South America
Eastern Europe
Southeast Asia
Africa
Oceania
Mid East
Eastern Asia
Western Europe
Total Annual Sales Volume: US$10 Million - US$50 Million  

Factory Information

Factory Size (Sq.meters): 30,000-50,000 square meters  
Factory Location: 332 Xinguang Road, Xinyang Industry Area, Haicang District, Xiamen City, Fujian Province. China  
Number of Production Lines: Above 10  
Number of R&D Staff: Above 50 People  
Number of QC Staff: 41 - 50 People  
Management Certification: ISO9001   ISO13485  
Contract Manufacturing: OEM Service Offered   Design Service Offered   Buyer Label Offered  

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Verified Supplier - Intec Products, Inc. (Xiamen)
China (Mainland) | Manufacturer | Contact Details
Experience: Established 1989

Communicate with Supplier:

Ms. Frances Zou
Ms. Frances Zou:
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