One Step Typ Typhoid Igg/Igm Rapid Test Kit Manufacturer

• Type: IVD Reagent
• Quality Certification: ISO13485 9001 CE
• Specimen: Wb/S/P
• Format: Strip/Cassette
• MOQ: 300PCS
• Transport Package: 66*36*56.5cm 2000/CTN
• Model NO.: 101016
• Specification: 40pcs/box
• Trademark: testsealabs
• Origin: Hangzhou
• HS Code: 3822001090
• Production Capacity: 500000000000000piece/Year

Product Description

item	value
Place of Origin	China
Brand Name	testsealabs
Model Number	TYP Typhoid IgG/IgM Rapid Test Kit
Power Source	Manual
Warranty	2 years
After-sale Service	Online technical support
Power Supply Mode	Plug-in
Material	Plastic
Shelf Life	2 years
Quality Certification	ISO9001/ ISO13485 CE
Instrument classification	Class II
Safety standard	GB15979-2002

Intended Use
The Typhoid IgG/IgM Rapid Test(TYP tast cassette) is a lateral flow immunoassay for the simultaneous detection and differentiation of anti-Salmonella typhi (S. typhi) IgG and IgM in human serum, plasma . It is intended to be used as a screening test and as an aid in the diagnosis of infection with S. typhi. Any reactive specimen with the Typhoid IgG/IgM Rapid Test must be confirmed with alternative testing method(s).


Product Name: IgG/IgM antibody to Salmonella typhi (S.typhi)in human whole blood,serum or plasma
Specimen volume: Serum/Plasma Specimen:40μl
                Venipuncture or Fingerstick Whole Blood Specimen: 40μl
Reading Time: 15 minutes
IgG Results:
Sensitivity:89.5%
Specificity:97.2%
Accuracy:96.5%
IgM Results:
Sensitivity:87.9%
Specificity:97.4%
Accuracy:96.3%
 

Summary
Typhoid fever is caused by S. typhi, a Gram-negative bacterium. World-wide an estimated 17 million cases and 600,000 associated deaths occur annually1. Patients who are infected with HIV are at significantly increased risk of clinical infection with S. typhi2. Evidence of H. pylori infection also presents an increase risk of acquiring typhoid fever. 1-5% of patients become chronic carrier harboring S. typhi in the gallbladder. 

The clinical diagnosis of typhoid fever depends on the isolation of S. typhi from blood, bone marrow or a specific anatomic lesion. In the facilities that can not afford to perform this complicated and timeconsuming procedure, Filix-Widal test is used to facilitate the diagnosis. However, many limitations lead to difficulties in the interpretation of the Widal test3,4. 

In contrast, the Typhoid IgG/IgM Rapid Test is a simple and rapid laboratory test. The test simultaneously detects and differentiates the IgG and the IgM antibodies to S. typhi specific antigen5 t in whole blood specimen thus aid in the determination of current or previous exposure to the S. typhi.