Tp Syphilis (Anti-treponemia Pallidum) Rapid Test Kit Medical Equipment Home Test Manufacturer

• Type: IVD Reagent
• Quality Certification: ISO13485 9001 CE
• Specimen: Wb/S/P
• Format: Strip/Cassette
• MOQ: 300
• Transport Package: 2000/CTN,66*36*56.5cm-Cassette,50*34.5*38cm-Strip
• Model NO.: 101015
• Specification: 40pcs/box-cassette, 50pcs/box-strip
• Trademark: testsealabs
• Origin: Hangzhou
• HS Code: 3822001090
• Production Capacity: 500000000000000piece/Year

Product Description

item	value
Place of Origin	China
Brand Name	testsealabs
Model Number	TP Syphilis (Anti-treponemia Pallidum)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
Syphilis(SYP) Antibody Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid, serological, immunochromatographic assay for the qualitative detection of antibodies (IgG, IgM and IgA) to Treponema Pallidum (TP) in human serum or plasma. It is intended to be used as a screening test and as an aid in the diagnosis of infection with TP. Any reactive specimen with the SYP Ab Rapid Test Cassette must be confirmed with alternative testing method(s) and clinical findings.

Quick Details
Detection for: antibodies(lgG and lgM) to Treponema Pallidum(TP) qualitatively in whole blood.Serum or plasma
Specimen volume:
For test strip: Serum or Plasma Specimen:50μL
Venipuncture or Fingerstick Whole Blood specimen: 50μL
For test cassette: Serum or Plasma specimen:40μL
Venipuncture or Fingerstick Whole Blood Specimen:80μl
Reading time: 10 minutes
Relative sensitivity: >99.9%(95%C1*:97.7%~100.0%) ;
Relative specificity:99.7%(95%C1*:98.2%~100.0%);
Accuracy: 99.8%(95%C1*:98.2%~100.0%).
 

 

Summary
Treponema Pallidum (TP) is the causative agent of the venereal disease syphilis. TP is a spirochete bacterium with an outer envelope and a cytoplasmic membrane. Relatively little is known about the organism in comparison with other bacterial pathogens. According to the Center for Disease Control (CDC), the number of cases of syphilis infection has markedly increased since 1985. Some key factors that have contributed to this rise include the crack cocaine epidemic and the high incidence of prostitution among drug users. One study reported that a large number of HIV-infected females exhibited reactive syphilis serological test results. Multiple clinical stages and long periods of latent, asymptomatic infection are characteristic of syphilis. Primary syphilis infection is defined by the presence of a chancre at the site of inoculation. The antibody response to the TP bacterium can be detected within 4 to 7 days after the chancre appears. The infection remains detectable until the patient receives adequate treatment.

1. who are we?
We are based in Zhejiang, China, start from 2018,sell to South Asia(40.00%),South America(10.00%),Africa(10.00%),Mid East(10.00%),Eastern Asia(10.00%),Western Europe(10.00%),Southern Europe(10.00%). There are total about 201-300 people in our office.

2. how can we guarantee quality?
Always a pre-production sample before mass production;
Always final Inspection before shipment;

3.what can you buy from us?
infectiouse disease test,drug of abuse test,tumor marker test,Hormone Rapid Test ,cardiac marker test,vet diagnostic test

4. why should you buy from us not from other suppliers?
high-tech enterprise , specialized in the research, development productio and sales of raw materials, more than 2000 square meters , including 400 square meters of GMP100 000-level purification workshop , follow with ISO

5. what services can we provide?
Accepted Delivery Terms: FOB,CFR,CIF,EXW,FCA,DDP,DDU;
Accepted Payment Currency:USD,EUR,CNY;
Accepted Payment Type: T/T,Credit Card,PayPal,Western Union,Cash;
Language Spoken:English,Chinese,Japanese