Testsealabs Chagas Antibody IgG/IgM Test
Short Description:
Fast & Accurate：Achieve reliable results in minutes.
Simple Operation：No complex equipment required.
High Accuracy：Lab-grade precision you can trust.
Clear Visual Readout：Results are easy to read and interpret.
Certified Quality Systems：Compliant with ISO 13485 and MDSAP.
Room-Temperature Stability：No cold chain needed—easy to transport and store.
Product Specification
| Principle | Chromatographic Immunoassay | Specimen | Whole Blood/Serum/Plasma |
| Reading Time | 15 minutes | QMS Certification | ISO 13485 and MDSAP |
| Storage Temperature | 4-30°C | Shelf life | 2 years |
| Format | Cassette | Specification | 25T/40T |
Intended Use
The Chagas Antibody IgG/IgM Test is a lateral flow chromatographic immunoassay for the qualitative detection of IgG/IgM anti-Trypanosoma cruzi in human serum, plasma or whole blood. It is intended to be used as a screening test and as an aid in the diagnosis of infection with T. cruzi.
Summary
Chagas disease is an insect-borne, zoonotic infection by the protozoan T. cruzi,which causes a systemic infection of humans with acute manifestations and long term sequelae. It is estimated that 16-18 million individuals are infected worldwide, and roughly 50,000 people die each year from chronic chagas disease (World Health Organization) 1. Buffy coat examination and xenodiagnosis used to be the most commonly used methods2,3 in the diagnosis of acute T. cruzi infection. However, both methods are either time consuming or lack sensitivity. Recently, serological tests have become the mainstay in the diagnosis of chagas’s disease. In particular, recombinant antigen based tests eliminate false-positive reactions which are commonly seen in the native antigen tests4-5.The Chagas Antibody IgG/IgM Test is an instant antibody test which detects antibody to T. cruzi within 15 minutes without any instrument requirements. By utilizing T. cruzi specific recombinant antigen, the test is highly sensitive and specific.
