TRFIA Serum Amyloid A （SAA）POC Test Kit ISO13485 Certification

High sensitivity cFDA approved SAA Quantitative Detection Kit (TRFIA)

1. Product Description

Principle: This SAA Quantitative Detection Kit(Time Resolved Fluorescence Immunochromatographic Assay) is based on time-resolved fluorescence immunochromatography for quantitative determination of serum amyloid A in serum, plasma and whole blood.

The sample detection solution and blood sample were mixed and added to the reagent card. The test substance (SAA) was combined with the mouse anti-human serum amyloid A monoclonal antibody nano-microsphere fluorescent probe on the marker pad to form a complex (i.e., the monoclonal antibody probe). The monoclonal antibody detection line containing mouse anti-human serum amyloid A was detected by capillary action chromatography and captured to form a double antibody sandwich complex (i.e. monoclonal antibody-monoclonal antibody-monoanti-nano-microsphere fluorescent probe). As a result, the more SAA in the sample, the more the double antibody sandwich complex accumulates on the detection line. The excess unreacted Mono-anti-nano-microspheres fluorescence probe continued to chromatography to the control line. The fluorescence intensity on the detection line is positively correlated with the concentration of the object (SAA) in the sample, and the regression equation is calculated and written into the IC card.

The Time Resolved Fluorescence Immunoanalyzer reads the regression equation data in the IC card, tests the fluorescence intensity on the detection line, and then replaces the fluorescence intensity with the regression equation for automatic calculation, that is, the concentration of the object (SAA) in the output sample.

Intended Use: 

This serum amyloid A detection kit (time-resolved fluorescence immunoassay) is suitable for quantitative determination of serum amyloid A in human serum, plasma and whole blood in vitro.

Serum amyloid A (SAA) is an acute phase protein,Its detection helps to diagnose inflammation and assess acute phase reaction processes. During inflammatory, infectious and noninfectious diseases, its concentration in the blood can rise sharply within hours. SAA is associated with high density lipoprotein (HDL), which regulates HDL metabolism during inflammation. SAA degradation products can be deposited in different organs in the form of amyloid A fibrils, which is a serious complication in chronic inflammatory diseases. During clinical laboratory diagnosis, chemiluminescence and colloidal gold immunochromatography are common methods for detecting SAA.

2. Specification

3. High sensitivity cFDA approved SAA Quantitative Detection Kit (TRFIA) Main component

• SAA Quantitative Detection Kit(Time Resolved Fluorescence Immunochromatographic Assay):Contains 20/50 reagent cards ,1 IC card ,1 manual , 20 samples /50 samples.
• The reagent card consists of a plastic shell and a test strip consisting of a sample pad, a marker pad (mainly made of glass fiber and sprayed with a fluorescent probe (0.25 mg/mL) of mouse anti-human serum amyloid A (SAA) monoclonal antibody (AA) monoclonal antibody (1.5 mg/mL) and a polyclonal antibody (1.1) of goat anti-mouse immunoglobulin G (IgG) on the sample pad and a test strip consisting of a plastic cartridge mg/mL), absorbent paper and polystyrene (PVC) plywood. and the main component of the sample detection solution was phosphate buffer solution (10 mmol/L PBS).
• ※Do not exchange different batch numbers

4. Storage conditions and expiry date?

The kit is stored in 2℃~8℃, valid for 18 months. If the use period of printing on the package is not exceeded, the product can be stored stably at temperature (20℃~30℃) for 30 days. The temperature change during transportation (<37℃) has no effect on product quality. The reagent strip and the sample detection solution are used in one-to-one mode, that is, a reagent strip is matched with a bottle of sample detection solution to detect a sample. After unsealing, it can be stabilized for 1 hour at room temperature. Under normal humidity and light conditions, store and use according to the above requirements.