Research test for the quantitative determination of SAA Kit in human serum on automate chemistry analyzers

SAA (Serum Amyloid A) is is an acute-phase protein. During
inflammation, infectious and non-infectious diseases, its concentration in the blood can rise sharply within a few hours, and can rise to 1000 times the initial concentration. SAA is
related to HDL, and it can It regulates the metabolism of HDL
during inflammation. A particularly important feature of SAA is
that its degradation products can be deposited in different organs
in the form of amyloid A fibrils. This is a serious complication in
chronic inflammatory diseases; Elevated serum amyloid A is also
seen in atherosclerosis, diabetic nephropathy, acute myocardial
infarction, coronary heart disease, and chronic kidney disease

Components

【Procedure】

Reagent preparation:

R1: Ready for use; R2: Ready for use. Wavelength:570nm Temperature:37℃

Direction: Increase

Calibration

It is recommended to use the SAA Calibrators for calibration. Dissolve the lyophilized SAA calibrator with 1ml distilled water, and dilute to 6 calibrators as follows,

Calibration Method:Spline or other non-linear method

Quality control

It is recommended to use the SAA Quality Control level 1 and level 2 for daily quality control.

Two levels of controls should be assayed at least once a day. Values obtained should fall within a specified range.

Each laboratory should establish its own internal Quality Control scheme and procedures for corrective action if controls do not recover within the acceptable tolerances.

Calculation:

The analyzer automatically calculate the analyte concentration of each sample.

Biovantion Inc is independent from international department of Bioneovan Co., Ltd., which established in 2 0 0 5, is an in vitro diagnostic reagents manufacturer engaged in the research, development, production, and focus on clinical testing for infectious diseases, such as Hepatitis virus, Noro virus, Parvo virus test kits, our products include rapid test cassette and Elisa kits.

All our products have been registered in National Medical Products Administration of China, in year 2020 we get Certificate of ISO 13485:2016 – QUALITY MANAGEMENT SYSTEMS FOR MEDICAL DEVICES from SGS. More importantly, we have awarded the registration certificate from National Medical Products Administration for Diagnostic Kit for IgM Antibody to COVID-19 and IgG antibody to COVID-19 during the outbreak in China, and also we developed COVID-19 Antigen test ; Neutralizing Antibody Test, these products selling well all overthe world