Immunofluorescence-Based test strip was prepared with K7c5-K8d6 matched antibody pairs (30 Siemens calibrators, Concentration: 3-300 ug/ml, R² > 98%)

R1: Buffer

R2: Combination of K1016-K1017 matched antibody pairs and latex particals

Sample: SAA calibrator

Equipment: Hitachi 7080

Six calibrators were prepared using Latex particals and SAA antibody. Data show that Linear dependence > 99% with concentration between 2-500 ug/mL as indicated in Fig. 3 and Table 1.

SAA antibody was employed to prepare kits to detect 48 clinical coincidence rates. With R² > 99%, the antibody can be used to develop SAA immunonephelometry materials.

The strip was prepared with K7c5-K8d6 matched antibody pairs. With R2 > 99% of 48 Siemens clinical samples, the antibodies can be used to develop SAA immunonephelometry materials.

The quality control samples with concentration of 10 ng/ml-20 ng/ml and 70 ng/ml-80 ng/ml respectively were required to repeat test three times. B= (M-T) / T×100% (B: Relative Standard Deviation, M: Average, T: Concentration)

The quality control samples with concentration of 10 ug/ml-20 ug/ml and 70 ug/ml-80 ug/ml respectively were required to repeat test over 10 timers. CV= (S /) ×100% (CV < 15% as indicated in the following table)

Serum amyloid A (SAA) is an AP apolipoprotein associated with high-density lipoproteins (HDL) in plasma. It is reported that SAA as a biomarker in a variety of diseases ranging from bacterial infection, virus infection, atherosclerosis, coronary heart disease, acute rejection of transplantation and cancer. SAA showed a wider range of concentrations and a significantly superior overall diagnostic performance compared with CRP in diagnosis of certain diseases.

SAA is also a strong marker for cardiovascular and all-cause mortality, interacting with the functionality of HDL. Concomitantly measuring SAA concentrations may represent a convenient method to estimate HDL functionality in clinical routine.