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- W4387080017 abstract "Abstract Background Elevated serum concentrations of Anti- Streptolysin-O(ASO) can be used to provide serologic evidence of past or present infection by β-Hemolytic Streptococci. Increasing serum concentrations of ASO antibodies are produced in response to ASO exotoxins secreted by the bacteria. Measurement of ASO antibody levels in serum can be used as an aid in the diagnosis of diseases such as glomerulonephritis, rheumatic fever, bacterial endocarditis, tonsillitis, and scarlet fever, etc. The New ASO assay has been evaluated on Mindray BS-2800M that is an automated, high throughput, and low cross-contamination system. The evaluation of this assay included precision, linearity, dilution accuracy, interference, high dose hook, and method comparison studies. Methods The new ASO reagent contains R1 buffer and R2 with latex particles conjugated with in-house made ASO antigen. The R1 is incubated with human serum sample containing ASO antibodies for 5 min at 37°C and then R2 is added. After another 5 min of incubation, immune-aggregation complex is formed. The increased turbidity is measured at 570 nm. By constructing a six-level calibration curve (water is used as reagent blank) from the absorbances of calibrators, the ASO antibody concentration of the sample is determined. Results The precision study was run according to EP05A3 with two commercial controls (approximately 80 and 300 IU/mL) and two serum sample pools (approximately 150 and 400 IU/mL) on the Mindray BS-2800M system. The repeatability and within-lab CVs ranged from 0.8% to 2.0% and 2.0% to 6.0%, respectively. The analytical linearity of the assay was determined as from 20 IU/mL to 1000 IU/mL with the limit of blank of 2 IU/mL and limit of detection of 10 IU/mL. The dilution accuracy was evaluated by diluting high ASO level samples at upper region of assay range using saline with 5-fold and run neat and diluted samples. The deviation in recoveries between diluted sample after calculation and the neat sample was found to be less than ±10%. The new ASO assay showed <±10% interference with bilirubin (conjugated or free) up to 40 mg/dL,hemolysate hemoglobin up to 1000 mg/dL,Intralipid up to 1000 mg/dL,and Triglycerides up to1000 mg/dL. The assay on the Mindray BS-2800M system(y) correlated well with the ASO assay(x) on the Beckman AU5800 system:y = 1.01 x + 1.55(r = 0.9514,n = 95,range:50–971 IU/mL). No prozone was observed with the assay on the Mindray BS-2800M system up to the highest ASO antibody concentration of 5000 IU/mL. Conclusion We conclude that the New ASO assay with in-house developed ASO antigen raw material, when used on the Mindray BS-2800M system, can measure serum ASO antibody concentrations precisely and accurately over a broad range. It is suitable for use in routine clinical laboratories." @default.
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- W4387080017 date "2023-09-27" @default.
- W4387080017 modified "2023-09-29" @default.
- W4387080017 title "B-048 Performance Evaluation of the New Anti-Streptolysin-O Assay on Mindray BS-2800M System" @default.
- W4387080017 doi "https://doi.org/10.1093/clinchem/hvad097.391" @default.
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