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Objectives:
The objective of this prospective study performed between January and February 2021 was to validate a stall-side point-of-care (POC) assay for the measurement of equine Serum Amyloid A (SAA) (VMRD, Pullman WA, USA) in comparison to a turbidimetric immunoassay VET-SAA (TIA-VET, Eiken Chemical) serving as reference method.
Methods:
Analytical validation of the SAA POC assay included the assessment of linearity, precision, interferences, hook effect and the comparison of the SAA POC results in different concentration ranges with the reference method. The use of residual equine serum samples was ethically approved (Regierungspraesidium Giessen, Wetzlar, Germany, ethics committee: JLU_kTV_03_2021).
Results:
The POC test was linear for SAA concentrations of 0-404 mg/L (R2 = 0.91) and for SAA concentrations of 377-1918 mg/L (R2 = 0.94). POC intra- and inter-assay CVs (14.9-31.3% and 35.3-44%) were higher than TIA-VET CVs (3-6.4% and 3.4-26.6%), respectively. Both intralipid and hemoglobin exhibited positive bias on SAA POC (66.3-16.9%). The addition of bilirubin yielded a negative bias (-29.8%). A hook effect was not present for SAA concentrations up to 15300 mg/L as the POC assay still reported SAA values >3000mg/L, i.e., results exceeding its working range. Bias between POC and TIA-Vet was -81.3%. Correlation between POC/TIA-VET was good (rs=0.89).
Conclusions:
The POC test demonstrates good linearity and correlation with the reference method, however, bias and relatively high imprecision have to be considered. The POC showed no hook effect, which is advantageous compared to other POCs and for clinical interpretation.
34th Annual Scientific Meeting proceedings
Stream:
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Session:
Date/Time: 30-11--0001 (00:00 - 00:00) | Location:
Date/Time: 30-11--0001 (00:00 - 00:00) | Location:
Analytical validation of a recently introduced point-of-care assay in equine practice in comparison to an immunoturbidimetric assay for serum amyloid A in horses
Aner E1, Kiemle J1, Hines S3, Hindenberg S2, Bauer N2, Roecken M1
1Department of Equine Surgery and Orthopaedics, Faculty of Veterinary Medicine, Justus-Liebig-University, Giessen, Germany, 2Department of Veterinary Clinical Sciences, Clinical Pathology and Clinical Pathophysiology, Faculty of Veterinary Medicine, Justus-Liebig-University, Giessen, Germany, 3Veterinary Medical Research and Development, Pullman, WA, USA.
Objectives:
The objective of this prospective study performed between January and February 2021 was to validate a stall-side point-of-care (POC) assay for the measurement of equine Serum Amyloid A (SAA) (VMRD, Pullman WA, USA) in comparison to a turbidimetric immunoassay VET-SAA (TIA-VET, Eiken Chemical) serving as reference method.
Methods:
Analytical validation of the SAA POC assay included the assessment of linearity, precision, interferences, hook effect and the comparison of the SAA POC results in different concentration ranges with the reference method. The use of residual equine serum samples was ethically approved (Regierungspraesidium Giessen, Wetzlar, Germany, ethics committee: JLU_kTV_03_2021).
Results:
The POC test was linear for SAA concentrations of 0-404 mg/L (R2 = 0.91) and for SAA concentrations of 377-1918 mg/L (R2 = 0.94). POC intra- and inter-assay CVs (14.9-31.3% and 35.3-44%) were higher than TIA-VET CVs (3-6.4% and 3.4-26.6%), respectively. Both intralipid and hemoglobin exhibited positive bias on SAA POC (66.3-16.9%). The addition of bilirubin yielded a negative bias (-29.8%). A hook effect was not present for SAA concentrations up to 15300 mg/L as the POC assay still reported SAA values >3000mg/L, i.e., results exceeding its working range. Bias between POC and TIA-Vet was -81.3%. Correlation between POC/TIA-VET was good (rs=0.89).
Conclusions:
The POC test demonstrates good linearity and correlation with the reference method, however, bias and relatively high imprecision have to be considered. The POC showed no hook effect, which is advantageous compared to other POCs and for clinical interpretation.
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