Clinic for Horses, Department of Equine Surgery and Orthopaedics, Faculty of Veterinary Medicine, Justus-Liebig-University Giessen, Giessen, Germany.
Department of Veterinary Clinical Sciences, Clinical Pathology and Clinical Pathophysiology, Faculty of Veterinary Medicine, Justus-Liebig-University Giessen, Giessen, Germany.
J Vet Diagn Invest. 2022 Jan;34(1):42-53. doi: 10.1177/10406387211056029. Epub 2021 Nov 11.
Rapid, accurate detection of serum amyloid A (SAA) is needed in equine practice. We validated a patient-side point-of-care (POC) assay (Stablelab; Zoetis) compared to the turbidimetric immunoassays LZ-SAA (TIA-Hum) and VET-SAA (TIA-Vet; both Eiken Chemical). Analytical performance was assessed at 3 different concentration ranges and with interferences. Inter-method comparison using 49 equine serum samples revealed a significant difference between median SAA results ( < 0.0001), with the strongest bias between the POC and TIA-Vet (median 1,093 vs. 578 mg/L). The median SAA value obtained with the TIA-Hum method was 752 mg/L. Correlation between POC/TIA-Hum and between POC/TIA-Vet was fair (r = 0.77 and 0.69) and excellent between both TIAs (r = 0.93). Bias between POC/TIA-Hum, POC/TIA-Vet, and TIA-Hum/TIA-Vet was -56.7%, -80.9%, and -28.2%, respectively. POC intra- and inter-assay CVs (16.1-30% and 19.8-35.5%) were higher than TIA CVs (generally <12%). Bilirubin and hemoglobin had a negative bias on POC and TIA-Vet results (-16.6 to -45.6%); addition of intralipid yielded a positive bias (35.9-77.4%). The POC had good linearity of SAA concentrations up to 10,312 mg/L ( = 0.92). A hook effect was present at SAA >3,000 mg/L for the POC assay. Equine serum SAA was stable over a median period of 2.5 y when stored at -80°C. Overall, there was excellent-to-moderate correlation between tests, but imprecision and hook effect of the POC, as well as bias between the methods, must be considered.
在马医学中需要快速、准确地检测血清淀粉样蛋白 A (SAA)。我们对一种床边即时检测(POC)测定法(Stablelab;Zoetis)与浊度免疫测定法 LZ-SAA(TIA-Hum)和 VET-SAA(TIA-Vet;均来自 Eiken Chemical)进行了验证。在 3 个不同浓度范围内和存在干扰的情况下评估了分析性能。使用 49 份马血清样本进行的方法间比较显示,SAA 结果的中位数存在显著差异( < 0.0001),POC 与 TIA-Vet 之间的偏差最大(中位数为 1093 与 578 mg/L)。使用 TIA-Hum 方法获得的 SAA 中位数为 752 mg/L。POC/TIA-Hum 之间以及 POC/TIA-Vet 之间的相关性为中等(r = 0.77 和 0.69),而 TIA 之间的相关性则极好(r = 0.93)。POC/TIA-Hum、POC/TIA-Vet 和 TIA-Hum/TIA-Vet 之间的偏差分别为-56.7%、-80.9%和-28.2%。POC 的批内和批间变异系数(16.1-30%和 19.8-35.5%)高于 TIA 的变异系数(通常<12%)。胆红素和血红蛋白对 POC 和 TIA-Vet 结果有负偏差(-16.6 至-45.6%);添加脂肪乳剂会产生正偏差(35.9-77.4%)。POC 在 SAA 浓度高达 10,312 mg/L 时具有良好的线性( = 0.92)。POC 测定法在 SAA >3000 mg/L 时存在钩状效应。当在-80°C 下储存时,马血清 SAA 在中位数为 2.5 y 的时间内稳定。总体而言,测试之间具有极好到中等的相关性,但 POC 的不精密度和钩状效应以及方法之间的偏差必须考虑在内。