- 期刊
評估Alifax Roller 20PN自動紅血球沉降速率分析儀之效能
Performance Evaluation of the Alifax Roller 20PN Analyzer for Erythrocyte Sedimentation rate
摘要
紅血球沉降速率（erythrocyte sedimentation rate, ESR）的測試廣泛應用於在醫學實驗室領域，諸如發炎、感染、惡性腫瘤、糖尿病、腎臟病與心臟病皆影響該數值。本研究評估義大利製造的ESR全自動分析儀Alifax Roller 20PN的品質，結果發現各種高低範圍檢驗數值其重複性大致符合實驗室規範，此外發現執行檢驗需新鮮檢體，若將檢體保存於4℃冰箱且歷經24小時之後，報告無法再度呈現原有數值。儘管欲評估的新儀器Alifax Roller 20PN與過去2011－2018年所使用的Vacuette SRT10/II分析儀相關性不佳（R^2=0.7327; y=1.1671x+4.4755），殘差為-42～+44 mm/hr，然而正確性無誤，並不需要調整儀器的係數。本研究同時證明廠商所宣稱的精確性與實際吻合，另外亦驗證參考值。雖然Roller 20PN與現有儀器相關性不佳但正確性無誤，此外，報告時效、重複性、精確性皆符合規範，參考值亦無誤。吾等認為Roller 20PN屬於嶄新的自動分析設備且符合實驗室的品質要求。
關鍵字
紅血球沉降速率並列摘要
The erythrocyte sedimentation rate (ESR) is probably the most widely performed laboratory test in medical practice. ESR may be affected by a wide variety of factors including inflammation, infection, malignancy, diabetes, renal disease, and heart disease. In this study, we evaluated the performance of Alifax Roller 20PN (Italy), a fully automated analyzer for the measurement of ESR. Intra-assay repeatability was satisfactory for a wide range of ESR values. However, there was a significant decrease in ESR values when the samples were stored at 4℃ for more than 24 hours. Compared with the Vacuette SRT10/ II analyzer (Austria), which we have used from 2011 to 2018, a poor correlation (R^2=0.7327; y=1.1671x+4.4755) was found. However, the bias between the two methods was within the agreement limits, -42~ +44 mm/hr. Alifax Roller 20PN showed acceptable accuracy without any adjustment of the instrument. No results of within-run or total run precisions exceeded the recommended values or were beyond the range of desirable standards. Reference ranges were as claimed. Although results generated with this instrument did not correlate well with those of the Vacuette SRT10/II analyzer, it provided excellent time saving, repeatability, precision, and well-established reference ranges. We therefore conclude that Alifax Roller 20PN is a useful fully automated system for ESR measurement in a clinical setting.