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比較Arkray Aution Max-4030/Sysmex UF1000i尿液分析儀與細菌培養方法診斷尿路感染的效能

Comparison between Arkray Aution Max-4030/Sysmex UF1000i Urine Analyzer and Bacterial Culture for Diagnosis of Urinary Tract Infection

摘要


尿路感染屬於人類高發病率的感染疾病,雖然傳統感染源的診斷係藉著尿液的常規微生物培養,但需花費至少24至48小時才能獲得結果。因此,有必要尋求一種快速且可靠的篩選方法。本研究於2020年5月至6月之間從資料庫中選取同時具有尿液培養與尿液常規的所有1,290名病患的檢驗報告,以尿液培養為金標準,探究Arkray Aution Max-4030/Sysmex UF 1000i分析儀之檢驗效能。結果指出在1,290件檢體中,此分析儀測出731件陽性、210件陰性以及349件不確定結果,經與尿液培養結果比較,其敏感性為89.2%(903/1012)、特異性36.3%(101/278)、陽性預測值83.6%(903/1080)、陰性預測值48.1%(101/210)、一致性77.8%(1004/1290)、偽陽性16.4%(177/1080)以及偽陰性51.9%(109/210)。若將報告呈現不確定結果的349件檢體排除統計計算,此分析儀的檢測效能分別為敏感性85.8%(661/770)、特異性59.1%(101/171)、陽性預測值90.4%(661/731)、陰性預測值48.1%(101/210)、一致性81.0%(762/941)、偽陽性9.6%(70/731)以及偽陰性51.9%(109/210)。因為陰性預測值及一致性達到最佳化,因此分析儀的檢測效能符合醫師與檢驗室的期望。本研究亦發現在尿路感染的診斷中,自動化尿沈渣的白血球分析比自動化尿化學的白血球酯酶(leukocyte esterase)來的正確,且二者正確性皆優於尿沈渣的自動化細菌分析。

並列摘要


Urinary tract infection is the most common infection in humans with a high morbidity. Although conventional urine culture is the major method of diagnosis, it takes at least 24 to 48 hours to get results. Therefore, a rapid and reliable screening method is needed. In this study, we examined 1,290 urine samples collected from May to June 2020 by urinalysis with the Arkray Aution Max-4030/Sysmex UF1000i urine analyzer and compared the performance results with those of culture. Among the 1,290 samples, the Sysmex UF1000i analyzer determined 731 as positive, 210 as negative, and 349 as equivocal (+/-). Compared with culture results, we obtained the following statistics: sensitivity, 89.2% (903/1,012); specificity, 36.3% (101/278); positive predictive value, 83.6% (903/1,080); negative predictive value, 48.1% (101/210); agreement, 77.8% (1,004/1,290); false positive rate, 16.4% (177/1,080); and false negative rate 51.9% (109/210). When the 349 equivocal samples were excluded from statistic calculations, the parameters were as follows: sensitivity, 85.8% (661/770); specificity, 59.1% (101/171); positive predictive value, 90.4% (661/731); negative predictive value, 48.1% (101/210); agreement, 81.0% (762/941); false positive rate, 9.6% (70/731); and false negative rate, 51.9% (109/210). Because consistency and negative predictive value were maximized, the efficacy of this analyzer meets the expectations of physicians and laboratory. We also found that analysis of urine sediment WBC by UF1000i yielded better results than determination of leukocyte esterase by Max-4030 in the diagnosis of urinary tract infection and that analysis of urine sediment or leukocyte esterase yielded better results than microbial culture of urine sediments analyzed by UF-1000i.

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