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研究生：	曾雅暄 Tseng, Ya-Hsuan
論文名稱：	評估IRIS自動化尿液分析儀的常規篩檢及泌尿道感染之特性分析 Evaluation of IRIS automated urinalysis analyzers for routine test and characterization of urinary tract infection
指導教授：	楊孔嘉 Young, Kung-Chia
學位類別：	碩士 Master
系所名稱：	醫學院 - 醫學檢驗生物技術學系 Department of Medical Laboratory Science and Biotechnology
論文出版年：	2014
畢業學年度：	102
語文別：	中文
論文頁數：	86
中文關鍵詞：	尿液分析、泌尿道感染、IRIS iQ200 、IRIS iChem 、廣效性乙型內醯胺酶
外文關鍵詞：	urinalysis, urine tract infection, IRIS iQ200, IRIS iChem, extended-spectrum beta- lactamase
相關次數：	點閱：127 下載：2
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自動化尿液分析儀加速腎臟與泌尿道疾病的篩檢。本篇研究我們評估成大醫院內IRIS自動尿液生化 (iChem Velocity, IRIS diagnostics) 及尿沉渣分析儀 (iQ200 Elite, IRIS diagnostics) 篩選泌尿道感染的效能。2013年3-7月份，懷疑泌尿道感染之病患之尿液檢體 (n=315) ，經由自動化尿液分析儀與尿液培養分析。尿液培養為診斷泌尿道感染之標準方法，菌落數>105 CFU/ml視為泌尿道感染陽性 (n=98) ; 而<105 CFU/ml視為陰性 (n=217) 。iChem Velocity與iQ200 Elite在紅血球、白血球與細菌的定量結果具相關性 (p-value<0.001) ，但一致性較弱 (κ<0.4) 。若以iChem Velocity檢測白血球酯酶與亞硝酸鹽及iQ200 Elite計數白血球 (臨界值>5 cells/hpf) 與細菌 (>trace) 用於篩選泌尿道感染，其敏感性、特異性及診斷勝算比結果如下：白血球酯酶為94.9%/56.2%/23.9，亞硝酸鹽為30.6%/96.8%/13.2，白血球為79.6%/77.4%/13.4及細菌為80.6%/81.6%/18.4，白血球酯酶、白血球與細菌適用於排除泌尿道感染 (陰性概似比，NLR<0.3) ，同時，亞硝酸鹽、白血球與細菌項目適用於納入泌尿道感染 (陽性概似比，PLR>3) 。接受者操作曲線下面積 (AUC) 分別為：白血球酯酶為0.85，亞硝酸鹽為0.64，白血球為0.84及細菌為0.84。並且。單獨使用白血球酯酶有低的偽陰性率 (5.1%) ，而單獨使用亞硝酸鹽有低的偽陽性率 (3.2%) 。iChem Velocity合併iQ200篩選泌尿道感染，可改善執行效能。當白血球酯酶或細菌其一為陽性，預測泌尿道感染陽性，敏感性為96.9%適用於排除泌尿道感染 (NLR<0.06) 。分離的尿路病原菌常見E. coli (59.4%) ，K. pneumoniae (9.4%) 及Enterococcus (9.4%) 。革蘭氏陰性菌iQ200計數細菌數高於革蘭氏陽性菌 (p-value=0.023) 。此外，廣效性乙型內醯胺酶 (Extended-spectrum β-lactamase, ESBL) 陽性細菌iQ200 Elite計數細菌數高於ESBL陰性細菌 (p-value=0.047) 。總結本篇研究，自動化尿液分析儀有助於預測泌尿道感染之應用。

IRIS automated urine chemistry analyzer (iChem Velocity) and automated urine sediment analyzer (iQ200 Elite) are combined to screen routine urinalysis. In the study, we evaluated the performance of automated urine analyzers for predict urinary tract infection (UTI) and correlated with characterizations of UTI etiology. From March to July in 2013, urine specimens from patients with suspected UTI were recruited consecutively (n=315), and analyzed by automated urinary analyzers and urine culture in National Cheng Kung University Hospital. Urine culture yield 98 positive and 217 negative UTI results. The values between iChem, and iQ200 for WBCs, bacteria, and RBCs were significantly correlated (p<0.001) but fairly consistent (κ<0.4). Leukocyte esterase (LE) and nitrite, measured by iChem for screening UTI were analyzed. The results showed sensitivities, specificities, and diagnostic odds ratios were 94.9%/56.2%/23.9 for LE and 30.6%/96.8%/13.2 for nitrite. Single measurement of LE had a low false negative rate (5.1%) and single measurement of nitrite had a low positive rate (3.2%). Combined the items that iChem LE or iQ200 bacteria positive was considered as UTI, rule out of UTI could be predictive (NLR=0.06), with a false negative rate of 3.1% and diagnostic odds ratio of 39.2. The frequently isolated uropathogens were E. coli (59.4%), K. pneumoniae (9.4%), and Enterococcus (9.4%). Gram-negative bacteria exhibited a higher bacteria count by iQ200 than Gram-positive bacteria (p=0.023), whereas the extended-spectrum beta-lactamase (ESBL)-positive bacteria exhibited a higher bacteria count by iQ200 than that ESBL-negative bacteria (p=0.047). In conclusion, automated urinalysis might contribute to the application in prediction of UTI.

目錄
中文摘要	I
英文延伸摘要	II
致謝	VI
表目錄	X
圖目錄	XII
附錄目錄	XIII
縮寫索引	XIV
抗生素縮寫	XVI
儀器與試紙	XVII
I.	緒論	1
1.	尿液分析	1
2.	尿液物理性質檢查	1
2.1	尿液生化性質檢查	2
2.2	尿沉渣的顯微鏡檢查	6
3.	自動化尿液分析儀	9
3.1	自動化尿液生化分析儀	9
3.2	自動化尿液鏡檢分析儀	10
4.	泌尿道感染	11
5.	Extended spectrum β-lactamase-producing Enterobacteriaceae感染之檢測	12
6.	研究目的	13
II.	材料與方法	14
1	病患與臨床分析結果的收樣	14
1.1	收樣病患之數據	14
1.2	臨床分析結果的數據	14
2	統計方法分析	15
2.1	評估iChem Velocity自動化尿液生化分析儀之檢測	15
2.2	評估IRIS自動化尿液分析診斷泌尿道感染的執行	17
2.3	泌尿道感染的特性分析	19
2.4	IRIS自動化尿液分析儀於ESBL-positive Enterobacteriaceae感染之預測	20
2.5	評估IRIS自動化尿液分析儀於ESBL-positive Enterobacteriaceae感染之預測	21
III.	結果	22
1	尿液培養診斷泌尿道感染	22
2	評估iChem Velocity自動化尿液生化分析儀之檢測	22
3	評估IRIS自動化尿液分析儀於泌尿道感染之篩選	23
3.1	評估iChem Velocity自動化尿液生化分析儀於泌尿道感染之篩選	23
3.2	評估iQ200 Elite自動化尿液顯微鏡分析儀於泌尿道感染之篩選	24
3.3	評估合併iChem Velocity與iQ200自動化尿液分析儀於泌尿道感染之篩選	26
4	成大醫院內泌尿道感染之特性分析	27
4.1	成大醫院內革蘭氏陰性細菌感染之特性分析	28
4.2	成大醫院內革蘭氏陽性細菌感染之特性分析	29
5	IRIS自動化尿液分析儀於ESBL-positive Enterobacteriaceae感染之預測	30
IV.	討論	32
1	自動化尿液分析儀的發展	32
1.1	自動化尿液生化分析儀的比較	33
1.2	自動化尿液生化分析儀於泌尿道感染的診斷	35
1.3	自動化尿液鏡檢分析儀的比較	36
1.4	自動化尿液鏡檢分析儀於泌尿道感染的診斷	37
1.5	自動化尿液分析儀於泌尿道感染的診斷	39
2	台灣泌尿道感染之特性	40
3	ESBL-positive Enterobacteriaceae之偵測	42
4	結論	42
V.	參考文獻	44

表目錄
Table 1. The distribution of age and gender in UTI.	51
Table 2. The performance of iChem velocity for screening UTI.	52
Table 3. The performance of WBC and bacteria at different cut-off value of positivity for screening UTI.	53
Table 4. The performance of combination of bacteria and WBC at different cut-off value of positivity for screening UTI.	54
Table 5. The performance of combination of iChem velocity and iQ200 elite for screening UTI.	55
Table 6. The distribution of age and gender in gram positive and negative bacterial infection.	57
Table 7. The distribution of isolated bacterial species from urine specimens	58
Table 8. Total number of patients with or without urinary tract infection from the different departments in NCKU hospital.	59
Table 9. Total number of Enterobacteriaceae with or without ESBL from the different departments in NCKU hospital.	60
Table 10. The susceptibility of common antibiotics against E. coli and K. pneumoniae.	61
Table 11. The susceptibility of common antibiotics against ESBL-negative and ESBL-positive E. coli.	62
Table 12. The susceptibility of common antibiotics against ESBL-negative and ESBL-positive K. pneumoniae.	63
Table 13. The susceptibility of common antibiotics against other gram negative bacteria.	64
Table 14. The susceptibility of common antibiotics against Enterococcus.	66
Table 15. The susceptibility of common antibiotics against Streptococcus species.	67
Table 16. The measurements of urinalysis in UTI patients with gram negative and positive bacteria.	68
Table 17. The measurements of urinalysis in UTI patients with and without ESBL.	69
Table 18. Differences between various automated urinalysis analyzers for excluding the unnecessary urine culture.	70


圖目錄
Figure 1. The values between iChem velocity and iQ200 ELITE for WBCs, bacteria, and RBCs were highly correlated.	71
Figure 2. Receiver operating characteristic (ROC) curve for WBCs and RBCs detection.	72
Figure 3. Receiver operating characteristic (ROC) curve for screening UTI.	73
Figure 4. The distribution of isolated bacterial species from urine specimens.	75

附錄目錄
Appendix 1. The characteristic color of urine.	76
Appendix 2. The difference of commercial urinary strip in difference brands.	77
Appendix 3. The comparison of commercial urinalysis standardized system.	81
Appendix 4. The type of urinary casts associated with pathologic condition.	82
Appendix 5. Technical specifications of automated urinary chemistry analyzer.	83
Appendix 6. Technical specifications of automated urinary microscopic analyzer.	84
Appendix 7. ESBL screening method for Enterobacteriaceae following CLSI and EUCAST guidelines.	85

                                    

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坂本純子, & 林昌宏. 尿検査システムの更新と運用. 飯塚病院中央検査部一般検査室.

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