| 摘要: | 尿液成分分析對腎臟及代謝性疾病之篩檢與追蹤均能提供良好的指標資訊，亦有助於泌尿系統感染診斷。尿液常規檢驗包括尿液十項法及顯微鏡尿沈渣檢查。依臨床檢驗標準制定機構(CLSI )GP16-A3建議未冷藏之尿液，應於2小時完成檢測。院外健檢存有冷藏保存困難性，而院內健診有於院外提早留取可能性，均具有影響報告正確性的風險，故對保存溫度(冷藏2-8℃與室溫20-28℃)及報告完成時效(0,3,4,5小時)等2項變數進行檢測結果比較評估。
研究收集院外260件、院內62件樣本，使用Clinitek Atlas與Iris iQ200等尿液分析儀檢測。依CLSI EP12-A2一致性的90%信賴區間評估模式在93.5-100%間，達到良好一致性。Spearman's 係數與Kendal等級係數檢定在0.639-1.000間，唯尿沉渣檢查紅血球第3小時(0.294)/5小時(0.437)相關性弱。Kappa統計量於0.623-0.932間，僅尿潛血第4小時(0.539)/5小時(0.400)一致性較弱。Wilcoxon符號等級檢定與Friedman二因子等級變異數分析檢定，pH值第5小時與Blood第4及5小時等3組檢測結果p值<0.05相關性不顯著。NcMemar檢定與Cochran's Q檢定，第3,4,5小時草酸鈣結晶p值0.029關聯性較弱。接受者操作特徵曲線檢定顯示在第0,3,4,5小時執行檢測對尿潛血與紅血球的鑑別結果無明顯差異。
本研究結果發現室溫(20-28℃)下與冷藏(2-8℃)保存4小時候期檢測結果無顯著的差異；健康檢查尿液成分分析於室溫保存3,4,5小時後檢測，其結果與0小時(立即檢測)無明顯差異，顯示室溫儲存五小時不影響尿液穩定性。其結果可提供與臨床醫師對健康檢查族群尿液報告判讀參考，對考量執行院外健康檢查之環境限制、保存設備及運送路程等因素，與院內健康檢查尿液樣本採檢至送達實驗室此段時間的不確定性，實驗室應可修改尿液樣本允收標準為留取後，尿液須在室溫下5小時內完成檢測，另實驗室應對其尿液樣本保存、運送流程等重新建立適當處理模式。
The urine analysis provides good index information for the screening and tracking of kidney and metabolic diseases, but also contributes to the diagnosis of urinary tract infections. Routine urine tests include 10 Parameter Urinalysis Test and microscopic urine sediment examination. According to CLSI GP16-A3, it is recommended that unfrozen urine should be tested in 2 hours. Physical health examinations outside the hospital have the difficulty of refrigerating storage and hospital health examinations have the possibility of taking urine outside the hos-pital early. Both have the risk of affecting the correctness of the report. Therefore, the test results of the storage temperature (refrigerated 2-8 ? C and room tempera-ture 20-28 ? C) and the reported completion time (0, 3, 4, 5 hours) were compared and evaluated.
The study collected 260 samples from outside the hospital and 62 samples from the hospital, using a urine analyzer such as Clinitek Atlas and Iris iQ200. Agree-ment % is based on the 90% confidence interval evaluation model of the CLSI EP12-A2 document. The Concordance of the specimens was 93.5-100%, and the results were in good agreement. The coefficient test of Spearman's rank cor-relat-eon test and Kendall tau rank correlation test is between 0.639-1.0. Only the red blood cell number of the urine sediment examination was weakly correlated at 3th hour (0.294) and 5th hour (0.437). The consistency coefficient of Kappa sta-tistics is between 0.623-0.932. Just, urinary occult blood was weakly at the 4th hour (0.539) and 5th hour (0.4). Only the occult blood of the 10 Parameter Uri-nalysis was slightly weakness at the 4th hour (0.539) and 5th hour (0.4). Wilcoxon Rank Signed testand Friedman Two-way ANOVA analysis test, the pH value of 10 Parameter Urinalysis at the 5th ho-ur and urinary occult blood at the 4th and 5th hour were not significantly associated with the control group. The results of the McNemar change test and the Cochran's Q test showed that the urinary sediment was slightly weaker at the 3rd, 4th, 5th hour of thecalcium oxalate crystals (p val-ue=0.029). The receiver's operating characteristic curve test showed that the occult blood and red blood cell number were identified on the 0th, 3rd, 4th, and 5th hours. There was no significant difference in the results.
The results of this study found no significant difference between the test results at room temperature (20-28 ? C) and cold storage (2-8 ? C) for 4 hours. Health examination urine composition analysis was stored at room temperature for 3, 4, and 5 hours, and the results were not significantly different from 0 hours (imme-diate detection). Indicates that storage at room temperature for 5 hours does not affect urine stability The results can be provided with the clinician's interpretation of the health examination group urine test report. The factors such as the environ-ment, preservation equipment and transportation distance when performing the out-of-hospital health examination, and the uncertainty of the time during the in-spection of the urine samples from the hospital health examination to the delivery laboratory. The laboratory should be able to modify the urine sample acceptance criteria. After the retention, the urine must be tested within 5 hours at room tem-perature. In addition, the laboratory should reconstruct the appropriate processing mode for its urine sample storage and delivery processes. |
