检验医学与临床
檢驗醫學與臨床
검험의학여림상
JOURNAL OF LABORATORY MEDICINE AND CLINICAL SCIENCES
2009年
15期
1259-1260
,共2页
幽门螺杆菌%试剂盒,诊断%银染色法
幽門螺桿菌%試劑盒,診斷%銀染色法
유문라간균%시제합,진단%은염색법
helicobacter pylori%reagent kits,diagnostic%silver staining
目的 观察幽门螺杆菌检测试剂盒(银染法)(商品名:幽必现)的稳定性. 方法 将试剂盒分别保存于室温和-15～5 ℃环境中,抽样测定其特异性、精密性、灵敏度、批内差异、批间差异,根据检测结果评价幽门螺杆菌检测试剂盒的稳定性,并预测有效期.结果 幽必现在不同保存时间、不同保存温度、不同储运环境的敏感性、特异性、批内不精密度差异均无统计学意义,且均无批间差异.结论 幽必现具有良好的稳定性,有效期至少2年或2～3年.
目的 觀察幽門螺桿菌檢測試劑盒(銀染法)(商品名:幽必現)的穩定性. 方法 將試劑盒分彆保存于室溫和-15～5 ℃環境中,抽樣測定其特異性、精密性、靈敏度、批內差異、批間差異,根據檢測結果評價幽門螺桿菌檢測試劑盒的穩定性,併預測有效期.結果 幽必現在不同保存時間、不同保存溫度、不同儲運環境的敏感性、特異性、批內不精密度差異均無統計學意義,且均無批間差異.結論 幽必現具有良好的穩定性,有效期至少2年或2～3年.
목적 관찰유문라간균검측시제합(은염법)(상품명:유필현)적은정성. 방법 장시제합분별보존우실온화-15～5 ℃배경중,추양측정기특이성、정밀성、령민도、비내차이、비간차이,근거검측결과평개유문라간균검측시제합적은정성,병예측유효기.결과 유필현재불동보존시간、불동보존온도、불동저운배경적민감성、특이성、비내불정밀도차이균무통계학의의,차균무비간차이.결론 유필현구유량호적은정성,유효기지소2년혹2～3년.
Objective To study the stability of Helicobacter pylori detection kit(Silver staining) (Trade names: Heli Emerging).MethodsWe developed the sampled inspection method to determine the specificity, precision, sensitivity, within run-precision and between run-precision of helicobacter pylori detection kits, which are stored at the enviroment with room temperature of 15-5℃.Results The sensitivity, specificity, precision within-run precision and between-run precision were found, and there was no statistical difference in different preservation time,temperatures and storage environment. Conclusion Helicobacter pylori detection kit (Silver staining) has a good stability and is valid for at least 2 or 3 years.
