中国药事
中國藥事
중국약사
CHINESE PHARMACEUTICAL AFFAIRS
2014年
9期
990-994
,共5页
李晓波%王洪%付瑞%王吉%卫礼%王淑菁%岳秉飞
李曉波%王洪%付瑞%王吉%衛禮%王淑菁%嶽秉飛
리효파%왕홍%부서%왕길%위례%왕숙정%악병비
大鼠细小病毒%H-1 株%能力验证
大鼠細小病毒%H-1 株%能力驗證
대서세소병독%H-1 주%능력험증
ratparvovirus%H-1strain%capacityevaluation
目的:了解全国实验动物检测相关实验室在大鼠细小病毒 H-1株抗体检测项目的技术水平,发现并解决检验中存在的问题,促进各实验室加强质量管理,提高检测水平。方法不限定检测方法,推荐各参加实验室参照国标规定的方法,对统一发放的大鼠血清样品进行细小病毒 H-1株的定性检测,结果以阳性或阴性表示,与预期结果均一致判为满意结果,不完全一致或逾期未反馈结果判为不满意。结果来自13个省市自治区的18家单位报名参加本次比对实验,1家单位因故退出,实际参加并发放比对样品共17家单位,其中16家在规定时间反馈了检测结果,1家未在规定时间反馈结果,反馈结果的16个实验室检测结果均为满意,占参加比对实验室的94%,其中13个实验室使用外购试剂盒,14个实验室采用酶联免疫吸附法(ELISA)检测,仅2个实验室对阳性结果进行了复检。结论全国各实验动物检测机构大鼠细小病毒 H-1株总体检测能力较高,个别实验室因故未参加或逾期未反馈结果,检测能力有待考察。
目的:瞭解全國實驗動物檢測相關實驗室在大鼠細小病毒 H-1株抗體檢測項目的技術水平,髮現併解決檢驗中存在的問題,促進各實驗室加彊質量管理,提高檢測水平。方法不限定檢測方法,推薦各參加實驗室參照國標規定的方法,對統一髮放的大鼠血清樣品進行細小病毒 H-1株的定性檢測,結果以暘性或陰性錶示,與預期結果均一緻判為滿意結果,不完全一緻或逾期未反饋結果判為不滿意。結果來自13箇省市自治區的18傢單位報名參加本次比對實驗,1傢單位因故退齣,實際參加併髮放比對樣品共17傢單位,其中16傢在規定時間反饋瞭檢測結果,1傢未在規定時間反饋結果,反饋結果的16箇實驗室檢測結果均為滿意,佔參加比對實驗室的94%,其中13箇實驗室使用外購試劑盒,14箇實驗室採用酶聯免疫吸附法(ELISA)檢測,僅2箇實驗室對暘性結果進行瞭複檢。結論全國各實驗動物檢測機構大鼠細小病毒 H-1株總體檢測能力較高,箇彆實驗室因故未參加或逾期未反饋結果,檢測能力有待攷察。
목적:료해전국실험동물검측상관실험실재대서세소병독 H-1주항체검측항목적기술수평,발현병해결검험중존재적문제,촉진각실험실가강질량관리,제고검측수평。방법불한정검측방법,추천각삼가실험실삼조국표규정적방법,대통일발방적대서혈청양품진행세소병독 H-1주적정성검측,결과이양성혹음성표시,여예기결과균일치판위만의결과,불완전일치혹유기미반궤결과판위불만의。결과래자13개성시자치구적18가단위보명삼가본차비대실험,1가단위인고퇴출,실제삼가병발방비대양품공17가단위,기중16가재규정시간반궤료검측결과,1가미재규정시간반궤결과,반궤결과적16개실험실검측결과균위만의,점삼가비대실험실적94%,기중13개실험실사용외구시제합,14개실험실채용매련면역흡부법(ELISA)검측,부2개실험실대양성결과진행료복검。결론전국각실험동물검측궤구대서세소병독 H-1주총체검측능력교고,개별실험실인고미삼가혹유기미반궤결과,검측능력유대고찰。
Objective To investigate the technical level of rat parvovirus H-1 strain detection for experimental animal testing laboratories. To explore and solve the existing problems in H-1 strain detection,so as to promote quality management of laboratories and improve the detection capacity. Methods The detection methods were not restricted.The national standards for laboratory animal were recommended.The aim was to test rat parvovirus H-1 strain of rat serum samples provided and results were expressed as positive or negative. If the test results were consistent with expected results, the laboratory was rated satisfactory.If the results were not entirely consistent or feedback was not got on schedule,the laboratory was rated unsatisfactory.Results 18 laboratories from 13 provinces enrolled in the evaluation and one laboratory withdrew.A total of 1 7 laboratories participated in the evaluation and received the samples, 1 6 of them submitted detection results on time but 1 laboratory did not gave feedback results. The results of the 16 laboratories were all satisfactory, account for 94% of all laboratories.13 of 16 laboratories used outsourcing kit and 14 of them adopted ELISA.Only 2 laboratories rechecked the positive results.Conclusion The H-1 strain detection ability level of animal test laboratories was high. Two laboratories did not attend the evaluation or failed to submit results. Their detection capability remained to be investigated.