In clinical in vitro fertilization (IVF), optimal culture conditions are required for production of high quality embryos and for achieving high pregnancy rates. Cell culture systems require vigilant attention to quali...In clinical in vitro fertilization (IVF), optimal culture conditions are required for production of high quality embryos and for achieving high pregnancy rates. Cell culture systems require vigilant attention to quality control and quality assurance, and upgrades to equipment and procedures require strenuous deliberation. During a 2-week maintenance period, we undertook an extensive analysis of incubator carbon dioxide (CO2) monitoring and the effect on culture media pH by comparing our traditional liquid Fyrite instruments to a certified and calibrated digital CO2 analyzer. The digital analyzer produced consistently lower CO2 readings and significantly greater precision than the liquid Fyrite. Media pH measurements showed significant variation depending on CO2 calibration device;however pH remained within manufacturers’ specifications. After superior performance by the digital analyzer, we incorporated this device into the incubator calibration and daily quality control procedures. A retrospective comparison of overall lab performance before and after this equipment switch demonstrated improved clinical pregnancy and implantation rates. This report illustrates the necessary caution when altering established laboratory procedures and equipment while highlighting the benefits of judiciously updating techniques and equipment in a laboratory setting that is often stubborn to change pre-existing, ingrained methodology.展开更多
Introdution Laboratory diagnosis in medical practice,the position has been established,hernostasis and thrombosis.expefimental testing is no different.Experimental test of information not only for early diagnosis and ...Introdution Laboratory diagnosis in medical practice,the position has been established,hernostasis and thrombosis.expefimental testing is no different.Experimental test of information not only for early diagnosis and guide treatment,prognosis and estimated recurrence.展开更多
This paper describes the development and challenge of HIV/AIDS testing laboratory network and quality assurance system in China. At present,the HIV/AIDS testing laboratories includes three classes,the National AIDS Re...This paper describes the development and challenge of HIV/AIDS testing laboratory network and quality assurance system in China. At present,the HIV/AIDS testing laboratories includes three classes,the National AIDS Reference Laboratory,HIV/AIDS confirmatory laboratories and HIV/AIDS screening laboratories. All of them are accredited by the health authorities,and each class of laboratories take charge of their function strictly according to the "National Management of HIV/AIDS Detection (2006)". A complete quality assurance and quality control system for HIV/AIDS testing has been developed,which includes technical training,strict laboratory monitoring and approval,examination or proficiency testing on HIV/AIDS detection,and quality evaluation and supervision of HIV/AIDS diagnostic kits. Besides conduct the routine anti-HIV antibody test,more and more laboratories began to conduct other tests,such as CD4+ T lymphocyte cell counting,HIV viral load,HIV DNA PCR,genotyping,drug resistance,and HIV-1 recent infection test. The primary challenges faced by the HIV/AIDS testing laboratory network are in the areas of laboratory management and quality control. For example,the provincial PT program is inefficient,the internal quality control is conducted perfunctorily,personnel training can not met the needs of the workplace,which need to be improved.展开更多
Collecting baseline information on how laboratories perform testing is a reasonable first step towards establishing intra- and inter-laboratory standardization and quality control for semen analysis. We carried out a ...Collecting baseline information on how laboratories perform testing is a reasonable first step towards establishing intra- and inter-laboratory standardization and quality control for semen analysis. We carried out a survey of the laboratories performing the testing in China's Mainland. A questionnaire, composed of 36 questions covering all aspects of semen analysis, was designed, and a copy was distributed to each of the 145 laboratories. Of these, 118 laboratories completed the questionnaires. The survey results showed that semen volume was measured visually in 53.6% （59/110） of the responding laboratories, and 70.9% （73/103） of laboratories analysed incompletely liquefied semen without any treatment. In addition, both manual-microscopic and computer-assisted semen-analysis systems were applied to analyse sperm concentration, motility and morphology. However, more than five methods were employed in routine sperm staining. An enzyme-linked immunosorbent assay was commonly used for determining whether antisperm antibodies were present. Several seminal biochemical markers were analysed in only 27.1% （32/118） of the responding laboratories. Generally, there was a lack of intra- and inter-laboratory quality control measures for semen analysis in all laboratories responding to this survey. In conclusion, the methods of semen analysis and the interpretation of test results in the surveyed laboratories differed markedly. In particular, many laboratories employed methods other than those recommended by the World Health Organization Laboratory Manual for the Examination of Human Semen and Sperm- cervical Mucus Interaction （1999）. These findings suggest an urgent need for the standardization of semen analysis with acceptable quality controls for each parameter to make the results repeatable and meaningful.展开更多
目的通过危害分析及关键控制点(hazard analysis and critical control point,HACCP)体系系统化控制核酸检测实验室质量,以期能够实现核酸检测实验室质量的提升,为有效制定核酸检测质量控制对策提供借鉴。方法根据HACCP体系初步探究核...目的通过危害分析及关键控制点(hazard analysis and critical control point,HACCP)体系系统化控制核酸检测实验室质量,以期能够实现核酸检测实验室质量的提升,为有效制定核酸检测质量控制对策提供借鉴。方法根据HACCP体系初步探究核酸检测实验室质量控制,重点分析HACCP体系在核酸标本接收、准备试剂、提取标本核酸、核酸扩增、结果判读、核酸检测结果报告环节制定的监控程序、验证措施以及纠偏措施等重要控制点。结果通过分析2021年12月-2022年12月的检测数据,结果显示,各批次核酸检测阳性质控品均满足判定规则,每一批次的实验均处于在控状态。对HACCP体系下实验室数据进行统计,计算其标准差、均值以及变异系数,对箱型图绘制后,展开离群值检验,结果发现,均值没有产生离群值。结论核酸检测实验室中应用HACCP体系,能够有效控制核酸检测实验室质量,全面掌控核酸检测实验室重要控制点,实现实验室生物安全水平与质量的提升,保证核酸检测实验室质控的有效性与科学性,继而有效控制核酸检测实验室质量。展开更多
文摘In clinical in vitro fertilization (IVF), optimal culture conditions are required for production of high quality embryos and for achieving high pregnancy rates. Cell culture systems require vigilant attention to quality control and quality assurance, and upgrades to equipment and procedures require strenuous deliberation. During a 2-week maintenance period, we undertook an extensive analysis of incubator carbon dioxide (CO2) monitoring and the effect on culture media pH by comparing our traditional liquid Fyrite instruments to a certified and calibrated digital CO2 analyzer. The digital analyzer produced consistently lower CO2 readings and significantly greater precision than the liquid Fyrite. Media pH measurements showed significant variation depending on CO2 calibration device;however pH remained within manufacturers’ specifications. After superior performance by the digital analyzer, we incorporated this device into the incubator calibration and daily quality control procedures. A retrospective comparison of overall lab performance before and after this equipment switch demonstrated improved clinical pregnancy and implantation rates. This report illustrates the necessary caution when altering established laboratory procedures and equipment while highlighting the benefits of judiciously updating techniques and equipment in a laboratory setting that is often stubborn to change pre-existing, ingrained methodology.
文摘Introdution Laboratory diagnosis in medical practice,the position has been established,hernostasis and thrombosis.expefimental testing is no different.Experimental test of information not only for early diagnosis and guide treatment,prognosis and estimated recurrence.
基金MOH Program on Applied Research in the Prevention and Treatment of AIDS (WA 2003-17)
文摘This paper describes the development and challenge of HIV/AIDS testing laboratory network and quality assurance system in China. At present,the HIV/AIDS testing laboratories includes three classes,the National AIDS Reference Laboratory,HIV/AIDS confirmatory laboratories and HIV/AIDS screening laboratories. All of them are accredited by the health authorities,and each class of laboratories take charge of their function strictly according to the "National Management of HIV/AIDS Detection (2006)". A complete quality assurance and quality control system for HIV/AIDS testing has been developed,which includes technical training,strict laboratory monitoring and approval,examination or proficiency testing on HIV/AIDS detection,and quality evaluation and supervision of HIV/AIDS diagnostic kits. Besides conduct the routine anti-HIV antibody test,more and more laboratories began to conduct other tests,such as CD4+ T lymphocyte cell counting,HIV viral load,HIV DNA PCR,genotyping,drug resistance,and HIV-1 recent infection test. The primary challenges faced by the HIV/AIDS testing laboratory network are in the areas of laboratory management and quality control. For example,the provincial PT program is inefficient,the internal quality control is conducted perfunctorily,personnel training can not met the needs of the workplace,which need to be improved.
文摘Collecting baseline information on how laboratories perform testing is a reasonable first step towards establishing intra- and inter-laboratory standardization and quality control for semen analysis. We carried out a survey of the laboratories performing the testing in China's Mainland. A questionnaire, composed of 36 questions covering all aspects of semen analysis, was designed, and a copy was distributed to each of the 145 laboratories. Of these, 118 laboratories completed the questionnaires. The survey results showed that semen volume was measured visually in 53.6% （59/110） of the responding laboratories, and 70.9% （73/103） of laboratories analysed incompletely liquefied semen without any treatment. In addition, both manual-microscopic and computer-assisted semen-analysis systems were applied to analyse sperm concentration, motility and morphology. However, more than five methods were employed in routine sperm staining. An enzyme-linked immunosorbent assay was commonly used for determining whether antisperm antibodies were present. Several seminal biochemical markers were analysed in only 27.1% （32/118） of the responding laboratories. Generally, there was a lack of intra- and inter-laboratory quality control measures for semen analysis in all laboratories responding to this survey. In conclusion, the methods of semen analysis and the interpretation of test results in the surveyed laboratories differed markedly. In particular, many laboratories employed methods other than those recommended by the World Health Organization Laboratory Manual for the Examination of Human Semen and Sperm- cervical Mucus Interaction （1999）. These findings suggest an urgent need for the standardization of semen analysis with acceptable quality controls for each parameter to make the results repeatable and meaningful.
文摘目的通过危害分析及关键控制点(hazard analysis and critical control point,HACCP)体系系统化控制核酸检测实验室质量,以期能够实现核酸检测实验室质量的提升,为有效制定核酸检测质量控制对策提供借鉴。方法根据HACCP体系初步探究核酸检测实验室质量控制,重点分析HACCP体系在核酸标本接收、准备试剂、提取标本核酸、核酸扩增、结果判读、核酸检测结果报告环节制定的监控程序、验证措施以及纠偏措施等重要控制点。结果通过分析2021年12月-2022年12月的检测数据,结果显示,各批次核酸检测阳性质控品均满足判定规则,每一批次的实验均处于在控状态。对HACCP体系下实验室数据进行统计,计算其标准差、均值以及变异系数,对箱型图绘制后,展开离群值检验,结果发现,均值没有产生离群值。结论核酸检测实验室中应用HACCP体系,能够有效控制核酸检测实验室质量,全面掌控核酸检测实验室重要控制点,实现实验室生物安全水平与质量的提升,保证核酸检测实验室质控的有效性与科学性,继而有效控制核酸检测实验室质量。
