ABSTRACT
Under the circumstances of the rapid development of etiological diagnostic technology and the increasing application of new testing technologies to microbial detection, laboratory workers and clinical related departments should promptly propose Chinese standards, Chinese guidelines, and Chinese diagrams, and always adhere to the promotion and application of clinical microbiology related standards and guidelines in clinical practice, to continue to promote the virtuous cycle of standardization of etiology diagnosis, and gradually improve the laboratory diagnosis ability and technological progress of infectious diseases in China.
ABSTRACT
To evaluate the implementation of Survey of oncomelanid snails (WS/T 563—2017) in schistosomiasis-endemic foci, two schistosomiasis-endemic counties were selected from two provinces of Sichuan and Anhui. Professional staff working in province-, city-, county- and township-level disease control and prevention institutions, parasitic disease control institutions or medical institutions were recruited, and the understanding, use and implementation of Survey of oncomelanid snails (WS/T 563—2017) were investigated using questionnaires and interviews. The awareness, use, proportion of propagation and implementation and correct rate of answering questions pertaining to Survey of oncomelanid snails (WS/T 563—2017) were analyzed. A total of 270 questionnaires were allocated, and 269 were recovered, including 254 valid questionnaires. The overall awareness of Survey of oncomelanid snails (WS/T 563—2017) was 84.64% (215/254), and propagation and implementation of Survey of oncomelanid snails (WS/T 563—2017) was not performed in 23.28% (17/73) of the survey institutions following implementation of Survey of oncomelanid snails (WS/T 563—2017), with meeting training and allocation of propagation materials as the main type of propagation and implementation. Among 254 respondents, 77.16% (196/254) were familiar with the standard, 66.14% (168/254) understood the conditions for use of the standard during snail surveys, and 96.85% (246/254) had the approach for identifying snails. In addition, there were 41.73% (106/254), 50.78% (129/254) and 7.48% (19/254) of respondents that considered the operability of Survey of oncomelanid snails (WS/T 563—2017) was very good, good and general, respectively. The findings demonstrate that the issue and implementation of Survey of oncomelanid snails (WS/T 563—2017) has filled the gap for the standardization of snail control techniques, and which plays an importang guiding role in the national schistosomiasis control program.
ABSTRACT
Objective:To establish the industry standard for growth hormone quantitative labelling immunoassay kit, and to validate it by chemiluminescence labeling and time-resolved fluorescence labeling method which are suitable for the standard.Methods: Different assay method kits, including magnetic particle chemiluminescent assay, electrochemiluminescence assay, chemiluminescence assay and time-resolved fluorescent assay, were used to verified the blank limitation, linearity, accuracy, precision, specificity and stability in accordance with protocol industry standard.Results: Other verification results could meet requirements of the protocol industry standard besides accuracy in part of kits couldn't achieve to anticipative remand (relative deviation couldn't be more than ±10%).Conclusion: According to the verification results, the accuracy requirements was adjusted to ±15%. The other items of industry standard were maintained. The industry standard for growth hormone quantitative labeling immunoassay kit is ultimately established. The standard would contribute to unity quality standard of growth hormone quantitative labeling immunoassay kit, and provide the basis for the supervision and administration of its production, examination, circulation, clinical application and other areas.
ABSTRACT
Objective To investigate the current application status of reference intervals in routine chemistry and compare with the current health industry standards draft for approval.Methods By using web-based external quality assessment (EQA)software system,collected the submitted data from the laboratories which attended national reference intervals inves-tigation,used professional statistical software to analyze the data.Results 385 laboratories had submitted the investigation results.The vast majority of the analytes of attended laboratories had significant statistical differences in comparison with the health industry standards draft for approval in no grouping and not filled groups[t = - 55.435 ~ 17.070,P < 0.05, 86.1% (31/36)].Only a few of laboratories’reference interval had been grouped (approximately 20%).There were some differences in grouping rules between laboratories and standards.Even though some of the laboratories adopt the grouping rules as same as the standards,there were still big differences in reference intervals between the laboratories and the stand-ards[t=-39.365~13.155,P <0.01,62.5% (10/16)].Conclusion The reference intervals of routine chemistry analytes suggested by the health industry standards draft for approval had quite big differences from the reference intervals used in current clinical laboratories daily work.It is important to propel the authority health industry standards to use in the daily work of clinical laboratories.The evaluation and validation of using them should be done first.
ABSTRACT
Objective To verify the industry standard for total IgE quantitative labelling immunoassay kit .Methods Different methods of kits were used and were verified in accordance with industry standard .Results The appearance ,limit of blank ,linearity , accuracy ,precision and stability could meet requirements ,while specificity of individual kits was just partly qualified .Conclusion The establishing of the industry standard for total IgE quantitative labelling immunoassay kit was reasonable ,which could help to standardized the experimental methods and technical requirements and promoted the improvement of quality ,and offer the basis for the admistration .