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Objective@#To establish the review criteria for children′s blood cell analysis, ensure the accuracy of blood cell analysis results, and ensure that pathological cells are not missed.@*Methods@#A total of 1 420 samples of blood cell analysis were collected from outpatients and inpatients in Shanxi Children′s Hospital from May to June 2018, which were detected by SYSMEXXN-350 and XN-A1 automated blood cell analyzer. Blood smears weredouble-blindly examinedunder microscope. Among them, 463 were used for the establishment of review criteria, 586 were used for the verification and evaluation of review criteria, and 371 were used for the application effect study of review criteria. According tothe 41 rules recommended by ISLH, combining the characteristics of children′s physiology, pathology, disease and abnormal alarming information of hematology analyzer, the review criteria suitable for children′s blood cells were established.@*Results@#Through the evaluation and optimization of 41 rules recommended by ISLH, 23 rules for reexamination of children′s blood cell analysis were formulated, with a reexamination rate of 25.09%, and a false positive rate was 14.16%. A total of 371 samples of patients with hematological diseases were selected for the application of the review criteria. The false negative rate was 2.96%, and no pathological cells were missed.@*Conclusion@#The children′s blood cell review criteria established in this study has been verified and evaluated, which not only ensures the quality of the report, but also improves the work efficiency, and provides an important basis for the diagnosis and differential diagnosis of childhood leukemia, infectious mononucleosis and other hematological diseases.
ABSTRACT
In October 2017, the General Office of the CPC Central Committee and the General Office of the State Council issued "The opinion on deepening the reform of the review and approval system and encouraging the innovation in pharmaceutical and medical devices" which clearly requires the unification of the evaluation stand for the second class medical device and realizes national review gradually. According to this requirement, this paper firstly reviews situation of foreign medical device evaluation system, and then introduces general situation of medical device review in our country, including the establishment of institutions and existed problem of medical device registrations, and corresponding reasons are also be analyzed. Finally we focus on giving proposal on how to realize the unification of class Ⅱ medical device technology review in China combined with real situation based on referring foreign experience.
Subject(s)
China , Device Approval , TechnologyABSTRACT
Context: The International Consensus Group for Hematology Review (ICGHR) are essentially review criteria designed to reduce the number of manual smear reviews following analysis in automated hematology analyzers (AHAs). Although AHAs are an indispensable part of the present-day clinical laboratory, manual smear reviews still play an integral role in identifying morphological abnormalities and to confirm the results of the analyzers. Aims: The aim of this study is to evaluate the efficacy of the ICGHR criteria and our laboratory criteria using the Sysmex XN-1000 for manual peripheral smear review (MSR). Study Design: A prospective cross-sectional comparative study between the two sets of criteria for MSR was performed. Material and Methods: A total of 860 whole blood samples sent over a period of 19 months for complete blood count testing to our laboratory were collected using systematic random sampling. Truth tables were prepared for each set of criteria. Tests of proportion were used to compare performance specifications between both sets of criteria. Results: Using ICGHR criteria, sensitivity was 81.58%, specificity was 84.61%, 83.38% positive predictive value, and 82.92% negative predictive value. The microscopic smear review rate was 47.56% and efficiency was 83.14%. Using our laboratory criteria, sensitivity was 98.80%, specificity was 41.40%, positive predictive value of 61.46%, and negative predictive value of 97.34%. The microscopic smear review rate was 78.14% and efficiency 69.30%. Conclusions: There was a significant reduction in the microscopic smear review rates using the ICGHR criteria compared to our laboratory criteria. The ICGHR criteria can thus be adapted to daily laboratory practice provided they are first optimized and locally validated before use.
ABSTRACT
Objective To establish and evaluate the review criteria of blood routine detection by the Sysmex XE‐5000 hematolo‐gy analyzer in our hospital for improving the effectiveness of the measurement results .Methods 606 blood samples were collected from the outpatients and inpatients during 2014 and performed the microscopic examination by 2 technologists‐in‐charge with the double‐blind method .The average value of these results was used as the judging criteria .According to the 41 items of rule formula‐ted by the international expert group and combining with the patients characteristics of infectious disease hospital and instrument features in this hospital ,20 items of review criteria for blood routine test of our hospital was formulated .Results With the micro‐scopic examination results as the criteria ,among 606 detected samples ,116 samples were in line with the rules and the review rate was 19 .14(116/606) ,in which the true positive rate was 6 .93% (42/606) ,the false positive rate was 12 .21% (74/606) ,the false negative rate was 2 .64% (16/606) ,the true negative rate was 78 .22% (474/606) ,the sensitivity was 72 .41% and the specificity was 86 .5% .The expected values of positive and negative results were 36 .21% and 96 .73% respectively .The total effective rate was 85 .15% .Conclusion The review criteria formulated by this laboratory are reasonable and effective ,which has an important significance in the clinical application for increasing the detection speed of blood routine ,improving the laboratory reports quality , without missed true blood patients and accurately providing the valuable information for clinicians .
ABSTRACT
Since 1956 when Wallace Coulter developed a first automated analyzer for counting and sizing cells,the microscopic complete blood count(CBC)and WBC differentiation method has been revolutionized by modern multi-parameter analyzers.Flagging properties in these analyzers can alert the operator to the existence of abnormalities. Microscopic examination of a stained blood film is used to complement analyzer results to provide a comprehensive hematology report.Now it is recognized that the automated systems are superior for counting WBC,RBC and platelets and for differential counting of WBC for mature cell types,whereas visual microscopy is superior for differentiating cells based on nuances of cytological features,especially for immature cells.Therefore the decision as to whether smear review is necessary for each sample plays a major role in hematology laboratory operations.For many samples,we need only review smears to provide information additional to or missing from analyzer results,or to confirm results produced by the analyzer. Each laboratory has developed its own criteria for action after an automated analysis of a blood sample. The objective is to reduce the number of samples unnecessarily requiring action such as smear review(false positives)to the greatest possible extent,while not endangering the patient by reporting false or misleading results(false negative results).However,there is little opportunity for an individual laboratory to know whether the rules it follows are optimally effective for minimizing false negatives and false positives.At the initiative of Dr.Berend Houwen,an international group of experts set up their criteria for review following automated hematology analyzer results and published International Hematology Consensus Group rules for action.These publications also contain guidelines to enable any laboratory to validate rules for action following automated hematology analyzer results. In general,the rules for action should be commonly used in all laboratories because a uniform standard of performance can be achieved by all participating laboratories if they follow these guidelines.In addition,a much larger and more comprehensive set of data can be obtained by combining data from many laboratories. When the consensus rules were compared with the rules of each of the participating laboratories in Consensus Group,there was improvement to a greater or lesser extent in every laboratory.Information from other laboratories now using these rules is that hematology laboratory operations have been improved. Although it has not been confirmed yet,the International Group's consensus rules could be applicable for all laboratories.But there are definite cautions which depend on the analyzers.It is likely that the physiology based rules would be applicable to patients worldwide;however,because the rules were just tested on patients from countries in the Consensus Group and there was no Asian participation in the group, we have no knowledge whether different prevalence of different diseases in Asia might affect applicability and suitability of certain rules. For those rules that are analyzer-based,especially those based on analyzer flags,some differences could be expected due to the differences in flagging sensitivity and efficiency for different manufacture's products. The Consensus Group recommends that any laboratory wishing to use the guidelines perform validation testing in its own situation first.In the country of China,it might be advantageous for testing and potential subsequent modification of the guidelines,for this to be performed under the guidance and control of a national body,such as the Chinese Society for Laboratory Medicine. No three part WBC differential analyzers were included in the Consensus Group study.Of the 41 rules, probably no more than 16 of them would be applicable to three part WBC differential analyzers as written; and these would have to be validated for the characteristics and performance of the WBC,RBC and platelet channels of three part WBC differential analyzers.Other rules could be developed for three part differential analyzers using a similar approach to that used by the International Consensus Group and making use of the suggested procedures included in the publications.The Chinese Society for Laboratory Medicine might consider establishing a Consensus Group of Chinese experts to develop guidelines for national use.
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As there is widely application in clinical diagnosis and treatment with complete blood count(CBC)and differential count(DC),the experts of clinical hematology laboratory in the word have paid highly attention to the review of CBC and DC.In this paper,we would like to have an introduction for the suggested criteria for action following automated CBC and WBC differential analysis obtained from The International Consensus Group for Hematology Review and Clinical and Laboratory Standards Institute (CLSI).