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1.
The importance of measuring blood lipids in determining the absolute risk of a cardiovascular event is now well established. In Australia, the National Heart Foundation of Australia and the Cardiac Society of Asutralia and New Zealand (NHFA/CSANZ) have done much to educate doctors. In recent years the recommendations of the NHFA/CSANZ have been based on values for Low-density lipoprotein (LDL-C) as well as High-density lipoprotein cholesterol (HDL-C) and Triglyceride (TG). This change has been reflected in requests to pathology laboratories. However the interpretation of these results may be difficult and the NHFA guidelines outline desirable values for patients at high risk only. There are no formal recommendations for reference intervals or interpretive comments. With the availability of expert systems, some pathology laboratories are now in a better position to provide specific comments to assist with the interpretation of test results.An ad hoc committee of private and public chemical pathologists met to draft recommendations for lipid testing and reporting by Australian pathology providers, on the basis of current guidelines and their own expertise. Provisions in the current Medicare Benefits Schedule (MBS) for lipid testing were reviewed, and the indications for lipid testing, recommended tests, the logistics of managing specimens, methods of analysis and availability of specialised tests have been documented. Recommendations are made on the provision of desirable values for lipid tests. Suggestions are provided on interpretive comments which could accompany reports of lipid test results, including categorisation of the likely associated lipoprotein abnormalities, their causes, contribution to risk for cardiovascular disease (CVD) and targets for treatment. Current and future approaches to the assessment of risk for CVD are discussed.  相似文献   

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In order to discover whether laboratories have policies regarding the testing of unaffected children, we surveyed all laboratories registered with Helix, a national net-work of DNA diagnostic laboratories. Of 186 laboratories asked to respond anonymously to a four-page questionnaire, 156 (84%) replied. A screening question removed 51 laboratories that provided no clinical services. Of the remaining 105, 92% said that their requisition forms asked the person's age. Substantial minorities had policies for the testing of minors for late-onset disorders (46%), for carrier status for recessive disorders (33%), or for disorders for which the test offers no medical benefit within 3 years (33%). Most laboratories are responsive to parental requests. For 12 of 13 late-onset disorders, the majority of laboratories that offered testing had had requests to test children. The majority had tested healthy children, <12 years of age, for eight disorders. Approximately 22% had tested children, <12 years of age, for Huntington disease. Majorities had received requests to test healthy children for carrier status for 10 of 15 recessive or X-linked disorders and had tested children, <12 years of age, for 6 of these disorders, including cystic fibrosis, hemophilia A, fragile X syndrome, and Duchenne muscular dystrophy. Approximately 45% of the laboratories occasionally had provided tests directly to consumers. In view of the possibility that the harms of presymptomatic diagnoses of children sometimes may outweigh the benefits, our results suggest a need for consistent laboratory policies designed for the best interests of the child and the family.  相似文献   

4.
Nowadays the development of pesticides is not only directed to design compounds with sufficient efficacy against resistant and non-resistant strains of pests as well as with a high margin of safety for man and the environment, but also to allow their potential use in IPM (Integrated Pest Management) programmes. For identification of IPM suitable pesticides, a whole battery of standardised laboratory and semi-field test protocols have been developed. Based on the observed lethal and sublethal effects in those tests, compounds are categorised into different hazard groups which should advise farmers on their suitability for IPM. For a valid classification of compounds on the basis of laboratory test results, threshold values for lethal and sublethal effects have to be developed which reliably differentiate between harmful and safe compounds without bearing the risk of erroneous labelling and/or too frequent requests for higher tier testing. As an evaluation criterion for sublethal effects of pesticides, the reproductive performance of beneficial insects is frequently considered in standard laboratory assays. A preliminary analysis of available data on the reproductive performance of several standard test species elaborated during regulatory testing indicates that this evaluation criterion is subject to high variability. As expected, individual test species differed in their reproductive performance. Aleochara bilineata (Coleop-tera: Staphylinidae) and Orius insidiosus (Heteroptera: Anthocoridae) showed a fairly homogeneous reproductive performance within test series. Based on the observed variability of the reproductive performance in control groups, the average probability of an erroneous labelling of pesticides for these two species was only 4% and 6% (maximum probability: 13% and 19%), respectively, when an adverse effect threshold value of 30% (= actual value of the EU (European Union)) was applied. In contrast, Coccinella septempunctata (Coleoptera: Coccinellidae), Chryso-perla carnea (Neuroptera: Chrysopidae), Aphidius rhopalosiphi (Hymenoptera: Aphidiidae) and Trichogramma cacoeciae (Hymenoptera: Trichogrammatidae) exhibited a high variability in their reproductive performance, giving a mean probability between 25% and 35% (maximum probability: 36–64%) to label a pesticide either false positive or false negative. Besides species-inherent variability, there was an indication that test-inherent factors including parent sex ratio and parent breeding density may have had an influence on the reproductive performance of these insect species. Seasonal influences on the reproductive performance of the beneficial insects in laboratory testing were not evident. Based on our data analyses, there is a significant risk of erroneous classification of pesticides when the reproductive performance is quantitatively assessed following the currently established test protocols and an adverse effects threshold value of 30% is applied. We propose therefore that either the testing procedure for assessing the reproductive performance, or the effect threshold value for this evaluation criterion is reconsidered in the light of the high “species-inherent” variability in the reproductive performance of some beneficial insects.  相似文献   

5.
Thirty compounds tested in the Drosophila wing spot test   总被引:2,自引:0,他引:2  
The Drosophila wing somatic mutation and recombination test (SMART) was evaluated for its suitability in genotoxicity screening by testing 30 chemicals. Of the 2 crosses used, the mwh-flr3 cross turned out to be more convenient than the previously used mwh-flr cross. Based on the experience gained with both acute exposures and chronic exposures of different duration, we suggest that the optimal strategy in genotoxicity screening is to start with chronic exposure of 3-day-old larvae for 48 h (that is, until pupation). Only for unstable compounds and very volatile compounds and gases are acute treatments, including inhalation, recommended. In general, a qualitative evaluation of the genotoxicity of a compound in the wing assay is possible with as few as 1-2 different exposure concentrations. A more quantitative evaluation of genotoxicity, based upon dose-response data, can often be achieved with as few as 3-4 concentrations. The results reported here were obtained in 2 different laboratories, demonstrating that the wing spot test is easily transferable to other laboratories. The experience gained indicates that the assay has now been developed to an extent that a coordinated international comparative validation study is desirable.  相似文献   

6.
Opportunistic screening based on the Pap smear has been undertaken in Croatia since 1953. However, cervical cancer remains an important health problem in Croatia when compared to European countries with organised screening programmes. In Croatia, in addition to screening based on well established cytology, Human papillomavirus (HPV) testing is widely used as secondary test as a triage to borderline cytology and as a follow-up after treatment of severe cervical lesions. Many different approaches for HPV testing arose in Croatia over the last decade depending on the needs of each medical institution involved. Presently, there is an urgent need for better networking between the laboratories, the implementation of quality assessment and the adaptation of a uniform system of referring to and reporting of HPV testing. In conclusion, the best possible organisation for HPV testing would be essential for implementation of HPV testing as primary screening test in Croatia, an thus ultimately and hopefully, the more successful cervical cancer control.  相似文献   

7.
OBJECTIVE: To compare data on the practices of molecular genetic testing (MGT) in laboratories in the United States with those in 18 other countries. METHODS: A Web-based survey of MGT laboratory directors (n = 827; response rate 63%) in 18 countries on three continents was carried out, and the response from U.S. laboratories compared to all others. Quality assurance and reporting indices were developed and calculated for each responding laboratory. RESULTS: A comparison of U.S. results with all other countries identified differences in laboratory setting, personnel qualifications, and the specific tests being offered, but similar rates of adherence to MGT quality standards and reporting practices were found. The survey also documented substantial transborder flow of specimens, most commonly due to the lack of availability of the test in the United States or because the test was available only through a research protocol, highlighting the need for common reporting and practice guidelines for the international MGT community. CONCLUSION: The findings presented here provide further support for the need to consider the application of the Organisation for Economic Cooperation and Development (OECD) Guidelines and the establishment of compatible accreditation programs or equivalent mechanisms across national borders to ensure the quality of laboratory services and the clinical usefulness of molecular genetic test reports for referred specimens.  相似文献   

8.
The ability to perform predictive genetic testing of children raises ethical concerns regarding whether and when to test and the disclosure of results. Semi-structured interviews with a convenience sample of pediatricians (12) and geneticists (13) were conducted to see how they would react to parental requests for predictive genetic testing of their children, and their attitudes about testing their own children. We also asked about disclosure attitudes and practices for their patients' relatives and within their own families. Respondents would provide predictive genetic testing for most conditions, yet were less likely to seek this information about their own children. Respondents believed it was very important for patients to share some types of genetic information with relatives, and were directive in their counseling about intrafamilial disclosure, especially within their own families. Although respondents would almost never breach patient confidentiality, many would breach confidentiality within their own families. Health care professionals distinguish between their professional and personal roles with regard to issues of access and confidentiality in predictive testing of children. They are willing to provide greater access and more confidentiality for their patients than within their own families.  相似文献   

9.
OBJECTIVE: Urine cytology is costly because of the skilled manpower required for analysis. Inappropriate requests are a significant drain both financially and on the cytopathologist's time. The present study aimed at identifying the extent and cause of this misuse and reduce it. METHODS: An audit of urine cytology usage was undertaken using the hospital results reporting system to identify requests. Patient case notes were then obtained to gain further clinical information. Initially a 2-week period was analysed, following which departmental guidelines for requesting urine cytology were produced and circulated. The audit loop was then closed. RESULTS: Over the initial 2-week period, 117 urine cytology requests were received. Thirty-three per cent were inappropriate, either because they were from patients with benign disease or because of duplication. Following the education programme this number fell to 6%. Expenditure on unnecessary samples thus decreased from pounds 2418 to only pounds 310, giving an annual overall saving of pounds 55,000. CONCLUSION: Significant cost and time savings can be made if urine cytology is sent appropriately. Simple guidelines and staff education are the key to reducing inefficiency. Our findings have implications not just for cytopathology costs but for laboratory and radiology requests in general.  相似文献   

10.
Boot R 《Laboratory animals》2012,46(3):253-257
The Quality Assurance Program (QAP) of the Deutsches Krebsforschungszentrum (DKFZ) was a proficiency testing system developed to service the laboratory animal discipline. The QAP comprised the distribution of bacterial strains from various species of animals for identification to species level and antibiotic susceptibility testing (AST). Identification capabilities were below acceptable standards. This study evaluated AST results using the DKFZ compilations of test results for all bacterial strains showing the number of participants reporting the strain as resistant (R), sensitive (S) or intermediate susceptible (I) to each antibiotic substance used. Due to lack of information about methods used, it was assumed that what the majority of the participants reported (R or S) was the correct test result and that an opposite result was a major error (ME). MEs occurred in 1375 of 14,258 (9.7%) of test results and ME% ranged from 0% to 23.2% per bacterial group-agent group combination. Considerable variation in MEs was found within groups of bacteria and within groups of agents. In addition to poor performance in proper species classification, the quality of AST in laboratory animal diagnostic laboratories seems far below standards considered acceptable in human diagnostic microbiology.  相似文献   

11.
The Ontario Laboratory Proficiency Testing Program's testing model and the results of early surveys of cytology laboratories have been previously described. To test consistency and accuracy, the same slides from one survey were recirculated to the same laboratory in the next survey. There was no statistical difference in either the accuracy or consistency in reporting by the various categories of personnel. Analysis of the data by category of diagnosis showed the reporting of "no abnormal cells" and "benign atypia" to be slightly more accurate and "moderate dysplasia" and "severe dysplasia" to be slightly less accurate than the reporting in other categories. Consistency in reporting appeared to be slightly less accurate in severe dysplasia than in the other categories. The analysis, which includes the results from all licensed cytology laboratories in Ontario, provides evidence that, in the reporting of cervical cytologic material, it is feasible to differentiate among the various categories within the spectrum of squamous epithelial abnormalities with a general level of accuracy and consistency that, although satisfactory, is not yet ideal.  相似文献   

12.
Proceed with Care: Direct Predictive Testing for Huntington Disease   总被引:7,自引:1,他引:6       下载免费PDF全文
The cloning of the Huntington disease (HD) gene allows highly accurate predictive testing using direct analysis of the CAG repeat. This new test provides results with almost complete certainty but poses unique counseling issues related to direct testing for an adult-onset disease. These include testing individuals who are at 25% risk, without the need for blood from a 50% at risk relative; the assessment of symptomatic individuals; the need for ongoing counseling despite simplification of laboratory procedures; and counseling of persons from families who represent a new mutation for HD. This paper describes protocols for direct predictive testing for adult and prenatal assessment, on the basis of the experience of the Canadian Collaborative Study on Predictive Testing (CCSPT). Over the past 8 years, we have provided >400 results by using linked markers and, more recently, 416 results by using direct assessment of CAG expansion in the HD gene. The vast majority (86%) of requests for direct predictive testing have been from persons who have not previously received results by using linked markers. Despite the ability to now directly assess for the mutation associated with HD, we still recommend assessment of DNA from an affected relative, as this may significantly enhance the accuracy of information to be provided to the at-risk individual. Distance from a genetics center has previously limited the availability of testing, and therefore we have developed approaches to providing predictive testing in the patient's own community.  相似文献   

13.
There has been much discussion in recent years regarding the most appropriate follow-up testing in vivo when positive results are obtained in vitro but the in vivo micronucleus (MN) test (traditionally the most widely-used test) is negative. Not all rodent carcinogens give positive results in the micronucleus test, and so it has been common practice to include a second in vivo assay such as the unscheduled DNA synthesis (UDS) test. This has proved useful but is usually limited to analysis of rodent (usually rat) liver. With the increased evaluation and use of other in vivo assays, e.g. for transgenic mutations (TG) and DNA damage (Comet assay) it was important to investigate their usefulness. We therefore examined the published in vivo UDS, TG and Comet-assay results for 67 carcinogens that were negative or equivocal in the micronucleus test. Between 30 and 41 chemicals were evaluated in each of the three in vivo tests, with some overlap. In general, the UDS test was disappointing and gave positive results with <20% of these carcinogens, some of which induced tumours in rat liver and produced DNA adducts in vivo. The TG assay gave positive responses with >50% of the carcinogens, but the Comet assay detected almost 90% of the micronucleus-negative or equivocal carcinogens. This pattern of results was virtually unchanged when the in vitro profile (gene mutagen or clastogen) was taken into account. High sensitivity (ability to detect carcinogens as positive) is only really useful when the specificity (ability to give negative results with non-carcinogens) is also high. Based on small numbers of publications with non-carcinogens, the TG and Comet assays gave negative results with non-carcinogens on 69 and 78% of occasions, respectively. Although further evaluation of the Comet and TG assays, particularly with non-carcinogens, is needed, these data suggest that they both should play a more prominent role in regulatory testing strategies than the UDS test.  相似文献   

14.
HiperLAN/2 (HIgh PErformance Radio Local Area Network) is a new standard from ETSI (European Telecommunications Standards Institute) for high-speed wireless LANs, interconnecting portable devices to each other and to broadband core networks, based on different networking technologies such as IP, ATM, IEEE 1394, and others. This paper introduces the basic features of the HiperLAN/2 MAC protocol. It presents performance evaluation results, specifically related to the mechanisms provided by HiperLAN/2 to manage bandwidth resource requests and granting. These results are assessed in terms of their flexibility and efficiency in supporting delay sensitive traffic, such as voice and Web data traffic, which are expected to be transported by broadband wireless LANs.  相似文献   

15.
J. H. F. Smith ABC3 Part I: a review of the guidelines for terminology, classification and management of cervical cytology in England The provision of guidance on cytology reporting and evaluation, first outlined in 1995 with the publication of Achievable Standards, Benchmarks for Reporting, and Criteria for Evaluating Cervical Cytopathology (ABC), and subsequently revised and expanded in a second edition in 2000, has been pivotal to the success of the National Health Service Cervical Screening Programme (NHSCSP), ensuring that standards are upheld, and that rigorous evaluation and quality assurance take place. In the last decade, major changes to the NHSCSP, notably the adoption of revised age ranges and screening intervals for all women in England, implementation of liquid‐based cytology and, most recently, the decision to introduce high‐risk human papillomavirus (HR‐HPV) testing for triage of low‐grade and borderline (equivalent to 'atypical') cytological abnormalities and test of cure after treatment of cervical intraepithelial neoplasia (CIN) determined that an updated version of ABC was required. The third edition of ABC recommends adoption, with minor modification, of the revised British Society for Clinical Cytology terminology and provides guidance on the management of abnormal cytology results linked to this terminology taking account of HR‐HPV testing. To accommodate these changes, expanded result codes, which are electronic codes used to transfer management information to central computers for follow‐up, call and recall of individual women, have been developed. Further guidance on specimen adequacy is also provided. Revised performance indicators are described and explained in a separate article by R. Blanks in this issue of Cytopathology. All the changes in ABC3 are designed to support the mission statement of the NHSCSP that ‘the objective of cervical screening is to reduce cervical cancer incidence and mortality by screening with a high sensitivity for the detection of CIN2 or worse, whilst maintaining a high specificity’.  相似文献   

16.
Irinotecan is widely used in the treatment of solid tumors, especially in colorectal cancer and lung cancer. Molecular testing for UGT1A1 genotyping is increasingly required in China for optimum irinotecan administration. In order to determine the performance of laboratories with regard to the whole testing process for UGT1A1 to ensure the consistency and accuracy of the test results, the National Center for Clinical Laboratories conducted an external quality assessment program for UGT1A1*28 genotyping in 2015. The panel, which comprised of four known mutational samples and six wild-type samples, was distributed to 45 laboratories that test for the presence of UGT1A1*28 polymorphisms. Participating laboratories were allowed to perform polymorphism analysis by using their routine methods. The accuracy of the genotyping and reporting of results was analyzed. Other information from the individual laboratories, including the number of samples tested each month, accreditation/certification status, and test methodology, was reviewed. Forty-four of the 45 participants reported the correct results for all samples. There was only one genotyping error, with a corresponding analytical sensitivity of 99.44% (179/180 challenges; 95% confidence interval: 96.94−99.99%) and an analytical specificity of 100% (270/270 challenges; 95% confidence interval: 98.64−100%). Both commercial kits and laboratory development tests were commonly used by the laboratories, and pyrosequencing was the main methodology used (n = 26, 57.8%). The style of the written reports showed large variation, and many reports showed a shortage of information. In summary, the first UGT1A1 genotyping external quality assessment result demonstrated that UGT1A1 genotype analysis of good quality was performed in the majority of pharmacogenetic testing centers that were investigated. However, greater education on the reporting of UGT1A1 genetic testing results is needed.  相似文献   

17.
Lateral flow devices (LFDs) are quickly being implemented for use in large-scale population surveillance programs for SARS-CoV-2 infection in the United Kingdom. These programs have been piloted in city-wide screening in the city of Liverpool and are now being rolled out to support care home visits and the return home of University students for the Christmas break. Here, we present data on the performance of LFDs to test almost 8,000 students at the University of Birmingham between December 2 and December 9, 2020. The performance is validated against almost 800 samples using PCR performed in the University Pillar 2 testing lab and theoretically validated on thousands of Pillar 2 PCR testing results performed on low-prevalence care home testing samples. Our data show that LFDs do not detect infections presenting with PCR Ct values over 29 to 30 as determined using the Thermo Fisher TaqPath asssay. This may be of particular importance in detecting individuals that are either at the early, or late stages of infection, and reinforces the need for frequent, recurrent testing.

Antigen-detecting lateral flow tests are faster than PCR tests in detecting SARS-CoV-2 infection and are being implemented for use in large-scale population surveillance in the UK. An evaluation of the performance of the lateral flow devices, validated using PCR, concludes that lateral flow devices do not detect infections presenting with higher PCR Ct values, reinforcing the need for frequent, recurrent testing.  相似文献   

18.
OBJECTIVES: This study assesses interest in genetic testing for gene variations associated with bipolar disorder and associated information needs. METHODS: Two hundred individuals (95 unaffected and 105 affected with either bipolar disorder, schizoaffective disorder--manic type, or recurrent major depression) from families with multiple cases of bipolar disorder were assessed, using mailed, self-administered questionnaires. RESULTS: The percentage of participants reporting interest in genetic testing was associated with the degree of certainty with which any test would indicate the development of bipolar disorder. Interest in genetic testing, given a 25% lifetime risk scenario, was lowest (with 77% of participants indicating interest), and highest for the 100% lifetime risk scenario (92%). Eighty percent of participants indicated interest in genetic testing of their own children; of these 30% reported wanting their children tested at birth, and 33% in early childhood. Forty-one percent of participants reported that they would be interested in preimplantation genetic diagnosis, and 54% in prenatal testing. LIMITATIONS: The possibility of ascertainment bias cannot be ruled out. Interest in hypothetical genetic testing for bipolar disorder may not necessarily translate into actual utilization. CONCLUSIONS: These results indicate that uptake of genetic testing for genotyping for low-risk alleles related to bipolar disorder is likely to be lower than for testing for high-penetrance gene mutations that follow Mendelian inheritance. The discrepancy between the desired age of testing children and the accepted current practice may be a source of distress and conflict for parents and health professionals alike.  相似文献   

19.
S. Piana, A. Frasoldati, M. Ferrari, R. Valcavi, E. Froio, V. Barbieri, C. Pedroni and G. Gardini Is a five‐category reporting scheme for thyroid fine needle aspiration cytology accurate? Experience of over 18 000 FNAs reported at the same institution during 1998–2007 Objective: Fine needle aspiration (FNA) has long been recognized as an essential technique for the evaluation of thyroid nodules. Although specific cytological patterns have been recognized, a wide variety of reporting schemes for thyroid FNA results have been adopted. This study reports our experience with a five‐category reporting scheme developed in‐house based on a numeric score and applied to a large series of consecutive thyroid FNAs. It focuses mainly on the accuracy of thyroid FNA as a preoperative test in a large subset of histologically distinct thyroid lesions. Methods: During the 1998–2007 period, 18 359 thyroid ultrasound‐guided FNAs were performed on 15 269 patients; FNA reports were classified according to a C1–C5 reporting scheme: non‐diagnostic (C1), benign (C2), indeterminate (C3), suspicious (C4), and malignant (C5). Results: Non‐diagnostic (C1) and indeterminate (C3) FNA results totalled 2 230 (12.1%) and 1 461 (7.9%), respectively, while suspicious (C4) and malignant (C5) results totalled 238 (1.3%) and 531 (2.9%), respectively. Histological results were available in 2 047 patients, with thyroid malignancy detected in 840. Positive predictive value of FNA was 98.1% with a 49.0 likelihood ratio (LR) of malignancy in patients with a C4/C5 FNA report. Conclusions: This five‐category scheme for thyroid FNA is accurate in discriminating between the virtual certainty of malignancy associated with C5, a high rate (92%) of malignancy associated with C4, and a 98% probability of a histological benign diagnosis associated with C2. Further sub‐classifications of C3 may improve the accuracy of the diagnostic scheme and may help in recognizing patients eligible for a ‘wait and see’ management.  相似文献   

20.
目的:利用校准周期图科学确立奥林帕斯Au640全自动生化分析仪校准周期。方法:生化分析仪定标校准后,每隔2小时分别测定三种浓度水平的质控血清一次,24小时后每天测定一次,总计测定30天。所有检测项目均重复测定四次取平均值。以积变异系数(CV)大于1/6 CLIA’88为评价标准,绘制校准周期图。结果:碱性磷酸酶(ALP)L1校准周期最短每12 h一次。酶类项目较稳定,校准周期可达30天以上,低水平质控血清必不可少,这样有利于测得更为准确的校准周期。结论:科学、合理地确立各检测项目的校准周期,对生化分析仪检测系统进行定期校准,既能够避免不必要的校准、又能够节省检验工作的时间和成本,保证生化检验项目检测结果可靠性。  相似文献   

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