New Centers for Disease Control and Prevention's guidelines on HIV counseling and testing for the general population and pregnant women

We review two new HIV counseling and testing guidelines by the U.S. Centers for Disease Control and Prevention. The guidelines, which address the general population and pregnant women, reflect an important shift in the goals and methods of counseling and testing that has widespread implications. The guidelines' defining characteristic is the greater emphasis on increasing the numbers of people knowing their HIV status while maintaining the historical focus on extensive pretest counseling and consent procedures. We discuss the policy and practice implications by evaluating five factors: 1) Will the guidelines be adopted? 2) Will at-risk and infected individuals be identified for counseling and testing? 3) Will health care providers offer counseling and testing and patients accept counseling and testing, obtain their test results, seek treatment, and change risky behaviors? 4) Will the guidelines be relatively cost-effective? 5) Will the guidelines be compatible with ethical standards?     

Genetic testing of the general population: ethical and informatic concerns

Whether we like it or not, genetic testing will almost certainly become routine medical practice within the next 25 years. Integrated circuit chips already exist that can perform 400 genetic tests simultaneously, thus greatly reducing the costs. At least one company is already working on a prototype for a handheld genetic tester that would allow primary care physicians to perform hundreds or thousands of genetic tests on a simple blood smear in just a few minutes. "Genetic report cards" for children are not very far off at all. The use of such widespread testing poses a variety of ethical dilemmas. One problem that has not been appreciated sufficiently, however, is the question of how to interpret the test results. Because of the ways the genes implicated in diseases are discovered and marketed, quantitative analysis of the tests can be extremely misleading. The difficulty is that we simply do not have sufficient information about variance in genetic and other factors in the general population to make accurate projections of a patient's risk, given the presence of a gene. This uncertainty is obscured, however, when we provide the patient with a numerical analysis of risk because it is well established that people tend to overestimate the information content of numerical projections. This situation is made far worse by the fact that we do not have enough adequately trained genetic counselors to handle the load that will soon be placed on them (and studies have shown that physicians are generally very poorly prepared to act as accurate sources of information on complex genetic issues). For these reasons, I argue that access to genetic testing should be treated the same way as access to new medical procedures and medications--namely, withheld from the general public until proven safe and effective in large-scale trials. This is certain to be an unpopular policy, but it seems the only way to prevent a great deal of abuse of genetic tests.     

Results of the Centers for Disease Control experimental proficiency testing survey for serum alpha-fetoprotein.

An experimental proficiency testing survey for serum alpha-fetoprotein was conducted among 16 cooperating laboratories. Samples of placental cord serum serially diluted in normal adult serum (simulated maternal serum) were assayed. Results were analyzed for qualitative and quantitative relative accuracy, precision on duplicate and nonduplicate (dilution-related) samples, parallelism, and comparability of units. Although some results had wide distribution, relative accuracy improved when results were normalized against a standard. This procedure improved the overall geometric standard deviation among laboratories on quantitative results from 1.300 to 1.088 and compressed the limits for consensus ranges of results to 40% of that of the unnormalized data. No significant differences in actual mean values were noted between international units per milliliter and nanograms per milliliter in measuring alpha-fetoprotein concentrations at the precision obtained in this study. In interpreting whether a sample was "low or normal" or "abnormally high" for alpha-fetoprotein, we observed that an 80% or greater consensus was achieved on only 6 of the 10 survey samples because borderline samples were included in the survey.     

Genetic testing, ethical concerns, and the role of patent law

This article examines the changing debate over gene patenting and the possible connection between patent law and the ethical and policy concerns associated with the use of genetic testing technologies (e.g. the premature implementation and inappropriate marketing of genetic tests). Arguably, patent law helps to form the market forces that lead to these concerns. It is suggested that existing safeguards fail to control these concerns because of, for example, a lack of provider knowledge and an absence of an adequate regulatory framework. While patent law can be associated with a number of ethical and policy concerns, the article also suggests that patent law may have a positive role in reducing them. Patent law provides policy makers and the public with a focal point - the patent holder - upon which to attach accountability for ethical and legal conduct. The article concludes by inviting policy makers to consider the ways in which patent law could be modified in order to optimize its constructive influence.     

Priorities for public health research on craniosynostosis: summary and recommendations from a Centers for Disease Control and Prevention-sponsored meeting

On June 8-9, 2006, the National Center on Birth Defects and Developmental Disabilities at the Centers for Disease Control and Prevention held a meeting entitled "Prioritizing a Public Health Research Agenda for Craniosynostosis". The meeting goals were to review current knowledge in the area, discuss research gaps, and identify future priorities for public health research. Participants with a broad range of expertise (including clinical and molecular genetics, cranial morphology, epidemiology, pediatrics, psychology, public health, and surgery) contributed to the development of the research agenda. Meeting participants were asked to consider public health significance and feasibility when identifying areas of priority for future public health research. Participants identified several priorities, including the need to better delineate the prevalence and phenotype of craniosynostosis (CS); to identify factors important in the causation of CS (including potentially modifiable environmental risk factors as well as genes involved in isolated CS and gene-gene and gene-environment interactions); and to better understand short- and long-term outcomes of CS (e.g., surgical, neurocognitive and neuropsychological outcomes, psychological adjustment, and social relationships) and issues related to clinical care that could affect those outcomes. The need for improved collaboration among clinical treatment centers and standardization of data collection to address these priorities was emphasized. These priorities will be used to guide future public health research on CS.     

Current HIV epidemiology and revised recommendations for HIV testing in health-care settings

The Centers for Disease Control and Prevention (CDC) estimates that about one quarter of the 1-1.2 million persons living with HIV/AIDS in the United States are unaware they are infected. Persons who do not know they are HIV infected are unable to access effective treatment and, compared with those who know they are infected with HIV, are more likely to transmit HIV to others. Pregnant women need to know if they are HIV infected so they can take steps to avoid transmitting HIV to their infants and access medical care for themselves. Despite past CDC recommendations for routine, voluntary HIV testing of all persons in acute-care hospitals with high HIV prevalence and those with risks for HIV, many HIV-infected persons who encounter the health-care system are not tested. Promoting HIV testing as a routine part of medical care is a key strategy of the CDC's Advancing HIV Prevention initiative launched in 2003. The CDC has recently revised recommendations for HIV testing of adults, adolescents, and pregnant women in health-care settings to help increase the number of HIV-infected Americans who are aware they are infected so they can receive prevention, care, and treatment. The new recommendations advocate voluntary "opt-out" HIV screening in health-care settings, with appropriate follow-up care and treatment; eliminating requirements for separate, written consent for HIV testing; annual retesting for persons with known risk factors; and expanded rescreening in the third trimester for women who test negative for HIV early in pregnancy. The CDC issued the revised recommendations on September 22, 2006, and is now engaged with numerous professional organizations on practical strategies for implementation.     

Routine HIV screening in the emergency department using the new US Centers for Disease Control and Prevention Guidelines: results from a high-prevalence area

BACKGROUND: In 2006, the US Centers for Disease Control and Prevention (CDC) released new recommendations for routine HIV testing. Among these were recommendations that emergency departments (EDs) offer routine opt-out HIV screening to their patients. We established a screening program implementing these recommendations at an urban university hospital ED in Washington, DC. We report the results of this program. METHODS: During a 3-month period, ED patients being treated for a wide range of conditions were approached by trained HIV screeners and offered point-of-care rapid HIV testing. Patients with positive results were referred to hospital or community resources for confirmatory testing and treatment. RESULTS: During the program period, 14,986 patients were treated in the ED and 4151 (27.6%) were offered HIV screening. The mean patient age was 37.5 years; 48.5% were black, 39.0% were non-Hispanic white, 4.1% were Hispanic, 1.7% were Asian, and 6.7% responded as being other race. A total of 56.1% were female, and most lived within the Washington, DC metropolitan area. Of the patients offered HIV screening, 2476 (59.7%) accepted the test. Of the 26 patients with a preliminary positive screen, 13 were lost to follow-up, 9 were confirmed positive by Western blot, and 4 were confirmed negative by Western blot. Eight of the 9 patients with confirmed HIV infection were successfully linked to follow-up care. CONCLUSIONS: The implementation of the CDC recommendations establishing routine opt-out HIV screening programs in EDs is feasible. Further efforts to establish routine ED HIV testing are therefore warranted.     

茂名市疾病预防控制机构应急能力的调查

目的了解茂名市疾病预防控制机构突发公共卫生事件应急反应能力建设状况。方法用问卷方法对茂名市级及各县（市、区）级7所疾病预防控制机构进行应急能力调查。结果各级疾病预防控制机构针对不同突发公共卫生事件已做好预案和应急准备，应急体系初步形成。市疾病预防控制中心应急能力较强，基层疾病预防控制机构应急能力亟需提高。结论突发公共卫生事件应急能力建设是长期的任务．需各级疾病预防控制机构不懈努力：应加强专业技术人员特别是基层疾病预防控制机构的应急意识和现场处詈能力培训．     

Summary of the Centers for Disease Control human immunodeficiency virus (HIV) performance evaluation surveys for 1985 and 1986

During 1985 and 1986, the Centers for Disease Control conducted eight surveys to evaluate laboratory performance in testing for antibody to human immunodeficiency virus (HIV). (Other names for this virus include "human T-lymphotropic virus type III" and "lymphadenopathy associated virus.") The first survey was conducted with ten samples and 50 laboratories; the remaining surveys used six samples, but enrollment increased to as many as 475 laboratories. The purpose of these surveys was to measure test performance by the laboratories under the actual conditions of use. The surveys contained duplicate samples to permit measurement of within- and between-survey reproducibility. One survey included positive and negative reference materials as evaluation samples. Results of the Western blot (WB) test were not always positive on samples that were positive by enzyme immunoassay (EIA), and sometimes they were positive on samples that had negative results by EIA. The percentage of positive results reported by laboratories using Electronucleonics tests was lower than that reported by users of Abbott and of Litton tests. positive results on the negative reference material were reported by 13.7% of the Abbott EIA test users. The tests do not seem to be calibrated against an equivalent standard. Within-survey reproducibility was usually above 95% for EIA and WB methods and for the major manufacturers of EIA tests. Between-survey reproducibility was usually above 90%. Reproducibility was below 75% for some combinations of samples, method, and manufacturer. The test performance observed in these surveys may be lower than is actually achieved on patient samples because the samples were selected to measure technical competence and contain a higher frequency of samples with low reactivity than would be encountered with clinical samples. Stratification and weighting of the results in these surveys to estimate performance parameters for a blood bank population indicate that the tests are performing well in this application. If single EIA tests at the performance levels achieved in these surveys were used (no repeat and no confirmation), about 1 sample with positive results in every 50,000 samples tested would be missed and about 2.5% would be false positive results. Because tests are duplicated and confirmed in blood banks, better performance would be expected. Testing for antibody to HIV virus continues to undergo rapid change because of the introduction of new tests, changes in technical aspects of existing tests, and application of testing to changing populations. Such dynamic factors necessitate an ongoing, comprehensive monitoring of test performance.     

Centers for Disease Control perspective on quality assurance for human immunodeficiency virus type 1 antibody testing. Model Performance Evaluation Program

Ensuring high quality in human immunodeficiency virus type 1 (HIV-1) antibody testing is an essential component of the organized public health response to epidemic HIV-1 infection. In 1986, the Centers for Disease Control designed the Model Performance Evaluation Program to assess and improve the analytic quality of HIV-1 antibody testing. In addition, the program was designed to gather information about HIV-1 antibody testing practices. The utility of this information is in identifying potential barriers to quality throughout the total testing process. Currently, 1405 laboratories participate in the program. Participating laboratories are located both within and outside the United States and consist primarily of hospitals, blood banks, health departments, and independent laboratories. The responses to a questionnaire completed by 1050 program-participant laboratories in September 1988 suggest that at several stages in the HIV-1 antibody total testing process, laboratory practices (including the interpretation of Western blot patterns) are variable and that standardization of these practices would improve quality.     

Lymphocyte immunophenotyping at the Centers for Disease Control: the program and special studies

Lymphocyte immunophenotyping has been done at the Centers for Disease Control since 1981. The technology is constantly evolving, and changes have been instituted to keep up with and improve this technology. In the last 7 years we have analyzed approximately 8300 specimens from patients and persons at risk in projects related to the acquired immunodeficiency syndrome. Though several subsets of lymphocytes have been found to be increased or decreased in HIV infection, no lymphocyte determination is more sensitive than CD4 alone in predicting the outcome of human immunodeficiency virus infection.     

Offering parents individualized feedback on the results of psychological testing conducted for research purposes with children: ethical issues and recommendations.

Research protocols involving children often include psychological testing as part of an assessment battery. Inclusion of such testing raises the question of whether parents (or others) should be offered the individualized results of their children's psychological testing conducted for research purposes. The purpose of this article is to provide a review of the ethical issues and principles associated with individualized feedback of psychological testing conducted for research purposes. Two hypothetical cases are offered to illustrate the complexities of this topic. Detailed recommendations for the management of disclosure of the results of psychological testing in research settings are also proposed.     

Disease Surveillance: The Bedrock for Control and Prevention

How to cite this article: Krishna B. Disease Surveillance: The Bedrock for Control and Prevention. Indian J Crit Care Med 2021;25(7):745–746.     

Indirect immunofluorescence test performance and questionnaire results from the Centers for Disease Control Model Performance Evaluation Program for human immunodeficiency virus type 1 testing.

Results from laboratories performing indirect immunofluorescence (IIF) testing for human immunodeficiency virus type 1 antibody and participating in the Centers for Disease Control Model Performance Evaluation Program in 1988 are presented. Approximately 90% of all laboratories receiving specimen panels or questionnaires furnished results to the Centers for Disease Control. In September 1988, 111 reports were received from IIF laboratories from 34 states and nine countries; most of these laboratories did IIF testing in conjunction with other antibody tests. Hospital laboratories were the most common type of laboratory participating in the program. Laboratories that performed IIF employed fewer personnel and performed testing less frequently than did laboratories that performed enzyme immunoassays or Western blot (immunoblot) tests and were likely to use a commercial test kit. Most of the laboratories that referred specimens for IIF testing sent them to the state laboratory. The analytic specificity for the Model Performance Evaluation Program specimens was 98.5% when indeterminate results on a negative specimen were considered correct (negative) and 89.6% when indeterminate results on a negative specimen were considered incorrect; analytic sensitivity was 94.8% when indeterminate results on a positive specimen were correct (positive) and 91.4% when indeterminate results on a positive specimen were considered incorrect. When indeterminate results were considered correct, all types of laboratories (blood bank, state, hospital, independent, and other) had analytic specificities over 96%, and all manufacturers had analytic specificities above 95%. All types of laboratories had analytic sensitivities over 92%, and analytic sensitivities were above 94% for all manufacturers and reagent sources except Cellular Products. Comparison of percentages of correct responses between IIF and Western blot assays on those samples for which there was good agreement on the target interpretation revealed no significant differences. Both individual donor and diluted materials were included in the evaluations; the diluted donor material presented the greatest testing difficulty. Within-survey reproducibility was about 93% overall and by specimen type. Between-survey reproducibility was about 81% for negative and indeterminate specimens and 88.5% for positive specimens, for an overall between-survey reproducibility of 84.3%. Differences in performance were noted when results were compared by type of laboratory and test manufacturer.