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PubMed2004

Highly sensitive biosafety model for stem-cell-derived grafts.

BACKGROUND: The recent success in the derivation of differentiated cell types from stem cells has raised prospects for the application of regenerative cell therapy. In particular, embryonic stem cells are attractive sources for cell transplantation, due to their immortality and rapid growth. These cells, however, also possess tumorigenic properties, which raises serious safety concerns and makes biosafety testing mandatory. Our goal was to establish a highly sensitive animal model for testing the proliferative potential of stem-cell grafts. METHODS: BALB/c nude mice received cell grafts of non-neoplastic MRC-5 cells containing defined numbers of mouse embryonic stem cells. We either injected 1 million viable cells into the kidney capsule, or mixed 2 million cells with Matrigel for s.c. transplantation. To analyze the possible impact of an intact immune response on tumor development, we also transplanted the cells into immunocompetent mice. Animals were sacrificed when the tumors became >1 cm and were analyzed in detail. RESULTS: The nude mouse model reproducibly allowed detection of 20 tumorigenic cells, and even as few as 2 ES cells were found to form teratoma. Interestingly, the administration of cell grafts at two different application sites resulted in different growth kinetics and tumor phenotypes. The highest level of sensitivity (100% detection of 20 tumorigenic ES cells) was achieved by s.c. injection of cells mixed with Matrigel. The influence of the immune system on tumor-cell development was demonstrated by a higher tumor rate of transplants in immunodeficient nude mice compared with immunocompetent mice. DISCUSSION: We have established a reliable animal model for routine assessment of the biosafety profile of stem-cell-derived cell transplants. This model will facilitate the generation of homogenous non-tumorigenic cell populations, and will help to integrate standardized safety systems into the application of stem-cell-derived grafts for clinical purposes.

Animals↗
PubMed2000

Training of obstetric nurses and HIV testing in pregnancy at a managed care organization.

The purpose of this study was to evaluate the effectiveness of an HIV Training Programme for obstetric nurses at a managed care organization. Nurses were trained to counsel pregnant women about the HIV antibody test according to the latest recommendations made by the US Public Health Service and the Texas legislature. Training improved the nurses' overall knowledge about the content of the programme and nurses were more likely to offer the HIV test to all pregnant women. Still, contrary to what was predicted, the nurses did not give more information to increase the knowledge pregnant women had about HIV infection, transmission and available treatments. However, pregnant women who received prenatal care after the nurses attended the programme were more likely to be tested than women who received prenatal care before the nurses were trained (96% versus 48%); in turn, the likelihood that high-risk women would be tested for HIV also increased (94% versus 60%). There was no evidence that mandatory testing with right of refusal would deter pregnant women from being tested for HIV. The increased rate of HIV testing was attributable to the providers asking their patients to be tested rather than on their patients' knowledge of its benefits.

Adult↗
PubMed1997

The surgeon's database for AIDS: a collective review.

BACKGROUND: The human immunodeficiency virus infection and acquired immunodeficiency syndrome have had a dramatic effect on the practice of surgery. Critical issues include quantifying the risk encountered by surgeons when operating on infected patients, the benefits of chemoprophylaxis after injury by a health care worker, the likelihood of infected surgeons transmitting human immunodeficiency virus to patients, and the debate over mandatory testing. STUDY DESIGN: Literature review of English-language publications. RESULTS: The incidence of human immunodeficiency virus infection ranges from 1.3 percent of patients hospitalized at sentinel hospitals to 1.5/1,000 patients in lower risk environments. The rate of percutaneous injury during an operation is 5 percent to 6 percent, and human immunodeficiency virus transmission after percutaneous injury with a needle contaminated with the human immunodeficiency virus is 0.3 percent. Here, we review current Public Health Service recommendations for chemoprophylaxis after percutaneous injury and address the debate over mandatory human immunodeficiency virus testing for patients and surgeons in the context of new information regarding the test for the human immunodeficiency virus. CONCLUSIONS: Controversial issues regarding acquired immunodeficiency syndrome and the human immunodeficiency virus infection must be addressed by all surgeons on the basis of objective information.

Acquired Immunodeficiency Syndrome↗
PubMedDate not supplied

HIV testing of health care workers.

Until recently, nothing much beyond education and the dispensing of condoms was being done to control the spread of AIDS. We have not yet taken sufficient measures to prevent the spread of this disease. Instead, we insist on protecting the privacy of the HIV-positive individual. However, we ignore the right to privacy by mandating testing for syphilis, which is not nearly as serious a disease as AIDS. Now, mandatory testing of health care workers is being proposed more frequently.

Acquired Immunodeficiency Syndrome↗
PubMed1990

Privacy rights and HIV testing in the hospital setting: a medicolegal quagmire for administrators.

The results of HIV testing must protect public health while preserving individual rights against unnecessary intrusions. To determine whether actual risks justify mandatory testing and reporting, the best possible objective medical information must be considered. Legislators and courts must not cave in to public sentiment and fears. Courts must scrutinize HIV testing legislation carefully to ensure that the legislative history is accurate and the primary goal is concern for public health, not for discriminating or creating scapegoats.

AIDS Serodiagnosis↗
PubMedDate not supplied

Canadian experience in cytology proficiency testing.

The mandatory Laboratory Proficiency Testing Program (LPTP) of the province of Ontario as applied to cytology laboratories is briefly described. LPTP evaluates reporting of test slides to identify laboratories that have deficiencies. Such laboratories receive an on-site visit, followed by recommendations on means of improvement (especially educational) and subsequent monitoring. Most of the 18 cytology laboratories visited to date have shown an improved level of performance on later tests.

Cytodiagnosis↗
PubMed1996

Quality improvement of diagnostic microbiology through a peer-group proficiency assessment program. A 20-year experience in Ontario. The Microbiology Committee.

OBJECTIVE: To evaluate the microbiology laboratory performance in Ontario over a 20-year period of participation in a quality assessment program and to assess the impact of quality improvement strategies. DESIGN: Longitudinal review of isolation, identification, and antimicrobial susceptibility testing of bacteria from lyophilized, simulated patient samples. SETTING: Ontario medical laboratories, licensed by the Ministry of Health, have been subjected to mandatory testing by the Laboratory Proficiency Testing Program of the Ontario Medical Association since 1974. Survey reports, information bulletins, correspondence, on-site consultations, educational assistance tutorials, and teleconference education are used as quality improvement strategies. PARTICIPANTS AND INTERVENTIONS: Laboratories were subjected annually to 20 external quality assessment challenges. Performance was assessed against consensus reference values. Single survey and cumulative profiles were reviewed by a peer-group panel for acceptable or unacceptable performance. Specific interventions are used to improve collective and individual laboratory performance. RESULTS: The number of microbiology laboratories declined from 335 in 1974 to 190 in 1994. Twenty-one percent failed expected performance standards on initial review. One hundred forty-two on-site consultations and 61 educational assistance tutorials have been provided. Twenty-five laboratories were declared nonproficient. Since 1989, 50% of the laboratories have scored at or above 80% for isolation and identification, but 25% have scored at or below 50% on susceptibility testing, and 10% or fewer have scored at or above 80%. Poor susceptibility testing performance is due to inappropriate agent selection, not testing errors. CONCLUSIONS: The emphasis of the Laboratory Proficiency Testing Program is on quality improvement, not punishment. Performance has improved, but poor performers have the same characteristics as in 1974. Identification to species is common owing to the use of commercial systems. Automated susceptibility testing has increased to 45% of participants.

Bacterial Infections↗
PubMed1992

HIV testing: an ethical analysis.

As the epidemic of the human immunodeficiency virus continues to grow, the relationship between patients and health care workers is being tainted with fear and mistrust. The demand for mandatory testing of health care providers has caused many of us to assess our basic values of autonomy, beneficence, nonmaleficence, and justice. Is our "right to privacy" more important than our "right to know"? This article will analyze some of the legal, moral, and ethical issues to be considered in identifying possible alternatives and a justified solution to this dilemma.

AIDS Serodiagnosis↗
PubMedDate not supplied

[Effects of Cisplatin on Auditory Function in Children with cancer. Otoacoustic Emission Evaluation].

This study was done to ascertain prospectively whether distortion product-evoked otoacoustic emissions (DP-EOAE) might detect changes in specific frequencies damaged in inner ear function earlier, before they become permanent after cisplatinum exposure for cancer treatment in children. Sixteen children treated with cisplatinum for various types of cancer were repeatedly evaluated after each chemotherapy session; results were compared to 44 controls. We observed a progressive damage in auditory function. In second assessment 50% of DP-EOAE studies were abnormal; in the third study, 66% were abnormal, and in the fourth test 71% were abnormal. Our results suggest that DP-EOAE are useful tests for earlier auditory changes induced by cisplatinum therapy; higher frequencies are the most affected, and we propose that DP-EOAE be a mandatory test before treatment and during cisplatinum therapy to detect or diagnose early hearing loss.

Acoustic Stimulation↗
PubMed2000

[HIV-testing of patients and operating room staff: myths and facts].

Orthopedic surgeons are at risk of acquiring HIV. Multi-center studies have estimated the risk of infection related with exposure to blood and other body fluids. New discussion concerning mandatory testing of patients who require invasive procedures has arisen as several reports on occupationally acquired HIV infections have been published. The case of the French surgeon highlighted the high risk of infection by blood-born pathogens related to certain surgical techniques. Cases of patients infected by HIV by medical personnel (by an American dentist and the mentioned before French surgeon) are also discussed. Basing on these two cases, the procedures with the highest infection risk are discussed, along with HIV testing policies towards surgeons of health care authorities in different countries. The importance of preventive measures, considering no cure for HIV infections is available is also stressed.

HIV Seropositivity↗
PubMed1992

Clinical decision analysis of HIV screening.

BACKGROUND: Various health organizations, and government agencies have developed differing recommendations to address the issue of who should be tested for HIV (human immunodeficiency virus). This study used decision analysis to evaluate approaches to testing for HIV infection in a variety of clinical situations. METHODS: Four decision tree branches were evaluated to determine the relative importance of HIV seroprevalence, test sensitivity, test specificity, and other factors in four testing scenarios: 1) no HIV testing of anyone, 2) mandatory HIV testing for all health care workers and hospitalized patients younger than age 65, 3) testing of persons determined to be at high risk for HIV infection based on risk assessment, and 4) voluntary HIV testing and reporting. RESULTS: No HIV testing results in a situation in which HIV status is unknown for all patients and health providers; issues of test sensitivity and specificity are not pertinent. Mandatory testing of health care workers and hospitalized patients, and testing only of high-risk persons, is heavily dependent on assumptions regarding HIV disease prevalence and on test sensitivity and specificity. Voluntary testing is more dependent on political decisions regarding the consequence of positive tests than it is on HIV prevalence or test characteristics. CONCLUSIONS: Policies regarding HIV testing are heavily dependent on the prevalence of HIV seropositivity, the sensitivity and specificity of HIV blood tests, and public policy.

AIDS Serodiagnosis↗
PubMed2005

From mandatory to voluntary testing: balancing human rights, religious and cultural values, and HIV/AIDS prevention in Ghana.

This paper examines efforts by some churches in Ghana to reduce the spread of HIV/AIDS. The analysis is based on focus group discussions with two groups of men and two groups of women, along with in-depth interviews with 13 pastors and marriage counsellors in the churches studied. In response to government and public criticisms about human rights violations, churches that previously imposed mandatory HIV testing on members planning to marry now have voluntary testing programmes. However, the results suggest that what the churches refer to as voluntary testing may not be truly voluntary. Cultural values and traditional practices, including traditional courtship and marriage rites (which are performed before church weddings), not only clash with considerations about pre-marital HIV testing but also complicate the contentious issue of confidentiality of information on HIV testing. Associated with these complexities and issues of confidentiality is a reluctance among participants, particularly those from northern Ghana, to test for HIV. The results reveal how broader social impacts of HIV testing for those planning to marry may extend beyond individuals or couples in different cultural contexts. The findings also support the general view that there are no perfect or easy solutions to combating the HIV/AIDS pandemic. Practical solutions and programs for Ghana cannot be neutral to cultural values and need to be tailored for particular (ethnic) populations.

Adult↗
PubMed2005

Oral acute toxic class method: a successful alternative to the oral LD50 test.

The oral acute toxic class method (ATC method) was developed as an alternative to replace the oral LD50 test. The ATC method is a sequential testing procedure using only three animals of one sex per step at any of the defined dose levels. Depending on the mortality rate three but never more than six animals are used per dose level. This approach results in the reduction of numbers of animals used in comparison to the LD50 test by 40-70%. The principle of the oral ATC method is based on the Probit model and it was first evaluated on a biometric basis before a national and subsequently an international ring study were conducted. The results demonstrated an excellent agreement between the toxicity and the animal numbers predicted biometrically and observed in the validation studies. The oral ATC method was adopted as an official test guideline by OECD in 1996 and was slightly amended in 2001. The ATC method has been successfully used in Germany and in 2003 >85% of all tests on acute oral toxicity testing was conducted as oral ATC tests. In member states of the European Union the ATC method is used in the range of 50% of all tests conducted. Meanwhile the oral LD50 test has been deleted by OECD, by the European Union and by the USA, making the use of alternatives to the oral LD50 test mandatory.

Administration, Oral↗
PubMed1992

Physicians' attitudes toward mandatory workplace urine drug testing.

BACKGROUND: Workplace drug testing programs are being increasingly implemented in both the public and private sectors, and health care workers are unlikely to be excluded from such testing. METHODS: A survey of attending physicians' attitudes toward mandatory hospital-based urine drug testing was undertaken in a medium-sized, midwestern county. RESULTS: Seventy-four percent (272/368) of the sample responded. Seventy-two percent of the subjects believed physician drug use to be a minor or nonexistent problem, 38% lacked confidence in the testing procedure, and 60% believed that testing infringed on the physician's right to privacy; yet 87% would submit to testing if required by a hospital. Forty-five percent of respondents agreed with the policy of mandatory testing for physicians with hospital privileges, 34% disagreed, and 21% were uncertain. Respondents were more supportive of mandatory testing of other health care and non-health care occupations than for themselves. Support for testing was greatest for illicit drugs. If implemented, physicians preferred mandatory testing to be performed by hospital medical staff independent of hospital administration. CONCLUSIONS: Further education and discussion within the physician community appears to be necessary before widespread mandatory workplace urine drug testing of physicians is implemented.

Attitude of Health Personnel↗
PubMed2001

Validation and standardisation of nucleic acid amplification technology (NAT) assays for the detection of viral contamination of blood and blood products.

Standardisation of NAT assays is necessary before the introduction of such assays for routine screening of blood and blood products for viral contaminants such as HBV, HCV, and HIV-1. Standardisation can be achieved by the use of well-characterised reference materials (working reagents) to validate each assay run. Working reagents for HCV, HIV-1, HBV, HAV, and human parvovirus B19 have been established by the NIBSC. Such reagents and reference panels are also available from other official medicinal control laboratories and commercial organisations. However, the nucleic acid content of these reagents are expressed in many different units, e. g. genome equivalents/ml, copies/ml, PCR detectable units/ml, making comparisons of results from laboratories using different reagents difficult. The establishment of internationally accepted standards against which all working reagents could be calibrated, using a common standard unit of measurement, IU, would overcome this major problem. The first International Standard for HCV RNA assays was established in 1997. This reagent, 96/790, is a lyophilised preparation of a genotype 1 isolate and the concentration of the standard is 10(5) IU/ml. Two further International Standards have since been established; for HIV-1 and HBV, containing 10(5) IU/ml and 10(6) IU/ml respectively. The establishment of the HCV International Standard has been critical in the introduction of mandatory testing. Since 1st July 1999, all batches of blood products marketed in Europe have to be prepared from plasma pools tested and found non-reactive for HCV RNA using a validated assay which can detect a sample containing 100 IU/ml of HCV RNA. In Germany, screening of blood donations for HCV RNA by NAT has been mandatory since 1st April 1999. The minimum sensitivity of assays should be 5000 IU/ml for a single donation.

DNA, Viral↗