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PubMed1999

Assessment of validation studies from a fractionator's point of view.

NAT testing has become an integral part in the safety programs of both plasma fractionators and transfusion services. NAT testing for HCV RNA is now mandatory for plasma fractionators in Europe and for transfusion services in Germany and Austria. Before NAT testing of plasma could become mandatory, a defined environment had to be created to allow comparison of different NAT procedures. To create such an environment, international virus standards, as well as guidelines for validation, assessment of robustness, and quality assurance of NAT have been released. This paper is a critical review of currently available standards and national reference preparations, detection limits, and national regulations of NAT in view of the specific nature of NAT.

Blood Transfusion↗
PubMed1998

HIV screening for pregnant women in south eastern France: evolution 1992-1994-1996.

OBJECTIVES: To assess the evolution of the HIV screening practices towards pregnant women between 1992 and 1996, in relation with the 1993 French mandatory obligation to offer prenatal HIV testing and recent therapeutic possibilities to reduce HIV vertical transmission. STUDY DESIGN: Three successive surveys (January 1992, May 1994 and May 1996) about HIV screening policies among medical chiefs of all prenatal care and abortion departments of South Eastern France. Sixty-seven of the 74 departments concerned agreed to participate in the three surveys. RESULTS: The proportion of departments practising routine prenatal HIV screening had not increased since 1992 (89%) but systematic women's consent is more often requested (65.5 vs. 38.2%, P < 0.01). In the context of abortion, HIV testing is more often routinely offered (38.1 vs. 16.4%, P < 0.05) but selective screening remains a frequent practice (29.1%). CONCLUSION: Mandatory proposal of HIV testing to women who terminate could improve access to test but is not sufficient to guarantee adequate preventive counselling.

Abortion, Induced↗
PubMedDate not supplied

A national survey of state maternal and newborn drug testing and reporting policies.

The prevalence rate of drug use by pregnant women in the United States has been shown to range from 7.5 percent to 11 percent. Drug exposure in utero has been associated with deleterious effects on the fetus and newborn. Public health officials are currently confronted with difficult policy decisions with regard to testing and reporting of pregnant and post-partum women and the provision of appropriate services. The widespread lack of consistent policy on the State level has led to bias in testing and reporting procedures and to the inappropriate use of the legal system as a deterrent to drug use during pregnancy. A survey of the 50 States and the District of Columbia found that no State currently has enacted legislation regarding testing. Thirteen States have mandatory reporting policies for drug-exposed newborns. Eleven of these States require reporting to social service agencies, at least 3 States routinely report to criminal justice agencies, and 10 require that reports be filed as child abuse or neglect. Many States without mandatory reporting statutes indicate that reports are made to social service agencies at the discretion of the health care provider. During fiscal year 1990, only 22 States specifically allocated funds for programs that address perinatal substance use. In States with mandatory reporting policies, reports should be made only to social service agencies in conjunction with the provision of appropriate preventive, medical, and social services to the woman and her infant. Interagency coordination is necessary to standardize testing and reporting practices within States and to effectively allocate resources.

Female↗
PubMed1987

[Comparison of nyctohemeral somatotropin secretion and response to pharmacological tests in 38 children with growth retardation].

We report a comparative study of the growth hormone nycthemeral secretion and the response of growth hormone secretion to pharmacological stimulation tests in 38 children with growth retardation. Two groups were separated according to the results of the nycthemeral growth hormone secretion study: a group of 26 children with normal secretion (mean maximum peak: 26.6 +/- 9.6 ng/ml and mean integrated concentration: 4.26 +/- 2.13 ng/ml/min) and a 2nd group of 12 children with hyposecretion (mean maximum peak: 6.7 +/- 2.6 ng/ml and mean integrated concentration: 1.08 +/- 0.45 ng/ml/min). There was no correlation between nycthemeral secretion and the responses to pharmacological tests. Thus, in the group with hyposecretion, 5 children had normal responses to a pharmacological test and in the group with normal secretion 13 children had intermediate responses to 2 pharmacological tests and 4 had dissociated responses. Thus, it appears mandatory to perform 2 different pharmacological tests in any investigation and to study the nycthemeral secretion in cases with intermediate or dissociated responses as well as in cases with normal responses when the clinical picture is consistent with growth hormone deficiency.

Adolescent↗
PubMed1994

Confirmatory tests for drugs in the workplace by gas chromatography-mass spectrometry.

The Mandatory Guidelines for Federal Workplace Drug Testing Programs require the use of gas chromatography-mass spectrometry (GC-MS) for the confirmation of presumptive positive urine specimens. This review focuses upon GC-MS methods developed specifically for forensic confirmation of amphetamine, methamphetamine, 11-nor-delta 9-tetrahydrocannabinol-9-carboxylic acid (THC-acid), benzoylecgonine, morphine, codeine and phencyclidine in urine for purposes of workplace drug testing. In addition, current laboratory issues pertaining to each drug class are reviewed. Generally, drug assays utilized either liquid-liquid or solid-phase extraction methods, derivatization if necessary, and GC-MS detection operating in the selected ion monitoring mode or by full scan acquisition.

Amphetamines↗
PubMed1992

Performance of the Kodak DT-60 physician's office analyzer as measured by CLIA-88 proposed evaluation criteria. Assessment of demographic and quality assurance factors influencing performance.

The 1988 Clinical Laboratories Improvement Act (CLIA-88) proposes to mandate universal proficiency testing and internal quality assurance practices for all laboratories, including those in physician offices. For 3 years, we have provided an independent voluntary proficiency testing program to more than 400 physician office laboratories using Kodak DT-60 analyzers (Eastman Kodak, Rochester, NY). This unique data set enables us to evaluate, using the CLIA-88 proposed grading criteria, the ability of these laboratories to meet the proposed regulatory standards. Using the equivalent of a year's participation under the CLIA proficiency testing format (20 challenges per analyte), at least 88% would "pass," ie, achieve acceptable performance. We investigated the relationship between proficiency testing performance and several internal quality assurance practices as well as other factors commonly associated with quality performance, including analyst's professional background, monthly test volume, number of physicians served, and source of training on the instrument. The best indicator of successful performance in proficiency testing was on-site training provided by the manufacturer, as opposed to training provided by distributor personnel. We conclude that with proper on-site training and retraining, physician office laboratories will be able to meet the mandatory CLIA-88 proficiency testing requirements.

Calibration↗
PubMed1991

Health care professionals with AIDS: public health or public relations concern?

Testing--whether voluntary or mandatory--for HIV among workers is one of the biggest concerns at this time in the health care industry. While most health officials and governing bodies agree that the risk of transmission from worker to patient is negligible, many believe that voluntary testing is beneficial. The question is, beneficial to whom--the patient, the worker, or the employing agency or facility?

Acquired Immunodeficiency Syndrome↗
PubMed1999

Value of the test for serum HCV-RNA in clinical practice.

The test to identify genomic RNA is the only tool currently available to directly evidence the presence of the hepatitis C virus (HCV) in infected subjects. In this review we examined the most commonly used qualitative and quantitative methods to detect HCV-RNA in serum or plasma, focusing particular attention on commercially available methods. Furthermore, we report the clinical conditions in which the viremia test is useful or even mandatory for the diagnosis of HCV infection, and comment on the usefulness of the test for monitoring patients in the course of antiviral therapy.

Journal Article↗
PubMed2006

Attitudes of new mothers towards genetics and newborn screening.

OBJECTIVE: To evaluate new mothers' opinions of genetics and newborn screening. SETTING: An Australian tertiary referral hospital. POPULATION: 232 women who delivered a liveborn infant and had received written and verbal information on newborn screening from midwifery staff during their antenatal care. METHODS: Participants were interviewed within 24 hours of blood being taken from their baby by heel prick for the newborn screen. Non-English speaking women were included using medical interpreters. The questionnaire evaluated opinions about newborn screening and parental consent. The opportunity was used to also question their views on the impact on lifestyle and discrimination of a theoretical diagnosis of genetic disease or carrier status in their baby. MAIN OUTCOME: Descriptive data on mother's attitudes. RESULTS: 200 women consented to participate in the study (86.2% response). New mothers supported newborn screening programs where outcomes could be used to prevent or reduce the severity of a disease (85-86% support), but were less supportive if screening had been used to assist with future family planning (65%). The majority of women (86%) felt that parental consent was mandatory before newborn screening tests were performed. A similar number felt that consent would be required before blood samples could be used if a National DNA library were to be created. The majority of women expressed concern that a child with a genetic illness would face discrimination and difficulty obtaining insurance or employment. A third of women felt that even a carrier of a genetic illness would face similar discrimination. CONCLUSION: Acceptance of newborn screening programs is high but mothers consider the need for consent to be mandatory. They have concerns about discrimination children with genetic illnesses may face.

Adult↗
PubMed1994

Mandatory screening of pregnant women for the human immunodeficiency virus.

In this AIDS Commentary, Dr. Catherine Wilfert addresses the issue of vertical transmission of the human immunodeficiency virus type 1 (HIV-1). She reviews the results of the recently completed trial conducted by the AIDS Clinical Trials Group that evaluated the effectiveness of administering zidovudine to pregnant women in reducing the incidence of vertical transmission. In view of the success of this trial, Dr. Wilfert addresses the problem of the efficacy of voluntary counseling and testing of pregnant women. Identification and treatment of HIV-1 infected women could potentially reduce the incidence of pediatric HIV-1 infection and increase the number of women receiving appropriate therapy. She makes the point that legislative mandates have been necessary to produce rates of childhood immunization that are effective in reducing the occurrence of vaccine-preventable diseases. This suggests that such mandates are an option to consider in the effort to control vertical transmission of HIV-1 infection. Her cost-benefit analysis indicates that universal screening of pregnant women for HIV infection would result in enormous overall savings for the health care system. Obviously, making the testing of pregnant women mandatory raises a number of difficult issues and is controversial. Dr. Wilfert has provided a service by raising this issue; further discussion is needed.

Female↗
PubMed2000

Rocuronium anaphylaxis and multiple neuromuscular blocking drug sensitivities.

PURPOSE: To report a case of anaphylaxis to rocuronium and the sensitivities to multiple neuromuscular blocking drugs in a patient with no previous exposure to this group of drugs. We describe the current recommendations for both intraoperative and postoperative testing of these patients. CLINICAL FEATURES: A 36-yr-old man was admitted for repair of a ruptured Achilles tendon. Following induction of general anesthesia with fentanyl and propofol, 60 mg of rocuronium were given to facilitate tracheal intubation. He immediately became profoundly hypotensive with impalpable pulses, and blood pressure could not be recorded. Airway pressure increased markedly, and hand ventilation of the lungs became very difficult. His airway was secured and he was successfully resuscitated with 3 mg epinephrine and three litres crystalloid and colloid intravenous fluid therapy. His recovery in the intensive care unit was uneventful and the operation was performed four days later under spinal anesthesia. Subsequent skin prick testing, performed six weeks later, demonstrated strong positive weal and flare reactions to rocuronium, vecuronium and pancuronium, and some cross-reactivity with the benzylisoquinolinium group of muscle relaxants. CONCLUSION: Muscle relaxants are responsible for 61.6% of cases of anaphylaxis during general anesthesia. Cross-reactivity is common, as this group of drugs share a quaternary ammonium group. It is mandatory that patients be tested for both the agent responsible and cross-reactivity following an anaphylactic response. We suggest a protocol for investigation of suspected anaphylaxis.

Achilles Tendon↗
PubMed2002

Comparison between buserelin and dexamethasone testing in the assessment of hirsutism.

Many hirsute women may present a form of functional ovarian hyperandrogenism (FOH), since they show an exaggerated 17-hydroxyprogesterone (17-OHP) response to GnRH agonists administration. As the failure of dexamethasone to reduce testosterone levels may be indicative of an ovarian source of androgen secretion, we evaluated the usefulness of dexamethasone suppression test, in comparison with buserelin challenge, in the assessment of hirsutism. Twenty-seven hirsute women (aged 15-42 yr) underwent ACTH and buserelin tests: 4 patients were heterozygotes for 21-OH deficiency and 8 patients were affected with FOH: 2 of the patients with hyperresponse to buserelin also had 21-hydroxylase deficiency. The results of the dexamethasone suppression test (2 mg/day for 7 days) were compared to those obtained after buserelin test. Basal T and delta4 levels (mean+/-SE) were higher than in controls (4.2+/-0.5 vs 2.2+/-0.2 nmol/l and 10.9+/-0.9 vs 5.9+/-0.6 nmol/l, p<0.02), while no differences were found in 17-OHP and DHEAS levels. A significant reduction (p<0.001) in T (1.8+/-0.4 nmol/l), delta4 (3.2+/-0.5 nmol/l) and DHEAS levels (2.4+/-0.3 micromol/l) was observed at the 3rd day of dexamethasone administration and no differences between sampling at 3rd, 5th and 7th day were found. Serum T was not suppressed in 6 cases, delta4 and DHEAS levels in 3 and 1 of them, respectively. Buserelin injection caused an excessive 17-OHP response in 8 patients, only 4 of them did not reduce T levels during dexamethasone. The sensitivity and specificity of the dexamethasone suppression test, with respect to the buserelin test, were 50% and 89%, respectively. In conclusion, 37% of hirsute patients had an abnormal responsiveness to buserelin and/or ACTH tests, indicating that hormonal investigations are mandatory. An ovarian origin of hirsutism was identified by buserelin test in 30% of patients and by dexamethasone in 22% of cases; only 4 of 8 patients showed concordant results to both tests. Therefore, buserelin challenge seems a more useful, cost-effective and less time consuming tool than dexamethasone administration in order to recognize the possible ovarian origin of hyperandrogenism.

Adolescent↗
PubMed1990

HIV-testing of dental students and faculty: benefits, detriment and implications.

Many medical and legal problems have been raised by the acquired immunodeficiency disease. While there is a large volume of literature which addresses these problems, scant attention has been paid to problems which arise when health care faculty and students are affected by this disease. Some health care administrators have discussed the propriety the routine testing of faculty and students for HIV disease, especially when invasive procedures are involved: This article discusses some of the legal issues which attend routine HIV testing in this context. Arguments for and against routine testing are presented. In addition, routine testing is distinguished from targeted testing in response to the reasonable belief that a health care worker is HIV-positive. It is argued that routine testing of health care workers is legally unwarranted. There are arguments, however, that testing of those believed to be HIV-positive is legally sound. Targeted HIV testing may be especially useful and permissible when the worker performs invasive procedures.

AIDS Serodiagnosis↗
PubMed1999

Antenatal HIV screening--knowledge, attitudes and practices of obstetricians in KKH.

AIM OF STUDY: To determine the knowledge, attitudes and practices of obstetricians with regards to HIV screening in pregnant women. METHOD: This is a cross-sectional study based on a questionnaire survey of all obstetricians in KKH from January to August 1997. MAIN OUTCOME MEASURES: Obstetricians' knowledge and beliefs of HIV epidemiology and HIV perinatal transmission, and attitudes and practices with regards to antenatal HIV screening. RESULTS: Forty-one (77.4%) obstetricians responded to the survey. At the time of the survey, only 43.9% of the respondents had offered the HIV serology test to their patients with only 17.1% and 19.5% providing pre-test and post-test counselling respectively. Seventy-eight percent of them were aware of reports that zidovudine could reduce the vertical HIV transmission rate. All the respondents felt that HIV testing should be performed in pregnant women. The majority (70.7%) felt that antenatal HIV testing should be voluntary rather than mandatory and 56.1% felt that the patients' civil rights and confidentiality could be more assured if HIV testing is voluntary than if it was mandatory. Most respondents (56.1%) felt that antenatal HIV screening should be universally offered rather than targeted to those with risk factors. Most obstetricians did not feel comfortable (58.5%) or competent (80.5%) to manage HIV infection in pregnancy. Those who felt competent were more likely to feel comfortable, more likely to have provided HIV test in the clinic, and less likely to opt out of caring for an HIV-infected patient. CONCLUSION: The majority of the surveyed obstetricians would support a program of voluntary antenatal HIV screening that is universally offered to all pregnant women. The feelings of discomfort and incompetence of the obstetricians towards caring for an HIV-infected pregnant woman need to be addressed further. There is a need for continuing medical education to help obstetricians keep abreast with the advances in HIV screening and its management.

AIDS Serodiagnosis↗
PubMed1989

To tell or not to tell: the ethical dilemmas of HIV test notification in epidemiologic research.

Epidemiologic studies involving HIV (human immunodeficiency virus) antibody testing create ethical dilemmas, particularly about notifying asymptomatic seropositive subjects. Four study designs address this problem: mandatory notification, optional notification, anonymous testing, and blind testing. No single design consistently optimizes the trade-off between valid and ethical research. Each strategy differs substantially from the others in its effect on response rates, bias, ability to perform longitudinal studies, numbers of subjects who learn their test results, and the number of subjects counseled about HIV risk reduction. Both local institutional review boards and potential subjects of study (and their sexual partners) should participate in decisions regarding the conduct of sensitive AIDS (acquired immunodeficiency syndrome) research.

Epidemiologic Methods↗
PubMedDate not supplied

Prevention of road accidents in Australia.

Since 1970, the Australian road fatality rate has been reduced by two-thirds. Legislation for compulsory wearing of seat belts reduced the vehicle occupant fatality rate by more than one-third. Drunk driving countermeasures have included the 0.05 g% legal limit and mandatory disqualification, random breath testing, compulsory blood alcohol tests on all road crash casualties and a zero blood alcohol limit for learner and probationary drivers and motor cyclists. Since 1977 there has been a steady reduction in the proportion of driver and motor cyclist fatalities and casualties with illegal blood alcohol concentrations. Helmet wearing is compulsory for motor cyclists. A one-third reduction in accidents with injury among learner and probationary motor cyclists followed legislation restricting them to machines of 260 cm3 maximum engine capacity. Safety helmet wearing has been recently popularized among pedal cyclists and legislation is anticipated which will make approved safety helmet wearing mandatory. A considerably smaller reduction in our road toll would have occurred if Australians had been unwilling to accept countermeasures opposed by civil libertarians.

Accidents, Traffic↗