Consequences of nucleic acid amplification testing for blood transfusion centres.
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Cytomegalovirus (CMV) infection is an important cause of morbidity in solid organ recipients. Early markers to identify the progress of the infection and patients at high risk are required in order to apply a strategy of pre-emptive therapy. The efficacy of pre-emptive therapy relies on accurate laboratory tests to monitor CMV infection. The evaluation of CMV DNA kinetics by the polymerase chain reaction (PCR) is widely used for the management of CMV infection but markers predicting the progression of the infection and standardization of the technique are essential for the clinical interpretation of PCR results. A commercially available PCR system, the COBAS AMPLICOR Monitor (Roche Diagnostics, Brachburg, NJ), was used for the quantitation of CMV DNA in weekly blood samples (n = 504) from 47 solid organ recipients in the first 6 months after transplantation. PCR results were evaluated according to the development of clinical disease in order to find a DNA threshold and time points predicting the progression of CMV infection. Week 4 from transplantation was the earliest time point to note a significant difference between those patients who eventually developed CMV disease (n = 30) and those who remained asymptomatically infected (n = 17). At week 4, viral loads were significantly higher in patients who developed CMV disease than in asymptomatic infections (median value: 4 log(10)/10(6) leukocytes vs. 2.8, P < 0.0001). At week 4, a DNA level >/=4 log(10)/10(6) leukocytes was associated with a 45.37 odds ratio for CMV disease. Any increase >/=1 log from the first DNA detection to week 4 correlated with the clinical progression of CMV infection (odds ratio 1.74). In those patients who were treated with anti-CMV therapy, a >97% reduction of the baseline viral load was associated with a complete therapeutic success. In conclusion, CMV infection is a highly dynamic process and the quantitation of CMV DNA by PCR is a powerful marker to control successfully the infection, but a strict follow-up of the recipient and standardized PCR tests are mandatory for the best management of the infection.
In order to be successfully implemented, some interventions to prevent vertical transmission of human immunodeficiency virus (HIV) will require prior identification of HIV-infected women. The testing and counselling of pregnant women should therefore be promoted. Promoting testing and counselling within prenatal clinics would be a good strategy; however, additional data on the social and economic implications of HIV testing are needed to demonstrate the relevance of such a strategy. Promotion of testing and counselling should be developed in collaboration with community-based organizations, non-governmental organizations and people living with HIV, in order to increase the involvement and understanding of the community at large.
To reduce the cost of treatment in renal transplant patients, ketoconazole, an inhibitor of the cytochrome P-450 enzyme system, was added to their triple immunosuppressive treatment (prednisone, azathioprine and cyclosporine). Thirty seven patients were included; they received 100-200 mg/day of ketoconazole and the amount of cyclosporine given was adjusted to keep its whole blood concentration within a therapeutic range. The dose of cyclosporine was decreased 70.4% by the first month of combined treatment and 76% by the ninth month. The benefit obtained with this reduction allowed the use of cyclosporine to be extended to all the patients and to administer it permanently. In 3 patients the increase in the serum hepatic enzymes made us stop ketoconazole. In order to detect hepatotoxicity early, periodic monitoring of liver function tests is mandatory.
Doping-control (DC) procedures, particularly as used at the 1996 Olympic Games, are described, and the role of pharmacists in DC is discussed. DC procedures must be strict and precisely followed to avoid contamination of samples, the appearance of bias, and breaches in security and confidentiality. The process of selecting athletes for testing can be random, nonrandom, or a combination of the two. Escorts are used to notify athletes of their selection, verify their identity, and accompany them to the DC station. When urine specimens are obtained for DC, the voiding process must be directly observed. The specimen is checked for pH and specific gravity and then processed for shipping to a laboratory to be analyzed for banned substances. Medication histories are also obtained, giving athletes the opportunity to declare any substance that has been taken for legitimate medical purposes. Laboratory analysis involves screening and confirmation phases. During the Atlanta Games, roughly 50 pharmacists participated in the DC program as escorts or technical officers. It is logical to involve pharmacists in DC programs because they can develop and conduct drug-testing protocols; educate athletes, coaches, and trainers about drug use and abuse; and help ensure the safe and effective use of medications. Sophisticated doping-control procedures have been developed for athletic competitions, and pharmacists have much to offer DC programs.
OBJECTIVES: This study examined attitudes, knowledge, and behaviors reported by postpartum women in an AIDS epicenter toward voluntary human immunodeficiency virus (HIV) counseling and testing. METHODS: From February 1993 to March 1994, a convenience sample of 544 women underwent postpartum interviews at a municipal hospital in the Bronx, New York City. Demographic information and obstetric, sexual, drug use, and HIV testing histories were elicited, and selected variables were abstracted from the medical charts. Univariate and multivariate logistic regression analyses were performed. RESULTS: Seventy-nine percent of women were voluntarily tested for HIV. In the multivariate model, the strongest individual correlate of HIV testing was a history of drug use. Other independent correlates were being age 25 or younger, having only one child, knowing someone who died of AIDS, and having stigma-related concerns about testing. In univariate analysis, women with a drug risk were more than nine times as likely as others to have delivered without receiving any prenatal care during this pregnancy. CONCLUSIONS: Voluntary counseling and testing programs can succeed in testing a majority of hospitalized childbearing women. However, women at risk of drug use, who more often reported testing, were probably tested outside of prenatal care settings. Efforts to reduce vertical transmission of HIV infection must focus on bringing more women, especially women who use drugs, into prenatal care.
The American College of Sports Medicine (ACSM) gives the following definition of health-related physical fitness: Physical fitness is defined as a set of attributes that people have or achieve that relates to the ability to perform physical activity. It is also characterized by (1) an ability to perform daily activities with vigor, and (2) a demonstration of traits and capacities that are associated with a low risk of premature development of hypokinetic diseases (e.g., those associated with physical inactivity). Information from an individual's health and medical records can be combined with information from physical fitness assessment to meet the specific health goals and rehabilitative needs of that individual. Attaining adequate informed consent from participants prior to exercise testing is mandatory because of ethical and legal considerations.A physical fitness assessment includes measures of body composition, cardiorespiratory endurance, muscular fitness, and musculoskeletal flexibility. The three common techniques for assessing body composition are hydrostatic weighing, and skinfold measurements, and anthropometric measurements. Cardiorespiratory endurance is a crucial component of physical fitness assessment because of its strong correlation with health and health risks. Maximal oxygen uptake (VO2max) is the traditionally accepted criterion for measuring cardiorespiratory endurance. Although maximal-effort tests must be used to measure VO2max, submaximal exercise can be used to estimate this value. Muscular fitness has historically been used to describe an individual's integrated status of muscular strength and muscular endurance. An individual's muscular strength is specific to a particular muscle or muscle group and refers to the maximal force (N or kg) that the muscle or muscle group can generate. Dynamic strength can be assessed by measuring the movement of an individual's body against an external load. Isokinetic testing may be performed by assessing the muscle tension generated throughout a range of motion at a constant angular velocity. The ability of a muscle group to perform repeated contractions over a specific period of time that is sufficient to cause fatigue is termed muscular endurance. Musculoskeletal flexibility evaluations focus on the joints and associated structures, ligaments, and muscles that cross the joints. The sit-and-reach test and the behind-the-back reach test satisfy many of the criteria for physical assessment of musculoskeletal flexibility. A physical fitness assessment must be integrated into all activities of daily living, as well as the physician's examination, to assess and promote health.
Substance abuse continues to increase and permeate all sectors of US society including the medical profession. This article details the importance of testing everyone associated with health care organizations, including physicians, as a means of protecting patient welfare, increasing quality of care, and reducing negligence lawsuits, as well as providing treatment and recovery opportunities for those with addictions.
The use of bone densitometry, by dual energy x-ray absorptiometry, allows the identification, at an early stage, of subjects who will, 15-20 years later, present a fracture event. Furthermore, this technique is the most appropriate to confirm the efficacy of preventive or curative therapeutic approaches of osteoporosis. A balanced utilisation of biochemical tests is mandatory to exclude a secondary cause of osteoporosis, to help in the choice of the most appropriate therapeutic strategy and to evaluate the early response of patients to the administered drugs.
SETTING: Hungary, Central Europe, with a population of 10.3 million living in 20 administrative districts (19 counties and the capital). OBJECTIVE: To summarize the results of the first year of the revised National Tuberculosis Surveillance System. DESIGN: Retrospective survey of the National Tuberculosis Surveillance Center (NTSC) database. METHODS: Analysis of data on all tuberculosis cases reported to the NTSC in 2000. Drug susceptibility results were evaluated in line with WHO and IUATLD definitions. RESULTS: During 2000, a total of 3598 patients with tuberculosis were reported. Only 40% of these were bacteriologically confirmed. Although susceptibility testing has been required for previously untreated culture-positive cases, only 801 (67.8% of the bacteriologically confirmed cases) were tested in 2000. Drug resistance was detected in 10.7% of previously untreated and in 23.5% of previously treated patients. Multidrug-resistant (MDR) cases were not common: only 1.5% of the isolates from previously untreated patients and 4.9% of those from previously treated patients were MDR. CONCLUSIONS: The results suggest that the NTSC should work towards increasing the numbers of cases that are bacteriologically confirmed. In addition, some form of surveillance system should be instituted to ensure that mandatory susceptibility testing is performed on all isolates from previously untreated tuberculosis patients.
BACKGROUND: Numerous trials and meta-analyses have shown that extended out-of-hospital prophylaxis with low-molecular-weight heparin reduces asymptomatic and symptomatic venous thromboembolism after total hip arthroplasty. We hypothesized that knowledge of the results of screening tests may have resulted in overdiagnosis of symptomatic venous thromboembolism in many of these studies. The purpose of this analysis was to obtain an accurate estimate of the absolute risk reduction (ARR) of symptomatic venous thromboembolism after discharge from hospital in controlled studies that avoided this potential bias for overdiagnosis. METHODS: Articles were identified using MEDLINE, EMBASE, and the Cochrane Library databases (January 1980-April 2002). Studies were eligible if the assessment of symptomatic venous thromboembolism was standardized and performed independently of mandatory objective testing. RESULTS: Two studies (907 patients) were eligible for assessment of symptomatic venous thromboembolism, 5 studies (1917 patients) for symptomatic pulmonary embolism, and 7 studies (2425 patients) for fatal pulmonary embolism. In controls vs extended treatment groups, after hospital discharge, the frequency of symptomatic venous thromboembolism was 2.7% vs 1.1% (ARR, 1.56%; 95% confidence interval [CI], -0.21% to 3.3%; number needed to treat, 64); symptomatic pulmonary embolism was 0.36% vs 0% (ARR, 0.36%; 95% CI, -0.3% to 1.36%; number needed to treat, 278); and fatal pulmonary embolism was 0.09% vs 0% (ARR, 0.09%; 95% CI, -0.08% to 0.27%; number needed to treat, 1093). CONCLUSIONS: The absolute reduction in symptomatic venous thromboembolism attributed to extended prophylaxis in some studies and meta-analyses seems to have been overestimated.
It is worthwhile reconsidering the debate on mandatory or voluntary testing for HIV antibody among women of childbearing age, in the light of recent virological and therapeutic discoveries that have altered the parameters of the issue. The therapeutic possibilities of reducing the risk of transmission for women confirmed as seropositive are an incontestable benefit for anyone who is aware of her serological status; the fact of being able to detect real infection at birth could mean that causing unnecessary distress to the antibody positive but uninfected newborn infant is avoided. Medical professionals now have convincing arguments to persuade women at risk to accept the test when it is offered. But, in any case, the voluntary nature of the decision for testing must be respected.
BACKGROUND: Several studies carried out in the USA and in Europe have shown the presence of HTLV-I/II antibodies in subjects belonging to high-risk groups for HIV infection as well as blood donors. Concern about the presence of HTLV-I/II markers in the normal population, as well as the efficient transmission of HTLV-I/II by whole blood or infected blood cells have led several countries to include screening for anti-HTLV-I/II among the mandatory serological testing of blood donors. OBJECTIVE: In order to assess the risk of HTLV-I/II infection related to blood transfusions, a multicentric survey for antibodies against HTLV-I and HTLV-II was carried out involving 10 Italian sites during the spring of 1991. STUDY DESIGN: Serum specimens were collected from 14,598 blood donors, 1,411 injecting drug users, 1,015 thalassemics, 142 hemophiliacs and 138 hemodialysis patients. HTLV antibodies were detected by a screening EIA which combines a viral lysate with a recombinant HTLV-I env protein (p21e). The serological confirmation was performed by a semi-automated dot-blot immunoassay that detects gag p19 and p24 and env p21e specific antibodies, while the discrimination of HTLV-I and HTLV-II reactivities was carried out by EIAs employing synthetic peptides of the ENV region specific for each virus. RESULTS: The seroprevalence of confirmed positives was 0.034% among blood donors and 3.61% among IDUs, while no sample of the other categories could be confirmed, although several were indeterminate and one thalassemic reacted against HTLV-I on peptide testing. HTLV-I reactivity was observed in one blood donor, while all 38 of the 51 confirmed seropositive IDU's reacted only to the HTLV-II synthetic peptide. CONCLUSIONS: These data confirm a high prevalence of HTLV-II among Italian IDUs and show an HTLV-I/II seroprevalence among blood donors very similar to that which was found in the USA volunteer blood donors. A surveillance program among blood donors seems advisable in order to establish the possible need of a mandatory screening for HTLV-I/II.
This manuscript reviews data available in the scientific literature relative to drug testing for the five mandated drug classes and circumstances other than abuse of the drug itself that could result in a positive test. For marijuana, passive inhalation, unknowing oral ingestion, and the use of Marinol are discussed. Data are presented on the concentration of delta9-tetrahydrocannabinol (THC) and its precursors, acid-A and acid-B, in illicit marijuana and the extent of extraction of THC in boiled (tea) or cooked products. For cocaine, passive inhalation and passive exposure issues are reviewed. For opiates, poppy seed ingestion and guidelines for exclusion of poppy seeds as a cause for a positive test are discussed. For amphetamines, issues such as the presence of other phenethylamines, l-methamphetamine (Vicks' inhalers), and other prescription drugs are discussed. Although passive inhalation of methamphetamine and phencyclidine is theoretically possible, no data were available on these issues.
Proposals to make prenatal HIV testing routine and universal dramatize ethical issues regarding early detection of HIV. These proposals would abolish pretest counseling and written informed consent for prenatal HIV testing. Ethical concerns include whether pregnant women are adequately informed that they may refuse such testing and whether patients have an opportunity to obtain more detailed information about the benefits and risks of HIV testing in this context. Several pertinent research questions need to be studied, including whether pregnant women find routine universal HIV testing acceptable and whether safeguards adequately protect women who receive testing. If analogous policies to enhance early detection of HIV are considered in other clinical contexts, the important clinical and ethical differences between vertical transmission and other situations of HIV transmission must be kept clearly in mind.
The choice of therapy in urinary tract infections depends on the infection site, complications, previous history, and recrudescence. Acute uncomplicated urinary tract infections which do not respond to general measures as increased fluid intake will be cured with antibiotics for 3 days. If the compliance of the patient is sufficient a single shot therapy may be applied. Infections of the upper urinary tract with typical signs such as fever, nausea and increase of the so-called acute phase proteins have to be treated with antibiotics for 7 to 14 days. When treating the first episode of urinary tract infection the choice of antibiotics is unimportant. Trimethoprim and quinolones are standard. In recurrent infections urine cultures and susceptibility testing are mandatory. Patients with recurrent urinary tract infections should receive a long-term suppressive therapy with low-dose trimethoprim or a quinolone. Patients with urinary catheters must not receive any long-term therapy.
Hungary is a country with relatively low HIV prevalence. Since 1989, a wide range of HIV prevention projects has been developed both by government agencies and by an increasingly active voluntary sector. While energy and resources continue to be invested in HIV information and education, some senior public health officials have argued that it is the country's compulsory HIV testing and compulsory reporting system which have enabled it to maintain its low seroprevalence levels. The testing and reporting system are soon to be reformed, however, in response to growing demands for better protection of personal privacy and confidentiality. Whether or not the forthcoming reforms will have an impact on HIV prevention, and what the nature of this impact will be, remain to be seen.
OBJECTIVE: Since August 1999, New York has required expedited human immunodeficiency virus (HIV) testing of pregnant women in labor or their newborns, with results available within 48 hours if no intrapregnancy test result was available. We documented the frequency and circumstances of expedited HIV testing, the time required for a result to be available, and hospital factors associated with different intervals. METHODS: We conducted chart reviews for women listed in the expedited HIV testing logbook between October 1, 2000 and December 31, 2000, abstracting prenatal care history and the dates and times of hospital admission, blood specimen collection, expedited HIV testing result availability, and the infant's birth. RESULTS: Of 1115 women admitted for labor and delivery during this period, 13.6% were tested under the expedited HIV testing procedure, and none were found to be HIV positive. Twenty-seven percent of women having expedited HIV testing had documentation of testing during prenatal care that was unavailable or overlooked during admission. Expedited HIV testing results were available at 48 hours or less time for 96% of the women, although results for women admitted Friday to Sunday took longer than weekday results (mean +/- standard deviation, 30.4 +/- 11.7 hours versus 21.3 +/- 9.3 hours, P <.001). Expedited HIV testing results were available before delivery for 3.3% of women and less than 12 hours after birth for 31.7% of infants. CONCLUSION: We found excellent compliance with the 48-hour time limit for expedited HIV testing but report lapses in access to prenatal HIV testing documentation, resulting in frequent duplicative testing. Further, the potential for optimal neonatal prophylaxis within 12 hours of birth was limited, as the turnaround time for HIV results exceeded 12 hours for two thirds of the infants in our sample.