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Comparative analysis of a liquid-based Pap test and concurrent HPV DNA assay of residual samples. A study of 608 cases.

OBJECTIVE: To retrospectively study the HPV DNA assay of residual samples from the ThinPrep Pap Test (Cytyc Corporation, Boxborough, Massachusetts, U.S.A.) PreserveCyt (Cytyc) vial as a quality improvement (QI) indicator for management of patients with abnormal cervical cytology. STUDY DESIGN: Six hundred eight residual sample vials of liquid-based Pap-Test specimens were selected for the study based on Pap-test results from October 1998 to March 2001. The specimen vials were forwarded to the reference laboratory (American Medical Laboratories, Chantilly, Virginia, U.S.A.) for HPV DNA assay using the Hybrid Capture System method (Digene Corporation, Gaithersburg, Maryland, U.S.A.). At the time of HPV DNA assay, the residual samples were between 8 days to 10 months old, and each vial contained 4 mL. Of the 608 study cases, 76 were WNL, 115 contained BCC, 172 contained ASCUS, 179 were LSIL and 66 were HSIL. In this study, the 191 WNL and BCC cases were designated as the disease-free control group. The HPV DNA typing results were reported as low-risk, high/intermediate-risk or HPV DNA "not detected" HPV types. The HPV DNA testing results were compared to the Pap-Test diagnoses and statistical analysis performed. RESULTS: The following information reflects the percentage of HPV DNA-positive cases based on the Pap-Test diagnoses: 16.2% in WNL and BCC, 51.1% in ASCUS, 94.4% in LSIL and 98.4% in HSIL. Sensitivity (95.5%), specificity (83.7%), false negative value (4.4%), false positive value (16.2%) and predictive value of a positive (88.3%) and negative (93.5%) Pap-Test were calculated on the basis of HPV DNA testing results for 436 cases that were diagnosed as either SIL or negative (WNL and BCC). ASCUS (172) Pap-Test cases were considered borderline--disease positive and excluded from statistical analysis. CONCLUSION: The HPV DNA assay of residual samples from ThinPrep Pap-Test liquid-based specimens is an objective adjunct to the gynecologic cytology QI protocol and is the gold standard reference test for triaging women with equivocal cytologic diagnoses. The great value of HPV DNA testing is its high sensitivity (95.5%), specificity (83.7%) and negative predictive value (93.5%). HPV DNA testing results can be used as a tool to better determine the need for referrals for colposcopic biopsy, especially for patients with an ASCUS diagnosis. The residual Pap-Test specimens are stable and reproducible for HPV DNA typing. A working flow chart for our gynecologic cytology QI program was produced from the Pap-Test and HPV DNA assay results. This offer presents the added benefit of minimizing the problem of sample variation. The prevalence of HPV infection was 16.2% in this study.

Adult↗

Health human resources: consider the health technology professions.

Any analysis of health human resources must take into account the critical shortages in the health technology professions, such as medical laboratory technology, medical radiation technology, respiratory therapy and other allied health professions. These professions are often overlooked or invisible to patients, but they provide a vital role in diagnostic and therapeutic services. If projected shortages are not addressed, there will be a major impact on patient care. Accurate human resources information about these professionals must be collected; funding for additional spaces in educational institutions is essential; and a reconsideration of scopes of practice to allow more effective utilization of health technologists' knowledge and skills should be initiated as soon as possible.

Allied Health Occupations↗

[A survey of medical equipment displayed at the "Healthcare-2004" exhibition].

Surveyed in the paper is medical equipment displayed, November 29-December 3, 2004, in the Exhibition Hall in Krasnaya Presnya within the framework of the "Healthcare, Medical Equipment and Drugs-2004" Exhibition. The survey is made for the below categories of medical equipment: instruments and apparatuses; X-ray, neonatal, ophthalmologic and stomatological equipment; medical instruments; laboratory medical equipment; equipment for rehabilitation of patients and disabled and mobile medical equipment. A conclusion is made on that a lot of novel high-quality and high-tech medical equipment has emerged in the Russian market. The diversified equipment displayed at the Exhibition enables any medical facility to choose for its needs the most appropriate medical equipment, instruments and spares.

Delivery of Health Care↗

Design and operation of a current good manufacturing practices cell-engineering laboratory.

Medical centers and biotechnology companies active in cellular and gene therapy increasingly are working to design and build clinical laboratories capable of performing cellular engineering and vector production using current good manufacturing practices (cGMPs). Because cell engineering is a rapidly changing field, and definitions for cell engineering cGMPs are still being established, a cGMP cell-engineering laboratory most often should be designed with a broad range of potential applications in mind. While the laboratory facility is the most tangible aspect of cGMP, it represents only part of a larger process, which it must be designed and built to support.

Biological Products↗

Elevated blood lead in California adults, 1987: results of a statewide surveillance program based on laboratory reports.

California medical laboratories that test for blood lead are required to report results exceeding 1.21 mumols/L (25 micrograms/dl). Between April and December 1987, the California Department of Health Services received 3,077 blood lead reports from 34 laboratories for 1,293 civilian, non-institutionalized adults. Approximately 1 percent of all reports exceeded 3.87 mumols/L (80 micrograms/dl), 7 percent exceeded 2.42 mumols/L (50 micrograms/dl), and 21 percent exceeded 1.93 mumols/L (40 micrograms/dl). Individuals tested were overwhelmingly male (94 percent), disproportionately Hispanic surnamed (44 percent), and most often residents of Los Angeles County (81 percent). Workers in lead smelting, battery manufacturing, and brass foundries accounted for nearly 80 percent of reports. Construction, radiator repair, pottery and ceramics manufacturing, and gun firing ranges accounted for the remainder. All adults with reports of greater than or equal to 2.90 mumols/L who were contacted reported on occupational exposure. Approximately half were not in routine medical monitoring programs. Despite OSHA standards, elevated blood lead with the potential for serious acute and chronic lead poisoning in California adults remains a significant public health and major occupational health concern.

Adolescent↗

Quality management in the ART laboratory.

Unlike most medical laboratories that play a diagnostic role, laboratories for assisted reproductive technologies, ART laboratories, are involved in the treatment of infertile couples. Handling human gametes and producing human embryos in order to achieve much-sought pregnancies form the key tasks of an ART laboratory. The impact of the activities and the possible risks makes it necessary to ensure the safety and reproducibility of all methods. To achieve and maintain the highest level of patient care and the highest success rates, a quality management system should be implemented. Several guidelines, compiled by professional associations of ART experts, official international standards and quality management models have been developed and issued and can be applied. Irrespective of the choice, establishing a quality management system in an ART laboratory leads to a huge amount of additional work and requires a lot of investment in all kind of areas. However, due to the increased standardization and efficiency of all procedures as well as the improved transparency and traceability of all actions performed, the quality of service provided by the laboratory will improve substantially and the effort will be worthwhile.

Humans↗

Construction and validation of an equivalency examination for an MLT/MT career mobility curriculum.

A career mobility program in medical technology, recently developed at the University of Illinois Medical Center, Peoria, utilizes equivalency examinations to recognize professional competencies achieved by a medical laboratory technology graduate with an associate degree toward completion of a bacclaureate degree in medical technology. Four criterion-referenced examinations in clinical chemistry, clinical microbiology, hematology, and blood bank-serology were constructed by 30 medical laboratory technician (MLT) and medical technology educators from Illinois community colleges and universities in 1976-1977. A description of the development of these exams, the process of criterion referencing, the administration of the exams for norming, and the utilization of the exams by applicants of the career mobility program is presented.

Career Mobility↗

Educational technology transfer in newly independent states: developing a medical multimedia laboratory in Lithuania.

This paper discusses the development of an interactive multimedia computer laboratory within the Vilnius University Medical Faculty involving transfer of hardware and courseware developed in the USA. The contexts in which the laboratory was developed are described and factors helping and hindering successful technology transfer are identified. The future of the laboratory and its potential role in international distance education and information access are discussed. While this paper does not focus on international distance education in the traditional sense of offering courses or training from one or more source institutions to individuals off-site, it has implications for providing education internationally, especially in the Baltic and other newly independent states of the former USSR.

Databases, Bibliographic↗

Dermatological, medical, and laboratory findings of patients in Taiwan and their treatments.

This paper describes in detail the dermatological, medical, and laboratory findings of patients poisoned with PCBs and related compounds in Taiwan. Together with their symptoms, their skin lesions as well as their hematological, immunological, and other clinical features are explained. A grading of their clinical severity was tried, and its possible association with PCB concentrations in their blood was examined but could not be demonstrated. Various treatments have been applied but without notable success. Even so, a follow-up study of patients one year later showed that about 38% of patients were somewhat clinically improved, while 54% were not altered.

Acne Vulgaris↗

PCB poisoning in Japan and Taiwan. Dermatological, medical, and laboratory findings of patients in Taiwan and their treatments.

This paper describes in detail the dermatological, medical, and laboratory findings of patients poisoned with PCBs and related compounds in Taiwan. Together with their symptoms, their skin lesions as well as their hematological, immunological, and other clinical features are explained. A grading of their clinical severity was tried, and its possible association with PCB concentrations in their blood was examined but could not be demonstrated. Various treatments have been applied but without notable success. Even so, a follow-up study of patients one year later showed that about 38% of patients were somewhat clinically improved, while 54% were not altered.

Acne Vulgaris↗

Wireless clinical alerts for physiologic, laboratory and medication data.

A fully interfaced clinical information system (CIS) contains physiologic, laboratory, blood gas, medication and other data that can be used as the information base for a comprehensive alerting system. Coupled with an event driven rules engine, a CIS can generate clinical alerts which may both prevent medical errors and assist caregivers in responding to critical events in a timely way. The authors have developed a clinical alerting system which delivers alerts and reminders to clinicians in real time via a alphanumeric display pagers. This paper will describe the system, the type and number of alerts generated, and the impact on clinical practice. A major issue remains in measuring the impact of wireless alerts on patient outcomes.

Algorithms↗

Mortality and cancer incidence among laboratory technicians in medical research and routine laboratories (Sweden).

OBJECTIVES: To investigate cancer incidence and mortality among laboratory employees. METHODS: Mortality and cancer incidence were investigated among 2553 female and male laboratory workers employed at the Karolinska Institute and Karolinska Hospital in Stockholm between 1950 and 1989. Mortality was followed from 1952-1993 and cancer incidence from 1958-1992. Expected numbers were based on the general population in Stockholm, standardizing for age, gender, and calendar period. RESULTS: The overall mortality and cancer incidence in the cohort was lower than expected. There were in all 10 cases of hemato-lymphatic malignancies (three acute myeloid leukemias, four non-Hodgkin lymphomas, two Hodgkin's lymphomas, and one multiple myeloma) in the cohort. The standardized incidence ratio (SIR) for hematolymphatic tumors was increased among workers who had ever been employed in laboratories with a high probability for chemical exposure, SIR 224 (95% CI 108-412). The risk of breast cancer among women was increased after more than 10 years of work in high-exposure laboratories, SIR 225 (128-365). The number of malignant melanomas exceeded those expected. CONCLUSIONS: The findings support earlier observations of an increased risk of hematolymphatic cancer among laboratory workers. The routine for handling chemicals and functionality of ventilatory equipment must be under continuous supervision.

Adult↗