摘要:

&NA;A validation study has been performed to determine the error detection capabilities of a new quality control (QC) technology called “intelligent Quality Management (iQM).” iQM is a completely automated statistical QC process that uses frequent measurements of internal process control solutions to monitor measurement variation and signal abnormal drifts, then applies pattern recognition algorithms to identify the type of error and trigger appropriate corrective actions. The validation methodology follows National Committee for Clinical Laboratory Standards (NCCLS) and International Standards Organization (ISO) guidelines and involves characterizing method performance on the sigma‐scale, characterizing instrument drift limits as statistical control rules, then assessing the probabilities of rejecting runs whose errors would exceed defined quality requirements, such as the Clinical Laboratory Improvement Amendment (CLIA) proficiency criteria for acceptable performance. Practical measures of performance are obtained by determining the average run lengths and converting them to the average times for detecting errors. With iQM, medically important errors will be detected within 0.05 to 0.5 hours for pH, PCO2, PO2, potassium, calcium, lactate, and hematocrit; 0.12 to 1.2 hours for glucose; and 0.17 to 1.7 hours for sodium. Compared to current QC practices where controls are analyzed every 8 to 24 hours, the iQM technology is expected to provide faster detection of errors.

ISSN:1533-029X    

出版商:OVID    

年代:2003

数据来源: OVID

摘要:

&NA;The availability of a point‐of‐care testing (POCT) analyzer for hemoglobin provides an enhancement of the assessment of patients' hemoglobin levels. These levels can be used to help assess the extent of blood loss, anemia, or nutritional status. To be clinically useful, the POCT analyzer must give results that are highly correlated, if not equivalent to results obtained using the central laboratory instruments. The analytical performance of the Stat‐Site MHgb (GDS Technology, Inc., Elkhart, IN), a POCT hemoglobin analyzer, was evaluated relative to the Roche Sysmex SE‐9500 (Roche Diagnostics, Corp., Indianapolis, IN). The within‐run (n = 5; two levels) precision of the Stat‐Site MHgb ranged from 2.83% (mean = 13.98 g/dl) to 5.10% (mean = 11.10 g/dL). For the day‐to‐day (n = 23; two levels) precision CVs were 3.87% (mean = 13.95 g/dL) and 5.21% (mean = 10.49 g/dL). A correlation of 0.96 and 0.98 with a slope of 0.96 and 0.99 was found for capillary and venous samples, respectively. The study shows that the Stat Site MHgb has acceptable precision and relative accuracy, and can be used for POCT service.

ISSN:1533-029X    

出版商:OVID    

年代:2003

数据来源: OVID

摘要:

&NA;Although the use of the oral glucose tolerance test (OGTT) for the routine diagnosis of diabetes mellitus is discouraged in recent practice standards, physicians continue to order the OGTT, sometimes as an initial screening test for diabetes mellitus.Measuring a fasting glucose level before administration of the oral glucose solution in an OGTT can be performed and the result used to discontinue the OGTT in many patients with diabetes mellitus. In a hospital setting, a rapid plasma glucose value can be obtained relatively easily in the central laboratory. However, in a community setting with many practice locations, alternative methods for obtaining a rapid glucose screen must be used. We report the results of a program involving the use of capillary blood glucose meters to screen patients before an OGTT. We also established a cutoff value for the capillary glucose test above which an OGTT should not be performed.

ISSN:1533-029X    

出版商:OVID    

年代:2003

数据来源: OVID

摘要:

&NA;An immunochromatographic assay (ICA) system including test strip reader and related test strip device for the quantitative determination of alpha‐fetoprotein (AFP) was developed. The desktop type test strip reader is composed of an optical sensor, photoelectrical converter device, single chip computer, and a coding chip fitted to the related lot of test strips. The main reagents of the test strip were a pair of monoclonal antibodies, one conjugated to colloidal gold, and the other immobilized on a nitrocellulose membrane. The test procedure is simple and rapid, producing a result after 5 minutes that is shown on the display window and printed out as AFP IU/ml. The measuring range of the system is 30 to 400IU/ml. Determination of AFP calibrators showed good accuracy. Coefficients of variation for within‐day and between‐day precision were 7.7% to 12% and 11% to 19%, respectively. Thirty‐seven serum samples from pregnant women and patients with suspected liver disease were determined simultaneously using the ICA system and the Roche Elecsys 2010 (Roche Diagnostics, Corp., Indianapolis, IN). The two assays showed a high correlation (r=0.9620; y=0.934x+3.599). The ICA system could be useful as a POCT procedure for the determination of AFP.

ISSN:1533-029X    

出版商:OVID    

年代:2003

数据来源: OVID

摘要:

&NA;The examinations of labile specimens under the bright‐field or phase contrast microscope are classified as provider‐performed microscopy (PPM). With a PPM certificate issued by the Centers for Medicare and Medicaid Services Administration, a physician, nurse practitioner, nurse midwife, physician assistant, or dentist may perform PPM and waived procedures. Provider‐performed microscopy procedures use specimens, such as body fluids or skin scrapings. Because quality control material is not available for PPM procedures, quality assurance assessment is complicated. Policies and procedures must be written for each test procedure. Provider‐performed microscopy procedures include wet mounts, KOH preparations, pinworm detection, fern test, postcoital test, microscopic urinalysis, fecal leukocytes, semen analysis for presence of sperm and motility, and eosinophils in nasal smears. The quality of PPM is dependent on adequate training and retraining to achieve optimal skills.

ISSN:1533-029X    

出版商:OVID    

年代:2003

数据来源: OVID

摘要:

&NA;Point‐of‐care testing (POCT) for the diagnosis ofHelicobacter pyloriinfection includes various serologic tests and the urea breath test (UBT). Multiple commercial serologic tests are available for near‐patient testing with blood, saliva, or urine specimens. Rapid serologic tests generally have reduced sensitivities and specificities when compared with enzyme immunoassay (EIA) formats. Rapid serologic tests are useful for screening and presumptive diagnosis ofH. pyloriinfection and require confirmatory testing for definitive diagnosis. The UBT offers the possibility for near‐patient definitive diagnosis and follow‐up testing in larger clinic or office settings. Near‐patient testing options for the diagnosis ofH. pyloriinfection include multiple commercial tests that may be useful for diagnosis and effective patient management.

ISSN:1533-029X    

出版商:OVID    

年代:2003

数据来源: OVID

摘要:

&NA;Enterprise Analysis Corporation (EAC) conducted a survey of 20 vendors of hospital point‐of‐care devices and data management systems to assess progress in implementing theNCCLS POCT1‐A Point‐of‐Care Connectivity: Approved Standard.Just one year after the Connectivity Industry Consortium released the standard, EAC found that five vendors already offer products compliant with it. Moreover, all of the vendors with products in the development cycle intend to incorporate the standard in most or all of their new products. Legacy products generally will not be upgraded to meet the standard. The majority of vendors assert that the POCT1‐A standard is easy to implement; it eliminates the task of designing unique solutions. Vendors are enthusiastic in support of the standard, but note that customer requirements govern the development and availability of product features and functions. In their view, customer awareness and understanding of POCT1‐A is limited primarily to hospitals with integrated POC systems, and thus customer demand to date for products that incorporate the standard is minimal.

ISSN:1533-029X    

出版商:OVID    

年代:2003

数据来源: OVID

摘要:

&NA;The use of POCT glucose meters has become routine in our health system. This study was organized to find the existing evidence supporting the optimal use of glucose meters in patient care. Medline OVID database was searched, and the 171 citations found were systematically reviewed and graded (A, B, C, or E) based on the ADA evidence grading system. Several conclusions were synthesized: 1) optimal meter performance requires a defined quality assurance program (C evidence); 2) quality assurance programs for glucose meters should emphasize operator training (C evidence); 3) the laboratory should be involved in the quality assurance of glucose meters whenever possible (C evidence); 4) there is a lack of consensus for meter performance criteria (accuracy and precision expectations) (E evidence); 5) the selection of meters should match the clinical application to user feature and analytical performance (C evidence); 6) meter performance is limited by a variety of environmental, physiologic, and operator factors that the clinician should understand to adequately interpret results (C evidence); 7) the analytical performance of the current generation of meters is inadequate for clinical use in diagnosis of diabetes or in the general screening of asymptomatic patients (E evidence); and 8) there is significant support for the role of glucose meters in management (hospital, outpatient, home self‐management) of patients already diagnosed with diabetes (C evidence). While this study was limited in scope, there is support for general use of glucose meters on diabetics and a need for quality assurance and improved international performance criteria. The power and limitations of the evidence‐based process are also discussed.

ISSN:1533-029X    

出版商:OVID    

年代:2003

数据来源: OVID

摘要:

&NA;From the results of the Diabetes Control and Complications Trial (DCCT) and the United Kingdom Prospective Diabetes Study, there is no doubt that improved glycemic control in subjects with diabetes mellitus results in the development of fewer microvascular and neuropathic complications. How improved glycemic control and lower hemoglobin A1c levels are best achieved is a matter of debate. This review focuses on two questions: 1) What evidence‐based medicine data exist that support the use of selfmonitoring of blood glucose (SMBG) in the care of either type 1 or type 2 diabetes patients; and 2) Does the number of SMBG tests per unit time beneficially influence glycosylated hemoglobin or other measures of diabetic control? A review of the available data demonstrates that there is substantial evidence to support the use of SMBG in type 1 diabetes. Although controversial, most studies do not show a benefit when subjects with type 2 diabetes perform SMBG. Properly designed and powered prospective studies are encouraged to further explore the usefulness of SMBG.

ISSN:1533-029X    

出版商:OVID    

年代:2003

数据来源: OVID

ISSN:1533-029X    

出版商:OVID    

年代:2003

数据来源: OVID