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PubMed1992

Automation and other recent developments in clinical chemistry.

The decade 1980 to 1990 was the most progressive period in the short, but turbulent, history of clinical chemistry. New techniques and the instrumentation needed to perform assays have opened a chemical Pandora's box. Multichannel analyzers, the base spectrophotometric key to automated laboratories, have become almost perfect. The extended use of the antigen-monoclonal antibody reaction with increasing sensitive labels has extended analyte detection routinely into the picomole/liter range. Devices that aid the automation of serum processing and distribution of specimens are emerging. Laboratory computerization has significantly matured, permitting better integration of laboratory instruments, improving communication between laboratory personnel and the patient's physician, and facilitating the use of expert systems and robotics in the chemistry laboratory.

Automation↗
PubMed1995

HEPAXPERT-III: knowledge-based interpretation of serologic tests for hepatitis A, B, C, and D.

1. The HEPAXPERT-III SYSTEM. HEPAXPERT-III--the successor of HEPAXPERT-I[1] and HEPAXPERT-II [2]--is a routinely-used, integrated medical database and knowledge-based system that stores and interprets the results of serologic tests for infection with hepatitis A, B, C, and D viruses. The following tests are included: Anti-HAV, IGM anti-HAV, and HAV in stool; HBsAg, anti-HBs, anti-HBc, IGM anti-HBc, HBeAg, anti-HBe, and anti-HBs titre; Anti-HCV, HCV-immunoblot, and HCV-PCR; Delta-Ag and anti-delta. HEPAXPERT-III provides the following functions: a) screen input of patient's personal data (patient ID, surname, first name, name at birth, date of birth, and sex), administrative data (department requiring the tests and date of specimen sample), and medical data (results of serologic tests); and/or b) automatic transfer of patient's personal, administrative, and medical data by connecting HEPAXPERT-III to a laboratory information system, a hospital information system, or an automated laboratory analyzer; and c) automatic generation of interpretive reports of the obtained serologic findings, including an analysis of possible virus exposition, immunity, disease stage, prognosis, and degree of infectiousness. HEPAXPERT-I and HEPAXPERT-II have been routinely used at the Vienna General Hospital, the teaching hospital of the University of Vienna Medical School. The interpretive reports are well-accepted and lead to several improvements in patient care [3]. HEPAXPERT-III will not only extend the scope of interpretation to hepatitis C and D serologic tests, but will also offer a state-of-the-art graphical user interface. 2. HARDWARE AND SOFTWARE. IBM-compatible personal computer (minimum 80386 SX processor), 8 MB RAM (OS/2) and 4 RM RAM (MS-Windows), resp., graphic adapter (minimum 640x480) and printer supported by OS/2 and MS-Windows 3.1, resp., IBM OS/2-2.1 or higher and MS-Windows 3.1 or higher, resp., and for the OS/2 version IBM Database 2 (DB2/2).

Diagnosis, Computer-Assisted↗
PubMed1992

[Antistreptolysin O].

Automated analyzers based on the quantitative immunochemical methods have been developed and can allow quantitative measurements of antistreptolysin O concentrations in the clinical laboratories. Automated ASO determinations improve in point of operation, time, effort, precision and accuracy, compared with the usual semiquantitative methods of tube dilution techniques based on the method of Rantz and Randall or some modification thereof, microtitration of the Edward method and agglutination test using latex or other particles. However, confusion and many kinds of problems have been brought about by the rapid development of automated ASO measurements in routine use. The principle quantitative immunochemical measurements of automated ASO determinations are immune agglutination assays, which are nephelometric immunoassay (NIA), latex agglutination photometric immunoassay (LAPIA) and turbidimetric immunoassay (TIA). Principles and methods of these automated immunoassay, reagents, ASO standard serum, automated analyzers, precision and accuracy, the present conditions and problems of automated analysis in the clinical laboratories were discussed in comparison with usual semiquantitative measurements. There was a good correlation between automated immune agglutination assay (NIA, LAPIA and TIA) and the usual semiquantitative assay. However, the quantitative accuracy of automated immune agglutination assay was decreased in the regions of low and high ASO values. Availability, precision and accuracy of ASO measurement were improved by the automated analysis. However, the methods of ASO measurements were increased and varied by the automated assay. Therefore, it is necessary to standardize the automated ASO measurements. The limitation and the clinical significance of the automated immune agglutination assay of ASO have to be studied for practical use in the future.

Adult↗
PubMed1994

A network-based laboratory data processing system for use with the Coulter STKS haematology analyser.

A highly automated laboratory data processing environment for use with Coulter STKS haematology analysers is described. This in-house system is based on a network of personal computers running Novell Network software and communicating with an IBM mainframe. The system captures the leucocyte scatterplot graphic and numeric parameters from the blood analysers, integrating this with patient demographic and request data held on the host computer. This composite picture is then reviewed on the network by laboratory personnel before generating printed reports. The system has provided greater data integrity, reduced paper flow and improved efficiency in the laboratory's operations and lays the foundations for dealing effectively with the next generation of advanced haematology analysers.

Blood Cell Count↗
PubMed2002

[Transition of Japanese societies related to clinical chemistry in the mid-Showa period (1955-1980) (part 3) - related to the medical field].

Remarkable progress in the Japanese clinical chemical field was observed in the mid-Showa period (1955-1980). Many biochemists, pharmacists, medical doctors, and medical technologists started their studies and reported their accomplishments in the clinical chemical societies during this period. I recently reported on the transition of pharmaceutical science societies in the clinical chemical field in JJHP, Vol. 35, No. 2, in 2000, and Vol. 36, No. 1, in 2001. In these reports, the transition of medical societies in the clinical chemical field and social insurance medical fee payments were discussed. The Japan Society of Clinical Pathology (JCCP) was started in 1951 and the Japanese Association of Medical Technologists (JAMT) in 1952. The former mainly consists of biochemists and medical doctors and the latter of medical technologists in Japanese hospitals. Because many clinical examinations in hospitals were undertaken with the support of instruments (for example, the Auto Analyzer AA-1), the Japan Society for Clinical Laboratory Automation (JSCLA) started in 1969. The Japan Committee for Clinical Laboratory Standards started in 1984. The Japan Medical Association helped to promote clinical chemical examinations in the medical field, especially since 1957, by increasing the social insurance medical fee payment.

Chemistry, Clinical↗
PubMed2006

Laboratory productivity and the rate of manual peripheral blood smear review: a College of American Pathologists Q-Probes study of 95,141 complete blood count determinations performed in 263 institutions.

CONTEXT: Automated laboratory hematology analyzers are capable of performing differential counts on peripheral blood smears with greater precision and more accurate detection of distributional and morphologic abnormalities than those performed by manual examinations of blood smears. Manual determinations of blood morphology and leukocyte differential counts are time-consuming, expensive, and may not always be necessary. The frequency with which hematology laboratory workers perform manual screens despite the availability of labor-saving features of automated analyzers is unknown. OBJECTIVE: To determine the normative rates with which manual peripheral blood smears were performed in clinical laboratories, to examine laboratory practices associated with higher or lower manual review rates, and to measure the effects of manual smear review on the efficiency of generating complete blood count (CBC) determinations. DESIGN: From each of 3 traditional shifts per day, participants were asked to select serially, 10 automated CBC specimens, and to indicate whether manual scans and/or reviews with complete differential counts were performed on blood smears prepared from those specimens. Sampling continued until a total of 60 peripheral smears were reviewed manually. For each specimen on which a manual review was performed, participants indicated the patient's age, hemoglobin value, white blood cell count, platelet count, and the primary reason why the manual review was performed. Participants also submitted data concerning their institutions' demographic profiles and their laboratories' staffing, work volume, and practices regarding CBC determinations. The rates of manual reviews and estimations of efficiency in performing CBC determinations were obtained from the data. SETTING: A total of 263 hospitals and independent laboratories, predominantly located in the United States, participating in the College of American Pathologists Q-Probes Program. RESULTS: There were 95,141 CBC determinations examined in this study; participants reviewed 15,423 (16.2%) peripheral blood smears manually. In the median institution (50th percentile), manual reviews of peripheral smears were performed on 26.7% of specimens. Manual differential count review rates were inversely associated with the magnitude of platelet counts that were required by laboratory policy to trigger smear reviews and with the efficiency of generating CBC reports. Lower manual differential count review rates were associated with laboratory policies that allowed manual reviews solely on the basis of abnormal automated red cell parameters and that precluded performing repeat manual reviews within designated time intervals. The manual scan rate elevated with increased number of hospital beds. In more than one third (35.7%) of the peripheral smears reviewed manually, participants claimed to have learned additional information beyond what was available on automated hematology analyzer printouts alone. CONCLUSION: By adopting certain laboratory practices, it may be possible to reduce the rates of manual reviews of peripheral blood smears and increase the efficiency of generating CBC results.

Blood Cell Count↗
PubMed1999

Immobilized sample amplification for quantitative determination of retroviruses.

Immobilized sample amplification (ISA) is a novel method for amplification, detection, monitoring, and quantitative determination of nucleic acids from a minute amount of sample. We present here a novel quantitative ISA assay for retroviruses using a replication-defective recombinant retrovirus as a model retrovirus. Samples, as small as 5 to 10 microl or as large as 1 ml or more in volume, are readily immobilized on a nylon or polyester matrix. Retroviral RNA is directly amplified following the rehydration of the immobilized samples, thus eliminating the needs for retroviral RNA extraction. An ISA assay of a 10-microl viral sample generates results equal to or better than that of RT-PCR on equivalent amount RNA isolated from larger sample volumes. Recovery of RNA from small volumes, such as 10 microl, is almost impossible, whereas ISA assay detects retroviruses from as small as 1 to 5 microl of viral samples containing 10(4) cfu/ml determined by colony-forming assay. Extraction of RNA from a small amount of infectious viral samples not only is a difficult, biohazardous procedure, but also introduces random errors which contribute to variability in viral quantitation. Since the ISA method eliminates the isolation/extraction of the nucleic acids, it significantly shortens the handling time for the biohazardous materials and simplifies the procedure for analyzing small quantities of biological samples. This method detects less than 10 infectious retroviral particles as determined by both colony-forming assay and electron microscope studies. The format and protocol of this quantitative ISA assay can be easily automated to fit into numerous platforms, thus making it attractive for laboratory automation.

3T3 Cells↗
PubMed2001

Measurement of cholesterol in plasma and other body fluids.

Measurement of cholesterol has become increasingly important with recognition of its predictive association with cardiovascular diseases. Government and professional groups in the United States and other countries have developed consensus guidelines for using cholesterol and the lipoproteins in identifying patients at risk and in managing therapies. Accuracy in the measurements is essential not only for reliable classification of patients, but also in public health/wellness programs and in research. Laboratory experts have developed requisite analytical performance targets and guidelines for measurements. Manufacturers of diagnostic reagents and laboratories can assure accuracy by accessing the Cholesterol Reference Method Laboratory Network, which offers reference methods for total, high-density lipoprotein, and low-density lipoprotein cholesterol. Recommendations for controlling pre-analytical sources of variation and uniform interpretation of patient results facilitate reliable classification of patients. Driven by increasing workloads and the need for increased efficiency in laboratory testing, dramatic improvements have been made in recent years in automating laboratory analyzers, as well as the methods used for lipoprotein analysis. Newer technology allows multiple sequential measurements in the same cuvette, as well as point-of-care measurements, using strip tests and compact analyzers. Efforts continue to develop reliable, minimally invasive tests in body fluids other than serum.

Analysis of Variance↗
PubMed1996

Automated slide preparation system for the clinical laboratory.

An automated device has been developed to prepare a wide variety of cytology preparations. Using the device, cells collected in suspension are mildly dispersed and transferred to a glass slide using filter-transfer technology. The cell density on the slide is controlled by the instrument. A companion product, the solution used in specimen transport and preparation, provides long-term preservation of diagnostic cells while lysing red blood cells. The overall process yields clean, uniform samples with better visualization of the diagnostic cells. The use of a disposable filter prevents sample-to-sample contamination. Collection of the sample in solution makes it possible to produce multiple slides from one sample.

Cell Biology↗
PubMedDate not supplied

Statistical techniques for evaluating the diagnostic utility of laboratory tests.

Clinical laboratory data is used to help classify patients into diagnostic disease categories so that appropriate therapy may be implemented and prognosis estimated. Unfortunately, the process of correctly classifying patients with respect to disease status is often difficult. Patients may have several concurrent disease processes and the clinical signs and symptoms of many diseases lack specificity. In addition, results of laboratory tests and other diagnostic procedures from healthy and diseased individuals often overlap. Finally, advances in computer technology and laboratory automation have resulted in an extraordinary increase in the amount of information produced by the clinical laboratory; information which must be correctly evaluated and acted upon so that appropriate treatment and additional testing, if necessary, can be implemented. Clinical informatics refers to a broad array of statistical methods used for the evaluation and management of diagnostic information necessary for appropriate patient care. Within the realm of clinical chemistry, clinical informatics may be used to indicate the acquisition, evaluation, representation and interpretation of clinical chemistry data. This review discusses some of the techniques that should be used for the evaluation of the diagnostic utility of clinical laboratory data. The major topics to be covered include probabilistic approaches to data evaluation, and information theory. The latter topic will be discussed in some detail because it introduces important concepts useful in providing for cost-effective, quality patient care. In addition, an example illustrating how the informational value of diagnostic tests can be determined is shown.

Clinical Chemistry Tests↗