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Biomedical subjects

J A Koepke

Publications and source records attributed to J A Koepke.

At least 19 recordsLinked to original sources

Molecular marker test standardization.

A review of the status of standardization of laboratory tests of particular interest to oncologists is presented. Currently, relatively few of these tests are standardized; as a result, interlaboratory and interinstitutional comparison of data is problematic. In 1992, additional interlaboratory studies of common tumor markers will be initiated by the College of American Pathologists. The National Committee for Clinical Laboratory Standards also has begun to develop standard methods and guidelines for these important tests.

Biomarkers, Tumor

The Automicrobic System for urines.

An evaluation of the Automicrobic System (AMS) for Urines (Vitek Systems, Inc.) was carried out under the auspices of the Product Evaluation Committee of the College of American Pathologists from the period June 1977 through October 1978. Data generated during this evaluation indicated that, when comparing the AMS methodology to our clinical microbiology laboratory methodology, a 37% time saving could be realized by utilizing the AMS. Quantitation with the AMS showed a 99% correlation with the clinical microbiology laboratory method except for yeast which correlated only 50% of the time. The average overall identification accuracy was 95%. Negative response accuracy was 99%. Other members of the Enterobacteriaceae which the instrument is not designed to identify may produce erroneous results if they occur in urine specimens. Specimens containing two organisms were identified with a 94% correlation when compared to our conventional methodology. The time when a well becomes positive may be used as a fairly reliable indicator of significance (count greater than 70,000 colony-forming units per ml) for Escherichia coli, Klebsiella-Enterobacter group, and group D Enterococcus, but not for Proteus sp., Pseudomonas aeruginosa, and yeast. Specimen collection must be performed properly since specimens considered as contaminated by conventional plating-out techniques may be reported out by the AMS as only one or two organisms and thus lead to an erroneous assumption as to significance. Cost per specimen was $1.83 more by utilizing the AMS method as compared to our conventional method. This is offset by a saving of 1.74 h daily of personnel time and a final report in 13 h. At least 30 urine specimens would be needed daily to pay for the instrument and specimen costs in 1 year. The AMS can provide significant aid to a clinical microbiology laboratory when all factors are considered.

Autoanalysis

The Comprehensive Blood Bank Survey Program of the College of American Pathologists, 1976.

The Comprehensive Blood Bank Survey Program for 1976 still shows that the participants are performing well on ABO and Rh typing (accuracy greater than 96.6%), antibody detection (greater than 97.0%), and crossmatching (greater than 97.3%). The only problem with less accuracy than that stated involved a specimen with an extremely weak antibody. Some errors are still due to failure to fill out results. In the 1976 survey, four ungraded problems were included as attempts to study the "state of the art." The problems consisted of an antibody whose titer was to be determined, a mixture of Rh+ and Rh-- cells to be detected, and two multiple-antibody problems. The results obtained in these studies are discussed. Finally, the participants were asked questions about the amount of Rh immune globulin used and the indications for its use, the incidence and types of transfusion reactions seen, and the notations used by laboratories to record results. The answers to these questions are also documented.

ABO Blood-Group System

The effect of heparin on the activated partial thromboplastin time.

Data from the 1976 and 1977 CAP surveys were analyzed for response of the activated partial thromboplastin time (APTT) to heparin. Different sources and concentrations of heparin were used. The results indicate that the precision of the APTT is more dependent on instrumentation than on partial thromboplastin. This was true for all four of the heparinized specimens evaluated. A single exception was found with the "old" Dade reagent activated cephaloplastin. The mean difference in the activated partial thromboplastin times obtained with differing concentrations of heparin was entirely dependent on the partial thromboplastin reagent used. No significant difference in the results was found when equal concentrations of bovine lung and porcine intestinal mucosal heparin were compared.

Animals

An innovative method for the determination of normal values in hematology using peer group laboratories.

The author describes a proposed innovative method for the determination of normal values in hematology in which a large number of laboratories participating in the CAP proficiency testing program submit results of a previously performed, complete blood count. These data are compared with those derived from more formal studies of normal values. The advantages of this system, if validated, include its inexpensive simplicity and the possibility of determining normal values for relatively uncommon groups of patients such as neonates, infants, and small children.

Adult

The CAP blood bank comprehensive survey program--1975.

The 1975 CAP Comprehensive Blood Bank Survey Program showed that the ABO and Rh typings were again at an excellent level of performance. What few errors still occurred were at least partially explained by a study that showed that many of these errors were directly traceable to clerical mistakes; many, in fact, were due to a complete failure to submit an answer. Antibody detection was very good when the antibody was strong, but lower levels of performance were attained when the antibody was weak. Low performance was also achieved with a cold-reacting anti-I, but here the difficulty was found to be more a lack of agreement on terminology of the antibody rather than a failure to demonstrate it. A study was performed to see whether the participants that were late in sending in the answer sheets had a higher error level than those that were not, but no difference was found. Finally, the preliminary results regarding the accuracies of various methods of antibody screening are presented. Although there was a statistically significant difference in the results obtained with the different methods, the study does not involve enough antibodies at this time to be valid, and therefore it will be continued.

ABO Blood-Group System

A delineation of performance criteria for the differentiation of leukocytes.

Performance criteria for manual differential leukocyte counting are tentatively set following analysis of the CAP interlaboratory survey programs in hematology. It is evident that intermediate levels of discrimination of five normal leukocyte types (neutrophils, eosinophils, basophils, lymphocytes, and monocytes) can be achieved by almost all laboratories. The most sophisticated level (differentiating band from segmented neutrophils and reactive from normal lymphocytes) is still somewhat controversial. Sampling and other variables when doing 100-cell differential counts at the intermediate level of discrimination are quite predictable, and CAP Survey results closely parallel the predicted results when uniform wedge of centrifuged smears stained in an acceptable manner are used. Automated differential counters should be expected to perform at a level of discrimination at least as good as that of human examiners.

Clinical Laboratory Techniques

The calibration of automated instruments for accuracy in hemoglobinometry.

The surveys of the College of American Pathologists indicate a consistent bias between the manual "reference" method for hemoglobin determinations and the Coulter S measurements. The Coulter S hemoglobin values are invariably lower; the difference averages 0.3 g/dl. The commonly used calibration methods for the Coulter appear to be subobtimal. The hemoglobin calibration and quality assurance method proposed by Bull and colleagues is advocated as the presently most acceptable method. Commercial hemoglobin control materials should not be used for hemoglobin calibration.

Automation

Calibration methods for automated hematology instruments.

Recent CAP survey data have documented marked improvement in the reproducibility of hematologic tests. The favorable outcome is attributable largely to the widespread use of automated whole-blood analyzers. Calibration variability, however, detracts from this enhanced precision, and there are clear indications that improvement is necessary. Primary calibration methods for hemoglobin, hematocrit and cell counting procedures are presented. The methods of applying these primary calibration methods to automated whole-blood analyzers are delineated. The use of both preserved reference blood and statistical control technics for the identification of calibration loss is described.

Automation

The prediction of prothrombin time system performance using secondary standards.

A method for the comparison of prothrombin time systems using single large lots of lyophilized plasma in the College of American Pathologists Surveys is presented. Systematic biases for prothrombin time methods as well as for thromboplastins have been measured, and their use allows a very accurate (within 2.25%) prediction of the prothrombin time for the great number of prothrombin time systems presently being used in the United States.

Blood

A critical analysis of platelet counting methods.

A careful analysis of platelet counting methods, including an assessment of accuracy, was done using data from the College of American Pathologists Comprehensive Hematology Survey preserved platelet suspension specimen (H-32-1976). Comparisons between methods suggest systematic biases probably related to the calibration methods used for automated instruments. Falsely elevated counts occurred with manual methods and one light-dispersion system. Methods for calibration and continuing quality assurance of platelet counting are proposed.

Automation