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Biomedical subjects

B E Statland

Publications and source records attributed to B E Statland.

At least 73 records · Page 4Linked to original sources

Assessing cost savings when unnecessary utilization of laboratory tests can be abolished.

The authors report on the theoretic cost savings that would be realized if presumed overutilization of selected laboratory tests could be eliminated. They limit the scope of this study to inpatients at the University Hospital and on a preselected subset of assays ordered in their institution. A baseline audit including the requests for 19 commonly ordered clinical chemistry tests made for all inpatients during three weekdays was performed at our 400-bed hospital. Eight of the 19 tests (the LYTES-Plus), were done on the ASTRA-8 selective multitest analyzer (Beckman Instruments Inc., Brea, CA 92621), while remaining 11 tests (MTA-11) were performed on the RA-1000 selective multitest system (Technicon Instruments Corp., Tarrytown, NY 10591). The average tests ordered per patient-day were 4.38 of the 19, and the average venipunctures were 0.67. The corresponding numbers for the intensive care patients were 16.6 tests and 2.45 venipunctures per patient-day. Although the intensive care units contributed approximately 8% of the patient days in the hospital, they represented more than 25% of the tests ordered. The authors noted that 5.89 of the eight possible LYTES-Plus assays were ordered per ASTRA-8 sample. The equivalent figure for MTA-11 was 4.55 of 11 possible tests. Using list prices of reagents and disposables, the savings in direct material costs resulting from implementing a number of rather conservative recommendations for decreasing overutilization was estimated to be $45,000 per annum or 31% of the total direct material costs.

Blood Chemical Analysis↗

Chemical and clinical evaluation of the random access analyzer "RA-1000".

In the RA-1000, a random-access discrete analyzer, an inert fluorocarbon fluid is used to prevent interaction and carryover. Production-model instruments were evaluated in two laboratories with respect to determination of glucose, creatinine, total protein, inorganic phosphorus, cholesterol, alkaline phosphatase, lactate dehydrogenase, creatine kinase, gamma-glutamyltransferase, and aspartate and alanine aminotransferases. Within-run, among-run, and day-to-day (for 15 days) precision was assessed, and results were correlated with those obtained by the methods routinely in use in our departments. Precision was excellent, correlation acceptable.

Autoanalysis↗

Reference values: are they useful?

To answer the question of whether reference values are useful in clinical decision-making, this article addresses the following major controversies: (1) Are reference subjects representative of the group from which they are selected? (2) To what extent should the process of collecting reference values be standardized and controlled? (3) Can a single distribution of reference values be used in an meaningful way in the process of clinical decision-making.

Clinical Laboratory Techniques↗

Alterations in human serum alkaline phosphatase and its isoenzymes by hypolipidemic agents: colestipol and clofibrate.

Total serum alkaline phosphatase (TSAP) determinations were done as part of the biochemical screening in comparative studies of lipid lowering agents in type lla hyperlipoproteinemic patients. TSAP determinations were made by using a modification of the Bessey-Lowry method and the Statland method. Increases in TSAP following colestipol treatment of 20% (P less than 0.05) and 32% (P less than 0.005) were seen by using the respective methods. Isoenzymatic determinations were done by employing the Statland method and all fractions were increased from baseline levels during colestipol therapy. Clofibrate was associated with 34% (P less than 0.005) and 28% (P less than 0.005) reductions in TSAP activity by using the respective methods; significant reductions in both "bone" and "other" isoenzymatic components occurred. Gamma-glutamyltransferase (gamma GT) results did not consistently reflect TSAP or "liver" isoenzyme results.

Adult↗

Antithrombin III and plasminogen: a comparison of two synthetic substrate-based methods.

We have evaluated and compared the DuPont aca and the KABI/CentrifiChem synthetic substrate-based methods for the quantitation of plasma plasminogen (PLG) and antithrombin III (AT III). Method precision was evaluated using normal human pooled plasma (NHP) as sample. Within-day and day-to-day PLG assays generated a CV of 2.0% and 2.9%, respectively, for the aca method. For the KABI/CentrifiChem PLG method, within-run (within-rotor) analysis produced a CV of 1.7%, and day-to-day analysis produced a CV of 5.3%. The relationship between the aca (y axis) and the KABI/CentrifiChem (x axis) methods for PLG was found to be y = 0.99X - 1.4%, r = 0.979. Within-day precision for AT III by the aca method generated a CV of 4.6%, and day-to-day analysis produced a CV of 7.0%. The KABI/CentrifiChem AT III method generated a CV of 4.2% and 4.4% for within-run and day-to-day assays, respectively. The AT III correlation demonstrated a relationship of y = 0.84X + 15.2%, r = 0.952. The AT III and PLG reference ranges as established in our laboratory for healthy adults, pregnant women, and for cord blood specimens also are presented.

Adult↗

The value of routine biochemical and surgical pathology quantities in predicting recurrence in high-risk patients following surgery for primary breast cancer.

The initial biochemical data (serum[S]-carcinoembryonic antigen, S-lactate dehydrogenase, S-gammaglutamyl transferase, S-alkaline phosphatase urine[U]-creatinine, and three urinary quantities related to collagen metabolism) and surgical pathology data (tumor size, grade of tumor anaplasia, number of positive lymph nodes, number of negative lymph nodes) were examined in 52 consecutive postmenopausal risk group II patients operated for primary breast cancer without metastatic disease (mastectomy + partial axillary resection) who participated in the Danish Breast Cancer Group's controlled clinical trial of radiation (RT) alone, and RT + levamisol. The follow-up (mean = 3.45 years, range = 3-4 years) included physical examination every three months, x-ray of chest, bone scan, and x-ray of axial skeleton every six months. Recurrence was defined as metastatic disease detected during the first three years of postoperative follow-up study. Twenty patients had recurrences. A stepwise discriminant analysis of the surgical pathology quantities showed that all quantities except tumor size contributed significantly (P less than 0.01) to the discrimination between controls (no recurrence after 3-4 years) and patients who had recurrences within three years. When each of the biochemical quantities was combined with the surgical pathology data it was found that only urinary total hydroxy-proline to creatinine ratio improved the discrimination significantly (P less than 0.05) and that the effect was marginal.

Aged↗

Assaying plasma prekallikrein (PPK) by a chromogenic based method: analytical considerations and reference values in healthy adults, the pregnant woman, and the neonate.

Analytical assays that measure the amidolytic activity of plasma kallikrein (PK) must overcome the problem of anti-kallikrein inhibition during the activation of PPK to PK. We resolved this problem by exposure of plasma to 50 mg/L dextran sulfate in acetone/water (35/65, vol/vol) at 0 degrees C for 15 minutes. PK activity was assayed using the chromogenic substrate, S-2302 (KABI). A centrifugal analyzer (CentrifiChem) was used to monitor the change in absorbance at 405 nm and 37 degrees C. The assay was linear to a value 3 times that found in normal human plasma. The specificity of the substrate for PK was demonstrated by using plasma deficient in PPK (Fletcher trait) diluted with normal human pooled plasma (NHPP). Day-to-day analytical variation was 2.4% for NHPP having a mean value of 85.9 mukat/L (n = 26). Using our amidolytic method, we determined PPK values in 50 healthy adults, 80 pregnant women during each trimester of gestation, and 151 neonates (cord blood specimens). The middle 95% reference interval for the adults was 54.0 - 118.8 mukat/L, for pregnant women at first trimester: 59.0 - 129.0, second trimester: 72.3 - 161.5, third trimester: 75.6 - 152.4, day of labor: 67.7 - 144.9, and 1-9 weeks postpartum: 69.4 - 151.0 mukat/L, and for the neonate: 11.5 - 44.9 mukat/L. We observed that women on oral contraceptives had significantly greater PPK values than those not on oral contraceptives. Intra-individual variation of PPK values was relatively low in non-pregnant women with the day-to-day coefficient of variation being 4.1 - 6.1% in 5 subjects monitored over a 30 day period. The high value of inter-individual/intra-individual ratio was appreciated in pregnant women in that the PPK value observed during the first trimester was a means to predict the value approaching term. The mean PPK value during the first trimester was 105.1% of the mean seen in non-pregnant women while the mean PPK value nearing term was 130.1% of that value.

Adult↗

Identifying the small-for-gestational-age fetus on the basis of enhanced surfactant production.

The clinical utility of concurrent measurements of the fetal biparietal diameter, as measured by ultrasonography and fetal pulmonary maturity, as assessed by the amniotic fluid consisted of 57 cases in which pregnancy produced a low birth weight neonate (less than 2500 g). The combination of a small fetal biparietal diameter (less than 8.5 cm) and a mature foam stability index value (0.47 or greater) was associated with small-for-gestational-age neonates in 16 of 19 cases. In addition, the occurrence of an immature foam stability index value (less than 0.47) and a fetal biparietal diameter of less than 8.5 cm was associated with appropriate-for-gestational-age newborns in 16 of 16 cases. The discriminating ability of the foam stability index test in identifying the small-for-gestational-age infant was lost when the fetal biparietal diameter was 8.5 cm or more. Of clinical note was the fact that 14 cases in which the neonatal respiratory distress syndrome occurred were all associated with appropriate-for-gestational-age infants and foam stability index values of less than 0.47 (ie, immature). The results of this study suggest a potentially important clinical role for the concurrent measurement of fetal biparietal diameter and performance of the amniotic fluid foam stability index test in the prenatal evaluation of the high-risk, small, third-trimester fetus.

Amniotic Fluid↗

Assessment of fetal pulmonary maturity by the Lumadex Foam Stability Index Test.

The authors describe the operational features and performance characteristics of a new commercial kit designed to measure the amount and functionality of amniotic fluid surfactant. This kit, the Lumadex-FSI Test, is based upon the manual foam stability index test. The test requires no more than 3.0 ml of centrifuged amniotic fluid. Initial experience based on 172 specimens, including 19 cases of neonatal respiratory distress syndrome (RDS), revealed the Lumadex-FSI Test to have excellent discriminating ability in predicting the likelihood of RDS. In 18 of 19 cases in which RDS was noted, the foam stability index was 46 or less. A foam stability index of 47 or above was associated in 133 of 134 cases with fetal pulmonary maturity. Based upon contamination studies with maternal serum and meconium, the authors observed that a 1% contamination with blood, or 4% contamination with meconium, would artifactually increase the Lumadex-FSI value. The Lumadex-FSI Test demonstrated a clinical reliability similar to that of the manual foam stability index procedure, in addition to making the test simpler, faster, and more accessible to the clinician, in whose hands this test will have unique input into the management of high-risk pregnancies.

Amniotic Fluid↗

Usefulness of clinical chemistry measurements in classifying patients with breast cancer.

Laboratory measurements can be used to detect, classify, and monitor patients with breast cancer. This review covers in detail the clinical usefulness of carcino embryonic antigen, tissue polypeptide antigen, various glycoproteins, pregnancy-associated proteins, casein, lactalbumin, beta-2-microglobulin, ferritin, immunoglobins, acute phase proteins, placental-like alkaline phosphatase, liver-associated enzymes, glycosyltransferases, human chorionic gonadotropin, calcitonin, polyamines, and collagen breakdown products, in relationship to their diagnostic utility in patients suspected of having or known to have breast cancer. In addition, these authors assess the merits of various multivariate techniques using a number of clinical chemistry quantities in the same regard. Finally, the relative contribution of biochemical tests vs. the information values gained from "surgical pathology" data (number of positive nodes, number of negative nodes, and degree of anaplasia) is discussed.

Alkaline Phosphatase↗