PubMed · 7311934
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A Scholer, E Müller, S Burri, V Pabst. [Changes in the Technicon MT-II-analyzer].. https://pubmed.ncbi.nlm.nih.gov/7311934/
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OBJECTIVE: To evaluate the Ames Glucometer Elite glucose meter for use in point-of-care glucose testing in the neonatal intensive care unit. METHODS: An important part of our quality control program involves a weekly comparison of glucose values obtained with each of the seven Elite analyzers and the Beckman CX7 analyzer located in the central laboratory. Each "split" sample involves measurement of the glucose by using the Elite analyzer in a sample of blood obtained from a heel stick at the bedside, followed by bleeding ("milking") 150 to 200 microl (4 to 5 drops) of blood into a heparinized microcontainer. This process should take no longer than 1 to 2 minutes, whereupon the microcontainer is placed on ice and sent to the laboratory. The values obtained were compared by regression analysis. Imprecision of the Elite meter was estimated at four levels of blood glucose concentration and on a normal-level quality control sample used for a period of 4 months. RESULTS: Regression analysis between the glucose values obtained on the Elite meter and the CX7 meter revealed r = 0.93, p less than 0.0001, n = 188, Sy/x = 0.59 mmol/L, intercept = 0.47 +/- 0.14 mmol/L (1 SEM), and slope = 0.91 +/- 0.028 (1 SEM). When we switched to on-ice delivery of split samples to reduce metabolic activity during transport of the specimens to the laboratory, scatter about the regression line was decreased and the Sy/x was reduced to 0.45 mmol/L. Before the on-ice delivery of split samples, 24% of the Elite analyzer's results differed from those of the CX7 analyzer by more than 15%, whereas only 8% differed from those of the CX7 meter by more than 15% after on-ice delivery of split samples. Of 30 samples read as "Lo" by the Elite meter, 29 were less than 2.2 mmol/L on the CX7 meter, whereas only 1 was 2.2 mmol/L. The coefficients of variation taken as a measure of imprecision were less than 5% for the normal-level aqueous control and less than 5% for four heel-stick blood glucose levels. CONCLUSIONS: The Ames Glucometer Elite analyzer can be used with confidence in measuring heel-stick blood glucose concentrations at the bedside in the neonatal intensive care unit. Hypoglycemic blood samples are reliably detected. As with adults, meticulous technique should be followed to prevent filling defects, and all split samples should be analyzed promptly on the CX7 analyzer, with delivery to the laboratory on ice. Unlike previous generations of glucometers, the Elite meter has been well accepted by the neonatal nursing staff.
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At present no method for glycohemoglobin (%HbA1c) is automated on a main-line analyzer to allow joint measurement with other indicators of diabetic control such as glucose and cholesterol. We describe an adaptation of a latex-enhanced competitive immunoassay for quantifying %HbA1c to the Dade International Dimension analyzer. After a manual hemolysis step, HbA1c and total hemoglobin (Hb) are determined separately. The concentration of glycated beta-subunit is obtained from the immunoassay, whereas Hb is assessed colorimetrically from a derivatized form. Both reactions were fully optimized for accuracy, precision, and specificity on the Dimension; stabilities of reagents and calibration were established; and potential interferences were assessed. The analyzer gave reliable results over the required clinical range of 1-15% HbA1c. Within-run and total assay variation were within 5% of the target CV limits, as determined by ANOVA with three representative sample pools across 20 days. Close agreement with an established HPLC procedure and a commercially available enzyme immunoassay was observed for 140 samples from clinically defined patient groups. Additional samples from patients with hemoglobinopathies (n = 20) demonstrated a more complex relationship between methods. We conclude that adaptation of the method for use with the Dimension analyzer is a valid method for quantifying %HbA1c.