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Policy statement on materials for testing glucose in the urine. The Committee on Materials and Therapeutic Agents, American Diabetes Association.

Semiquantitative methods for measurement of glucose in the urine are useful for monitoring glucose homeostasis in subjects with diabetes mellitus where quantitative blood and urine glucose measurements are not available. The use of a "plus" scale for glucose measurement is confusing because the same plus values are assigned to different quantities of glucose with different methods. The two-drop Clinitest method is the most quantifiable and readable test for urine sugar, particularly if there is high sugar spill. Therefore, it is the most useful method for monitoring insulin-dependent juvenile diabetes. Its major disadvantages are its potential toxicity, the cumbersome methodology, the cost, and the possibility of interference from other reducing substances. The enzyme "dipstick" methods are most sensitive for detecting the presence of glucose. Among the available "dipstick" methods, Diastix is the most quantifiable and readable. These methods are inhibited by the presence of ketones and a number of other substances. Tes-Tape is the least expensive and, where there are inhibiting substances, the most useful, because it can be read at the liquid front where the glucose reaction is chromatographically separated. Clinistix and Chemstrip are essentially screening methods for the presence of glucose and not useful for quantification. Basing therapy on these and other plus values is irrational and should be discontinued.

False Negative Reactions

Home blood glucose monitoring as an aid in diabetes management.

Home blood glucose monitoring, using Dextrostix and an Eyetone meter, has been utilized in several subcategories of patients with insulin-dependent diabetes mellitus. These include pregnant patients, anephric patients, patients undergoing weight reduction, patients with altered renal threshold for glucose reabsorption, and patients in whom diabetic regulation is difficult. Patients monitored home blood glucose continually (on a daily basis), intermittently, or only for particular problems or symptoms. Such monitoring can be practically accomplished in a manner acceptable to patients. Motivation, compliance with protocol, and an understanding of the objectives of the program are essential on the part of the patient. Home blood glucose monitoring, however, can provide an insight diabetes regulation that cannot be attained in any other way and can greatly facilitate regulation of diabetes. Such home blood glucose monitoring may increase the likelihood of achievement of a degree of control approximating euglycemia.

Adolescent

Radioassay services in developing countries. Findings and recommendations of an International Atomic Energy Agency advisory group.

The findings and recommendations of an advisory group convened by the IAEA to give guidance relating to the development of IAEA projects involving radioassay are presented. The current status of radioassay services in different countries is reviewed; guiding principles relating to the organization of such services are affirmed, with particular reference to services in developing countries; the needs of services at various levels as regards accommodation, staff, equipment, supporting services and running costs, including minimum initial needs, are specified; operational problems are identified and indications given how they may be solved; facilities for training in radioassay are reviewed; finally, reference is made to IAEA activities in the field in question.

Austria

Cobalamin analogues are present in human plasma and can mask cobalamin deficiency because current radioisotope dilution assays are not specific for true cobalamin.

Since R protein binds cobalamin (vitamin B12) and cobalamin analogues, whereas intrinsic factor is highly specific for true cobalamin, we compared the serum cobalamin values obtained with these proteins in radioisotope dilution assays. With R protein, eight of 21 patients with cobalamin deficiency had serum cobalamin levels (mean, 204, range, 85 to 355 pg per milliliter) that overlapped with values for 74 normal subjects (mean, 576, range, 220 to 1230). With intrinsic factor, no patient values (mean, 36, range, less than 10 to 78 pg per milliliter) overlapped with the normal values (mean, 322, range, 130 to 785). Paper chromatography showed that these differences were due to the presence of cobalamin analogues. R protein constituted 51 to 85 per cent of the cobalamin-binding protein in 10 commercial serum cobalamin assay kits, which were said to contain "intrinsic factor". Human plasma contains cobalamin analogues that can mask cobalamin deficiency with current radioisotope dilution assays.

Adult

Recognition of impending ketoacidosis delayed by ketone reagent strip failure.

During a one-year period, six patients were admitted to the hospital in diabetic ketoacidosis following 12 to 24 hours of illness at home. Urine testing with strips impregnated with sodium nitroprusside had indicated that no ketone bodies were present. Nine of 11 bottles of reagent strips in use for less than three months by these and other patients contained totally unreactive strips. Nitroprusside tablets exposed more than three months continued to give accurate readings.

Diabetic Ketoacidosis

Results with commercial radioassay kits compared with microbiological assay of folate in serum and whole-blood.

We compared results with three commercial folate radioassay kits [Bio-Rad, New England Nuclear (NEN), and RIA Products] with those by microbiological assay for more than 200 samples of human serum and whole blood. All but one kit (NEN) compared favorably with the microbiological assay for serum samples, although there were notable diagnostic discrepancies. Two kits (NEN and Bio-Rad) were tested on whole-blood samples; both yielded values significantly higher than those by microbiological assay. The frequency distributions of erythrocyte folate data differed strikingly between the two kits; the NEN method yielded a much narrower range of normal values than did either the Bio-Rad or the microbiological assay. Radioassay kits appear to be suitable diagnostic agents for serum folate, if the behavior of a particular kit is investigated thoroughly before its routine use. However, the diagnostic value of radioassays of erythrocyte folate needs to be validated.

Biological Assay

[Continuously measuring procedures for the determination of alpha-amylase in serum. Comparison with amyloklastic and chromolytic methods (author's transl)].

Alpha-amylase has been measured in 57 patients' sera with normal to highly elevated amylase activities. The results obtained with four enzymatic-kinetic test-kits have been compared with those from five conventional marketed procedures. The results are evaluated by regression analysis. The specificity of the methods was analysed with amylase samples from human pancreas, human saliva and pig pancreas. The susceptibility of the kinetic procedures to interferences is smaller. The problems of conversion of activity units and reference ranges are discussed. The UltraZyme and the Monamyl neu-methods have been found superior to the other procedures because of their good practicability, precision and broad linear range; their specificity for diagnostic purposes in pancreatic diseases is less favourable compared with that of conventional procedures.

Amylases

The use of in vitro diagnostic kits in hospital laboratories in Canada.

1. A survey conducted among hospital laboratories has yielded data from 640 institutions concerning the use of diagnostic kits and reagents in Canada. 2. Kits designed to test for chemical constituents were most frequently used in hospitals of 51 to 600 bed capacity whereas the ones for enzymes were most extensively used in 201 to 700 bed-size institutions. Kits based on the CPB principles were generally used in hospitals of more than 200 beds whereas those based on RIA were only in frequent use where the bed capacity was 351 or more. 3. The following tests were most often performed by kits: aminotransferases, amylase, urea, LDH, phosphatases, glucose, CPK, bilirubin, calcium, uric acid, T-4, T-3, digoxin and vitamin B12. 4. The survey reflects a continuing and increasing usage of in vitro diagnostic kits and associated blood analyzer systems. It also indicates a significant adoption of assay kits which utilize RIA and CPB principles.

Blood Chemical Analysis