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BACKGROUND: In 2003, a new General Medical Services (GMS) contract was agreed between UK general practitioners and the Department of Health. The three diabetes codes DM5-DM7 require glycated haemoglobin (HbA(1c)) testing and comprise 30 points in total, with 27 points being related to target glycaemic control. We compared two routinely used Diabetes Control and Complications Trial (DCCT)-aligned HbA(1c) methods to determine if different HbA(1c) methods could lead to postcode treatment to target across the UK. METHODS: A total of 164 specimens were randomly selected from diabetic patients attending the Diabetes Centre at the Ipswich Hospital. Samples were analysed on both a DCA 2000+ Analyser and a Variant II analyser. RESULTS: Despite a mean difference of only 6.5% between the two methods, 32 (19.5%) and 63 (38.4%) patient samples had an HbA(1c) < or = 7.4% with the Variant II analyser and DCA 2000+ Analyser, respectively. Thus, the two methods differed according to the DM6 GMS target by 31 patients, or 18.9% of the total number of patients in this study. The difference between the two methods was statistically significant with P < 10(-09) (McNemar's test). CONCLUSIONS: DCCT-alignment has improved the transferability of HbA(1c) values; however, it is not perfect. It is important that the limitations of current DCCT-aligned HbA(1c) methods are understood by health-care professionals and policy makers, as these may have important financial and clinical implications.

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BACKGROUND: Previously, different analytical methods could be compared on statistical and clinical grounds. Since 2003, the UK Departments of Health and general practitioners agreed a new primary care contract. This contract utilises clinical targets resulting in a third way to compare analytical methods. METHODS: We compared two DCCT-aligned HbA1c analysers (Variant II analyser and a Tosoh G7) using 161 randomly selected patient specimens to see if different methods could lead to a difference in the classification for glycaemic control. RESULTS: Ninety-seven (60.2%) and 109 (67.7%) patient specimens had a HbA1c

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We present the case of a 71-year-old man with anaplastic thyroid cancer. On presentation, his thyroid function was normal, but he subsequently developed sudden, rapid thyrotoxicosis. Thyrotoxicosis in anaplastic thyroid carcinoma is very rare, but in all previously reported cases the patient was thyrotoxic at presentation. Our case is unusual as our patient presented euthyroid, and thyrotoxicosis developed subsequently. We challenge current ideas regarding the biochemical pathophysiology of rapid thyrotoxicosis in anaplastic thyroid carcinoma and provide an alternative explanation.

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This report outlines a case of diabetic ketoacidosis associated hyponatraemia in an 18 year old woman with type 1 diabetes who presented to the accident and emergency department and was quickly admitted to the intensive treatment unit. Causes of hyponatraemia include sodium depletion, pseudohyponatraemia, and extracellular hypertonicity. Hypertonicity secondary to hyperglycaemia is thought to be the major cause of hyponatraemia in diabetic ketoacidosis. Indirect and direct sodium measurements were performed until the glucose concentration stabilised. The large difference between the presenting sodium concentrations is consistent with pseudohyponatraemia. However, the causes of pseudohyponatraemia (large increases in total protein, triglyceride, and cholesterol concentrations) were excluded. Analytical error should always be considered when the laboratory results do not agree with the clinical picture. Sometimes, however, even after excluding all known effects, the cause may remain unexplained, as in this case.

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BACKGROUND: Parathyroid hormone (PTH) is important in the evaluation of patients with calcium metabolism disorders and/or chronic renal disease. AIMS: To assess the differences between serum and plasma PTH measurements using the Advia Centaur. METHODS: Twenty six paired serum and edetate samples from patients with chronic renal failure were analysed using the Advia Centaur. RESULTS: The EDTA results ranged from 2.3 to 76.1 pmol/litre and the Deming regression equation was: serum = 0.8927 EDTA - 0.447. The percentage difference plot had a mean difference of 13.8% (95% confidence interval, 2.2% to 25.4%; significant). The available time to separation and freezing ranged from 10 to 231 (median, 85) minutes. The correlation coefficient for the percentage difference against the time to separation and the percentage difference against the mean PTH concentration were -0.13 and -0.07, respectively. CONCLUSIONS: These results go beyond the previous controlled research conditions by showing that such differences between serum and edentate plasma exist in routine clinical practice. They also show that intra-individual PTH differences as large as 25.0% can exist on the same day between serum and edetate plasma. This may partly explain some of the variability of PTH concentrations found in some patients with chronic renal failure.

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We have performed a comparative evaluation of two Immuno Radiometric Assay (IRMA) kits for parathyrin against an existing Radioimmuno Assay (RIA) technique for the measurement of intact parathyrin. The analytical evaluation which was performed in line with the ECCLS recommended kit evaluation protocol showed a marginal improvement in precision with the new assays. There was a substantial improvement in the theoretical limit of detection utilising the IRMA kits although it may prove difficult to realize this improvement in practice with individual samples because of differing protein matrices. The evaluation also demonstrated the degree of parallelism and range of linearity of both kits as well as inaccuracies when compared with the International Reference Preparation for parathyrin (IRP 79/500) as the accepted standard. The demonstration of lack of agreement between measured and kit assigned results for standards when cross-over studies between kits were performed may highlight a possible contributing factor to inaccuracy. Alternatively there may be a difference of antisera avidity within the kits for intact parathyrin. Whilst minor differences in sample stability were demonstrated between the kits, the sample stability was much improved compared to that for intact parathyrin measurement by RIA. The correlation studies showed a degree of correlation consistent with other comparisons similarly performed.

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The fortuitous detection of SIADH is described in a patient receiving clomipramine therapy.

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Eight onco-developmental proteins have been measured in the serum of women prior to their operation and treatment for ovarian cancer. Alpha-foetoprotein, CEA, hCG and PAPP-A were not often elevated whereas CPAP, SP1, CanAg 50 and CA 125 were. Many of our findings differed from those of previous workers, possibly due to differences in clinical material and analytical technique. We conclude that large profiles of tumour markers are no longer of use in the investigation of ovarian cancer. At the present time we think that CA 125 could prove the most useful marker in the investigation of ovarian cancer.

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Digoxin requesting patterns were studied prospectively over a 6-month period. Clinicians were not forewarned that the study was being undertaken. Many samples received in the laboratory were taken at incorrect times after the drug had been given. This led to inappropriate action being taken in some cases. Appropriate action was taken on most patients who had toxic serum digoxin levels together with clinical signs. The role of subtherapeutic digoxin levels seems unclear as these elicit a wide variety of responses.

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Serum galactosyl transferase activity was measured in patients with ovarian cancer, non-ovarian cancer, inflammation and infection, miscellaneous control patients and a normal group. Patients with cancer had widely dispersed results, high and low results being recorded. The majority of patients with inflammation and infection had elevated results. Differences in methodology and selection of clinical material make it difficult to compare results from different groups of workers. We conclude that it is not possible at present to decide on the usefulness of serum galactosyl transferase measurements in the investigation of ovarian cancer.

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Suitable tumour markers for monitoring the treatment of seminoma of the testis have not yet been established in clinical practice. Carcino-placental alkaline phosphatase (CPAP) has been suggested for this purpose but it is difficult to detect and specifically analyse this enzyme. We have devised an immunoenzymatic method of analysis in which cross-reactions with liver type and intestinal alkaline phosphatase are minimal and we have applied this test to seven patients with histologically proven seminoma. CPAP was raised in 4 patients prior to treatment and chorionic gonadotrophin in two of these. Alpha-fetoprotein was normal in all cases. We conclude that the use of CPAP in monitoring treatment of testicular seminoma is worthy of further attention.

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Three different methods for the assay of carcinoembryonic antigen were investigated--radioimmunoassay, enzyme-linked immunoassay, and a commercial immunoradiometric assay. Two standard preparations of CEA were used: the 1st British Standard (73/601) and a commercial preparation obtained as a component of the IRMA kit. Serum samples were assayed by each method against each standard material. Significant differences between results were obtained when the different methods were compared. When using the two standards in the same assay system no significant differences were found between results. A possible explanation and the implications of these findings for the routine assay of CEA are discussed.

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Three pregnancy-associated proteins, human placental lactogen, pregnancy-specific beta 1-glycoprotein and pregnancy-associated plasma protein-A have been measured in two groups of pregnant women. One group subsequently gave birth to children of normal birthweight, the other group were all delivered of a child with a birthweight less than the 10th centile. From the results obtained the values of the tests in predicting intrauterine growth retardation have been calculated. Human placental lactogen proved to be the most useful of the tests compared in predicting intrauterine growth retardation in the individual patient.

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Pregnancies with very low maternal serum concentrations of placental function monitors, yet resulting in a normal outcome, have been reported occasionally before (4, 6). We report here a case in which maternal serum placental lactogen (hPL) concentrations were very low, urinary estrogen output assessed by estrogen/creatinine ratio was satisfactory, but maternal serum pregnancy specific beta 1 glycoprotein (SP1 beta) concentrations were grossly elevated. Ultrasound findings suggested impairment of growth. The outcome of the pregnancy was satisfactory, although the baby, apparently of 38-40 weeks' gestation, developed mild respiratory distress.

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