External Quality Assessment of stat test intralaboratory turnaround times. Pilot study from the Members of the Working Group for the Standardization and Promotion of Turnaround Time Control under the Auspices of the Comitato Italiano per la Standardizzazione dei Metodi Ematologici e di Laboratorio.

We describe procedures, results and prospects of a pilot program in External Quality Assessment (EQA) of the stat test intralaboratory turnaround times. Our goals are to promote quality by systematic monitoring and comparison of performances by laboratories, continuous investigation into the state of the art of the processes from receipt of sample to transmission of results and creation of a data base for standardization of measures and definition of consensus values for turnaround time. Of 30 laboratories invited to participate, 25 took part, agreeing to record times of arrival and transmission for all determinations of three analytes (blood hemoglobin, serum/plasma potassium and plasma prothrombin time) for seven consecutive days and to continue for one or more further periods of seven days as necessary if there were less than 300 determinations for each analyte. Within a preset time limit, data were sent by e-mail on an Excel file and we sent back two reports per analyte, showing: i) the graph for time vs. percentage of tests completed and several measures of turnaround time; ii) results of all laboratories in graph form, allowing each laboratory to identify only its own data. The high proportion of participating laboratories among those invited (83%) encourages us to implement the EQA program systematically, on a half-yearly basis, extending it to all laboratories wishing to participate in Italy or elsewhere in Europe.

A new low-dose estrogen oral contraceptive combination: effect on endocrine parameters and lipid status.

In this study the variations of endocrine and metabolic parameters of 39 women treated with a new oral contraceptive combination containing 20 mcg of ethinylestradiol and 150 mcg of desogestrel were examined. Gonadotropins and androgen presented a significant decrease, showing the efficiency of suppression of the pituitary-ovarian activity and of the contraceptive effect. The significant increase of SHBG and the corresponding reduction of free testosterone reflect the estrogenic environment of this pill and the low androgenicity of desogestrel. During the observation period, plasma levels of total cholesterol, trglycerides, LDL-C and HDL2-C were not altered, whereas total phospholipids, HDL-C and HDL3-C increased significantly. Besides a general positive effect on the main lipid parameters involved in atherogenic process, this pill also presented an optimal subjective tolerability.

[Behavior of phosphoisomerase and lactate dehydrogenase in pediatric oncological pathology]. / Comportamento della fosfoisomerasi e della lattatodeidrogenasi in patologia oncologica pediatrica.

Two glycolytic enzymes, PHI and LDH, have been evaluated in 18 children affected by leukemia or solid tumors: 11 patients had just initiated therapy, 3 patients were about to initiate therapy, while 4 patients were out of therapy. The analysis of the data obtained has shown a good correlation with the course of the disease: we have found values above the normal range in patients with a favorable course of the disease (bone marrow relapse or CNS involvement in leukemic children; relapse or metastasis in solid tumors) almost always before it was possible to demonstrate by clinical and laboratory studies the inhanchement of tumoral cells growth. This was true in all patients except two children affected by neuroblastoma, who were in a favorable immunological status (presence in the serum of free specific antibodies), and who were out of therapy. In these patients the abnormal high values of PHI were interpretated as an index of necrotic phenomena of micrometastasis of tumor cells induced by specific committed T-lymphocytes. Values of PHI and LDH in the normal range were found in patients whose disease demonstrated a favorable course. The AA. suggest the introduction of these enzymatic parameters which may be a useful index of the efficacy of the chemotherapy in the follow-up of oncologic patients.

[A double-blind cross-over trial of a new hypolipidaemic drug (author's transl)]. / Studio in doppio cieco ed in cross-over di un nuovo farmaco ipolipemizzante.

A double blind cross-over trial has been carried out on the effects of a nicotinic acid compound on 27 patients affected by hyperlipidemia. The subjects have been treated over one year according the following plan: two peroids of 90 days each with the drug and two with placebo. The statistical analysis showed a significant reduction of serum cholesterol triglycerides, phospholipids and total lipids. In 4 patients out of 27, the treatment has not been completed because of drug intollerance.

[Enzymatic determination of total serum cholesterol by 4-aminophenazone-phenol: manual and automatic method (author's transl)]. / Determinazione enzimatica diretta del colesterolo totale nel siero con 4-aminofenazone-fenolo: metodo manuale ed automatico

A direct method is proposed for total serum cholesterol determination by two specific enzymes and a coupled colorimetric reaction according to Trinder. The red colored compound is antipyridilquinonimine. The method is simple (serum plus reagent), rapid (30 min of incubation) and relatively inexpensive. It is perfectly correlated with Röschlau's method and easy to apply to discrete automatic methods.