OBJECTIVE

To express the results of an evaluation of the Coulter STKS blood cell counter.

METHODS

The following data were collected: inaccuracy, carry-over, linearity, comparison with other systems, suspect morphology alarms, stability of calibration, time-stability of samples and working velocity. The protocol recommended by the ICSH was followed for the first four of the above.

RESULTS

Good results were achieved for cell counts and derived parameters. The leucocyte differential count showed fair results for neutrophils, lymphocytes, monocytes and eosinophils; false basophilia was usually associated with the presence of abnormal lymphocytes. No differences were found between adult and paediatric samples. The usefulness of the suspect morphology alarms was also evaluated; they were found fairly sensitive for the presence of stabs, large amounts of atypical lymphocytes and blast cells, and moderately sensitive for erythroblasts and platelet clumps. The predictive value of alarms was found high in any type of pathology, but scarcely valuable when considering the pathology indicated by the alarm, such predictive value being noticeably increased upon associated alarms.

CONCLUSIONS

The Coulter STKS cell counter appears as adequate for the haematology laboratory running daily high number of samples with high pathologic rates.

A majority of packed cell volume (PCV) assays performed in the United States are performed by multichannel hematology analyzers rather than by centrifugation of blood samples in glass capillary tubes. PCV results from both analytical approaches were compared to the recently described ICSH reference method to determine the effect of assay slope on clinical utility. Though not controllable by the end user, the slope of the PCV assay versus the reference was satisfactory when performed in centrifuged glass capillaries. In the small sample of multichannel analyzers surveyed, only two of six machines functioned as well in this respect as did the glass capillaries. The worst of the unsatisfactory multichannel analyzers would have identified correctly only about half of the anemic and the polycythemic patients in the 12,623 males surveyed in the Third National Health and Nutrition Examination Survey (NHANES III). The performance on the females in this U.S. Department of Health and Human Services study would have been similarly poor. It is important that manufacturers of multichannel analyzers attend to the slopes of their PCV assays if the results are to be diagnostically useful.

Five multichannel hematology analyzers (four different models) were evaluated to determine the ability of analyzers to correctly measure packed cell volume (PCV) values across the clinically relevant range. A sixth analyzer (fifth model) was subsequently included using archival data. Twenty-two different blood samples with PCVs ranging from 0.2 to 0.6 L/L were run in duplicate on each analyzer. Duplicate reference PCV determinations were also done using the recently described ICSH-recommended reference method. Simultaneously, a simpler "surrogate reference" procedure was performed in duplicate. Analyzer values were compared to ICSH reference and to surrogate reference PCV values using Deming regression analysis. Compared to either reference, all analyzers showed a slope of less than 1.0, thereby overestimating the PCV at 0.2 L/L and underestimating the PCV at 0.6 L/L to some extent. This outcome was surprising. Deming regression slopes would be expected to average at 1.0. Instruments whose slopes are significantly less than 1.0 will show decreased sensitivity to both anemic and polycythemic patients. We know of no inherent reason why multichannel analyzers should behave in this fashion.

This brief history of the origin and development of ICSH must, inevitably, be selective as it has been extracted from the many pages of the records of the meetings of the ICSH board and its secretariat, the annual assembly and the reports of the various expert panels and working groups. It is hoped that it will give a picture of the way in which ICSH functioned and the many experts around the world who have contributed to its activities - but with an apology and appreciation, to other colleagues who have not been named in this annotation, but who made significant contributions to the activities that are described.

OBJECTIVE

To evaluate three automated devices for measuring the erythrocyte sedimentation rate (ESR) (VES-MATIC 60, Menarini(R); SEDISCAN Becton-Dickinson(R) y SEDIMATIC, Ral(R)) by comparison with the Westergren method (WM).

METHODS

A total of 1576 whole blood samples (VM: 694, SC: 316 and SM: 566) from patients of the Hospital Clínic i Provincial de Barcelona were included in this study. In all the specimens, the ESR was determined following the ICSH recommendations (WM). The Student's t test for paired data and linear regression analysis were used for inaccuracy study. Reproducibility was assessed after five measurements of three different samples and establishing the coefficient of variation (CV).

RESULTS

Significant correlation was found between the systems studied and th WM. Moreover, for ESR>> 21 mm/h (groups II, III and IV) the results provided by VM system were not significantly different from those of WM. Finally, all the systems presented a good reproducibility, although the lower values of CV were obtained with the VM method.

CONCLUSIONS

The automatic systems for measurements of the ESR demonstrate important advantages and, from this analysis, we concluded that the VM could be the alternative method to conventional Westergren for the ESR determination.

The effect of methallibure (ICI 33,828) on the pituitary-gonad and the pituitary-thyroid axes of the Indian garden lizard, Calotes veriscolor was studied. Following administration of methallibure B2 (FSH) and B3 (ICSH) cells of the pars distalis exhibited significant alterations with concomitant changes in the seminiferous tubules, and in the interstitial cells and epididymis respectively. B1 (TSH) cells exhibited conspicuous hypertrophy and degranulation which was reflected in dramatic changes in thyroid morphology. The caudally localized acidophilic A1 (PRL) cells also showed hypertrophy, hyperplasia and intense granulation. The rostrally located A2 (STH) acidophils and the B4 (ACTH) cells were unaffected by the treatment. The possible model of action of this drug is discussed in the light of available literature.

The main organizations involved in standardization of laboratory medicine are described. At the international level these are mainly: ISO, IEC, WHO, ICSH, IFCC and COWS/WASP, while at the European level CEN, CENELEC and BCR are involved in standardization activities in Europe. At the present the European Commission is preparing a directive on in vitro diagnostic. This document will rely, for its implementation, on standards prepared by CEN/CENELEC.