Validation of the Sysmex sp-1000i automated slide preparer-stainer in a clinical laboratory.
BACKGROUND
The speed and quality of information have become essential items in the release of laboratory reports. The Sysmex(®)SP1000-I device has been developed to prepare and stain smear slides. However, for a device to be cleared for use in the laboratory routine it must pass through a validation process.


OBJECTIVE
To evaluate the performance and reliability of the Sysmex(®) SP-1000i slide preparer-stainer incorporated into the routine of a hospital laboratory in Porto Alegre.


METHODS
Peripheral blood samples of patients attending the laboratory for ambulatory exams with leukocyte counts between 7000/°L and 12,000/°L were evaluated, independent of gender and age. Two slides were prepared for each sample using the Sysmex(®) SP-1000i equipment; one of the slides was used to perform quality control tests using the CellaVision(®) DM96 device, and the other slide was used to compare pre-classification by the same device and the classification performed by a pharmacist-biochemist.


RESULTS
The results of all the slides used as controls were acceptable according to the quality control test as established by the manufacturer of the device. In the comparison between the automated pre-classification and the classification made by the professional, there was an acceptable variation in the differential counts of leukocytes for 90% of the analyzed slides. Pearson correlation coefficient showed a strong correlation for band neutrophils (r = 0.802; p-value < 0.001), segmented neutrophils (r = 0.963; p-value < 0.001), eosinophils (r = 0.958; p-value < 0.001), lymphocytes (r = 0.985; p-value < 0.001) and atypical lymphocytes (r = 0.866; p-value < 0.001) using both methods. The red blood cell analysis was adequate for all slides analyzed by the equipment and by the professional.


CONCLUSIONS
The new Sysmex(®)SP1000-i methodology was found to be reliable, fast and safe for the routines of medium and large laboratories, improving the quality of microscopic analysis in complete blood counts.
Pontifícia Universidade Católica do Rio Grande do Sul - PUCRS, Porto Alegre, RS, Brazil ; Laboratório Central de Analises Clínicas da Santa Casa de Porto Alegre - ISCMPA, Porto Alegre, RS, Brazil.
Eberson Damião Dos Santos
ED
de Bitencourt
Laboratório Central de Analises Clínicas da Santa Casa de Porto Alegre - ISCMPA, Porto Alegre, RS, Brazil.
Carlos Franco
CF
Voegeli
Universidade de Caxias do Sul - UCS, Caxias do Sul, Brazil.
Gabriela Dos Santos
Gdos S
Onzi
Universidade de Caxias do Sul - UCS, Caxias do Sul, Brazil.
Sara Cardoso
SC
Boscato
Instituto de Cardiologia do Rio Grande do Sul - IC/FUC, Porto Alegre, RS, Brazil.
Carine
C
Ghem
Pontifícia Universidade Católica do Rio Grande do Sul - PUCRS, Porto Alegre, RS, Brazil.
Terezinha
T
Munhoz
Automation, laboratory; Blood cell count/methods; Diagnostic equipment; Flow cytometry; Validation studies