Validation of the Sysmex sp-1000i automated slide preparer-stainer in a clinical laboratory

Abstract

BackgroundThe 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. ObjectiveTo evaluate the performance and reliability of the Sysmex® SP-1000i slide preparer-stainer incorporated into the routine of a hospital laboratory in Porto Alegre. MethodsPeripheral 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. ResultsThe 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. ConclusionThe 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.

Cross‐evaluation of five slidemakers and three automated image analysis systems: The pitfalls of automation?

“…The era of automation has not escaped haematology laboratories, where automated slidemakers and stainers and automated image analysis systems are being coupled with haematology analysers to achieve better efficiency and cost‐effectiveness. Even though there is widespread implementation of slidemakers, a striking lack of studies evaluating their performance has yet to be noticed, often settling for only a satisfactory mechanical operation 6‐8 …”

“…Even though there is widespread implementation of slidemakers, a striking lack of studies evaluating their performance has yet to be noticed, often settling for only a satisfactory mechanical operation. [6][7][8] Automated image processing systems have been developed to address the difficulties encountered with manual microscopic examination, allowing a faster, more efficient and more standardised morphological analysis of peripheral blood smears. This allows for faster slide review and can be used as a valuable learning tool.…”

Leukocyte Esterase Strip Quantitative Detection Based on RGB Photometry is a Probable Method to Diagnose Periprosthetic Joint Infection: An Exploratory Study

“…Leukocyte counting equipment and reagents: Sysmex XN (Sysmex) automatic modular hematology and humoral analyzer and the reagents were used. 11 Leukocyte counting method: The laboratory technicians operated by following the instructions of the analyzer, and the Body Fluid module was selected for counting the white blood cells in the joint fluid samples. After complete shaking, the specimens were tested, and the final results were recorded.…”

Valutazione del sistema Cellavision DM-96 nell’analisi della formula leucocitaria e nel conteggio piastrinico

“…In questi casi i sistemi Sysmex generano un segnale di errore sulla base del quale lo specialista del settore di ematologia può scegliere di ripetere la determinazione con metodica ottica, più specifica ma più costosa [7,9]. Il sistema ematologico è collegato in catena con il coloratore SP-1000i Sysmex, che allestisce automaticamente, selezionando in base a parametri pre-definiti, i vetrini degli strisci di sangue periferico colorandoli con il metodo MayGrünwald-Giemsa [10].…”