Evaluation of the detection of blasts by Sysmex hematology instruments, CellaVision DM96, and manual microscopy using flow cytometry as the confirmatory method.

INTRODUCTION: The aim of the present study was to evaluate the diagnostic ability of blast flags generated by Sysmex instruments (XE/XN) by comparing with immunophenotyping by flow cytometry (IFCM). Additionally, the ability of manual microscopy and CellaVision DM96 (pre- and reclassification) to predict the presence of "true" blasts was investigated. METHODS: Blood samples (n = 240) with suspect pathology flags reported by the XE were collected from the daily workload and examined by the XN, by manual microscopy, by CellaVision DM96 and by IFCM (CytoDiff Panel). RESULTS: The ROC analysis for blasts showed an area under the curve of 0.64 ("Blasts?") (XE), 0.57 ("Blasts/Abn Lympho?") (XN), 0.75 (CellaVision preclassification procedure), 0.78 (CellaVision reclassification procedure), and 0.81 (manual microscopy). The sensitivity of blast detection varied between the methods from 0.41 (XE) to 0.90 (XN), and the specificity varied from 0.17 (XN) to 0.95 (CellaVision reclassification). CONCLUSIONS: The CellaVision reclassification procedure has a diagnostic ability for predicting blasts close to that of manual microscopy. The blood smear methods show a notable number of false negative results. The Sysmex XN reported a higher rate of true positive blast flags than the XE. Taken together, the CytoDiff method could be a useful alternative to smear examination to correctly identify blasts.

Do the flags related to immature granulocytes reported by the Sysmex XE-5000 warrant a microscopic slide review?

OBJECTIVES: The Sysmex XE-5000 instruments (Sysmex, Kobe, Japan) count immature granulocytes (IGs) and use the "Imm Gran?" flag to signal unreliable results. This study investigated the usefulness of the "Imm Gran?" flag and the analytical and diagnostic performance of the IG measurements in a side-by-side evaluation. METHODS: In total, 408 samples were analyzed on three XE-5000 instruments. The IG count and the "Imm Gran?" flag reports from all three instruments were used for reproducibility studies. The diagnostic performance of the automated IGs and the "Imm Gran?" flag were studied by comparing the XE-5000 results with the results of the manual differential. RESULTS: The reproducibility of the "Imm Gran?" flagging between instruments was poor (қ, 0.75-0.80). The most significant contributor to the report of the "Imm Gran?" flag was bands, and the flag played a minor role in detecting blasts. The interinstrument reproducibility of the IG counts was high (intraclass correlation, 0.99). The IG count reported by XE-5000s was higher than the manual IG count (36%-55%), and the difference and the variability tended to increase with increasing levels of IGs. CONCLUSIONS: The "Imm Gran?" flag has a poor analytical quality and gives no substantial information on the presence of blasts in the sample. We therefore suggest reporting the automated IG count without initial microscopic slide review.

The usefulness of blast flags on the Sysmex XE-5000 is questionable.

Hematology analyzers generate suspect flags that involve microscopic reviews to confirm the presence of pathologic cells. This study investigated the reliability of the blast flag in a side-by-side evaluation of 3 Sysmex XE-5000 instruments (Sysmex, Kobe, Japan). The repeatability of the Q values reported by each instrument for 10 replicates of the same blood samples was low (intraclass correlation coefficient [ICC] values, 0.62-0.74). The reproducibility of the Q values obtained by analyzing 408 samples on all 3 instruments was reasonable (ICC value, 0.85). In addition, a systematic difference was observed among the instruments in the level of reported Q values. With cutoff commonly being 100, the observed reproducibility of the blast flagging among the instruments was evaluated as poor (κ = 0.73). Based on the observed low performances, we question the usefulness of the Q value as a predictor of blasts and whether a blast flag reported by the XE-5000 is sufficient as a criterion for performing a microscopic review.

Evaluation of OneTouch Verio(®), a new blood glucose self-monitoring system for patients with diabetes.

INTRODUCTION: Self-monitoring of blood glucose (SMBG) is important in diabetes management. Reliable and user-friendly instruments are essential. OneTouch Verio(®) is a new blood glucose concentration-measuring system designed to be used by patients with diabetes and healthcare professionals. The objective of the present study was to evaluate the analytical performance of the OneTouch Verio(®). METHOD: The OneTouch Verio(®) was evaluated by the Scandinavian evaluation of laboratory equipment for primary healthcare (SKUP) according to a protocol based on ISO 15197 and the American Diabetes Association (ADA) quality goals. Blood samples were collected and measured on the OneTouch Verio(®) by laboratory personnel and patients with diabetes (n = 91, randomized into groups receiving personal training or mail instructions for the OneTouch Verio(®) system). Results were compared to a validated routine method, imprecision and bias were calculated. User-friendliness was evaluated with a questionnaire. RESULTS: Quality specifications for blood glucose concentration monitoring systems according to ISO 15197 were fulfilled. The mean coefficients of variation (CV%) of repeatability was 3.4% when tested by laboratory personnel and within the goal of imprecision suggested by ADA. Mean CV% of repeatability for patient self-monitoring was 5.0% and 5.1% in the training- and the mail group, respectively. Total error was 6.4-10.0%. The OneTouch Verio(®) showed no hematocrit interference or variation between strip lots. CONCLUSION: The OneTouch Verio(®) displayed sufficient analytical quality and satisfactory user-friendliness. It is suitable for point-of-care testing of blood glucose concentration when handled by patients and healthcare professionals.