Initial performance evaluation of the UniCel^® DxH 800 Coulter^® cellular analysis system

Abstract

The Beckman Coulter UniCel® DxH 800 is a hematology analyzer incorporating new electronic and mechanical design with advanced algorithm technology to perform CBC, white blood cell (WBC) differential, nucleated red blood cell (NRBC), and reticulocyte analysis. Evaluation of this instrument was performed in our 800-bed tertiary care hospital and specifically centered upon the correlation of WBC, NRBC, and platelet (PLT) enumeration when compared to a predicate analyzer, the Coulter® LH 780, and flow cytometry (FCM) reference methods. Of particular interest were those samples with morphologically confirmed interference and extreme leukocytosis (evaluated with respect to red blood cell parameter correction). The sample set (n = 272) consisted of morphologically normal and hematologically abnormal patients. Correlation of the WBC, PLT, and NRBC showed r2 values of 0.994, 0.985, and 0.910 for the DxH 800 vs. FCM, respectively. The presence of interfering particles did not affect the accuracy of the DxH 800 with respect to WBC counts. The DxH 800 showed accurate PLT and NRBC counts in the clinically significant low range when compared to FCM. Compared to the LH 780, flagging rates were significantly reduced (NRBC flag), or equivalent (WBC, PLT flag) on the DxH 800. The DxH 800 demonstrated higher sensitivity and specificity for PLTs and NRBCs and achieved a lower NRBC false negative rate compared to the LH 780. The UniCel® DxH 800 represents a significant improvement to previous impedance analyzers in accurately detecting the presence of NRBCs at counts >1/100 WBC. Furthermore, it provides accurate PLT and WBC counts in the presence of interference and improved NRBC flagging efficiency when compared to the LH 780. Correction of red blood cell parameters is appropriate and accurate in cases of extreme leukocytosis.

Evaluation of the Beckman Coulter UniCel DxH 800, Beckman Coulter LH 780, and Abbott Diagnostics Cell-Dyn Sapphire Hematology Analyzers on Adult Specimens in a Tertiary Care Hospital

“…With the exception of MPV, the r values were greater than 0.97 and comparable to those in a multi-instrument study by Muller et al 6 and a recent evaluation of the DxH 800 vs the LH 780. 1 In addition to the r value, which indicates how well the data conform to the best-fit line, additional statistical parameters include the slope and y-intercept, which indicate the degree of proportional and absolute bias, respectively. All parameters for the CBC exhibited slopes close to 1 and y-intercepts close to 0, with the exceptions of the MPV and platelet count, for which the DxH 800 values were similar to those of the LH 780 but proportionately less than those of the Sapphire (slope = 0.820 for platelets; slope = 0.850 for MPV).…”

“…This study represents one of the few early reports on the DxH 800, which is a recently released, high-volume hematology analyzer intended to supplant the previous generation, Beckman Coulter LH 780. [1][2][3] The DxH 800 represents a new design from the manufacturer with less tubing and a smaller footprint than the LH 780. The Cell-Dyn Sapphire represents a comparable high-volume analyzer from Abbott Diagnostics that has been studied extensively.…”

Contamination of Patient Blood Samples by Avian RBCs From Control Material During Automated Hematology Analysis

“…The Unicel DxH 800 did not reproduce the contamination phenomenon in our hands and has superior sensitivity for NRBCs compared with the LH 750. 4 Our blood smears with unusual NRBCs did not contain other abnormalities that typically accompany NRBCs, such as immature cells or dysplastic granulocytes. Unexpected laboratory findings must be carefully evaluated in their clinical setting with careful consideration of preanalytical as well as analytical variables.…”

Influence of centrifuge brake on residual platelet count and routine coagulation tests in citrated plasma

“…The PLT count on this analyzer has been shown to be linear in the range comprised between 1 and 1297 Â10 9 /l [5]. The blood was collected by an experience phlebotomist, using a 21 gauge straight needle, directly into evacuated blood tubes containing 109 mmol/l buffered sodium citrate (Venosafe; Terumo Europe N.V., Leuven, Belgium; ref.…”