Dataset Information

Performance evaluation of the XPEN60 CRP&SAA, a novel automated hematology analyzer, in detecting complete blood count, C-reactive protein, and serum amyloid A.

ABSTRACT: BACKGROUND:The XPEN60 CRP&SAA (hereafter XPEN60) is a new automated hematology analyzer that can rapidly detect C-reactive protein (CRP), serum amyloid A (SAA), and blood cell counts (CBC), including the 5-part differential of white blood cells (5-DIFF). The aim of this study was to evaluate the analytical performance of XPEN60. METHODS:The analytical performance of XPEN60 was evaluated on the basis of several parameters, including the limit of blank (LoB), limit of detection (LoD), limit of quantitation (LoQ), precision, accuracy, carryover, linearity, clinical reportable range (CRR), and interference test. In addition, method comparisons between CBC and 5-DIFF, CRP, and SAA were performed on several systems. RESULTS:Total imprecision and accuracy for all parameters fell within acceptable criteria, and excellent measurements were observed in the dilution linearity (coefficient of determination, R2 > .99). LoBs and LoDs (0 and 0.21 mg/L for CRP, 1.1 and 2.27 mg/L for SAA) satisfy the manufacturer's statement. LoQs were 0.61 and 3.62 mg/L for CRP and SAA, respectively. No significant carryover or interference tests (<10%) were observed in this study. The comparison analysis demonstrated strong agreement between XPEN60 results and those of Sysmex-XN1000 (XN1000), except for basophils (Bas) and eosinophils (Eos). The data correlated well with E601 and Mindray CRP-M100 for CRP. CONCLUSION:XPEN60 was demonstrated satisfactory analytical performance, which made it well-suited for use in clinical laboratories, emergency departments, and community hospitals.

SUBMITTER: Zong Z

PROVIDER: S-EPMC7521309 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Performance evaluation of the XPEN60 CRP&SAA, a novel automated hematology analyzer, in detecting complete blood count, C-reactive protein, and serum amyloid A.

Zong Zengyan Z Kan Lijuan L Luo Yanping Y Wang Cheng C Wang Xibu X Wang Mengmeng M Xiong Dan D Zhang Xiuming X

Journal of clinical laboratory analysis 20200609 9

<h4>Background</h4>The XPEN60 CRP&SAA (hereafter XPEN60) is a new automated hematology analyzer that can rapidly detect C-reactive protein (CRP), serum amyloid A (SAA), and blood cell counts (CBC), including the 5-part differential of white blood cells (5-DIFF). The aim of this study was to evaluate the analytical performance of XPEN60.<h4>Methods</h4>The analytical performance of XPEN60 was evaluated on the basis of several parameters, including the limit of blank (LoB), limit of detection (LoD ...[more]

PMID: 32519385

Similar Datasets

Project description:BackgroundMindray's newly developed BC-7500 CRP auto hematology analyzers can simultaneously measure the routine blood and C-reactive protein (CRP) results, thereby significantly improving the efficiency and quality of clinical examination. This study was designed to evaluate the basic performance of the BC-7500 CRP as well as the performance characteristics of the new measurement mode combines routine blood and CRP.MethodsVenous whole blood samples with the anticoagulant ethylene diamine tetraacetic acid K2 (EDTA-K2) were collected at the Fujian Medical University Union Hospital according to the guidelines of the American Clinical Laboratory Standards Institute (CLSI) and International Standards Committee for Hematology (ISCH). We analyzed and evaluated the performance of blank counts, carryover contamination rate, precision, comparability, flagging capability, sample stability, and automatic micro-whole blood (MWB) mode analysis in the BC-7500 CRP hematology analyzer.ResultsAll parameters measured by the BC-7500 CRP showed good blank counts (CRP, 0.008-0.02 mg/L). The carryover contamination rates for each mode combination did not exceed 1%, it indicates a low carryover effect. The CRP showed high precision while the within-laboratory precision is 6.91% and 4.38% in two different levels. Relatively good correlation was found for the routine blood results between the BC-7500 CRP and Sysmex-XN (r=0.99), and CRP result between the BC-7500 CRP and IMMAGE 800 (r=0.99). The sensitivities of abnormal cell flagging for Blast, Immature Gran, and nucleated red blood cell (NRBC) were 93.9%, 91.6%, and 86.7%, while their specificities were 83.9%, 62.7%, and 97.5%. The test results of CRP at room temperature for 24 hours and refrigerated for 48 hours were -0.04% and -2.94%, which showed very stable changes. Also, the automatic micro-whole blood mode performed well (P=0.2014), which was very close to the test results of the automatic mixing test of peripheral blood and the manual mixing of open sampling.ConclusionsThe BC-7500 CRP analyzer provided reliable results on routine blood and CRP, which can meet the testing requirements of routine blood and CRP items in clinical whole blood samples and provide a guarantee for rapid and accurate laboratory diagnosis.

Project description:BackgroundAnemia is one of the most impactful nutrient deficiencies in the world and disproportionately affects children in low-resource settings. Point-of-care devices (PoCDs) measuring blood hemoglobin (Hb) are widely used in such settings to screen for anemia due to their low cost, speed, and convenience. Here we present the first iteration of Aptus, a new PoCD which measures Hb and hematocrit (HCT).AimTo evaluate the accuracy of Aptus and HemoCue® Hb 301 against an automated hematology analyzer (Medonic®) in Gambian children aged 6-35 months and the Aptus' usage in the field.MethodsAptus, HemoCue® and Medonic® were compared using venous blood (n = 180), and Aptus and HemoCue® additionally using capillary blood (n = 506). Agreement was estimated using Bland-Altman analysis and Lin's concordance. Usage was assessed by error occurrence and user experience.ResultsMean Hb values in venous blood did not significantly differ between Aptus and HemoCue® (10.44±1.05 vs 10.56±0.93g/dl, p>0.05), but both measured higher Hb concentrations than Medonic® (9.75±0.99g/dl, p<0.0001). Lin's coefficient between Aptus and Medonic® was rc = 0.548, between HemoCue® and Medonic® rc = 0.636. Mean bias between the PoCDs venous measurements was -0.11g/dl with limits of agreement (LoA) -1.63 and 1.40g/dl. The bias was larger for the comparisons between the Medonic® and both Aptus (0.69g/dl, LoA 0.92 and 2.31g/dl) and HemoCue® (0.81g/dl, LoA 0.17 and 1.78g/dl). ROC curves showed an AUC of 0.933 in HemoCue® and 0.799 in Aptus. Capillary Hb was higher with Aptus than HemoCue® (10.33±1.11g/dl vs 10.01±1.07g/dl, p<0.0001). Mean bias was 0.32g/dl with LoA of -1.91 and 2.54g/dl. Aptus' usage proved intuitive, yet time-to-results and cuvettes could be improved.ConclusionBoth PoCDs showed a relatively limited bias but large LoA. Aptus and HemoCue® showed similar accuracy, while both overestimated Hb levels. Aptus showed promise, with its operation unimpaired by field conditions as well as being able to show HCT values.

Dataset Information

Performance evaluation of the XPEN60 CRP&SAA, a novel automated hematology analyzer, in detecting complete blood count, C-reactive protein, and serum amyloid A.

Publications

Performance evaluation of the XPEN60 CRP&SAA, a novel automated hematology analyzer, in detecting complete blood count, C-reactive protein, and serum amyloid A.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets