Dataset Information

Clinical performance evaluation of serum amyloid A module of Mindray BC-7500CS automated hematology analyzer.

ABSTRACT:

Background

Laboratory detection of high values of serum amyloid A (SAA) is impaired by the hook effect. In response to this problem, Mindray has launched the new generation BC-7500CS automated hematology analyzer with an SAA autodilution (SAA-D) function. The present study aimed to verify the performance of the SAA module.

Methods

Venous whole-blood specimens anticoagulated with EDTA-K2 were randomly collected from outpatients and inpatient of the Children's Hospital of Nanjing Medical University (CH). Background, repeatability, precision, linear range, intermode comparison, and interference of the SAA module of the Mindray BC-7500CS were evaluated, and the performance of the SAA-D function was verified.

Results

The Mindray BC-7500CS showed an SAA background of 0.14 mg/L, well below that claimed by the manufacturer. Repeatability of SAA with standard deviation (SD) <0.6 mg/L and coefficient of variation (CV) <6%, the quality control (QC) precision was less than 8%. The measured value of the linear range was essentially consistent with the theoretical value, and the maximum measured values could reach 1932.38 mg/L. The deviation between whole-blood mode and micro-whole-blood mode was small (r=0.999), and the SAA module displayed high anti-interference ability. In addition, the measured results of specimens with high SAA concentration diluted by SAA-D were close to those after manual dilution (r=0.993).

Conclusions

The SAA module of the Mindray BC-7500CS had excellent performance, and the SAA-D function was highly accurate at measuring specimens with high SAA concentration, enabling reliable SAA detection in the laboratory and clinical practice.

SUBMITTER: Dai J

PROVIDER: S-EPMC9926133 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Clinical performance evaluation of serum amyloid A module of Mindray BC-7500CS automated hematology analyzer.

Dai Jincheng J Zhang Xiaoyu X Zhou Jing J Pan Wei W Yu Fei F

Translational pediatrics 20230116 1

<h4>Background</h4>Laboratory detection of high values of serum amyloid A (SAA) is impaired by the hook effect. In response to this problem, Mindray has launched the new generation BC-7500CS automated hematology analyzer with an SAA autodilution (SAA-D) function. The present study aimed to verify the performance of the SAA module.<h4>Methods</h4>Venous whole-blood specimens anticoagulated with EDTA-K2 were randomly collected from outpatients and inpatient of the Children's Hospital of Nanjing Me ...[more]

PMID: 36798927

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

Clinical performance evaluation of serum amyloid A module of Mindray BC-7500CS automated hematology analyzer.

Background

Methods

Results

Conclusions

Publications

Clinical performance evaluation of serum amyloid A module of Mindray BC-7500CS automated hematology analyzer.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets