Validation of the Sysmex XN analyser and Blood Bank mode for the quality and safety of donor blood and transfusion products.

IF 1.5 4区医学 Q3 HEMATOLOGY Transfusion Medicine Pub Date : 2024-02-01 Epub Date: 2024-01-09 DOI:10.1111/tme.13028

Ondrej Valina, Ida Vankova, Konstantinos Mintzas, Klara Knappova, Zdenka Gasova

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Abstract

Objectives: Our objective was to compare the measurement of residual white blood cell (rWBC) and residual red blood cell (rRBC) counts in blood products using the XN Blood Bank mode and the laboratory standard operating procedures for manual counts. In addition, to compare the whole blood complete blood count (CBC) values of blood donors and the quality of blood products using the Sysmex XN analyser versus the XS-1000i analyser.

Materials and methods: For blood donors, 190 samples from blood or apheresis donors were analysed on both the Sysmex XS-1000i and XN-1000 analysers and the mean values of six CBC parameters were compared: the white blood cell count (WBC), the red blood cell count (RBC), haemoglobin (HGB), haematocrit (HCT), the mean corpuscular volume (MCV), the platelet count (PLT). For blood products, 164 samples were collected: 13 Plasma products - whole blood, 9 Plasma products - apheresis, 36 RBC concentrates - whole blood, 30 PLT concentrates - buffy coats, 36 PLT concentrates - buffy coats - pooled and 55 PLT concentrates - apheresis.

Results: All CBC parameters of the blood donors tested showed similar performance, with excellent correlation coefficients (r) ranging from 0.821 to 0.995. The majority of the blood products did not have a quantifiable number of residual cells, meaning the number of rWBC and rRBC, if present, was below the limit of quantitation (LoQ) of the different methods. rWBC were detected by Blood Bank mode in Plasma products - whole blood with a mean rWBC of 0.012 × 10⁹ /L and in PLT concentrates - buffy coats with a mean rWBC of 0.19 × 10⁹ /L. The correlation coefficient in both analysers for all three parameters (HGB, HCT, RBC) in RBC concentrates - whole blood was excellent, ranging from 0.95 to 0.99. For platelet count, r ranged from 0.98 to 0.99.

Conclusion: The XN-Series analyser, equipped with a Blood Bank mode, demonstrated reliable performance when used for blood donor evaluation, rWBC enumeration and measurement of end blood products.

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验证 Sysmex XN 分析仪和血库模式，确保献血者血液和输血产品的质量和安全。

目标：我们的目的是比较使用 XN 血库模式和实验室手动计数标准操作程序对血液制品中残留白细胞（rWBC）和残留红细胞（rRBC）计数的测量结果。此外，还将使用 Sysmex XN 分析仪和 XS-1000i 分析仪对献血者的全血全血计数（CBC）值和血液制品的质量进行比较：使用 Sysmex XS-1000i 分析仪和 XN-1000 分析仪分析了 190 份献血者或无偿献血者的血样，并比较了六项全血细胞计数参数的平均值：白细胞计数（WBC）、红细胞计数（RBC）、血红蛋白（HGB）、血细胞比容（HCT）、平均血球容积（MCV）、血小板计数（PLT）。共采集了 164 份血液制品样本：13 份血浆制品--全血、9 份血浆制品--血液分离、36 份浓缩红细胞--全血、30 份浓缩血小板--水包衣、36 份浓缩血小板--水包衣--集合和 55 份浓缩血小板--血液分离：受测献血者的所有血细胞计数参数表现相似，相关系数（r）从 0.821 到 0.995 不等。血库模式在血浆产品--全血中检测到 rWBC，平均 rWBC 为 0.012 × 109 /L，在 PLT 浓缩物--水包衣中检测到 rWBC，平均 rWBC 为 0.19 × 109 /L。两种分析仪对浓缩红细胞-全血中所有三个参数（HGB、HCT、RBC）的相关系数都非常好，在 0.95 至 0.99 之间。血小板计数的相关系数为 0.98 至 0.99：配备血库模式的 XN 系列分析仪在用于献血者评估、红细胞计数和最终血液制品测量时表现出可靠的性能。

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来源期刊

Transfusion Medicine 医学-血液学

CiteScore

2.70

自引率

0.00%

发文量

审稿时长

6-12 weeks

期刊介绍： Transfusion Medicine publishes articles on transfusion medicine in its widest context, including blood transfusion practice (blood procurement, pharmaceutical, clinical, scientific, computing and documentary aspects), immunohaematology, immunogenetics, histocompatibility, medico-legal applications, and related molecular biology and biotechnology. In addition to original articles, which may include brief communications and case reports, the journal contains a regular educational section (based on invited reviews and state-of-the-art reports), technical section (including quality assurance and current practice guidelines), leading articles, letters to the editor, occasional historical articles and signed book reviews. Some lectures from Society meetings that are likely to be of general interest to readers of the Journal may be published at the discretion of the Editor and subject to the availability of space in the Journal.