Automated cell counts on CSF samples: A multicenter performance evaluation of the GloCyte system
Automated cell counts on CSF samples: A multicenter performance evaluation of the GloCyte system
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DOI：
10.1111/ijlh.12728
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发表时间：
2018-02-01
影响因子：
3
通讯作者：
Kratz, A.
中科院分区：
文献类型：
--
作者：
Hod, E. A.;Brugnara, C.;Kratz, A.
目的：自动化细胞计数器已经取代了人工计数血液和大多数体液中的细胞。然而，由于自动化方法在细胞计数非常低的情况下不可靠，大多数实验室继续对许多或所有脑脊液(CSF)样本进行劳动密集型人工计数。这项多中心临床试验调查了GloCyte系统(高级仪器，马萨诸塞州诺伍德)，这是一种最近获得FDA批准的自动化细胞计数器，用于浓缩和计数红细胞(RBCs)和有核细胞总数(TNCs)，在极低的细胞计数下是否足够准确和精确，以取代所有人工脑脊液计数。然后通过数字图像分析对红细胞和跨国公司进行计数。在五个不同的医疗中心获得用于临床分析的残留成人和儿童脑脊液样本用于研究。细胞计数由人工血球计数仪法进行，并在所有部位使用GloCyte系统执行相同的方案。结果：GloCyte最低检测限为1个TNC/亩L和1个红细胞/亩L，可靠计数最低为3个TNCs/亩L和2个RBC/L，总变异系数小于20%。结论：GloCyte血细胞分析仪是一种精确、准确、稳定的脑脊液中红细胞和有核细胞计数系统，适用于脑脊液中的红细胞和有核细胞计数。它允许对非常低的细胞数进行自动计数，这对脑脊液分析至关重要。这些结果表明，对于所有脑脊液样本，包括细胞计数正常的脑脊液样本，GloCyte是一种可以接受的替代手工方法。
Objectives: Automated cell counters have replaced manual enumeration of cells in blood and most body fluids. However, due to the unreliability of automated methods at very low cell counts, most laboratories continue to perform labor-intensive manual counts on many or all cerebrospinal fluid (CSF) samples. This multicenter clinical trial investigated if the GloCyte System (Advanced Instruments, Norwood, MA), a recently FDA-approved automated cell counter, which concentrates and enumerates red blood cells (RBCs) and total nucleated cells (TNCs), is sufficiently accurate and precise at very low cell counts to replace all manual CSF counts.Methods: The GloCyte System concentrates CSF and stains RBCs with fluorochrome-labeled antibodies and TNCs with nucleic acid dyes. RBCs and TNCs are then counted by digital image analysis. Residual adult and pediatric CSF samples obtained for clinical analysis at five different medical centers were used for the study. Cell counts were performed by the manual hemocytometer method and with the GloCyte System following the same protocol at all sites. The limits of the blank, detection, and quantitation, as well as precision and accuracy of the GloCyte, were determined.Results: The GloCyte detected as few as 1 TNC/mu L and 1 RBC/mu L, and reliably counted as low as 3 TNCs/mu L and 2RBCs/L. The total coefficient of variation was less than 20%. Comparison with cell counts obtained with a hemocytometer showed good correlation (>97%) between the GloCyte and the hemocytometer, including at very low cell counts.Conclusions: The GloCyte instrument is a precise, accurate, and stable system to obtain red cell and nucleated cell counts in CSF samples. It allows for the automated enumeration of even very low cell numbers, which is crucial for CSF analysis. These results suggest that GloCyte is an acceptable alternative to the manual method for all CSF samples, including those with normal cell counts.