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目的为了获得国产T淋巴细胞检测试剂(同生试剂),在FACSCalibur流式细胞仪上各指标检测结果的准确性和精确性。方法采用3个批次同生试剂(CD3-FITC/CD4-PE/CD45-PerCP三色荧光单克隆抗体试剂和CD3-FITC/CD8-PE/CD45-PerCP/CD4-APC四色荧光单克隆抗体试剂),对正常值和低值商用质控全血在FACSCalibur流式细胞仪上进行连续20天检测,计算批内和批间变异;对广西206份艾滋病病毒(HIV)感染者全血样本进行平行检测,计算各指标的准确性。结果同生三色试剂各指标的绝对数结果批内变异范围为2.66%~6.33%,百分数为1.12%~4.71%;同生四色试剂的绝对数结果批内变异范围为2.61%~6.38%,百分数为0.97%~4.96%。绝对数和百分数结果批间变异均小于5.72%。与参考方法比,各指标绝对数和百分数相关系数在0.97以上。三色和四色试剂CD4+T淋巴细胞绝对数平均偏差分别为(-0.3±54.2)个/μL和(5.0±55.3)个/μL;CD3+T淋巴细胞绝对数平均偏差分别为(15.0±145.2)个/μL和(0.4±129.2)个/μL;四色试剂CD8+T淋巴细胞绝对数平均偏差为(-22.4±87.1)个/μL;各指标百分数平均偏差均在1.28%以内。结论同生试剂在各指标FACSCalibur流式细胞仪上具有较高的准确性,可以应用于BD FACScilbur流式细胞仪。
Objective To obtain the accuracy and accuracy of the test results on FACSCalibur flow cytometer in order to obtain domestic T lymphocyte test reagent (syngeneic reagent). Methods Three batch reagents (CD3-FITC / CD4-PE / CD45-PerCP tristimulus monoclonal antibody reagent and CD3-FITC / CD8-PE / CD45-PerCP / CD4-APC four-color fluorescent monoclonal antibody Reagent), normal and low-value commercial control of whole blood on FACSCalibur flow cytometry for 20 consecutive days to calculate intra-assay and inter-batch variation; to Guangxi 206 HIV-infected whole blood samples Parallel testing, calculate the accuracy of the indicators. Results The results of in-vivo variation of in-vivo tri-color reagent ranged from 2.66% to 6.33% with a percentage of 1.12% to 4.71%. The intra-assay variation ranged from 2.61% to 6.38% , The percentage is 0.97% ~ 4.96%. The variation between absolute and percentage results was less than 5.72% between batches. Compared with the reference method, the correlation coefficient between the absolute number and the percentage of each index is above 0.97. The mean absolute numbers of CD4 + T lymphocytes in the three color and four color reagents were (-0.3 ± 54.2) / μL and (5.0 ± 55.3) / μL, respectively; the mean absolute numbers of CD3 + T lymphocytes were (15.0 ± 145.2) cells / μL and (0.4 ± 129.2) cells / μL. The average absolute deviation of CD8 + T lymphocytes of four color reagents was -22.4 ± 87.1 cells / μL. The average percentage deviation of each index was within 1.28%. Conclusions Tongsheng reagent has high accuracy in FACSCalibur flow cytometry and can be applied to BD FACScilbur flow cytometry.