Evaluation of clinical application of automatic acid-fast staining microscopic scanning system

doi:10.3969/j.issn.1000-6621.2021.10.019

Abstract

Abstract:

Objective To evaluate the application value of the automatic acid-fast staining microscopic scanning system (AFB-AS) in detecting sputum specimens of pulmonary tuberculosis patients. Methods A total of 462 pulmonary tuberculosis patients diagnosed at the Beijing Tuberculosis Control Institute from January to August 2019 were collected. Each patient retained 3 newly diagnosed sputum samples (n_total=1386). All specimens were stained by Ziehl-Neelsen (ZN) and double-blindly tested by traditional acid-fast bacillus staining microscopy and AFB-AS inspection; 2 sputum samples from each patient were selected for mycobacterial isolation and culture, a total of 924 were completed; the other one of sputum samples was tested by GeneXpert MTB/RIF (Xpert) simultaneously, and a total of 462 samples were completed. The results of different methods for detecting sputum specimens of pulmonary tuberculosis patients were compared. The efficacy of traditional acid-fast bacillus staining microscopy and AFB-AS for detecting sputum specimens of pulmonary tuberculosis patients was analyzed based on the results of mycobacterial isolation and culture, so was the level correlation between the traditional acid-fast bacillus staining microscopic examination and AFB-AS test for positive results. Results The positive rates of sputum specimens of pulmonary tuberculosis patients detected by various methods, from high to low, were Xpert (69.26%, 320/462), mycobacterial isolation and culture (43.61%, 403/924), AFB-AS (43.22%, 599/1386) and traditional acid-fast bacilli staining microscopic examination (38.24%, 530/1386). The positive rate of sputum specimens detected by AFB-AS was significantly higher than that by traditional acid-fast bacilli staining microscopy (χ²=67.015, P<0.01). The correlation coefficient between AFB-AS and traditional acid-fast bacilli staining microscopy to judge the positive result level was 0.954. Taking the results of mycobacterial isolation and culture as the reference, the sensitivity, specificity, positive predictive value and negative predictive value of AFB-AS were 94.29% (380/403), 90.40% (471/521), 88.37% (380/430) and 95.34% (471/494), respectively, and the Kappa value was 0.841. Conclusion AFB-AS has good application value in detecting sputum specimens of pulmonary tuberculosis patients. The inspection performance can meet the requirements of the project of monitoring acid-fast bacilli by Z-N.

Key words: Mycobacterium tuberculosis, Staining and labeling, Microscopy, Automation

DING Bei-chuan, ZHOU Fu, YANG Xin-yu, MENG Xian-jie, YI Jun-li, YE Jian-miao, WU Wen-qing. Evaluation of clinical application of automatic acid-fast staining microscopic scanning system[J]. Chinese Journal of Antituberculosis, 2021, 43(10): 1084-1088. doi: 10.3969/j.issn.1000-6621.2021.10.019

Figures/Tables 4

References 9

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抗酸染色全自动显微扫描系统人工复核	传统抗酸杆菌染色镜检						合计
抗酸染色全自动显微扫描系统人工复核	N条	1+	2+	3+	4+	阴性	合计
N条	12	2	0	0	0	49	63
1+	43	192	4	5	0	20	264
2+	0	4	113	0	0	0	117
3+	0	0	0	105	0	0	105
4+	0	0	0	1	49	0	50
阴性	0	0	0	0	0	787	787
合计	55	198	117	111	49	856	1386

抗酸染色全自动显微扫描系统软件识别	传统抗酸杆菌染色镜检						合计
抗酸染色全自动显微扫描系统软件识别	N条	1+	2+	3+	4+	阴性	合计
N条	5	0	0	0	0	92	97
1+	50	193	4	5	0	81	333
2+	0	5	113	0	0	0	118
3+	0	0	0	105	0	0	105
4+	0	0	0	1	49	0	50
阴性	0	0	0	0	0	683	683
合计	55	198	117	111	49	856	1386

抗酸染色全自动显微扫描系统软件识别	抗酸染色全自动显微扫描系统人工复核						合计
抗酸染色全自动显微扫描系统软件识别	N条	1+	2+	3+	4+	阴性	合计
N条	29	0	0	0	0	68	97
1+	34	263	0	0	0	36	333
2+	0	1	117	0	0	0	118
3+	0	0	0	105	0	0	105
4+	0	0	0	0	50	0	50
阴性	0	0	0	0	0	683	683
合计	63	264	117	105	50	787	1386

检查方法	分枝杆菌分离培养		敏感度 (95%CI,%)	特异度 (95%CI,%)	阳性预测值 (95%CI,%)	阴性预测值 (95%CI,%)	Kappa值
检查方法	阳性(份)	阴性(份)	敏感度 (95%CI,%)	特异度 (95%CI,%)	阳性预测值 (95%CI,%)	阴性预测值 (95%CI,%)	Kappa值
传统抗酸杆菌染色镜检			89.58 (85.73~93.43)	95.59 (93.00~98.18)	94.01 (91.02~97.00)	92.22 (88.85~95.59)	0.856
阳性	361	23
阴性	42	498
抗酸染色全自动显微扫描系统检测			94.29 (91.37~97.21)	90.40 (86.96~94.11)	88.37 (84.33~92.41)	95.34 (92.68~98.00)	0.841
阳性	380	50
阴性	23	471

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