Diagnostic accuracy of Xpert MTB/RIF Ultra for tuberculous meningitis

doi:10.3969/j.issn.1000-6621.2021.07.006

Abstract

Abstract: Objective To evaluate the performance of Xpert MTB/RIF Ultra (Xpert Ultra) for tuberculous meningitis (TBM) diagnosis. Methods All of 189 TBM suspected patients were consecutively enrolled from January 2017 to December 2018 at Beijing Chest Hospital. According to the clinical reference standard, the final sample size for analysis was 151 patients, which included 32 definite TBM, 55 probable TBM, 19 possible TBM, and 45 non-TBM patients. Uncentrifuged CSF specimens collected from each patient were subjected to smear, culture, Xpert and Xpert Ultra. The sensitivity and specificity of all the tests were assessed against uniform clinical case definitions of TBM. Results The direct head-to-head diagnostic performance comparison showed higher sensitivity of Xpert Ultra in contrast with Xpert (44.3% (47/106) vs. 24.5% (26/106); χ²=16.000, P<0.01) among 106 TBM patients. Xpert Ultra also produced a higher sensitivity than culture (44.7%, (34/76)vs. 18.4% (14/76); χ²=12.893,P<0.01) in 76 having culture results patients. When Xpert Ultra outcomes were integrated, the percentage of definite TBM cases increased from 30.2% (32/106) to 50.0% (53/106). Besides, among 62 patients with CSF culture-negative, the positive rate of Xpert Ultra was also higher than Xpert (38.7% (24/62)vs. 21.0% (13/62);χ²=7.692,P=0.003). Both Xpert Ultra (76.1% (35/46) vs. 20.0% (12/60); χ²=33.189, P<0.01) and Xpert (39.1% (18/46)vs. 13.3% (8/60); χ²=9.360, P=0.002) produced higher positive rate in patients without prior anti-TB treatment than those under anti-TB therapy. The positive rate of Xpert Ultra was higher than Xpert in patients without prior anti-TB treatment (χ²=15.059,P<0.01). Both Xpert Ultra and Xpert accurately identified the one rifampicin (RFP)-resistant and the 5 RFP-sensitive cases defined by phenotypic drug sensitivity test. Conclusion Xpert Ultra outperformed both Xpert and culture for TBM diagnosis, especially for CSF culture negative TBM patients, making it a useful tool for rapid diagnosis of TBM.

Key words: Xpert MTB/RIF Ultra, Tuberculosis, meningeal, Diagnosis, Comparative study

HUANG Mai-ling, SUN Qing, WANG Gui-rong, LI Wen-sheng, DU Ya-dong, CAI Bao-yun, HUANG Hai-rong, LI Qi, CHU Nai-hui. Diagnostic accuracy of Xpert MTB/RIF Ultra for tuberculous meningitis[J]. Chinese Journal of Antituberculosis, 2021, 43(7): 670-676. doi: 10.3969/j.issn.1000-6621.2021.07.006

Figures/Tables 3

References 24

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特征	TBM组(106例)	非TBM组(45例)	统计检验值	P值
年龄[岁,M(Q₁,Q₃)]	31(23,52)	42(29,51)	Z=-1.649	0.099
性别[例(构成比,%)]			χ²=0.183	0.669
男性	62(58.5)	28(62.2)
女性	44(41.5)	17(37.8)
症状[例(发生率,%)]
发热	97(91.5)	32(71.1)	χ²=10.560	0.001
头痛	81(76.4)	22(48.9)	χ²=11.038	0.001
呕吐	52(49.1)	11(24.4)	χ²=7.870	0.005
并发疾病[例(发生率,%)]
糖尿病	5(4.7)	2(4.4)	-^a	1.000^a
高血压病	10(9.4)	8(17.8)	χ²=2.095	0.148
其他结核病	86(81.1)	0(0.0)	χ²=84.814	<0.01
血行播散性肺结核	50(47.2)	0(0.0)	χ²=28.134	<0.01
检测前抗结核治疗时间[d,M(Q₁,Q₃)]	8(0,65)	0(0,0)	Z=-6.698	<0.01
脑脊液检测指标[M(Q₁,Q₃)]
白细胞计数(个/μl)	122.5(51.0,316.5)	12.0(3.0,135.0)	Z=-4.047	<0.01
单核细胞(%)	51.6(29.3,73.6)	6.1(0.0,53.6)	Z=-3.734	<0.01
蛋白(mg/dl)	133.5(88.5,212.3)	38.4(23.4,65.0)	Z=-6.450	<0.01
糖(mmol/L)	2.0(1.3,2.7)	3.5(3.0,4.3)	Z=-5.632	<0.01
氯化物(mmol/L)	114.1(108.0,120.1)	125.2(122.6,128.1)	Z=-6.020	<0.01

检测方法	临床诊断		敏感度<break/>(%)	特异度<break/>(%)	阳性预测<break/>值(%)	阴性预测<break/>值(%)	一致率<break/>(%)	Kappa值
检测方法	TBM组<break/>(106例)	非TBM组<break/>(45例)	敏感度<break/>(%)	特异度<break/>(%)	阳性预测<break/>值(%)	阴性预测<break/>值(%)	一致率<break/>(%)	Kappa值
Xpert Ultra			44.3	100.0	100.0	43.3	60.9	0.26
阳性	47	0
阴性	59	45
Xpert			24.5	100.0	100.0	36.0	47.0	0.13
阳性	26	0
阴性	80	45
MGIT 960培养^a			18.4	100.0	100.0	42.1	48.8	0.11
阳性	14	0
阴性	62	45