Enhancing TB case detection: experience in offering upfront Xpert MTB/RIF testing to pediatric presumptive TB and DR TB cases for early rapid diagnosis of drug sensitive and drug resistant TB.

Enhancing TB case detection: experience in offering upfront Xpert MTB/RIF testing to pediatric presumptive TB and DR TB cases for early rapid diagnosis of drug sensitive and drug resistant TB.
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DOI:
10.1371/journal.pone.0105346
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发表时间:
2014
期刊:
影响因子:
3.7
通讯作者:
Paramsivan CN
Paramsivan CN
中科院分区:
综合性期刊3区
文献类型:
--
作者:
Raizada N;Sachdeva KS;Nair SA;Kulsange S;Gupta RS;Thakur R;Parmar M;Gray C;Ramachandran R;Vadera B;Ekka S;Dhawan S;Babre A;Ghedia M;Alavadi U;Dewan P;Khetrapal M;Khanna A;Boehme C;Paramsivan CN

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由于难以获得高质量的痰液标本以及疾病的少菌性,儿童肺结核(PTB)的诊断具有挑战性。在全球范围内,很大比例的儿童结核病(TB)病例仅根据临床发现进行诊断。Xpert MTB/RIF是一种高度敏感和特异的快速工具,为应对这些挑战提供了一种有前途的解决方案。本研究介绍了参加大型示范研究的儿科组的结果,其中Xpert MTB/RIF检测取代了印度公共卫生机构所有假定PTB病例的涂片镜检。该研究覆盖了18个计划分区结核病单位(TU)的880万人口,每个研究TU都建立了一个Xpert MTB/RIF平台。前瞻性入组研究地区任何公共卫生机构的儿科推定PTB病例(TB和耐药TB(DR-TB)),并按照标准化诊断算法在Xpert MTB/RIF上进行检测。4,600例儿科疑似肺结核病例入组。诊断出590例(12.8%,CI 11.8-13.8)儿科PTB。总体而言,10.4%(CI 9.5-11.2)的推定PTB病例经Xpert MTB/RIF检测结果为阳性,而4.8%(CI 4.2-5.4)的病例涂片结果为阳性。对推定的PTB和推定的耐药结核病例进行的前期Xpert MTB/RIF检测分别诊断出79例和12例利福平耐药病例。利福平耐药检测的阳性预测值(PPV)较高(98%,CI 90.1-99.9),既往治疗史无统计学显著性差异。在印度,在儿科推定PTB病例中提前使用Xpert MTB/RIF检测与细菌学证实的PTB增加两倍以及在常规操作条件下利福平耐药结核病例的检出率增加相关。这些结果表明,常规Xpert MTB/RIF检测是解决目前儿科患者PTB诊断挑战的一种有前途的解决方案。
Diagnosis of pulmonary tuberculosis (PTB) in children is challenging due to difficulties in obtaining good quality sputum specimens as well as the paucibacillary nature of disease. Globally a large proportion of pediatric tuberculosis (TB) cases are diagnosed based only on clinical findings. Xpert MTB/RIF, a highly sensitive and specific rapid tool, offers a promising solution in addressing these challenges. This study presents the results from pediatric groups taking part in a large demonstration study wherein Xpert MTB/RIF testing replaced smear microscopy for all presumptive PTB cases in public health facilities across India. The study covered a population of 8.8 million across 18 programmatic sub-district level tuberculosis units (TU), with one Xpert MTB/RIF platform established at each study TU. Pediatric presumptive PTB cases (both TB and Drug Resistant TB (DR-TB)) accessing any public health facilities in study area were prospectively enrolled and tested on Xpert MTB/RIF following a standardized diagnostic algorithm. 4,600 pediatric presumptive pulmonary TB cases were enrolled. 590 (12.8%, CI 11.8–13.8) pediatric PTB were diagnosed. Overall 10.4% (CI 9.5–11.2) of presumptive PTB cases had positive results by Xpert MTB/RIF, compared with 4.8% (CI 4.2–5.4) who had smear-positive results. Upfront Xpert MTB/RIF testing of presumptive PTB and presumptive DR-TB cases resulted in diagnosis of 79 and 12 rifampicin resistance cases, respectively. Positive predictive value (PPV) for rifampicin resistance detection was high (98%, CI 90.1–99.9), with no statistically significant variation with respect to past history of treatment. Upfront access to Xpert MTB/RIF testing in pediatric presumptive PTB cases was associated with a two-fold increase in bacteriologically-confirmed PTB, and increased detection of rifampicin-resistant TB cases under routine operational conditions across India. These results suggest that routine Xpert MTB/RIF testing is a promising solution to present-day challenges in the diagnosis of PTB in pediatric patients.
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