Determining the diagnostic potential of Truenat MTB Plus for Tubercular lymphadenitis and detection of drug resistance and a comparison with GeneXpert Ultra,Tuberculosis

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Determining the diagnostic potential of Truenat MTB Plus for Tubercular lymphadenitis and detection of drug resistance and a comparison with GeneXpert Ultra
Tuberculosis ( IF 3.2 ) Pub Date : 2023-07-17 , DOI: 10.1016/j.tube.2023.102379
Kusum Sharma ₁ , Megha Sharma ₂ , Nalini Gupta ₃ , Tanish Modi ₄ , Himanshu Joshi ₁ , Ritu Shree ₅ , Aman Sharma ₆

Affiliation

Setting

Tubercular lymphadenitis (TBLA), the most common form of extrapulmonary tuberculosis, is a diagnostic challenge.

Objective

Truenat MTB Plus (TruPlus) along with Truenat Rif assay (TruRif) was evaluated for detection of TBLA and rifampicin resistance and compared with GeneXpert Ultra (Xpert Ultra).

Design

100 fine-needle aspirated specimens [50 confirmed by culture/smear/cytology, 20 clinically suspected, and 30 controls], processed in the mycobacteriology division of department of microbiology were subjected to TruPlus and TruRif, Xpert Ultra and multiplex PCR. The results of TBLA detection were compared against composite reference standard (CRS) and those of rifampicin resistance were compared against phenotypic drug susceptibility testing and rpoB gene sequencing.

Results

In comparison to CRS, the diagnostic yield of TruPlus, Xpert Ultra and MPCR was 77.14%, 59.18% and 84.28%, respectively; with substantial agreement for TruPlus (k = 0.66) and MPCR (k = 0.76) and moderate for Xpert Ultra (k = 0.60). TruRif reported four cases as RifR and Xpert Ultra reported two. On comparing with phenotypic DST and gene sequencing, only two cases of RifR were confirmed, hence TruRif reported false-RifR in two cases.

Conclusion

TruPlus could be used as a reliable tool for diagnosing TBLA. The reporting of RifR by TruRif should be confirmed by phenotypic DST or gene sequencing.

中文翻译：

确定 Truenat MTB Plus 对结核性淋巴结炎的诊断潜力和耐药性检测以及与 GeneXpert Ultra 的比较

环境

结核性淋巴结炎 (TBLA) 是肺外结核最常见的形式，是一种诊断挑战。

客观的

对 Truenat MTB Plus (TruPlus) 与 Truenat Rif 检测 (TruRif) 一起评估 TBLA 和利福平耐药性的检测，并与 GeneXpert Ultra (Xpert Ultra) 进行比较。

设计

对微生物科分枝杆菌科处理的 100 份细针吸取标本（50 份经培养/涂片/细胞学证实，20 份临床怀疑，30 份对照）进行TruPlus 和 TruRif、Xpert Ultra 和多重 PCR。将TBLA检测结果与复合参考标准（CRS）进行比较，利福平耐药结果与表型药敏试验和rpoB基因测序进行比较。

结果

与CRS相比，TruPlus、Xpert Ultra和MPCR的诊断率分别为77.14%、59.18%和84.28%；TruPlus (k = 0.66) 和 MPCR (k = 0.76) 基本一致，而 Xpert Ultra (k = 0.60) 则中等。TruRif 报告了 4 例，而 RifR 和 Xpert Ultra 报告了 2 例。与表型药敏试验和基因测序相比，仅确认了两例 RifR，因此 TruRif 报告了两例假 RifR。