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. 2016 Jun 6:16:246.
doi: 10.1186/s12879-016-1578-z.

Evaluation of Xpert® MTB/RIF and Ustar EasyNAT™ TB IAD for diagnosis of tuberculous lymphadenitis of children in Tanzania: a prospective descriptive study

Maira Bholla  1   2   3 , Neema Kapalata  4 , Edward Masika  4 , Hassan Chande  5   6 , Levan Jugheli  7   8   9 , Mohamed Sasamalo  9 , Tracy R Glass  7   8 , Hans-Peter Beck  7   8 , Klaus Reither  7   8   9
Affiliations

Evaluation of Xpert® MTB/RIF and Ustar EasyNAT™ TB IAD for diagnosis of tuberculous lymphadenitis of children in Tanzania: a prospective descriptive study

Maira Bholla et al. BMC Infect Dis. .

Abstract

Background: Fine needle aspiration biopsy has become a standard approach for diagnosis of peripheral tuberculous lymphadenitis. The aim of this study was to compare the performance of Xpert MTB/RIF and Ustar EasyNAT TB IAD nucleic acid amplification assays, against acid-fast bacilli microscopy, cytology and mycobacterial culture for the diagnosis of TB lymphadenitis in children from a TB-endemic setting in Tanzania.

Methods: Children of 8 weeks to 16 years of age, suspected of having TB lymphadenitis, were recruited at a district hospital in Tanzania. Fine needle aspirates of lymph nodes were analysed using acid-fast bacilli microscopy, liquid TB culture, cytology, Xpert MTB/RIF and EasyNAT. Latent class analysis and comparison against a composite reference standard comprising "culture and/or cytology" was done, to assess the performance of Xpert MTB/RIF and EasyNAT for the diagnosis of TB lymphadenitis.

Results: Seventy-nine children were recruited; 4 were excluded from analysis. Against a composite reference standard of culture and/or cytology, Xpert MTB/RIF and EasyNAT had a sensitivity and specificity of 58 % and 93 %; and 19 % and 100 % respectively. Relative to latent class definitions, cytology had a sensitivity of 100 % and specificity of 94.7 %.

Conclusions: Combining clinical assessment, cytology and Xpert MTB/RIF may allow for a rapid and accurate diagnosis of childhood TB lymphadenitis. Larger diagnostic evaluation studies are recommended to validate these findings and on Xpert MTB/RIF to assess its use as a solitary initial test for TB lymphadenitis in children.

Keywords: Childhood; Culture; Cytology; Fine needle aspiration; Lymphadenitis; Mycobacterium tuberculosis; Nucleic acid amplification; Ustar EasyNAT; Xpert MTB/RIF; Ziehl-Neelsen.

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Figures

Fig. 1
Fig. 1
Patient enrolment flow chart and clinical outcomes
Fig. 2
Fig. 2
Venn diagram of TB positive results from all diagnostic modalities for FNAB. Diagram shows positive results from culture (including M. tuberculosis and M. bovis BCG), Cytology, Xpert MTB/RIF and EasyNAT. The 3 AFB positive ZN smears are indicated by #
See this image and copyright information in PMC

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