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Background <p>The objective of this study was to analyze the tuberculosis(TB) positivity rate of formalin-fixed paraffin-embedded (FFPE) tissue samples, to explore the difference between the positivity rates of pulmonary tuberculosis (PTB) and extrapulmonary tuberculosis (EPTB), and to compare the value of fluorescent probe-based polymerase chain reaction (PCR) for the detection of <i>Mycobacterium tuberculosis</i> DNA (TB-DNA) and modified Ziehl-Neelsen acid-fast staining (Z-N staining) in the diagnosis of tuberculosis.</p> Methods <p>A total of 491 patients with histopathological suspected TB admitted to Hainan General Hospital from October 2022 to March 2024 were enrolled. FFPE tissue samples were collected from all participants and examined by fluorescence probe PCR for TB-DNA, acid‑fast staining, and hematoxylin-eosin (H&amp;E) staining. The positive detection rates of TB among different assays were compared. With fluorescent probe PCR results serving as the reference standard, the diagnostic performance of modified Z-N staining was further evaluated. Count data were analyzed using the chi-square test, and a fourfold table was applied to assess the diagnostic efficacy.</p> Results <p>TB was detected by PCR in 278 cases and by modified Z-N staining in 89 cases. analysis revealed that age, modified Z-N staining results, musculoskeletal tuberculosis (MSTB), and intra-abdominal tuberculosis were significantly associated with TB-PCR results (<i>P</i> &lt; 0.05). The median age was 52 years (interquartile range [IQR]: 37–65 years). Among FFPE tissue samples, the highest proportion of PCR positivity was found in the young group (18–44 years) at 65.97%, while the highest proportion of PCR negativity was seen in the middle-aged group (45–59 years) at 46.84%. The most common sites of EPTB involvement were the pleura, head and neck, and musculoskeletal system, with an overall proportion of 36.46% (179/491). modified Z-N staining was closely correlated with TB-PCR outcomes in both PTB and EPTB subgroups.</p> Conclusions <p>The use of PCR detection of TB-DNA is more effective than modified Z-N staining for the diagnosis of PTB and EPTB. It is recommended that FFPE tissue samples are prioritised for screening for <i>Mycobacterium tuberculosis</i> by PCR to speed up the diagnosis of TB.</p> Clinical trial <p>Not applicable.</p>

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Analysis of the prevalence of positivity for tuberculosis infection in formalin-fixed paraffin-embedded tissue

  • 期刊论文

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  • 发表日期：

    2026年8月5日

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  • Yu Wu,
  • Sha-sha Hu,
  • Shan-yong Wang,
  • Shu Chen,
  • Bo Wang

摘要

Background

The objective of this study was to analyze the tuberculosis(TB) positivity rate of formalin-fixed paraffin-embedded (FFPE) tissue samples, to explore the difference between the positivity rates of pulmonary tuberculosis (PTB) and extrapulmonary tuberculosis (EPTB), and to compare the value of fluorescent probe-based polymerase chain reaction (PCR) for the detection of Mycobacterium tuberculosis DNA (TB-DNA) and modified Ziehl-Neelsen acid-fast staining (Z-N staining) in the diagnosis of tuberculosis.

Methods

A total of 491 patients with histopathological suspected TB admitted to Hainan General Hospital from October 2022 to March 2024 were enrolled. FFPE tissue samples were collected from all participants and examined by fluorescence probe PCR for TB-DNA, acid‑fast staining, and hematoxylin-eosin (H&E) staining. The positive detection rates of TB among different assays were compared. With fluorescent probe PCR results serving as the reference standard, the diagnostic performance of modified Z-N staining was further evaluated. Count data were analyzed using the chi-square test, and a fourfold table was applied to assess the diagnostic efficacy.

Results

TB was detected by PCR in 278 cases and by modified Z-N staining in 89 cases. analysis revealed that age, modified Z-N staining results, musculoskeletal tuberculosis (MSTB), and intra-abdominal tuberculosis were significantly associated with TB-PCR results (P < 0.05). The median age was 52 years (interquartile range [IQR]: 37–65 years). Among FFPE tissue samples, the highest proportion of PCR positivity was found in the young group (18–44 years) at 65.97%, while the highest proportion of PCR negativity was seen in the middle-aged group (45–59 years) at 46.84%. The most common sites of EPTB involvement were the pleura, head and neck, and musculoskeletal system, with an overall proportion of 36.46% (179/491). modified Z-N staining was closely correlated with TB-PCR outcomes in both PTB and EPTB subgroups.

Conclusions

The use of PCR detection of TB-DNA is more effective than modified Z-N staining for the diagnosis of PTB and EPTB. It is recommended that FFPE tissue samples are prioritised for screening for Mycobacterium tuberculosis by PCR to speed up the diagnosis of TB.

Clinical trial

Not applicable.