Evaluation of Nanopore Sequencing for Diagnosing Pulmonary Tuberculosis Using Negative Smear Clinical Specimens

Abstract

Purpose

This study aimed to evaluate the efficacy of nanopore sequencing for diagnosing pulmonary tuberculosis (PTB) using smear-negative clinical specimens.

Methods

We conducted a retrospective study based on a review of patient medical records to assess the accuracy of nanopore sequencing as a diagnostic tool for smear-negative PTB. Compared with clinical diagnosis, we determined the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under the curve (AUC) of nanopore sequencing.

Results

A total of 647 patients were evaluated. Nanopore sequencing demonstrated an overall sensitivity of 91.7%, specificity of 85.3%, PPV of 95.1%, NPV of 76.4%, and AUC of 0.88. Notably, the overall diagnostic accuracy of nanopore sequencing was significantly higher than that of Mycobacterium tuberculosis (MTB) culture technique.

Conclusion

Nanopore sequencing exhibited satisfactory overall diagnostic accuracy for smear-negative PTB, regardless of MTB culture status. Therefore, if conditions permit, nanopore sequencing is recommended as a diagnostic method for smear-negative PTB.

Keywords:

• nanopore sequencing
• smear-negative specimens
• pulmonary tuberculosis
• diagnostic accuracy

Data Sharing Statement

Data will be available from the corresponding author on reasonable request.

Compliance with Ethical Standards

The study was approved by the Human Research Ethics Committee of Hangzhou Red Cross Hospital. This is a retrospective study conducted on already available data and will not have any impact on patients; therefore, our ethics committee waived informed consent from patients.

Acknowledgments

We would like to express our gratitude to the patients and colleagues in our department.

Disclosure

The authors declare that they have no conflicts of interest in this work.

Additional information

Funding

This work was supported by Hangzhou Science and Technology Bureau, http://kj.hangzhou.gov.cn. Guocan Yu, 20201203B183. The funder does not have a role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.