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歷年發表稿件

GeneXpert/GenoType 測試準確性的綜合評估及其與高危險結核病病人抗藥性的相關性

感控監測

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GeneXpert/GenoType 測試準確性的綜合評估及其與高危險結核病病人抗藥性的相關性

Comprehensive Assessment of GeneXpert/GenoType Test Accuracy and Its Correlation with Drug Resistance in High-Risk Tuberculosis Patients

Tuberculosis (TB) remains a global health challenge, particularly among high-risk populations prone to multidrug resistance. GeneXpert/GenoType testing offers rapid molecular diagnostics for detecting Mycobacterium tuberculosis complex (MTBC) and identifying drug-resistant strains like rifampin-resistant (RMP-R) and isoniazid-resistant (INH-R). This study evaluates the performance of GeneXpert/GenoType testing in high-risk TB patients, examining sensitivity, specificity, predictive values, and correlations with smear intensity, test results, and drug susceptibility testing (DST).

A retrospective analysis of a total of 67 cases from a regional hospital in southern Taiwan from 2021 to 2023 that met the CDC definition of high-risk tuberculosis patients and required GeneXpert/GenoType testing was collected. Patients categorized into five groups: "Apply for second-line drugs," "Treatment failure," "Recurrent cases," "High-burden countries," and "High-risk towns". Variables analyzed include smear Intensity,test Results(MTBC negative and MTBC positive),DST results. Use R statistical software to analyze the correlation between smear intensity, test results and DST patterns.

The diagnostic performance of the test demonstrated high sensitivity(93.48%) and specificity(90.48%) ,test also showed a positive predictive value (PPV) of 95.56%, negative predictive value (NPV) was 86.36%, overall, the diagnostic accuracy reached 92.54%. Correlation analysis revealed a strong positive relationship between smear intensity and test results, indicating higher smear intensities (e.g., "3+", "4+") align with MTBC positivity. There was minimal correlation between smears and susceptibility testing, showing that bacterial load did not predict resistance patterns. Test results were not significantly related to DST because most MTBC-positive cases were drug-susceptible (RMP-S). Most MTBC-positive cases were smear-positive and drug-sensitive (RMP-S), drug resistance patterns (RMP-R, INH-R) were rare, highlighting effective TB management in the study population.

GeneXpert/GenoType testing demonstrated high sensitivity and specificity, confirming its effectiveness as a rapid diagnostic tool for tuberculosis (TB) in high-risk populations. The strong positive predictive value (PPV) ensured accurate identification of MTBC-positive cases, providing confidence in the diagnosis. However, the moderate negative predictive value (NPV) highlighted the potential for false negatives, particularly in smear-negative cases, suggesting a need for supplementary diagnostic strategies in such scenarios. Correlation analysis revealed that smear intensity serves as a strong predictor of MTBC positivity. However, smear results did not correlate with drug resistance patterns, underscoring the need for additional methods to detect resistance. In conclusion, GeneXpert/GenoType testing proves to be a reliable diagnostic tool for TB management, particularly in facilitating early detection and guiding treatment strategies for high-risk patients. To further improve diagnostic outcomes, future efforts should prioritize enhancing specificity and developing molecular diagnostics capable of accurately predicting drug resistance patterns. Continuous surveillance and efforts to improve diagnostic accuracy are critical to achieving global TB elimination goals.

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