Sodium Hypochlorite Diagnostic Performance compared to Ziehl-Nelseen method among Presumptive Tuberculosis Patients in Uganda

Laban Habokwesiga, N. Lubowa
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Abstract

Background: Tuberculosis remains a major public health problem worldwide. Direct Ziehl Nelseen (ZN) is the conventional Laboratory method for diagnosis of TB. However, there are higher chances of missing TB positive cases due to insufficient sensitivity. This would eventually lead to TB transmission and hence mortality. Objective: To determine sensitivity and specificity of ZN diagnostic technique on concentrated and unconcentrated sputum samples as well as to assess how clinical, socio-demographic, and sample variables affect concentrated sputum ZN positivity. Method and Materials: This cross-sectional investigation was carried out in Mulago Hospital, covering adult TB presumptive patients. Sputum samples from 114 patients were collected and processed by both NaOCl concentration and direct ZN diagnostic techniques. Sensitivity and specificity were calculated and tabulated. Prediction of ZN positivity was assessed using Logistic regression analysis. Results: Out of the total 114 samples, 82 (71.9%) were positive by GeneXpert test (the gold standard), whereas by NaOCl concentration method 79 samples (69.3%) were found positive but with direct ZN method 65 samples (57.0%) were found positive, thus an increase of 14 samples (12.3%) in positivity was noted when used NaOCl concentration method which is highly significant with ρ<0.05 (χ2 =95.38). NaOCl concentration method got a higher sensitivity than direct sputum smear with 97.5% and 80.2% respectively. The specificities were almost the same with NaOCl method 93.9% and direct sputum smear with 90.9%. NaOCl concentration method had a PPV of 0.98 and NPV of 0.94 while direct sputum smear had PPV of 0.95 and NPV of 0.65. Conclusion: NaOCl concentration method was found to be more sensitive than direct ZN though the specificity was almost the same. Clinical, socio-demographic and sample factors’ effect on ZN positivity was not statistically significant (ρ value=0.796). NaOCl concentration method should be adopted for effective diagnosis of pulmonary TB.
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次氯酸钠诊断性能比较Ziehl-Nelseen方法在推定肺结核患者在乌干达
背景:结核病仍然是世界范围内的一个主要公共卫生问题。直接Ziehl - Nelseen (ZN)是诊断结核病的常规实验室方法。然而,由于灵敏度不足,遗漏结核阳性病例的可能性更高。这将最终导致结核病的传播和死亡。目的:确定锌诊断技术对浓、不浓痰样的敏感性和特异性,评价临床、社会人口学和样本变量对浓痰锌阳性的影响。方法与材料:本横断面调查在穆拉戈医院进行,调查对象为成年结核病推定患者。采用NaOCl浓度法和ZN直接诊断法对114例患者的痰液进行处理。计算敏感性和特异性并制成表格。采用Logistic回归分析评估ZN阳性预测。结果:114份样品中,GeneXpert法阳性82份(71.9%),NaOCl浓度法阳性79份(69.3%),直接锌法阳性65份(57.0%),NaOCl浓度法阳性14份(12.3%),p <0.05 (χ2 =95.38),差异有显著性。NaOCl浓度法的灵敏度分别为97.5%和80.2%,高于直接痰涂片法。NaOCl法的特异性为93.9%,直接痰涂片法的特异性为90.9%。NaOCl浓度法的PPV为0.98,NPV为0.94,直接痰涂片法的PPV为0.95,NPV为0.65。结论:NaOCl浓度法比直接锌法更敏感,但特异性基本相同。临床、社会人口学和样本因素对ZN阳性的影响无统计学意义(ρ值=0.796)。应采用NaOCl浓度法对肺结核进行有效诊断。
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