Abstract
ObjectiveTo investigate the potency of a hand-held point-of-care electronic-nose to diagnose pulmonary tuberculosis (PTB) among those suspected of PTB.MethodsSetting: Lung clinics and Dr. Sardjito Hospital, Yogyakarta, Indonesia. Participants: patients with suspected PTB and healthy controls. Sampling: 5 minutes exhaled breath. Sputum-smear-microscopy, culture, chest-radiography, and follow-up for 1.5–2.5 years, were used to classify patients with suspected PTB as active PTB, probably active PTB, probably no PTB, and no PTB. After building a breath model based on active PTB, no PTB, and healthy controls (Calibration phase), we validated the model in all patients with suspected PTB (Validation phase). In each variable (sex, age, Body Mass Index, co-morbidities, smoking status, consumption of alcohol, use of antibiotics, flu symptoms, stress, food and drink intake), one stratum’s Receiver Operating Characteristic (ROC)-curve indicating sensitivity and specificity of the breath test was compared with another stratum’s ROC-curve. Differences between Area-under-the-Curve between strata (p<0.05) indicated an association between the variable and sensitivity—specificity of the breath test. Statistical analysis was performed using STATA/SE 15.ResultsOf 400 enrolled participants, 73 were excluded due to extra-pulmonary TB, incomplete data, previous TB, and cancer. Calibration phase involved 182 subjects, and the result was validated in 287 subjects. Sensitivity was 85% (95%CI: 75–92%) and 78% (95%CI: 70–85%), specificity was 55% (95%CI: 44–65%) and 42% (95%CI: 34–50%), in calibration and validation phases, respectively. Test sensitivity and specificity were lower in men.ConclusionThe electronic-nose showed modest sensitivity and low specificity among patients with suspected PTB. To improve the sensitivity, a larger calibration group needs to be involved. With its portable form, it could be used for TB screening in remote rural areas and health care settings.
Highlights
On 26 September, 2018, the United Nations (UN) had a high-level meeting in the UN headquarters in New York on tuberculosis (TB)
After building a breath model based on active pulmonary tuberculosis (PTB), no PTB, and healthy controls (Calibration phase), we validated the model in all patients with suspected PTB (Validation phase)
With its portable form, it could be used for TB screening in remote rural areas and health care settings
Summary
On 26 September, 2018, the United Nations (UN) had a high-level meeting in the UN headquarters in New York on tuberculosis (TB). New diagnostic tools are needed to identify individuals in the community–and in health care facilities–that continue to spread this airborne disease. In many TB high-burden countries, pulmonary tuberculosis (PTB) is commonly diagnosed by sputum smear microscopic examination [1]. Sputum microscopy is labor-intensive, and the technique does not differentiate Mycobacterium tuberculosis (MTB) from non-tuberculosis mycobacteria [2]. Nucleic acid amplification techniques such as Xpert MTB/ RIF allows for fast identification of MTB [4], but costs remain challenging; it still requires sputum sampling and is neither portable nor fit for point-of-care in remote rural areas with unstable electricity supply. Chest radiography (CXR), a non-sputum-based test that is usually used, lacks specificity [3]
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