Electronic-nose had been used to diagnose other infectious lung diseases, such as tuberculosis. Universitas Gadjah Mada has developed an electronic-nose device which is easy-to-use, portable, and can be manufactured at a low price. Here the investigators test the electronic-nose to diagnose COVID-19 in Indonesia.
The validation of device is conducted to 43 confirmed COVID-19 patients and 40 confirmed
COVID-19 negative patients from Bhayangkara Hospital, RSLKC Bambalipuro in Yogyakarta Special
Region, Indonesia.
Afterwards, patients with symptoms suggesting COVID-19 will be recruited using multicentre
consecutive sampling. The minimum number of participants required is 1460 subjects. The study
use a triple-blind design where the research subjects, breath sample takers, and sample
examiners did not know the results of each sampling that had been done. The final data
processor was also blinded to the results of nose and throat swabs. The breath sampling data
is saved in graphic form which interpretation will be carried out later by the data processor
at the final stage.
This study population involve children and adults who come to the COVID-19 outpatient clinic
in each participating hospital with a diagnosis of suspected COVID-19 infection. All patients
remain in the setting under medical service in accordance with the standard operating
procedure (SOP) and clinical practice guidelines (CPG) protocols for handling patients with
suspected COVID-19. The patients underwent nasal and oropharyngeal swabs according to the
COVID-19 outpatient CPG.
The participants will be asked about symptoms that they have, such as fever, fatigue, dry
cough, stuffy/ runny nose, sore throat, myalgia, shortness of breath, and diarrhea.
Afterwards, they will be asked to breathe normally using a mask for 2 times, then inhale and
exhale in a forced expiratory volume to an air collecting bag that later is connected to the
e-nose machine via a HEPA-filter. The performance of breath test will be compared with the
performance of symptoms with the reference of RT-PCR results. In addition, participants'
demographic and clinical data will be collected.
Other: exhaled breath sampling
The participants breath through non-rebreathing mask until the reservoir bag is full. The reservoir bag is connected to Hepa-filter at one side, and another side of Hepa-filter is connected to the electronic-nose (Genosvid) device.
Other Name: GENOSVID portable exhaled breath sampling
Other: exhaled breath sampling
The participants breath through non-rebreathing mask until the reservoir bag is full. The reservoir bag is connected to Hepa-filter at one side, and another side of Hepa-filter is connected to the electronic-nose (Genosvid) device.
Other Name: GENOSVID portable exhaled breath sampling
Other: exhaled breath sampling
The participants breath normally using a mask for 2 times then they are asked to inhale and exhale in a forced expiratory volume through an e-nose tube connected to the Hepa-filter at the inlet.
Other Name: GENOSVID portable exhaled breath sampling
Inclusion Criteria:
- Patients diagnosed with COVID-19, non COVID-19, and suspected COVID-19 infection,
based on the results of anamnesis, physical examination, laboratory, X-rays and rapid
tests.
- Able to produce samples for RT-PCR examination.
- Agree to participate (sign informed consent). For children, informed consent are
obtained from the parents. For adolescent patients, accent consent is asked.
- Patients who do not need oxygen therapy supplementation in the form of mask-type or
ventilator. Patients who use oxygen supplementation with nasal cannula are still
included as study participants.
Exclusion Criteria:
- Unable to breath deeply due to difficulty breathing due to complications of COVID-19
or other diseases
- The quality of the breath do not meet the standard interpretation of the instrument
sensor curve (breath sampel is declared invalid).
RS Bhayangkara Tk I R.Said Soekanto
Jakarta, Indonesia
Saiful Anwar
Malang, Indonesia
Dr Sardjito Hospital
Yogyakarta, Indonesia
Bambanglipuro Hospital
Yogyakarta, Indonesia
Bhayangkara Tk III Polda DIY
Yogyakarta, Indonesia
RS Akademik UGM
Yogyakarta, Indonesia
RSPAU Hardjolukito
Yogyakarta, Indonesia
RST Tk III Dr Soetarto
Yogyakarta, Indonesia