Important Safety Information | NIOX VERO® User Manual (PDF)
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New study shows FeNO testing with NIOX VERO® is not an aerosol-generating procedure (AGP)
Pulmonary assessments are fundamental to the diagnosis and monitoring of respiratory disease. However, there has been some uncertainty about whether the procedures generate potentially infectious aerosols. Concern about transmitting COVID-19 in this way has seen some diagnostic services delayed or even cancelled during the pandemic. Fortunately, work has been carried out to pinpoint the levels of aerosol generated by each procedure so respiratory care can continue safely. One of the techniques that went under the microscope was FeNO testing with NIOX VERO®, where it was reported that researchers were unable to elicit any aerosol emission at all.
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Testing fractional exhaled nitric oxide (FeNO) is not listed as an aerosol-generating procedure (AGP) in any published documents, including those from Public Health England and the US Centers for Disease Control and Prevention (CDC)1-6. The Association for Respiratory Technology and Physiology (ARTP) classifies FeNO as a low-risk procedure thanks to the low potential for cough and the low expiratory flow it requires7. The British Thoracic Society also supports this conclusion8. In addition, there have been no spontaneous reports of cough using the NIOX VERO® and no coughing-related adverse events during NIOX VERO® clinical trials9.
Using a NIOX VERO® is safe, easy and non-invasive. Every volunteer or patient taking a FeNO test with a NIOX VERO® receives a fresh, single-use mouth filter in a sealed package that is unwrapped and attached to the device’s breathing handle. The patient completely closes their lips around the mouth filter before inhaling and exhaling steadily through the breathing handle.
NIOX VERO® is designed to filter out pathogens, including COVID-19, and its filters have exceptionally high efficiencies: ≥99.99% bacterial filtration efficiency and ≥99.97% viral filtration efficiency9. The airflow rate required during a FeNO test with NIOX VERO® is 50ml/s, meaning only gentle exhalation is needed to successfully obtain a result. Used in this way, FeNO testing with NIOX VERO® has been proven not to produce any significant level of aerosol or droplets.
A doctor explaining how the NIOX VERO® works before a test
Which new studies have been conducted?
A study published in November 2021 looked at the risk of aerosol generation from common test procedures (spirometry, peak flow and FeNO). During testing with NIOX VERO®, the investigators found that “FeNO measurement produced negligible aerosols” and that they “could not elicit any aerosol emission from the FeNO device”. They concluded that FeNO testing “does not generate significant aerosol concentrations compared with coughs in healthy volunteers and patients with lung disease”, supporting the removal or omission of FeNO from lists of AGPs.10
Another 2021 paper, which also excludes FeNO from the list of tests to avoid during the COVID-19 outbreak, said: “FeNO measurements do not cause significant risk of aerosolization and may be permissible. FeNO may be used when available as the risk of transmission is lower.”11 The authors cited a letter that notes FeNO “does not require forced manoeuvres and reduces the potential for coughing and droplet formation, [and] could represent a possible first functional approach to diagnosis and assessment of patients with asthma.”12
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A December 2020 review examining potential alternatives to pulmonary function testing during the pandemic stated: “Institutions familiar with FeNO testing may therefore consider using this technology as a potentially safer, ie less likely to generate aerosols, method in inpatient and outpatient settings for diagnosing and following patients with asthma characterised by Type 2 airway inflammation.”13
