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3.5.
UNDERSTANDING THE TEST QUALITY
After each test session, quality grading will be displayed on the app to provide information
about how well the breathing maneuver was performed. Note that the acceptability of the
test is purely decided by the doctor/operator etc. This grade refers to the consistency of the
patient's maneuvers, not the health of the patient's lungs.
Grading of the FVC and FEV
1
parameters in children and adults, according to the American
Thoracic Society (ATS) and European Respiratory Society (ERS) guidelines;
Summary of Acceptability, Usability, and Repeatability Criteria for FEV
1
and FVC
Acceptability and Usability Criterion
Required for
Acceptability
Required for
Usability
FEV
1
FVC
FEV
1
FVC
Must have BEV
≤
5% of FVC or 0.100 L, whichever is greater
Yes
Yes
Yes
Yes
Must have no evidence of a faulty zero-flow setting
Yes
Yes
Yes
Yes
Must have no cough in the first second of expiration
Yes
No
Yes
No
Must have no glottic closure in the first second of expiration*
Yes
Yes
Yes
Yes
Must have no glottic closure after 1 s of expiration
No
Yes
No
No
Must achieve one of these three EOFE indicators:
1. Expiratory plateau (
≤
0.025 L in the last 1 s of
expiration)
2. Expiratory time ≥15 s
3. FVC is within the repeatability tolerance of or is greater
than the largest prior observed FVC
*
No
Yes
No
No
Must have no evidence of obstructed mouthpiece or spirometer
Yes
Yes
No
No
Must have no evidence of a leak
Yes
Yes
No
No
First Pub. Date: 24.09.2018
R.9-1 / 10.03.2020
