Technical and Functional Assessment of 10 Office Spirometers: Research

Technical and Functional Assessment of 10 Office Spirometers: ResearchThe use of the 24 ATS standard waveforms for FVC and FEV1 is recommended, but the recent ATS/ERS statement does not require that these tests must be performed by an independent laboratory, such as the laboratory at LDS Hospital for example. We requested the results of these tests from the manufacturers of the office spirometers. Datospir models 70 and 120, Simplicity, OneFlow, Pneumotrac, and SpiroStar (Medikro; Kuopio, Finland) devices were tested by their manufacturers using 24 ATS standard waveforms, and the other devices were tested at LDS Hospital. All the spirometers tested at LDS Hospital using the 24 standard ATS waveforms had fewer than three accuracy errors and repeatability errors for FVC or FEVj at ambient testing conditions.

The OneFlow met the ATS criteria for monitoring devices but not for diagnostic spirometers. At variance with previous ATS quality criteria for spirometers, there is no longer distinction between diagnostic and monitoring devices in the recent ATS/ERS statement. The same degree of accuracy is required for all devices, and corresponds to the former criteria (ATS) for diagnostic spirometers. Using the 24 ATS waveforms, the OneFlow had better accuracy results for FEV1 than for FVC, and only the FEV1 was within the criteria for diagnostic devices. Accordingly, in our study, the OneFlow performed better for FEVX measurement than for FVC. By contrast, the results of the SpiroStar tested by its manufacturer (Medikro) showed no error for accuracy and intradevice testing with FEV1 and FVC, using the criteria for diagnostic devices, whereas this device presented large limits of agreement in our survey. At variance with the 24 ATS waveforms, we did not use a fixed signal to test the devices, so the differences between in vitro and in vivo performances may be explained by the fact that different populations were studied. However, if we limit our analysis to the small sample (n = 9) of ETs who tested all the models, we can see that EasyOne presented unacceptable limits of precision for FVC. However, this device, tested by an independent laboratory (LDS Hospital), met the ATS (diagnostic devices) recommendations for accuracy and precision in measuring FVC and FEV1, like the Spiro-bank, whereas the latter obtained acceptable limits of precision in our study.

This entry was posted in Spirometers and tagged comparative study, COPD detection, pulmonary function tests, spirometer, spirometry.