A proposal for a transfer standard for validating pulse oximeter sensors.
One method for validating a biosensor is through comparative assessment of the test sensor with a control sensor when both sensors are presented with the same inputs. In the case of adult pulse oximeter (SpO2) sensors, both sensors should ideally be placed on the same digit of the subject. However, at present, one SpO2 sensor interferes with another so that the two sensors are applied to two different digits, which may not be identical in SpO2 level. This article proposes a ring-shaped SpO2 sensor transfer standard that can be used on the same digit as the test sensor, based on the idea of timing, SpO2 is a slowly varying signal, while the two sensors can be gated to measure the same digit's SpO2 value very quickly. Hardware and software requirements for the transfer standard, and a statistical method for analyzing the data will be discussed. A method for the direct comparison of two SpO2 sensors using a "switch over" trial design will also be presented.
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C S
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HFZ-450, Rockville, MD 20850, USA.
Lin
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SC
D000328:Adult; D002986:Clinical Trials as Topic / Q000379:methods; D005385:Fingers; D006801:Humans; D010092:Oximetry / Q000592:standards*; D012107:Research Design