Validity and Reliability of a Novel Handheld Osmolarity System for Measurement of a National Institute of Standards Traceable Solution

PURPOSE:To evaluate the validity and reliability of a novel handheld osmolarity system (I-PEN Osmolarity System; I-MED Pharma Inc, Dollard-des-Ormeaux, Quebec, Canada) for measurement of the osmolarity of a National Institute of Standards and Technology (NIST) traceable solution at a variety of ambient temperatures. METHODS:A total of 65 measurements of an NIST solution with a verified osmolarity of 290 ± 2 mOsmol/L were taken using 3 separate handheld osmolarity systems, 65 unique single-use sensors (SUSs) from 3 different lots, and 2 adaptors. Mean values were calculated using the device, SUS, and adaptor. Measurements were taken using a handheld osmolarity system, an adaptor, and 56 individual SUSs at 6 different ambient temperatures ranging from 17.7 to 26.5°C. RESULTS:Overall, the mean osmolarity measured was 294.06 mOsmol/L (SD ±2.29; percent coefficient of variation 0.78), ranging from 286.60 to 298.18 mOsmol/L. This fell within a prespecified acceptable variability of ±4 mOsmol/L (SD ±7). Mean values did not vary across devices, adaptors, or single-use sensors used. Mean osmolarity measurements increased with rising ambient temperatures, with an R = 0.88. The temperature correction factor was calculated to be 2.01 mOsmol/L per °C. CONCLUSIONS:The osmolarity system reliably and accurately measured the osmolarity of an NIST solution in a laboratory setting, using an adaptor to correct for differences in resistance between a laboratory NIST solution measurement and direct measurements on the palpebral conjunctiva of the eyelid. The handheld osmolarity system represents a rapid and accurate instrument for measurement of tear osmolarity in a simulated testing setting.