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Abstract Background Precise and accurate measurements of whole blood glucose levels are important for the diagnosis, monitoring and treatment of carbohydrate metabolism disorders, such as diabetes and hypoglycemia. This study demonstrates the accuracy of the glucose test in the i-STAT G cartridge with the i-STAT 1 System in arterial, venous, and capillary whole blood specimens in point of care or clinical laboratory settings. Methods The accuracy of the glucose test in the i-STAT G cartridge was assessed at external clinical sites in a method comparison study using whole blood specimens across the measurement range of 20 - 700 mg/dL. Specimens used in this study were venous, arterial, and capillary specimens prospectively collected under Institutional Review Board-approved informed consent or were leftover de-identified venous or arterial specimens. The study included venous whole blood samples from 164 adult subjects (≥ 18 years) and arterial whole blood samples from 173 adult subjects at 3 clinical sites, and capillary whole blood samples from 211 adult subject at 3 clinicals sites and 23 neonate subjects (birth to 28 days) at 2 clinical sites. For venous and arterial whole blood, samples were collected and tested in duplicate on the i-STAT G cartridge and on the i-STAT CHEM8+ cartridge (comparator). For capillary whole blood samples, adult fingerstick samples and neonate heel-stick samples were collected in capillary tubes and tested in singlicate on the i-STAT G cartridge and in singlicate on the epoc® Blood Analysis System (comparator). Passing-Bablok linear regression was performed for venous and arterial whole blood samples using the first replicate from the i-STAT G cartridge versus the mean result of the comparator, and for capillary whole blood samples (adult and neonate combined) using the singlicate result from the i-STAT G cartridge versus the singlicate result of the comparator. Results Passing-Bablok regression of i-STAT G cartridge results versus the comparator was used to calculate slope and correlation coefficient (r). Adult venous whole blood results had slope = 1.00 and r = 1.00, and adult arterial whole blood results had slope = 1.00 and r = 1.00. Adult and neonate capillary whole blood results had slope = 1.00 and r = 1.00. Conclusions These results demonstrate that the i-STAT 1 System delivers accurate glucose test results within ∼2 minutes using the i-STAT G cartridge for venous, arterial and capillary whole blood samples for adult and neonate subjects across a glucose range of 20-700 mg/dL when tested by end-users in a point of care or clinical laboratory setting. This study was funded by Abbott Laboratories.
Kornfeld et al. (Tue,) studied this question.