RESUMO
The first calibration-free Near-Patient-Testing instrument (NPT7) for blood gases, pH and oximetry has been developed. With cartridges of 30 single-use cuvettes, the NPT7 needs no preparation prior to sample aspiration, no manual calibration, and no maintenance apart from paper and cartridge changes and regulatory quality control. Each cuvette measures pCO2, pO2, pH, total hemoglobin (ctHb), oxygen saturation (sO2), fractions of carboxyhemoglobin (FCOHb) and methemoglobin (FMetHb) on 95 microl whole blood with a 110-s measuring cycle. The measurement principles are as follows: pCO2-three-wavelength infrared spectroscopy of dissolved CO2; pO2-measurement of O2-induced changes in the decay time of phosphorescence; pH-the absorbance spectra change of an azo-dye color indicator; and oximetry is performed with a 128-wavelength spectrophotometer. We determined the within and between instrument variations with tonometered whole blood on seven prototype instruments, using between one and five control levels per analyte. The 95% analytical performance limits: +/-(/Bias/ +2 xS(T)) in the NPT7 instrument matched the analytical performance criteria for the measured quantities as defined by AACC guidelines. The application of these optical measuring methods for blood gases, pH and oximetry in single-use devices introduces a new concept into point-of-care testing (POCT), where preanalytical activities otherwise associated with instrument preparation are eliminated.
