Abstract: Objective The aim of this study is to explore the accuracy of the non-invasive hemoglobin (SpHb) detection device in high-altitude hypoxic environments and its consistency with results obtained by minimally invasive hemoglobin (POCT-Hb) detection, as well as to analyze the influencing factors affecting the performance of the non-invasive hemoglobin detection device. Methods A total of 528 healthy volunteers from plain areas were recruited, and their Hb concentrations were measured using the domestic MHS28 non-invasive hemoglobin detection device and an automatic hematology analyzer for comparative analysis. Additionally, 36 healthy volunteers residing at high-altitude were divided into two groups based on their duration of stay at high altitudes. In the hypoxic environment at an altitude of 3 700 meters, Hb concentrations were detected using the US-made Masimo RAD-57 and domestic MHS28 non-invasive hemoglobin detection devices. The detection success rates of the two devices were compared, and the accuracy and consistency of SpHb results were evaluated against those obtained from the minimally invasive hemoglobin analyzer. Additionally, influencing factors of non-invasive hemoglobin detection device were analyzed. Results In plain regions, non-invasive hemoglobin (SpHb) and invasive hemoglobin (tHb) measurements were (126.00±29.14) g/L and (126.06±21.68) g/L, respectively, with no statistically significant difference (P>0.05), demonstrating good agreement between two methods. Moreover, a significant correlation was observed (R=0.816, P<0.001). In high-altitude regions, the non-invasive MHS28-SpHb detection device success rate (100%) was significantly higher than that of Masimo-SpHb (P<0.01). Compared to POCT-Hb, Masimo-SpHb showed marginally better accuracy (73.68% of measurements within ±10% deviation) than MHS28-SpHb (64.89%) across all high-altitude measurements, though without statistical significance (P>0.05). After acclimatization to the plateau, the proportion of MHS28-SpHb was 88.46%, slightly higher than that of Masimo-SpHb (61.11%), without statistical significance (P>0.05). Conversely, upon rapid entry into the plateau, the Masimo-SpHb detection device exhibited better accuracy (85.0%) than the MHS28-SpHb (55.88%) (P<0.05). The Hb values measured by MHS28-SpHb, Masimo-SpHb, and POCT-Hb were (159.66±15.92) g/L, (151.84±13.21) g/L, and (158.13±17.80) g/L, respectively. Statistical analysis revealed no significant difference between MHS28-SpHb and POCT-Hb (P>0.05), whereas Masimo-SpHb differed significantly from POCT-Hb (P<0.01). Pearson correlation analysis demonstrated strong correlations between MHS28-SpHb (R=0.669) and Masimo-SpHb (R=0.674) with POCT-Hb (P<0.001). Both non-invasive and minimally invasive hemoglobin detection devices demonstrate good consistency. Multivariate linear regression identified SpO2 as positively correlated with MHS28-SpHb bias (P<0.05). Conclusion Both in plain and high-altitude regions, the domestic non-invasive MHS28-SpHb exhibits high detection success rates and good accuracy, instrong consistency with venous invasive tHb and minimally invasive POCT-Hb, supporting its utility as a reliable tool for hemoglobin detection device.

Key words: High-altitude, High-altitude hypoxia, Hemoglobin, Minimally invasive hemoglobin detection device, Non-invasive hemoglobin detection device, Multiple wavelength spectrum