Objective: Accurate measurement of hemoglobin is essential for the diagnosis of anemia, and point-of-care procedures are used where laboratory facilities are not available. The DiaSpect hemoglobinometer has a new technology for hemoglobin measurement, and this study evaluates its utility.
Methods: Hemoglobin values from the DiaSpect hemoglobinometry system were compared with a standardized laboratory-based reference analyzer (Sysmex XE-2100). Hemoglobin values were measured on 406 hospital-based patients (200 males and 206 females; age range, 17-60 years) and assessed for precision, linearity, comparability, and accuracy. Stability at 4 and 37°C and the effect of interference from analytes were also evaluated. The DiaSpect device was also accessed for potential use in a blood donor setting.
Results: Precision studies showed acceptable replicate hemoglobin levels tested (coefficient of variation, <5). Serial dilutions of hemoglobin (18 g/dL down to 4 g/dL) showed excellent linearity (r2 = 0.998). Hemoglobin values compared well with the reference analyzer within the range 5.5 to 19.3 g/dL (P > 0.5). At both temperatures tested, DiaSpect hemoglobin values were as stable as the reference analyzer values (P = 0.609). However, extreme leukocytosis (>28.0 g/dL) and marked hemoglobinopathy affected measurements (P < 0.001). Bilirubinemia did not cause any significant interference (P = 0.264).
The DiaSpect system compared well with established methods of blood donor screening, producing similar readings as the reference analyzer (P > 0.05).
Conclusions: This evaluation has shown this hemoglobinometer to be simple, reliable, extremely rapid and accurate, and comparable to the standardized reference analyzer. Overall, it is suitable for point-of-care where there are limited laboratory facilities or as a potential analyzer used in blood donor screening.