Vivaray Hb pro non-invasive hemoglobin device: A prospective diagnostic accuracy study measuring agreement with a calibrated blood cell counter
6 affiliations
- 1IR Innovate Research Pvt. Ltd., Noida, Uttar Pradesh, India
- 2City X-Ray and Scan Clinic Pvt. Ltd., New Delhi, India
- 3Citizen Hospital, Kalasipalya, Bengaluru, India
- 4Dr. Dipti’s Multispeciality Clinics, Sahibabad, Uttar Pradesh, India
- 5Panchsheel Hospital, New Delhi, India
- 6Department of Surgery, IMU University, Malaysia
Abstract
Background: Non-invasive hemoglobin measurement offers a painless and rapid alternative to conventional blood-based testing. The Vivaray Hb pro is a handheld photoplethysmography-based device designed for point-of-care hemoglobin assessment without blood sampling. We evaluated the clinical performance of the Vivaray Hb pro by comparing device-generated hemoglobin values with those obtained from a calibrated laboratory blood cell counter. Methods: In this cross-sectional, non-randomized clinical performance study, participants aged ≥8 years were prospectively recruited. Hemoglobin was measured non-invasively using the Vivaray Hb pro and compared with venous blood samples analyzed on a calibrated Coulter counter. Agreement between methods was assessed using Bland–Altman analysis, including regression-based evaluation for proportional bias. Mean difference, mean absolute error (MAE) and proportions of measurements within tolerance limits were also calculated. Complete paired measurements were available for 763 individuals. Results: Bland–Altman analysis returned a mean difference of −0.40 g/dL. The bias was hemoglobin-dependent, being higher than the true value at low hemoglobin levels and underestimation at higher levels. Regression-based analysis showed proportional bias (β1 = −0.178), indicating decreasing difference with increasing hemoglobin concentration. The MAE was 1.5 g/dL but was lower (1.2) in the clinically predominant ranges of 8.1–13 g/dL. Conclusion: The Vivaray Hb pro can function as a useful non-invsive screening and point-of-care assessment device for measuring hemoglobin, particularly in settings where rapid, painless and repeatable measurements are desirable.
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BibTeX
@article{kumar2026vivaray,
title = {{Vivaray Hb pro non-invasive hemoglobin device: A prospective diagnostic accuracy study measuring agreement with a calibrated blood cell counter}},
author = {Devesh Kumar and Sunita Kapoor and Ambanna Gowda and Dipti Gupta and Harsh Mittal and Suneet Sood},
journal = {PLOS One},
year = {2026},
month = nov,
doi = {10.1371/journal.pone.0353640},
url = {https://doi.org/10.1371/journal.pone.0353640},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Vivaray Hb pro non-invasive hemoglobin device: A prospective diagnostic accuracy study measuring agreement with a calibrated blood cell counter
AU - Devesh Kumar
AU - Sunita Kapoor
AU - Ambanna Gowda
AU - Dipti Gupta
AU - Harsh Mittal
AU - Suneet Sood
PY - 2026
DA - 2026/11/03
JO - PLOS One
DO - 10.1371/journal.pone.0353640
UR - https://doi.org/10.1371/journal.pone.0353640
AB - Background: Non-invasive hemoglobin measurement offers a painless and rapid alternative to conventional blood-based testing. The Vivaray Hb pro is a handheld photoplethysmography-based device designed for point-of-care hemoglobin assessment without blood sampling. We evaluated the clinical performance of the Vivaray Hb pro by comparing device-generated hemoglobin values with those obtained from a calibrated laboratory blood cell counter. Methods: In this cross-sectional, non-randomized clinical performance study, participants aged ≥8 years were prospectively recruited. Hemoglobin was measured non-invasively using the Vivaray Hb pro and compared with venous blood samples analyzed on a calibrated Coulter counter. Agreement between methods was assessed using Bland–Altman analysis, including regression-based evaluation for proportional bias. Mean difference, mean absolute error (MAE) and proportions of measurements within tolerance limits were also calculated. Complete paired measurements were available for 763 individuals. Results: Bland–Altman analysis returned a mean difference of −0.40 g/dL. The bias was hemoglobin-dependent, being higher than the true value at low hemoglobin levels and underestimation at higher levels. Regression-based analysis showed proportional bias (β1 = −0.178), indicating decreasing difference with increasing hemoglobin concentration. The MAE was 1.5 g/dL but was lower (1.2) in the clinically predominant ranges of 8.1–13 g/dL. Conclusion: The Vivaray Hb pro can function as a useful non-invsive screening and point-of-care assessment device for measuring hemoglobin, particularly in settings where rapid, painless and repeatable measurements are desirable.
SN - 1932-6203
ER -