Vivaray Hb pro shows 1.5 g/dL mean absolute error in hemoglobin measurementHandheld device shows promise for quick blood tests

medRxiv Published July 2, 2026 Study authors: Kumar, D.; Kapoor, S.; Gowda, A.; Gupta, D.; Mittal, H.; Sood, S. DOI ↗ Editorial oversight: Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

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Key Takeaway

Note that Vivaray Hb pro serves as a noninvasive screening tool with a mean absolute error of 1.5 g/dL.

This cross-sectional, non-randomized clinical performance study evaluated the accuracy of the Vivaray Hb pro, a handheld photoplethysmography-based device, compared to a calibrated laboratory blood cell counter. The study included 763 individuals aged 8 years and older in a point-of-care setting.

The primary outcome was the agreement between the Vivay Hb pro and the reference laboratory counter. Results showed an overall mean absolute error (MAE) of 1.5 g/dL, which decreased to 1.2 g/dL within the hemoglobin range of 8.1-13 g/dl. Regression analysis identified a proportional bias with a beta of -0.178, indicating a decreasing difference as hemoglobin concentration increased.

A Bland-Altman analysis revealed a hemoglobin-dependent bias: the device tended to overestimate at lower hemoglobin levels and underestimate at higher levels. No specific safety data or adverse events were reported during the study period.

While the results support the Vivaray Hb pro as a noninvasive screening tool for rapid, painless assessment in point-of-care settings, it is not intended to replace laboratory testing. The findings are based on an association/agreement analysis rather than a trial for causation.

Getting an accurate blood test usually requires a lab and a needle. However, some people need results fast in everyday settings where a traditional blood draw is not practical. This study looked at how a handheld device called the Vivaray Hb pro compares to standard laboratory machines used to measure hemoglobin, which is a protein in red blood cells.

The researchers tested the device on 763 people aged 8 and older. They found that the handheld tool had an average error of only 1.5 g/dL compared to the lab machine. In many cases, it was even closer, with an error of just 1.2 g/dL in common hemoglobin ranges. While the device showed some slight variations at very high or low levels, it performed well overall.

This tool is designed for quick screening rather than replacing laboratory tests. It offers a painless and repeatable way to check blood levels quickly. Because it is noninvasive, it could be helpful in places where speed is important. Always talk to your doctor about the best testing method for your specific health needs.

What this means for you:

A handheld device provides a fast, needle-free way to screen hemoglobin levels in many different settings.

Common questions

How accurate is the handheld device compared to lab tests?

The handheld device showed an average error of 1.5 g/dL when compared to a laboratory blood cell counter. In the common range of 8.1 to 13 g/dl, the error was even lower at 1.2 g/dl. While it is accurate for screening, it is intended as a point-of-care tool rather than a full replacement for lab testing.

Who can use this handheld blood test?

The study included individuals aged 8 years and older. The device is designed to provide a noninvasive and painless way to measure hemoglobin levels quickly in various settings where rapid results are needed.

Is the handheld device safe for patients?

Because the device is noninvasive, it does not require a needle. The study did not report any adverse events or safety concerns during the testing of the 763 participants. You should consult your doctor to see if this screening tool is right for you.

Study Details

Study typeRct

EvidenceLevel 2

PublishedJul 2026

View Original 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 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 demonstrated hemoglobin-dependent bias, with overestimation at lower hemoglobin levels and underestimation at higher levels. Regression-based analysis showed proportional bias ({beta}? = -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. Comment: The results support the use of the Vivaray Hb pro as a noninvasive hemoglobin screening and point-of-care assessment tool, particularly in settings where rapid, painless, and repeatable measurements are desirable.

Vivaray Hb pro shows 1.5 g/dL mean absolute error in hemoglobin measurementHandheld device shows promise for quick blood tests

Common questions

Study Details

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Vivaray Hb pro shows 1.5 g/dL mean absolute error in hemoglobin measurementHandheld device shows promise for quick blood tests

Common questions

Study Details

Biomarkers and clinical factors show statistical associations with sepsis-induced coagulopathy in 37,459 patients

Your Blood May Signal a Deadly Clotting Crisis Before It Strikes

Clinical research that matters. Delivered to your inbox.

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