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Change explorer · Chemistry

Smartphone-read point-of-care HbA1c in venous blood vs a reference laboratory

Public dataBuilt from a published open-access study.

Reference laboratory HbA1c method compared with smartphone-read point of care HbA1c, venous: 246 paired results from a published study by Rhode et al. (2025), re-analysed by NakedSignal as if one laboratory had switched from the first system to the second. At 39, 48, 53 mmol/mol, 18 results fall in a different category on the second system than on the first, against about 8 expected from repeat testing alone. That expected count uses a default repeat-test imprecision, the setting our program uses when no precision data are supplied, not one measured in this study, so the two numbers are not a test of whether the switch moves more results than repeat testing would.

Chemistry

HbA1c, mmol/mol

Reference laboratory HbA1c method compared with Smartphone-read point of care HbA1c, venous. 246 paired results.

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Comparison line

The new system reads 4% higher than the old system on average. The comparison line (Passing-Bablok) has a slope of 0.769 (95% interval 0.742 to 0.803) and an intercept of 22.115.

Public data
Comparison line, HbA1c (mmol/mol)Comparison line with slope 0.769 (95% interval 0.742 to 0.803) and intercept 22.115, drawn against the line of no change. Decision limits drawn at 39, 48, 53 mmol/mol. Where the comparison line sits above the line of no change, the new system reads higher; below, lower.204060204060394853No changeComparison lineOld system, mmol/molNew system, mmol/mol

Fig. 1. The comparison line against the line of no change, over the range of the decision limits (39, 48, 53 mmol/mol). Dots mark where each line meets each limit; the gap between them is the bias at that limit.

Crossing each limit

Results that fall on the other side of a decision limit on the new system than on the old, read as if the new system had replaced the old, against the number repeat testing on one unchanged system would move. The program reports the count across all limits together.

All decision limits together (39, 48, 53 mmol/mol)

Crossed between the two systems: 18

Expected from repeat testing alone: about 8

Grade and warnings

  • Re-test band: full (at least the protocol minimum of pairs).
  • Band half-width around each limit: 12.55%.
  • Results re-tested on data the band was not fitted to, median: 14%.
  • Share of the excess crossings caught on unseen data, comparison line and band together: 106%; comparison line alone: 25%. The excess is the crossings above what repeat testing alone would cause, so the share can exceed 100% or fall below zero.
  • Repeat-test imprecision: default value.

Source

Rhode S, Rogge L, Marthoenis M, Seuring T, Zufry H, Bärnighausen T, Sofyan H, Manne-Goehler J, Vollmer S (2025). Real-world smartphone-based point-of-care diagnostics in primary health care to monitor HbA1c levels in people with diabetes. Commun Med (Lond). doi:10.1038/s43856-025-00743-8 (opens in a new tab); PMC11799141 (opens in a new tab). Licence: CC BY 4.0 (opens in a new tab). Re-analysed by NakedSignal. The deposit names the systems.

Show the numbers
All values for HbA1c, Reference laboratory HbA1c method to Smartphone-read point of care HbA1c, venous
FieldValue
Paired results used246
Comparison line slope0.769231
Slope, 95% interval0.74188 to 0.802516
Comparison line intercept22.115385
Mean difference, new minus old, as % of old4.038
Decision limits (mmol/mol)39, 48, 53
Crossed between the two systems18
Expected from repeat testing alone7.88
Band half-width (%)12.55
Re-tested, unseen data, median (%)14.02
Re-tested, unseen data, range (%)13.41 to 14.63
Excess caught, line and band (%)105.81
Excess caught, line alone (%)24.7

Related

Other comparisons from the same study:

Guide: Point-of-care HbA1c against the laboratory

Every study behind the explorer, with its licence: public data. How the counts are made: how it works.

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