NakedSignal

Change explorer · Chemistry

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

Public dataA public method-comparison deposit, not a laboratory's data. Systems are described generically; the source names them.

Reference laboratory HbA1c method replaced by 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 the study were one laboratory. At 39, 48, 53 mmol/mol, 18 results changed category after the change, against about 8 expected from repeat testing alone.

run 25 September 2026 · config 6eb23df45893 · run file sha256 5586cd892ef1

Chemistry

HbA1c, mmol/mol

Reference laboratory HbA1c method replaced by 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 has a slope of 0.769 (95% interval 0.737 to 0.8) and an intercept of 22.115.

Public data
Comparison line, HbA1c (mmol/mol)Comparison line with slope 0.769 (95% interval 0.737 to 0.8) 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.

run 25 September 2026 · config 6eb23df45893 · run file sha256 5586cd892ef1

Crossing each limit

Results that moved across a decision limit when the new system 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 after the change: 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: 103%; comparison line alone: 15%. 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: assumed, not measured at this site.

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). Changes: Paired results re-analysed by NakedSignal's program; instruments described generically; only derived results are shown. 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% interval0.736788 to 0.8
Comparison line intercept22.115385
Mean difference, new minus old, as % of old4.038
Decision limits (mmol/mol)39, 48, 53
Crossed after the change18
Expected from repeat testing alone7.88
Band half-width (%)12.55
Re-tested, unseen data, median (%)13.82
Re-tested, unseen data, range (%)13.41 to 15.04
Excess caught, line and band (%)103.37
Excess caught, line alone (%)14.82

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: method.

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