NakedSignal

Change explorer · Chemistry

Point-of-care HbA1c vs the central laboratory (device A)

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

Central lab chemistry analyser replaced by point of care device A: 352 paired results from a published study by Giachino et al. (2024), re-analysed by NakedSignal as if the study were one laboratory. At 5.7, 6.5, 7 %, 236 results changed category after the change, against about 59 expected from repeat testing alone.

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

Chemistry

HbA1c, %

Central lab chemistry analyser replaced by Point of care device A. 352 paired results.

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Comparison line

The new system reads 18.5% higher than the old system on average. The comparison line has a slope of 1.103 (95% interval 1.014 to 1.197) and an intercept of 0.611.

Public data
Comparison line, HbA1c (%)Comparison line with slope 1.103 (95% interval 1.014 to 1.197) and intercept 0.611, drawn against the line of no change. Decision limits drawn at 5.7, 6.5, 7 %. Where the comparison line sits above the line of no change, the new system reads higher; below, lower.468104685.76.57No changeComparison lineOld system, %New system, %

Fig. 1. The comparison line against the line of no change, over the range of the decision limits (5.7, 6.5, 7 %). 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 (5.7, 6.5, 7 %)

Crossed after the change: 236

Expected from repeat testing alone: about 59

Grade and warnings

  • Re-test band: full (at least the protocol minimum of pairs).
  • Band half-width around each limit: 1.17%.
  • Results re-tested on data the band was not fitted to, median: 13%.
  • Share of the excess crossings caught on unseen data, comparison line and band together: 58%; comparison line alone: 48%. 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

Giachino M, Vetter B, Perone SA, Correia JC, Erkosar B, Heller O, Khanal VK, Lab B, Pataky Z, Poudel S, Rai M, Sharma SK (2024). Performance and usability of cardiometabolic point of care devices in Nepal: A prospective, quantitative, accuracy study. PLOS Glob Public Health. doi:10.1371/journal.pgph.0003760 (opens in a new tab); PMC11449279 (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, Central lab chemistry analyser to Point of care device A
FieldValue
Paired results used352
Comparison line slope1.103448
Slope, 95% interval1.01444 to 1.196988
Comparison line intercept0.61069
Mean difference, new minus old, as % of old18.49
Decision limits (%)5.7, 6.5, 7
Crossed after the change236
Expected from repeat testing alone59.17
Band half-width (%)1.17
Re-tested, unseen data, median (%)13.35
Re-tested, unseen data, range (%)12.5 to 14.77
Excess caught, line and band (%)57.76
Excess caught, line alone (%)48.35

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