NakedSignal

Change explorer · Chemistry

Point-of-care HbA1c analyser vs a laboratory HbA1c assay

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

Laboratory HbA1c assay replaced by point of care HbA1c analyser: 108 paired results from a published study by Berbudi et al. (2020), re-analysed by NakedSignal as if the study were one laboratory. At 5.7, 6.5, 7 %, 37 results changed category after the change, against about 17 expected from repeat testing alone.

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

Chemistry

HbA1c, %

Laboratory HbA1c assay replaced by Point of care HbA1c analyser. 108 paired results.

Compare it with the other comparisons in the explorer

Comparison line

The new system reads 3.5% higher than the old system on average. The comparison line has a slope of 0.958 (95% interval 0.898 to 1) and an intercept of 0.448.

Public data
Comparison line, HbA1c (%)Comparison line with slope 0.958 (95% interval 0.898 to 1) and intercept 0.448, 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.4684685.76.57No 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: 37

Expected from repeat testing alone: about 17

Grade and warnings

  • Re-test band: full (at least the protocol minimum of pairs).
  • Band half-width around each limit: 0.85%.
  • 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: 37%; comparison line alone: 30%. 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

Berbudi A, Rahmadika N, Tjahjadi AI, Ruslami R (2020). Performance of Point-of-Care Testing Compared with the Standard Laboratory Diagnostic Test in the Measurement of HbA1c in Indonesian Diabetic and Nondiabetic Subjects. J Diabetes Res. doi:10.1155/2020/2037565 (opens in a new tab); PMC7369652 (opens in a new tab). Licence: CC BY (the article states no version) (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, Laboratory HbA1c assay to Point of care HbA1c analyser
FieldValue
Paired results used108
Comparison line slope0.958333
Slope, 95% interval0.898408 to 1
Comparison line intercept0.447917
Mean difference, new minus old, as % of old3.51
Decision limits (%)5.7, 6.5, 7
Crossed after the change37
Expected from repeat testing alone16.86
Band half-width (%)0.85
Re-tested, unseen data, median (%)13.89
Re-tested, unseen data, range (%)11.11 to 15.74
Excess caught, line and band (%)36.88
Excess caught, line alone (%)29.8

Related

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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