NakedSignal

Change explorer · Haematology and immunology

Point-of-care haemoglobin meter A vs the laboratory, central laboratory setting

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

Laboratory haematology analyser (reference) replaced by point of care haemoglobin meter A (central laboratory setting): 60 paired results from a published study by Huub Gelderblom (2016), re-analysed by NakedSignal as if the study were one laboratory. At 8, 12, 13 g/dL, 14 results changed category after the change, against about 2 expected from repeat testing alone.

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

Haematology and immunology

Haemoglobin, g/dL

Laboratory haematology analyser (reference) replaced by Point of care haemoglobin meter A (central laboratory setting). 60 paired results.

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Comparison line

The new system reads 4.7% higher than the old system on average. The comparison line has a slope of 0.99 (95% interval 0.946 to 1) and an intercept of 0.656.

Public data
Comparison line, haemoglobin (g/dL)Comparison line with slope 0.99 (95% interval 0.946 to 1) and intercept 0.656, drawn against the line of no change. Decision limits drawn at 8, 12, 13 g/dL. Where the comparison line sits above the line of no change, the new system reads higher; below, lower.510155101581213No changeComparison lineOld system, g/dLNew system, g/dL

Fig. 1. The comparison line against the line of no change, over the range of the decision limits (8, 12, 13 g/dL). 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 (8, 12, 13 g/dL)

Crossed after the change: 14

Expected from repeat testing alone: about 2

Grade and warnings

  • Re-test band: Indicative: 60 pairs, below the 100-pair protocol minimum.
  • Band half-width around each limit: 1.36%.
  • 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: 74%; comparison line alone: 64%. 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: measured, precision file (patient-sample replicates, 5 per sample), the larger of the two systems.

Source

Data: Huub Gelderblom (2016). Performance characteristics of three point of care hemoglobin meters in Durban-2.xlsx. figshare. doi:10.6084/m9.figshare.3119449 (opens in a new tab). Licence: CC BY 4.0 (opens in a new tab). Supplement to Jaggernath M, Naicker R, Madurai S, Brockman MA, Ndung'u T, Gelderblom HC (2016). PLoS One. doi:10.1371/journal.pone.0152184 (opens in a new tab); PMC4821624 (opens in a new tab) (title on the source page; it names the instruments). 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 haemoglobin, Laboratory haematology analyser (reference) to Point of care haemoglobin meter A
FieldValue
Paired results used60
Comparison line slope0.990176
Slope, 95% interval0.946253 to 1
Comparison line intercept0.656095
Mean difference, new minus old, as % of old4.691
Decision limits (g/dL)8, 12, 13
Crossed after the change14
Expected from repeat testing alone1.59
Band half-width (%)1.36
Re-tested, unseen data, median (%)13.33
Re-tested, unseen data, range (%)10 to 18.33
Excess caught, line and band (%)74.21
Excess caught, line alone (%)64.49

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