NakedSignal

Change explorer · Haematology and immunology

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

Public dataBuilt from a published open-access study.

Laboratory haematology analyser (reference) compared with point of care haemoglobin meter A (central laboratory setting): 60 paired results from a published study by Jaggernath et al. (2016), re-analysed by NakedSignal as if one laboratory had switched from the first system to the second. At 8, 12, 13 g/dL, 14 results fall in a different category on the second system than on the first, against about 2 expected from repeat testing alone.

Haematology and immunology

Haemoglobin, g/dL

Laboratory haematology analyser (reference) compared with 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 (Passing-Bablok) has a slope of 1 (95% interval 0.946 to 1.022) and an intercept of 0.55.

Public data
Comparison line, haemoglobin (g/dL)Comparison line with slope 1 (95% interval 0.946 to 1.022) and intercept 0.55, 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.

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 (8, 12, 13 g/dL)

Crossed between the two systems: 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: 1.25%.
  • Results re-tested on data the band was not fitted to, median: 12%.
  • Share of the excess crossings caught on unseen data, comparison line and band together: 69%; 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: supplied by the study, 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). Re-analysed by NakedSignal. 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 slope1
Slope, 95% interval0.945908 to 1.021514
Comparison line intercept0.55
Mean difference, new minus old, as % of old4.691
Decision limits (g/dL)8, 12, 13
Crossed between the two systems14
Expected from repeat testing alone1.59
Band half-width (%)1.25
Re-tested, unseen data, median (%)11.67
Re-tested, unseen data, range (%)10 to 15
Excess caught, line and band (%)69.08
Excess caught, line alone (%)64.49

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