NakedSignal

Change explorer · Chemistry

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

Public dataBuilt from a published open-access study.

Central lab chemistry analyser compared with point of care device B: 352 paired results from a published study by Giachino et al. (2024), re-analysed by NakedSignal as if one laboratory had switched from the first system to the second. At 5.7, 6.5, 7 %, 89 results fall in a different category on the second system than on the first, against about 60 expected from repeat testing alone. That expected count uses a default repeat-test imprecision, the setting our program uses when no precision data are supplied, not one measured in this study, so the two numbers are not a test of whether the switch moves more results than repeat testing would.

Chemistry

HbA1c, %

Central lab chemistry analyser compared with Point of care device B. 352 paired results.

Compare it with the other comparisons in the explorer

Comparison line

The new system reads 2.6% lower than the old system on average. The comparison line (Passing-Bablok) has a slope of 0.833 (95% interval 0.794 to 0.883) and an intercept of 0.871.

Public data
Comparison line, HbA1c (%)Comparison line with slope 0.833 (95% interval 0.794 to 0.883) and intercept 0.871, 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.

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 (5.7, 6.5, 7 %)

Crossed between the two systems: 89

Expected from repeat testing alone: about 60

Grade and warnings

  • Re-test band: full (at least the protocol minimum of pairs).
  • Band half-width around each limit: 1.64%.
  • 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: 62%; comparison line alone: 39%. 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: default value.

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). Re-analysed by NakedSignal. The deposit names the systems.

Show the numbers
All values for HbA1c, Central lab chemistry analyser to Point of care device B
FieldValue
Paired results used352
Comparison line slope0.833333
Slope, 95% interval0.794048 to 0.882516
Comparison line intercept0.870833
Mean difference, new minus old, as % of old-2.634
Decision limits (%)5.7, 6.5, 7
Crossed between the two systems89
Expected from repeat testing alone59.64
Band half-width (%)1.64
Re-tested, unseen data, median (%)14.06
Re-tested, unseen data, range (%)12.78 to 15.34
Excess caught, line and band (%)61.72
Excess caught, line alone (%)39.17

Changing a system like this one?

Request a first site report