Chemistry analyzer A

Glucose · multi-day precision · Chemistry analyzer A

Glucose (mg/dL) · Multi-day precision

Criteria met

Instrument
Chemistry analyzer A (CA-41027)
Study date
Sep 8, 2026

Table 1. Acceptance criteria

QuestionLimitFindingResult
Within-laboratory SDLevel 1 SD ≤ 1.8 mg/dL; Level 2 SD ≤ 5.7 mg/dL2 of 2 levels withinMet
889092949612345Result (mg/dL)DayDay 1, run 1: result 91 mg/dLDay 1, run 1: result 91 mg/dLDay 1, run 1: result 92 mg/dLDay 1, run 1: result 92 mg/dLDay 1, run 1: result 93 mg/dLDay 2, run 1: result 92 mg/dLDay 2, run 1: result 92 mg/dLDay 2, run 1: result 93 mg/dLDay 2, run 1: result 93 mg/dLDay 2, run 1: result 94 mg/dLDay 3, run 1: result 90 mg/dLDay 3, run 1: result 90 mg/dLDay 3, run 1: result 91 mg/dLDay 3, run 1: result 91 mg/dLDay 3, run 1: result 92 mg/dLDay 4, run 1: result 92 mg/dLDay 4, run 1: result 92 mg/dLDay 4, run 1: result 93 mg/dLDay 4, run 1: result 93 mg/dLDay 4, run 1: result 94 mg/dLDay 5, run 1: result 90 mg/dLDay 5, run 1: result 90 mg/dLDay 5, run 1: result 91 mg/dLDay 5, run 1: result 91 mg/dLDay 5, run 1: result 92 mg/dLMeanDay mean±2 SD at SD 1.8Observed ±2 SD
Figure 1. Level 1: results by day.
27528028529029512345Result (mg/dL)DayDay 1, run 1: result 284 mg/dLDay 1, run 1: result 285 mg/dLDay 1, run 1: result 286 mg/dLDay 1, run 1: result 286 mg/dLDay 1, run 1: result 287 mg/dLDay 2, run 1: result 287 mg/dLDay 2, run 1: result 288 mg/dLDay 2, run 1: result 289 mg/dLDay 2, run 1: result 289 mg/dLDay 2, run 1: result 290 mg/dLDay 3, run 1: result 282 mg/dLDay 3, run 1: result 283 mg/dLDay 3, run 1: result 284 mg/dLDay 3, run 1: result 284 mg/dLDay 3, run 1: result 285 mg/dLDay 4, run 1: result 286 mg/dLDay 4, run 1: result 287 mg/dLDay 4, run 1: result 288 mg/dLDay 4, run 1: result 288 mg/dLDay 4, run 1: result 289 mg/dLDay 5, run 1: result 283 mg/dLDay 5, run 1: result 284 mg/dLDay 5, run 1: result 284 mg/dLDay 5, run 1: result 285 mg/dLDay 5, run 1: result 286 mg/dLMeanDay mean±2 SD at SD 5.7Observed ±2 SD
Figure 2. Level 2: results by day.

Table 2. Results by level (mg/dL)

LevelMeanRepeatability SDRepeatability CV (%)Within-lab SDWithin-lab CV (%)Result
191.80.8370.91.251.4Met
2286.01.140.42.340.8Met

Study details

Matrix
Serum
Method
Hexokinase
Reagent lot
GLU-R2609
Calibrator lot
GLU-C2609
Data
50 included
Design
5 days × 1 run × 5 replicates
Alex Rivera, MLS(ASCP)
alex.rivera@example.testSigned off by
Oct 23, 2026, 13:25 UTCDate

A Data listing

Source: CHEM-A_QC-2611_days-1-5_20260912.csv. 50 rows, all included.

Study rowSpecimenLevelResult (mg/dL)DayReplicateSource row
1QC-2611 L1192112
2QC-2611 L1191123
3QC-2611 L1193134
4QC-2611 L1192145
5QC-2611 L1191156
6QC-2611 L1193217
7QC-2611 L1194228
8QC-2611 L1192239
9QC-2611 L11932410
10QC-2611 L11922511
11QC-2611 L11913112
12QC-2611 L11903213
13QC-2611 L11923314
14QC-2611 L11913415
15QC-2611 L11903516
16QC-2611 L11924117
17QC-2611 L11934218
18QC-2611 L11924319
19QC-2611 L11944420
20QC-2611 L11934521
21QC-2611 L11905122
22QC-2611 L11915223
23QC-2611 L11925324
24QC-2611 L11915425
25QC-2611 L11905526
26QC-2611 L222861127
27QC-2611 L222841228
28QC-2611 L222871329
29QC-2611 L222851430
30QC-2611 L222861531
31QC-2611 L222892132
32QC-2611 L222902233
33QC-2611 L222882334
34QC-2611 L222872435
35QC-2611 L222892536
36QC-2611 L222833137
37QC-2611 L222853238
38QC-2611 L222843339
39QC-2611 L222823440
40QC-2611 L222843541
41QC-2611 L222874142
42QC-2611 L222884243
43QC-2611 L222864344
44QC-2611 L222894445
45QC-2611 L222884546
46QC-2611 L222845147
47QC-2611 L222835248
48QC-2611 L222855349
49QC-2611 L222865450
50QC-2611 L222845551

1 Results

1.1 Results by day

Table 3. Results by day (mg/dL)

DayLevel 1 meanLevel 1 SDLevel 2 meanLevel 2 SD
191.80.837285.61.14
292.80.837288.61.14
390.80.837283.61.14
492.80.837287.61.14
590.80.837284.41.14

5 results on each day.

1.2 Additional estimates

Table 4. Median, range, variance components and mean interval (mg/dL)

LevelMedianLowest–highestBetween-day/run SDMean 95% CI
192.090–940.92790.6–93.0
2286.0282–2902.05283.3–288.6

2 Study notes

  1. With one run per day, the between-day/run SD combines day and run effects.

Supporting diagnostics

S.1 Level 1 · distribution and diagnostics

Bin 90–91 mg/dL: 4 resultsBin 91–92 mg/dL: 6 resultsBin 92–92 mg/dL: 8 resultsBin 92–93 mg/dL: 5 resultsBin 93–94 mg/dL: 2 results024689091929394CountResult (mg/dL)
Figure 3. Distribution of included results; dashed: mean.

Table 5. Analysis of variance

SourceSum of squares ((mg/dL)²)dfMean square ((mg/dL)²)
Between days/runs20.000045.0000
Within runs14.0000200.7000

Raw combined between-day/run variance 0.8600 (one run per day).

Table 6. Spread of all results pooled

EstimateValueUnit
SD, all results pooled1.19mg/dL
CV, all results pooled1.3%
9091929394−2−1012Value (mg/dL)Theoretical standard-normal quantileSample QC-2611 L1: quantile −1.96, result 90.0 mg/dLSample QC-2611 L1: quantile −1.52, result 90.0 mg/dLSample QC-2611 L1: quantile −1.26, result 90.0 mg/dLSample QC-2611 L1: quantile −1.06, result 90.0 mg/dLSample QC-2611 L1: quantile −0.90, result 91.0 mg/dLSample QC-2611 L1: quantile −0.76, result 91.0 mg/dLSample QC-2611 L1: quantile −0.64, result 91.0 mg/dLSample QC-2611 L1: quantile −0.52, result 91.0 mg/dLSample QC-2611 L1: quantile −0.41, result 91.0 mg/dLSample QC-2611 L1: quantile −0.30, result 91.0 mg/dLSample QC-2611 L1: quantile −0.20, result 92.0 mg/dLSample QC-2611 L1: quantile −0.10, result 92.0 mg/dLSample QC-2611 L1: quantile 0.00, result 92.0 mg/dLSample QC-2611 L1: quantile 0.10, result 92.0 mg/dLSample QC-2611 L1: quantile 0.20, result 92.0 mg/dLSample QC-2611 L1: quantile 0.30, result 92.0 mg/dLSample QC-2611 L1: quantile 0.41, result 92.0 mg/dLSample QC-2611 L1: quantile 0.52, result 92.0 mg/dLSample QC-2611 L1: quantile 0.64, result 93.0 mg/dLSample QC-2611 L1: quantile 0.76, result 93.0 mg/dLSample QC-2611 L1: quantile 0.90, result 93.0 mg/dLSample QC-2611 L1: quantile 1.06, result 93.0 mg/dLSample QC-2611 L1: quantile 1.26, result 93.0 mg/dLSample QC-2611 L1: quantile 1.52, result 94.0 mg/dLSample QC-2611 L1: quantile 1.96, result 94.0 mg/dL
Figure 4. Normal Q–Q plot of the ordered values against expected normal quantiles.
Raw pointsBox9091929394Value (mg/dL)Sample QC-2611 L1: result 90.0 mg/dLSample QC-2611 L1: result 90.0 mg/dLSample QC-2611 L1: result 90.0 mg/dLSample QC-2611 L1: result 90.0 mg/dLSample QC-2611 L1: result 91.0 mg/dLSample QC-2611 L1: result 91.0 mg/dLSample QC-2611 L1: result 91.0 mg/dLSample QC-2611 L1: result 91.0 mg/dLSample QC-2611 L1: result 91.0 mg/dLSample QC-2611 L1: result 91.0 mg/dLSample QC-2611 L1: result 92.0 mg/dLSample QC-2611 L1: result 92.0 mg/dLSample QC-2611 L1: result 92.0 mg/dLSample QC-2611 L1: result 92.0 mg/dLSample QC-2611 L1: result 92.0 mg/dLSample QC-2611 L1: result 92.0 mg/dLSample QC-2611 L1: result 92.0 mg/dLSample QC-2611 L1: result 92.0 mg/dLSample QC-2611 L1: result 93.0 mg/dLSample QC-2611 L1: result 93.0 mg/dLSample QC-2611 L1: result 93.0 mg/dLSample QC-2611 L1: result 93.0 mg/dLSample QC-2611 L1: result 93.0 mg/dLSample QC-2611 L1: result 94.0 mg/dLSample QC-2611 L1: result 94.0 mg/dL
Figure 5. The box spans Q1 to Q3 and the whiskers reach the most extreme values within 1.5 × IQR.

Table 7. Box-plot summary

Q1 (mg/dL)Median (mg/dL)Q3 (mg/dL)IQR (mg/dL)Lower whisker (mg/dL)Upper whisker (mg/dL)
91.092.093.02.0090.094.0

S.2 Level 2 · distribution and diagnostics

Bin 282–284 mg/dL: 3 resultsBin 284–285 mg/dL: 8 resultsBin 285–287 mg/dL: 4 resultsBin 287–288 mg/dL: 6 resultsBin 288–290 mg/dL: 4 results02468282284286288290CountResult (mg/dL)
Figure 6. Distribution of included results; dashed: mean.

Table 8. Analysis of variance

SourceSum of squares ((mg/dL)²)dfMean square ((mg/dL)²)
Between days/runs88.9600422.2400
Within runs26.0000201.3000

Raw combined between-day/run variance 4.1880 (one run per day).

Table 9. Spread of all results pooled

EstimateValueUnit
SD, all results pooled2.19mg/dL
CV, all results pooled0.8%
282284286288290−2−1012Value (mg/dL)Theoretical standard-normal quantileSample QC-2611 L2: quantile −1.96, result 282.0 mg/dLSample QC-2611 L2: quantile −1.52, result 283.0 mg/dLSample QC-2611 L2: quantile −1.26, result 283.0 mg/dLSample QC-2611 L2: quantile −1.06, result 284.0 mg/dLSample QC-2611 L2: quantile −0.90, result 284.0 mg/dLSample QC-2611 L2: quantile −0.76, result 284.0 mg/dLSample QC-2611 L2: quantile −0.64, result 284.0 mg/dLSample QC-2611 L2: quantile −0.52, result 284.0 mg/dLSample QC-2611 L2: quantile −0.41, result 285.0 mg/dLSample QC-2611 L2: quantile −0.30, result 285.0 mg/dLSample QC-2611 L2: quantile −0.20, result 285.0 mg/dLSample QC-2611 L2: quantile −0.10, result 286.0 mg/dLSample QC-2611 L2: quantile 0.00, result 286.0 mg/dLSample QC-2611 L2: quantile 0.10, result 286.0 mg/dLSample QC-2611 L2: quantile 0.20, result 286.0 mg/dLSample QC-2611 L2: quantile 0.30, result 287.0 mg/dLSample QC-2611 L2: quantile 0.41, result 287.0 mg/dLSample QC-2611 L2: quantile 0.52, result 287.0 mg/dLSample QC-2611 L2: quantile 0.64, result 288.0 mg/dLSample QC-2611 L2: quantile 0.76, result 288.0 mg/dLSample QC-2611 L2: quantile 0.90, result 288.0 mg/dLSample QC-2611 L2: quantile 1.06, result 289.0 mg/dLSample QC-2611 L2: quantile 1.26, result 289.0 mg/dLSample QC-2611 L2: quantile 1.52, result 289.0 mg/dLSample QC-2611 L2: quantile 1.96, result 290.0 mg/dL
Figure 7. Normal Q–Q plot of the ordered values against expected normal quantiles.
Raw pointsBox282284286288290Value (mg/dL)Sample QC-2611 L2: result 282.0 mg/dLSample QC-2611 L2: result 283.0 mg/dLSample QC-2611 L2: result 283.0 mg/dLSample QC-2611 L2: result 284.0 mg/dLSample QC-2611 L2: result 284.0 mg/dLSample QC-2611 L2: result 284.0 mg/dLSample QC-2611 L2: result 284.0 mg/dLSample QC-2611 L2: result 284.0 mg/dLSample QC-2611 L2: result 285.0 mg/dLSample QC-2611 L2: result 285.0 mg/dLSample QC-2611 L2: result 285.0 mg/dLSample QC-2611 L2: result 286.0 mg/dLSample QC-2611 L2: result 286.0 mg/dLSample QC-2611 L2: result 286.0 mg/dLSample QC-2611 L2: result 286.0 mg/dLSample QC-2611 L2: result 287.0 mg/dLSample QC-2611 L2: result 287.0 mg/dLSample QC-2611 L2: result 287.0 mg/dLSample QC-2611 L2: result 288.0 mg/dLSample QC-2611 L2: result 288.0 mg/dLSample QC-2611 L2: result 288.0 mg/dLSample QC-2611 L2: result 289.0 mg/dLSample QC-2611 L2: result 289.0 mg/dLSample QC-2611 L2: result 289.0 mg/dLSample QC-2611 L2: result 290.0 mg/dL
Figure 8. The box spans Q1 to Q3 and the whiskers reach the most extreme values within 1.5 × IQR.

Table 10. Box-plot summary

Q1 (mg/dL)Median (mg/dL)Q3 (mg/dL)IQR (mg/dL)Lower whisker (mg/dL)Upper whisker (mg/dL)
284.0286.0288.04.00282.0290.0

B Methods

B.1 Additional study details

CAP COM.40300 · 9 December 2025Unmodified FDA-cleared or approved nonwaived tests. Supporting sections: Decision page; Results; Data listing. Associated laboratory evidence: Written assessment for each test and instrument, including investigation of discordant results.
CAP COM.40475 · 9 December 2025Approval of nonwaived test validation or verification before clinical use. Supporting sections: Decision page; Sign-off. Associated laboratory evidence: Director or qualified designee signed written assessment and approval tied to each test and instrument.
CAP GEN.20377 · 9 December 2025Laboratory record retention. Supporting sections: Evidence archive. Associated laboratory evidence: Keep method validation and verification records for the life of the test plus two years, or longer when applicable retention rules require it.
CAP GEN.20450 · 9 December 2025Corrections to laboratory records. Supporting sections: Data listing; Audit trail. Associated laboratory evidence: Retained original values and traceable corrections.

B.2 Statistical methods applied

  1. Random-effects model with days, runs within days and replicate error, one material per level. At least 2 days and at least one run with 2 or more replicates.
  2. Balanced design: repeatability variance = MS(error). Run variance = [MS(run) − MS(error)] / n. Day variance = [MS(day) − MS(run)] / (r n). With one run per day, the combined day/run variance = [MS(day) − MS(error)] / n.
  3. Unbalanced design (unequal runs or replicates): method-of-moments ANOVA estimators. With one run per day, day/run variance = [MS(day) − MS(error)] / n0, n0 = (N − Σnᵢ²/N) / (D − 1). With several runs per day, sequential sums of squares with E[MS(run)] = σe² + k1·σrun² and E[MS(day)] = σe² + k2·σrun² + k3·σday², where k1 = (N − ΣΣnᵢⱼ²/nᵢ) / (Σbᵢ − D), k2 = (ΣΣnᵢⱼ²/nᵢ − ΣΣnᵢⱼ²/N) / (D − 1) and k3 = (N − Σnᵢ²/N) / (D − 1).
  4. A negative component is set to zero. Within-laboratory variance is the sum of the components.
  5. SD allowances using a percentage require a ratio scale. With both limits required on an interval scale, a failed study-unit requirement fails the criterion; otherwise it is undecided.
  6. Grand-mean CI uses Student t with D − 1 degrees of freedom and the SD of the D day means divided by √D. It assumes independent, normally distributed day means.
  7. Distribution diagnostics: ordered values plotted against standard-normal quantiles at Blom positions pᵢ = (i − 3/8)/(n + 1/4).
  8. Box: type-7 quartiles, IQR = Q3 − Q1. Whiskers end at the most extreme values within Q1 − 1.5 IQR and Q3 + 1.5 IQR. Values beyond the whiskers stay in the analysis.
  9. Q–Q and box plots need at least 3 values that are not all identical. The strip plot shows every included value.

B.3 Decision rules and display precision

  1. Each acceptance criterion compares the unrounded estimate with its limit. Limits include their end values unless marked exclusive. A criterion with a missing estimate, too little data or a failed fit is inconclusive and does not count as met.
  2. Entered results, claims, targets and acceptance limits are shown as entered. Calculated concentrations, SDs and fitted parameters are shown to 1 decimal place. CVs are shown to 1 decimal place throughout this study. Very small or large values use exponent notation at the same precision. An SD or limit that would round to zero keeps two significant digits.

C Audit trail

Data version2
Criteria version1
Methodmulti-day precision (balanced ANOVA) (method ID LMS-PREC-1.17)
Criteria evaluationacceptance criteria evaluation (method ID LMS-CRITERIA-1.1)
Import CHEM-A_QC-2611_days-1-5_20260912.csvSHA-256 9486dfd05aabf4937669e4c926a177cb8c1e25163c921b9d8e39342b40617c81
Distribution diagnosticsQ–Q and box plots (method ID LMS-DIAG-1.0)
Report software0.1.0 · templates 2a6731123b96