Chemistry analyzer A

Glucose · repeatability · Chemistry analyzer A

Glucose (mg/dL) · Repeatability (single run)

Criteria met

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

Table 1. Acceptance criteria

Question	Limit		Finding	Result
Sample SD	Level 1 SD ≤ 1.8 mg/dL; Level 2 SD ≤ 5.7 mg/dL		2 of 2 levels within	Met

Figure 1. Level 1: results in run order.

Figure 2. Level 2: results in run order.

Table 2. Results by level (mg/dL)

Level	Mean	Mean 95% CI	SD	CV (%)	Result
1	91.9	91.4–92.4	1.02	1.1	Met
2	285.8	285.0–286.6	1.61	0.6	Met

Study details

Matrix: Serum
Method: Hexokinase
Reagent lot: GLU-R2609
Calibrator lot: GLU-C2609
Data: 40 included

A Data listing

Source: CHEM-A_QC-2611_within-run_20260908.csv. 40 rows, all included.

Study row	Specimen	Level	Result (mg/dL)	Replicate	Source row
1	QC-2611 L1	1	92	1	2
2	QC-2611 L1	1	91	2	3
3	QC-2611 L1	1	93	3	4
4	QC-2611 L1	1	92	4	5
5	QC-2611 L1	1	90	5	6
6	QC-2611 L1	1	92	6	7
7	QC-2611 L1	1	93	7	8
8	QC-2611 L1	1	91	8	9
9	QC-2611 L1	1	92	9	10
10	QC-2611 L1	1	94	10	11
11	QC-2611 L1	1	92	11	12
12	QC-2611 L1	1	91	12	13
13	QC-2611 L1	1	92	13	14
14	QC-2611 L1	1	93	14	15
15	QC-2611 L1	1	92	15	16
16	QC-2611 L1	1	90	16	17
17	QC-2611 L1	1	92	17	18
18	QC-2611 L1	1	93	18	19
19	QC-2611 L1	1	91	19	20
20	QC-2611 L1	1	92	20	21
21	QC-2611 L2	2	286	1	22
22	QC-2611 L2	2	284	2	23
23	QC-2611 L2	2	288	3	24
24	QC-2611 L2	2	285	4	25
25	QC-2611 L2	2	287	5	26
26	QC-2611 L2	2	283	6	27
27	QC-2611 L2	2	286	7	28
28	QC-2611 L2	2	289	8	29
29	QC-2611 L2	2	285	9	30
30	QC-2611 L2	2	286	10	31
31	QC-2611 L2	2	284	11	32
32	QC-2611 L2	2	287	12	33
33	QC-2611 L2	2	286	13	34
34	QC-2611 L2	2	288	14	35
35	QC-2611 L2	2	285	15	36
36	QC-2611 L2	2	283	16	37
37	QC-2611 L2	2	286	17	38
38	QC-2611 L2	2	287	18	39
39	QC-2611 L2	2	285	19	40
40	QC-2611 L2	2	286	20	41

1 Results

1.1 Additional estimates

Table 3. Median and range (mg/dL)

Level	Median	Lowest–highest
1	92.0	90–94
2	286.0	283–289

Supporting diagnostics

S.1 Level 1 · distribution and diagnostics

Figure 3. Distribution of included results; dashed: mean.

Normal Q–Q plot

Figure 4. Normal Q–Q plot of the ordered values against expected normal quantiles.

Box plot and individual results

Figure 5. The box spans Q1 to Q3 and the whiskers reach the most extreme values within 1.5 × IQR.

Table 4. Box-plot summary

Statistic	Value (mg/dL)
Q1	91.0
Median	92.0
Q3	92.3
IQR	1.25
Lower whisker	90.0
Upper whisker	94.0

S.2 Level 2 · distribution and diagnostics

Figure 6. Distribution of included results; dashed: mean.

Normal Q–Q plot

Figure 7. Normal Q–Q plot of the ordered values against expected normal quantiles.

Box plot and individual results

Figure 8. The box spans Q1 to Q3 and the whiskers reach the most extreme values within 1.5 × IQR.

Table 5. Box-plot summary

Statistic	Value (mg/dL)
Q1	285.0
Median	286.0
Q3	287.0
IQR	2.00
Lower whisker	283.0
Upper whisker	289.0

B Methods

B.1 Study configuration

CAP COM.40300 · 9 December 2025	Unmodified 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 2025	Approval 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 2025	Laboratory 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 2025	Corrections to laboratory records. Supporting sections: Data listing; Audit trail. Associated laboratory evidence: Retained original values and traceable corrections.

B.2 Statistical methods applied

Estimates and confidence interval

Arithmetic mean, and sample SD with an n − 1 denominator.
Quantiles use linear interpolation (Hyndman–Fan type 7). The histogram has ⌈√n⌉ equal-width bins, at most 40.
Two-sided 95% Student t CI for the mean.
Results are grouped by concentration level. Every included result is used.
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.

Distribution displays

Distribution diagnostics: ordered values plotted against standard-normal quantiles at Blom positions pᵢ = (i − 3/8)/(n + 1/4).
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.
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

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.
Entered results, claims, targets and acceptance limits are shown as entered. Calculated concentrations, SDs and fitted parameters are shown to 1 decimal place, percentages 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

Record versions

Data version	2
Criteria version	1

Source-file traceability

Import CHEM-A_QC-2611_within-run_20260908.csv

SHA-256 3a666b1d69c356f5911beb1e45a384ed32f8b537afbf778f44b2555a00739fea

Software and report generation

Method	single-run repeatability (method ID LMS-RPT-1.15)
Criteria evaluation	acceptance criteria evaluation (method ID LMS-CRITERIA-1.1)
Distribution diagnostics	Q–Q and box plots (method ID LMS-DIAG-1.0)
Report software	0.1.0 · templates 2a6731123b96