Chemistry analyzer A

Glucose · dilution verification · Chemistry analyzer A

Glucose (mg/dL) · Dilution verification

Criteria met

Instrument
Chemistry analyzer A (CA-41027)
Study date
Sep 16, 2026

Table 1. Acceptance criteria

QuestionLimitFindingResult
RecoveryBetween 90% and 110% at each dilution8 of 8 dilutions withinMet
909510010511024Recovery (%)Dilution factor (log scale)Pool HG-1 HG-1, row 1: dilution ×2, recovery 99.3%Pool HG-1 HG-1, row 2: dilution ×2, recovery 100.5%Pool HG-1 HG-1, row 3: dilution ×4, recovery 100.7%Pool HG-1 HG-1, row 4: dilution ×4, recovery 99.3%Pool HG-2 HG-2, row 5: dilution ×2, recovery 99.3%Pool HG-2 HG-2, row 6: dilution ×2, recovery 100.5%Pool HG-2 HG-2, row 7: dilution ×4, recovery 100.5%Pool HG-2 HG-2, row 8: dilution ×4, recovery 99.2%11090Pool HG-1Pool HG-2
Figure 1. Recovery of each dilution; dash-dot lines: limits.
020040060080024Diluted result (mg/dL)Dilution factor (log scale)Pool HG-1 HG-1, row 1: dilution ×2, result 596 mg/dLPool HG-1 HG-1, row 2: dilution ×2, result 603 mg/dLPool HG-1 HG-1, row 3: dilution ×4, result 302 mg/dLPool HG-1 HG-1, row 4: dilution ×4, result 298 mg/dLPool HG-2 HG-2, row 5: dilution ×2, result 735 mg/dLPool HG-2 HG-2, row 6: dilution ×2, result 744 mg/dLPool HG-2 HG-2, row 7: dilution ×4, result 372 mg/dLPool HG-2 HG-2, row 8: dilution ×4, result 367 mg/dL7502Pool HG-1Pool HG-2
Figure 2. Diluted results; dash-dot lines: reportable range.

Table 2. Results by pool (mg/dL)

PoolExpectedFactorsRecovery (%)Within limitVerified rangeResult
HG-11200×2 to ×499.3–100.74 of 41192.0–1208.0Met
HG-21480×2 to ×499.2–100.54 of 41468.0–1488.0Met

Study details

Matrix
Serum
Method
Hexokinase
Reagent lot
GLU-R2609
Calibrator lot
GLU-C2609
Data
8 included
Reportable range
2–750 mg/dL
Alex Rivera, MLS(ASCP)
alex.rivera@example.testSigned off by
Oct 23, 2026, 13:25 UTCDate

A Data listing

Source: CHEM-A_glucose_dilutions_20260916.csv. 8 rows, all included.

Study rowSpecimenPoolFactorResult (mg/dL)ReplicateSource row
1HG-1HG-1259612
2HG-1HG-1260323
3HG-1HG-1430234
4HG-1HG-1429845
5HG-2HG-2273516
6HG-2HG-2274427
7HG-2HG-2437238
8HG-2HG-2436749

1 Results

1.1 Dilutions

Table 3. Dilutions

PoolSpecimenRowPreparationFactorMeasured (mg/dL)In rangeCorrected (mg/dL)Recovery (%)Result
HG-1HG-11Stated×2596Yes1192.099.3
HG-1HG-12Stated×2603Yes1206.0100.5
HG-1HG-13Stated×4302Yes1208.0100.7
HG-1HG-14Stated×4298Yes1192.099.3
HG-2HG-25Stated×2735Yes1470.099.3
HG-2HG-26Stated×2744Yes1488.0100.5
HG-2HG-27Stated×4372Yes1488.0100.5
HG-2HG-28Stated×4367Yes1468.099.2

Diluent: Saline. Preparation: specimen + diluent volumes, serial steps or a stated factor. Factor = (specimen + diluent) / specimen. Corrected = measured × factor. Recovery = corrected / expected × 100. In range: measured inside the reportable range, 2–750 mg/dL.

B Methods

B.1 Additional study details

CAP CHM.13710 · 9 December 2025Chemistry results above or below the AMR. Supporting sections: Decision page; Results. Associated laboratory evidence: Reporting and dilution procedures.
CAP CHM.13720 · 9 December 2025Applicable chemistry dilution protocols. Supporting sections: Decision page; Results. Associated laboratory evidence: Validated dilution protocol and diluent suitability.
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. The dilution factor comes from volumes, a stated factor or serial steps. If you give more than one, they must agree.
  2. Factor from volumes = (specimen + diluent) / specimen. Serial steps are multiplied.
  3. Corrected result = measured value × factor. Recovery = 100 × corrected result / expected undiluted concentration.
  4. A dilution measured outside the reportable range cannot pass.
  5. The verified range spans the corrected results of at least 2 dilutions measured inside the reportable range that meet every recovery criterion.
  6. Claimed limits outside the verified range are flagged.

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 are shown to 1 decimal place, percentages to 1 decimal place. 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 version4
Criteria version2
Methoddilution verification of the measuring interval (method ID LMS-AMI-1.10)
Criteria evaluationacceptance criteria evaluation (method ID LMS-CRITERIA-1.1)
Import CHEM-A_glucose_dilutions_20260916.csvSHA-256 f0b0fcd98f225da96b7a8a20ba0de4e8ee159e66bc2125411d902b36805f82c5
Report software0.1.0 · templates 2a6731123b96