ReagentLotVerificationChecker

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of ReagentLotVerificationChecker for Reagent Lot Verification Checker.

Domain limits and critical parameters

• Performs lot-to-lot verification per CLSI EP26-A, CAP/CLIA §GEN.48800, ISO 15189 §7.3.5, FDA QSR 820 and EU IVDR Annex I §1.6: Certificate of Analysis verification (present, specs met), physical inspection (packaging, label match, storage, cold chain, visual), parallel testing on ≥5 reference samples spanning analytical range, statistical comparison (mean bias absolute or %, Pearson r ≥0.95, CV ≤15%, outlier detection), triple control verification with new lot (positive, negative, NTC), and docu
• ⚠️ Critical: Lot-to-lot variability is primary source of systematic errors during reagent changes. Manufacturer CoA does NOT guarantee equivalence for your specific application. For qualitative tests, verify 100% concordance. For quantitative tests, use Passing-Bablok/Deming regression when needed. New lot must be tested BEFORE old lot expires. Any control failure = automatic REJECT. Document ALL verifications; accreditation requirement. Tool performs STATISTICAL VERIFICATION only; does not repl

URS — User Requirements Specification

input.csv contract

NewLotNumber,OldLotNumber,ReagentName,Manufacturer,AssayName,CatalogNumber,ManufactureDate_New,ExpiryDate_New,CoA_Present,CoA_SpecsMet,CoA_Issues,PackagingIntact,LabelMatch,StorageCondition_Met,ColdChain_Verified,VisualInspection_Pass,ParallelTestResults_Raw,NumReferenceSamples,MetricName,MetricUnits,MaxAllowableBias_Percent,MaxAllowableBias_Absolute,UseAbsoluteBias,MaxCV_NewLot_Percent,Correlation_MinR,PositiveControl_NewLot_Pass,NegativeControl_NewLot_Pass,NTC_NewLot_Pass,VerifiedBy,VerificationDate,SOP_Reference
LOT-2026-0451,LOT-2026-0389,QIAseq_Targeted_Panel_Kit,Qiagen,NSCLC_CGP,G9999A,2026-05-15,2027-05-15,true,true,,true,true,true,true,true,REF01:0.45:0.47;REF02:1.20:1.18;REF03:0.08:0.09;REF04:2.50:2.45;REF05:0.32:0.33;REF06:0.85:0.88;REF07:0.15:0.14,7,VAF,% VAF,15,0.5,false,15,0.95,true,true,true,Dr. Smith,2026-06-08,SOP-LOT-VER-001
LOT-2026-0467,LOT-2026-0412,TaqMan_MasterMix,Thermo Fisher,KRAS_ddPCR,4440040,2026-06-01,2027-06-01,true,true,,true,true,true,true,true,REF01:25.3:26.8;REF02:28.1:29.9;REF03:22.5:24.2;REF04:30.2:32.1;REF05:26.8:28.5,5,Ct,Ct,10,0.5,true,5,0.95,true,false,true,Dr. Jones,2026-06-09,SOP-LOT-VER-001

Input validation rules

FS — Functional Specification

Example output.json

{
  "utilityId": "reagentlotverificationchecker",
  "utilityFolder": "ReagentLotVerificationChecker",
  "package": "LiquidBiopsy",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "processedAtUtc": "2026-06-10T00:00:00Z",
  "checks": [
    {
      "parameter": "NewLotNumber",
      "value": "LOT-2026-0451",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-001"
    },
    {
      "parameter": "OldLotNumber",
      "value": "LOT-2026-0389",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-002"
    },
    {
      "parameter": "ReagentName",
      "value": "QIAseq_Targeted_Panel_Kit",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-003"
    },
    {
      "parameter": "Manufacturer",
      "value": "Qiagen",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-004"
    },
    {
      "parameter": "AssayName",
      "value": "NSCLC_CGP",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-005"
    },
    {
      "parameter": "CatalogNumber",
      "value": "G9999A",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-006"
    },
    {
      "parameter": "ManufactureDate_New",
      "value": "2026-05-15",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-007"
    },
    {
      "parameter": "ExpiryDate_New",
      "value": "2027-05-15",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-008"
    },
    {
      "parameter": "CoA_Present",
      "value": "true",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-009"
    },
    {
      "parameter": "CoA_SpecsMet",
      "value": "true",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-010"
    },
    {
      "parameter": "CoA_Issues",
      "value": "",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-011"
    },
    {
      "parameter": "PackagingIntact",
      "value": "true",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-012"
    }
  ],
  "criticalFindings": [],
  "warnings": [],
  "audit": {
    "inputHash": "sha256:<calculated at runtime>",
    "rulesVersion": "<utility executable version>",
    "documentation": "ReagentLotVerificationChecker.documentation.html"
  }
}

Traceability matrix

IQ/OQ/PQ test scenarios

QA/QC and change control

• Do not rename columns without updating validator, documentation and test set.
• Retain input.csv, output.json, executable version and checksum.
• Before production use, perform IQ/OQ/PQ or equivalent CSV/CSA verification.
• Critical limits shall be verified against the approved specification, registration dossier and local SOPs.
• The utility provides structured QC decision support; final release decision remains with QA/QP and approved procedures.