LiquidBiopsySampleIntakeChecker

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of LiquidBiopsySampleIntakeChecker for Liquid Biopsy Sample Intake Checker.

Domain limits and critical parameters

• • EDTA Limit: ≤2 hours at room temperature — critical threshold for WBC lysis prevention.
• • Stabilized Tube Limit: ≤72 hours for Streck/PAXgene at RT.
• • Plasma Volume: Sufficiency for target analysis (typically ≥2 mL).
• • Freeze-Thaw Cycles: Number of freeze-thaw cycles (≤1 recommended).
• • Hemolysis >50 units correlates with PCR inhibition and elevated gDNA background.
• ⚠️ CRITICAL:
• • EDTA Time ≤ 2h: Exceedance = REJECT for clinical tests.
• • Plasma Volume ≥ 2 mL: Below = sensitivity below claimed LOD.
• • Hemolysis ≤ 50: Exceedance = CONDITIONAL or REJECT depending on assay.
• • Freeze-Thaw ≤ 1: Each additional cycle increases cfDNA fragmentation.

URS — User Requirements Specification

input.csv contract

SampleID,PatientID,TubeType,BiofluidType,CollectionTime,ReceiptTime,ProcessingTime,MaxTimeToProcessing_Hours_EDTA,MaxTimeToProcessing_Hours_Stabilized,StorageTemp_C,MinStorageTemp_C,MaxStorageTemp_C,PlasmaVolume_mL,MinPlasmaVolume_mL,HemolysisIndex,MaxHemolysisIndex,LipemiaIndex,MaxLipemiaIndex,ChainOfCustody_Complete,RequisitionForm_Complete,LabelMatch,PackagingIntact,TemperatureMonitor_Present,TemperatureExcursion_Detected,FreezeThawCycles,MaxFreezeThawCycles
LB-INT-2026-001,PAT-1001,Streck,Whole Blood,2026-06-08 08:00:00,2026-06-09 10:00:00,2026-06-09 11:00:00,2.0,72.0,22,15,30,4.5,2.0,8,50,12,100,true,true,true,true,true,false,0,1
LB-INT-2026-002,PAT-1002,EDTA,Plasma,2026-06-08 08:00:00,2026-06-08 16:00:00,2026-06-08 16:30:00,2.0,72.0,4,2,8,1.5,2.0,85,50,5,100,true,true,true,true,false,false,2,1
LB-INT-2026-003,PAT-1003,PAXgene,Plasma,2026-06-07 10:00:00,2026-06-09 09:00:00,2026-06-09 09:30:00,2.0,72.0,-70,-80,-20,3.0,2.0,15,50,120,100,true,true,true,true,false,false,0,1

Input validation rules

FS — Functional Specification

Example output.json

{
  "utilityId": "liquidbiopsysampleintakechecker",
  "utilityFolder": "LiquidBiopsySampleIntakeChecker",
  "package": "LiquidBiopsy",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "processedAtUtc": "2026-06-10T00:00:00Z",
  "checks": [
    {
      "parameter": "SampleID",
      "value": "LB-INT-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-001"
    },
    {
      "parameter": "PatientID",
      "value": "PAT-1001",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-002"
    },
    {
      "parameter": "TubeType",
      "value": "Streck",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-003"
    },
    {
      "parameter": "BiofluidType",
      "value": "Whole Blood",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-004"
    },
    {
      "parameter": "CollectionTime",
      "value": "2026-06-08 08:00:00",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-005"
    },
    {
      "parameter": "ReceiptTime",
      "value": "2026-06-09 10:00:00",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-006"
    },
    {
      "parameter": "ProcessingTime",
      "value": "2026-06-09 11:00:00",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-007"
    },
    {
      "parameter": "MaxTimeToProcessing_Hours_EDTA",
      "value": "2.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-008"
    },
    {
      "parameter": "MaxTimeToProcessing_Hours_Stabilized",
      "value": "72.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-009"
    },
    {
      "parameter": "StorageTemp_C",
      "value": "22",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-010"
    },
    {
      "parameter": "MinStorageTemp_C",
      "value": "15",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-011"
    },
    {
      "parameter": "MaxStorageTemp_C",
      "value": "30",
      "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": "LiquidBiopsySampleIntakeChecker.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.