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Compliance
ISO 15189:2022CLIACAP21 CFR Part 11HL7v2FHIR R4ASTM E1394Westgard

Interactive marketing demo running on Vercel with mock data. Click any feature to explore — no account needed.

Production stack for AssayCore Med

Core: PostgreSQL 16 + Redis 7 + Kafka 3.7 + MinIO + Keycloak 24 + Spring Boot 3.3 (Kotlin) + React 18/MUI + FastAPI ML (Python 3.11) + Nginx + Docker

Module-specific: HL7 v2.5.1 (HAPI HL7v2) · FHIR R4 (HAPI FHIR) · ASTM E1394 analyzer bridge · LOINC auto-mapping · Westgard 13-rule QC engine · HIPAA on-prem playbook (pgcrypto + AD/LDAP via Keycloak)

Deployable on your infrastructure or our managed Hetzner. Self-hosted source-license available.

Reagent Lot-Release QC

Multi-rule evaluation · Westgard Basic QC Practices 5th ed · CLSI EP05-A3 · CAP QC-Pearl

Lots pending release

2

Released

7

Rejected

7

Active QC rules triggered

8

Westgard rules: 1-3s = 1 control > ±3 SD (warning); 2-2s = 2 consecutive > ±2 SD; R-4s = range > 4 SD (reject); 4-1s = 4 consecutive on same side; 10x = 10 consecutive same side. Source: Westgard Basic QC Practices 5th ed, pp.145–162.
Reagent KitLotQC MaterialAcceptance RangeObserved mean ± SDWestgard RuleReceivedStatus
Glucose HK R1/R2
Roche
LOT-RO-958612Bio-Rad Lyphochek Chem L14.8 – 5.84.71 ± 0.04R-4s2026-09-17Rejected
Creatinine Jaffé R1/R2
Roche
LOT-RO-136702Bio-Rad Lyphochek Chem L285 – 105—4-1s2026-09-23Pending
ALT (IFCC) Reagent
Roche
LOT-RO-124128Randox Assayed Chem L132 – 4647.64 ± 0.97R-4s2026-09-22Rejected
AST (IFCC) Reagent
Roche
LOT-RO-198551Randox Assayed Chem L228 – 40—None2026-09-24Pending
Total Protein Biuret
Roche
LOT-RO-136806Stanbio Chemistry Ctrl L158 – 7469.92 ± 1.07None2026-09-25Released
HbA1c Cartridge
Abbott
LOT-AB-653014Bio-Rad LYPHOCHECK Diabetes L147 – 5948.22 ± 0.27None2026-09-25Released
Troponin I STAT
Abbott
LOT-AB-445719Randox Cardiac Ctrl L20.028 – 0.050.049 ± 0None2026-09-25Released
TSH 3rd Gen
Siemens Healthineers
LOT-SI-875489Bio-Rad Lyphochek Immunoassay L10.85 – 1.551.54 ± 0.05None2026-09-20Released
Free T4 (FT4)
Siemens Healthineers
LOT-SI-408953Bio-Rad Lyphochek Immunoassay L29.8 – 16.217.08 ± 0.44R-4s2026-09-19Rejected
PSA Total
Beckman Coulter
LOT-BE-555337Randox PSA Ctrl L13.2 – 5.84.61 ± 0.18None2026-09-26Released
PT (NeoPTimal)
Stago
LOT-ST-570318Stago CK Prest L210.5 – 13.511.6 ± 0.08None2026-09-18Released
aPTT Liquid
Stago
LOT-ST-906890Stago CK Prest L128 – 3839.21 ± 0.441-3s2026-09-20Rejected
D-Dimer STA-Liatest
Stago
LOT-ST-601315Stago CK-STA L20.35 – 0.650.68 ± 0.022-2s2026-09-27Rejected
HbA1c VARIANT II Turbo Kit
Bio-Rad
LOT-BI-526945Bio-Rad LYPHOCHECK Diabetes L270 – 8868.39 ± 1.431-3s2026-09-27Rejected
Urinalysis KOVA Stain
Iris Diagnostics
LOT-IR-774054Stanbio Urinalysis Ctrl4.2 – 5.85.88 ± 0.052-2s2026-09-22Rejected
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