As health remains a universal priority, the in vitro diagnostic (Ivd) industry acts as healthcare’s “frontline sentinel.” Aehealth, a leading IVD manufacturer rooted in Shenzhen—with global hubs in Hong Kong and Manchester—has emerged as a driver of “Made in China” excellence, serving 80+ countries via uncompromising Good Manufacturing Practice (GMP) and point-of-care testing (POCT) innovation.
Full-Chain Strength: Quality as the Core
Aehealth’s strength lies in its end-to-end IVD ecosystem, spanning analytical reagent R&D, diagnostic instrument production, quality control (QC) validation, and post-market surveillance (PMS). Its core product lines—fluorescence immunoassay (FIA), high-performance liquid chromatography (HPLC) hemoglobin testing, hematology analyzers, and colloidal gold rapid tests—act as “health decoders” for clinical biochemical diagnosis, infectious disease screening, and chronic disease monitoring, enabling evidence-based medical decisions.
At its production base, a Class 100,000 cleanroom (ISO 14644-1 compliant) with HEPA filtration prevents cross-contamination during reagent manufacturing. The Class 10,000 laboratory focuses on antibody engineering and assay sensitivity optimization, pushing limits for limit of detection (LoD). Annual throughput hits 10 million reagent tests, with 10,000+ analyzers produced yearly—all governed by 7S management and batch traceability. Instruments undergo calibration with standard reference materials (SRMs), accelerated aging testing, and final QC per Clinical and Laboratory Standards Institute (CLSI) guidelines to ensure inter-laboratory reproducibility.
Quality is validated by certifications: ISO 13485, CE IVDR (EU 2017/746), and China’s “National High-Tech Enterprise” title. Products like 5-part hematology analyzers are listed in Germany’s DMOS database, with proven analytical specificity and stability. A robust QC system—featuring calibrated precision balances, -86℃ cryogenic chambers, and leakage current testers—ensures pre-analytical, analytical, and post-analytical performance.
Technological Innovation: Empowering Precision
Innovation defines Aehealth’s offerings. Its FIA series, with 10–12 independent channels, supports 100+ tests: cardiac biomarkers (NT-proBNP, cTnI), tumor markers (AFP, CEA), thyroid panels (T3, T4, TSH), and infectious disease antigens (HBsAg, COVID-19). Tests deliver intra-assay CV ≤ 5% for speed and accuracy.
Hematology analyzers like the AerC-5 stand out: it uses semiconductor laser flow cytometry for 5-part WBC differential (neutrophils, lymphocytes), supports whole blood/prediluted modes, stores 50,000 results with scattergrams, and integrates with LIS/HIS via HL7. A veterinary-specific model offers species-tailored reference ranges for cats, dogs, and livestock.
The Laffinite II HPLC analyzer excels in diabetes care: primary tube piercing reduces errors, 18-position loaders include a STAT slot, and it meets NGSP standards for HbA1c testing (CV ≤ 1.5%), aiding glycemic control. Colloidal gold rapid tests (no equipment needed, 10–15 min results) serve POCT needs for COVID-19, fertility hormones (LH, β-HCG), and inflammation markers (hs-CRP).
Global Reach: Trusted Worldwide
Aehealth’s footprint spans 80+ countries, with 6,000+ installations in hospitals and clinics. It holds approvals from Germany’s BfArM, Brazil’s ANVISA, the UAE’s SFDA, and India’s CDSCO. Its service team provides installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), and calibration support in English, partnering with local distributors for timely assistance.
Active in global forums—Medlab (Africa/Asia/Middle East), ADLM, and Hospitalar Brazil—it showcases cost-effective IVD solutions and builds partnerships.
Our Vision
Guided by “Efficiency, Dedication, Innovation, Sharing,” Aehealth advances POCT miniaturization and multiplex assays to fulfill “Do Ahead of the Illness.” It aims to deepen global health impact, bringing precise diagnostics to every corner.
Contact
- China: 11th Floor, Building 1B, BTR Tech Park, Shenzhen
- UK: 007 Room, 7 Charlotte Street, Manchester
Email: sales@aehealth.uk | Website: www.aehealthgroup.com
Media Contact
Company Name: Aehealth Limited
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Country: China
Website: https://www.aehealthgroup.com/