Why Manufacturers Choose Laihe

Four Core Manufacturing Strengths

After nearly two decades in IVD, these are the capabilities our partners consistently rely on for global compliance and reliable delivery.

1. Smart Mfg

Smart Manufacturing, Reliable Delivery

Multiple fully automated production lines across 9,200㎡ — for both fluorescence immunoassay and colloidal gold platforms.

We guarantee excellent batch-to-batch consistency and sufficient capacity to handle concurrent bulk orders from multiple markets without compromise.

2. Quality Control

End-to-End Quality Control & Global Certifications

Our quality management system covers everything: incoming raw material screening, in-process monitoring at every stage, and final product release with full lot traceability.

Certified under ISO 13485, ISO 9001, and MDSAP — our QC laboratory validates every batch to internationally leading sensitivity and stability benchmarks.

3. Supply Chain

Industrial Cluster & Supply Chain Assuranc

Located within Hangzhou's mature IVD industrial cluster, we maintain long-term strategic partnerships with hundreds of premium raw material suppliers.

This dual advantage of geography and ecosystem means faster response to market demand, stable sourcing of core materials, and guaranteed lead times.

4. Technical Expertise

Technical Expertise & Process Mastery

With nearly two decades specialising in antibody screening, process optimisation, and mass production scaling, our R&D and production teams possess mature process transfer expertise.

Every formula that leaves the lab is industrialised without sacrificing the sensitivity and specificity achieved at bench scale — and at a cost efficiency that keeps your margins viable.

Product Portfolio

What types of rapid test kits
do we manufacture?

From routine drug screening to specialised cardiac markers — every test is manufactured on our automated lines and validated against international performance standards.

Drug Of Abuse Rapid Test Kits

High-sensitivity, high-specificity competitive binding immunoassays built on proven Lateral Flow Immunoassay (LFIA) technology for clinical, workplace, and point-of-care drug screening. Validated against GC/MS laboratory standards to deliver accurate, reliable results with minimized false positives.

Aligned with global standards for drugs of abuse screening

Customizable multi-panels (up to 14-in-1)

Read times under 5 minutes

Custom cut-off levels available for OEM customers

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respiratory disease rapid test kit

Utilizing Colloidal Gold Immunochromatographic Assay and Fluorescence Immunoassay technologies, our respiratory disease rapid tests support rapid antigen detection for Influenza A/B, RSV, COVID-19, ADV, HMPV, PIV, and co-infection panels. Designed for professional point-of-care testing (POCT) environments, these solutions are widely adopted by hospital emergency departments and public health programs worldwide.

Combo panels for simultaneous multiplex detection

Compatible with nasopharyngeal & nasal swab samples

CE-IVD compliant formats available

Shelf life up to 36 months at 2–30°C

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infectious disease rapid test kit

High-Sensitivity, High-Specificity Immunoassays for Global Infectious Disease Screening. Developed with high-sensitivity, high-specificity immunochromatographic (colloidal gold) technology, designed for reliable point-of-care and clinical laboratory screening. Each product is rigorously validated against reference laboratory methods (e.g., PCR, culture, or ELISA) to ensure accurate, reproducible results with minimal cross-reactivity.

Early detection of all four Dengue serotypes (DEN-1 to DEN-4)

ANVISA (Brazil) evaluated

Registered and popular in Southeast of Asia countries

Results in 15 minutes

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fertile test kit

Reusable Device + Smart APP Single-Use Rapid Test Kit (Standalone) Strip, cassette, midstream and digital formats

Ultra-early detection sensitivity (10–20 mIU/mL hCG)

Strip, cassette, and midstream formats

Full OEM/private-label packaging available

CE marked for EU OTC market

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cardiac marker rapid test kit

High-sensitivity fluorescence immunoassay panels for cTnI, NT-proBNP, D-Dimer, CK-MB, and Myoglobin. Designed for point-of-care use in chest pain units, emergency departments, and remote healthcare settings.

Quantitative limit ≤ 0.1 ng/mL for critical decision making

Results in 8–15 minutes from whole blood

Reader-compatible for quantitative reporting

Clinically validated against central laboratory methods

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tumor marker rapid test kit

Rapid screening assays for AFP, CEA, PSA, and other key oncology markers — enabling accessible, early-stage risk stratification in community health screening and specialist oncology settings.

Quantitative fluorescence & semi-quantitative

Low sample volume (50–100 µL serum/plasma)

Rapid screening for population health programmes

Multi-marker combo panels available

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inflammatory marker rapid test kit

Rapid CRP, PCT, and SAA assays for fast differential diagnosis of bacterial versus viral infections — critical for antibiotic stewardship programmes and sepsis triage in both hospital and primary care settings.

CRP + SAA combo for comprehensive infection screening

PCT for sepsis and ICU monitoring

Finger-stick whole blood compatible

Results within 10 minutes at the bedside

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veterinary rapid test kits

Species-specific rapid diagnostic tests for canine, feline, and livestock pathogens. Ideal for veterinary clinics, animal hospitals, and agricultural disease surveillance programmes that require rapid, reliable field results.

Canine & feline panels (Parvovirus, Distemper, FeLV, FIV)

No cold-chain required during field use

Custom OEM labelling for veterinary distributors

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Quality at Every Step

GMP-Certified 6-Stage IVD Rapid Test Kit Manufacturing Process

As an industry-leading In Vitro Diagnostic (IVD) manufacturer, our Lateral Flow Assay (LFA) production follows a strictly controlled, GMP-compliant sequence. From raw material formulation to final lot release, every test kit undergoes rigorous QA/QC validation to guarantee high analytical sensitivity, minimal batch-to-batch variation, and full compliance with global regulatory standards.

01

NC Membrane Precision Coating

Utilizing high-precision dispensers to evenly coat Nitrocellulose membranes with purified antigens/antibodies, establishing distinct and reliable test lines.

02

Conjugate Pad Preparation

Saturating fiberglass pads with optimized colloidal gold or fluorescent markers, followed by rigorous optical density validation to prevent false positives.

03

Humidity-Controlled Drying

Curing all treated materials in specialized drying rooms (RH ≤ 20%) to lock in protein biological activity and ensure long-term stability.

04

Assembling & Precise Cutting

Laminating components onto adhesive backing cards and utilizing programmed automated slitters to cut strips to exact millimeter widths (e.g., 3.0mm, 4.0mm).

05

Primary Foil Pouching

Automated sealing of individual strips/cassettes into medical-grade foil pouches alongside high-absorption desiccants to guarantee a 24-month shelf life.

06

Final QC & Release

Random lot sampling for analytical sensitivity and cross-reactivity testing before automated boxing and labeling for global export compliance.

Laihe Biotech IVD manufacturing facility

0+ Years of IVD
Expertise

About Laihe Biotech

A POCT Manufacturer Rooted in Scientific Validation

Laihe Biotech has been manufacturing rapid diagnostic test kits in Hangzhou since 2012. We control the full IVD production chain in-house — from antibody screening and conjugate preparation to membrane coating and final QC. Our typical batch-to-batch coefficient of variation (CV) is ≤ 5%, validated against GC/MS or LC/MS confirmatory methods depending on the assay.

9200㎡ GMP Workshop

EU IVDR Regulatory Support

Full Process Traceability

MOQ from 5,000 pcs

Our Dedicated Experts

Multidisciplinary IVD Specialists: Engineering Diagnostic Precision

We believe a robust supply chain starts with brilliant minds. Backed by a dedicated team of over 120+ professionals, our core competency is driven by specialized talent. Our Chief Scientists, Biomedical Engineers, and QA Auditors bring 15+ years of deep-rooted experience in Lateral Flow Assay (LFA) R&D, reagent formulation, and scale-up manufacturing. We don't just assemble test kits; we engineer diagnostic precision.

9200㎡ GMP Workshop EU IVDR Regulatory Support Full Process Traceability MOQ from 5,000 pcs

R&D Team

Specialising in fluorescence immunoassay and colloidal gold platforms, our scientists manage the entire development process — from antibody screening to production scale-up — ensuring industry-leading sensitivity, specificity, and batch consistency.

Regulatory Affairs Team

Well-versed in EU IVDR and global regulatory frameworks, our RA team provides professional market-access support — helping your products enter new markets compliantly, efficiently, and without costly delays.

Sales & Documentation Teams

Fluent in multiple languages, our sales team ensures seamless communication from inquiry to order. Our documentation specialists handle complex customs clearance for smooth delivery every time.

Supply Chain Team

Based in Hangzhou's mature IVD cluster, our supply chain team partners with hundreds of vetted suppliers and rigorously controls every input — meeting EU quality standards, Southeast Asia's fast-paced demands, and Africa's cost-effectiveness requirements, all with predictable lead times.

Global Presence

Meet Us at International IVD Exhibitions

As an international IVD manufacturer, Laihe Biotech collaborates with distributors, OEM partners, and healthcare brands worldwide — meeting them face to face at leading medical and diagnostics exhibitions across 80+ countries.

Proven Track Record

Distributor Success Cases

Laihe Biotech to Showcase Advanced DOA Testing and Hair Drug Testing Solutions at WHX Bangkok & WHX Labs Bangkok 2026

Date:July 8-10, 2026Location:Queen Sirikit National Convention Center, Bangkok, ThailandBooth Number:H64 Laihe Biotechis pleased to announce its participation in WHX Bangkok & WHX Labs Bangkok 2026, one of Southeast Asia's leading exhibitions for laborato

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Laihe Biotech to Showcase Rapid Test Solutions at WHX&WHX Labs (Medlab Asia&Asia Health) Malaysia 2025

Date: 16-18 July 2025 Location: Malaysia International Trade and Exhibition Centre (MITEC) Booth Number: S25 Laihe Biotech is excited to announce the participation in WHX Labs Kuala Lumpur 2025, the premier healthcare exhibition in Malaysia.

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LYHER Obtained ANVISA Approval for Dengue NS1 Antigen Test Kit in Brazil！

We have obtained the product certificate from ANVISA.

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Company Updates

Latest IVD News

Laihe Biotech to Showcase Advanced DOA Testing and Hair Drug Testing Solutions at WHX Bangkok & WHX Labs Bangkok 2026

Date:July 8-10, 2026Location:Queen Sirikit National Convention Center, Bangkok, ThailandBooth Number:H64 Laihe Biotechis pleased to announce its participation in WHX Bangkok & WHX Labs Bangkok 2026, one of Southeast Asia's leading exhibitions for laborato

View Details ➔

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Complete Guide to Covid-19 Antibody Testing for Global Buyers

Learn Covid-19 antibody tests: types, accuracy, certifications, and how to verify trustworthy suppliers using checklists and WHO-backed guidance.

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How Covid 19 Walgreens Testing works from booking to results

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Covid 19 Test Kits Comparative Analysis PCR vs Antigen

Compare Covid-19 PCR vs antigen tests, understand accuracy vs speed, and choose the right test for travel, work, or symptoms using WHO-backed guidance.

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