IVD Rapid Test Manufacturer & OEM Supplier

Lateral Flow Assay Cassettes — Private Label & OEM from 1,000 Units

ISO 13485 Certified · CE Marking Support · 30+ Countries Supplied
Infectious Disease · Cardiac · Fertility · Oncology · Metabolic

1,000
MOQ per SKU
30+
SKUs Available
3–6
Weeks Lead Time
ISO 13485
Certified

What Is a Rapid Test?

A rapid test (also called a rapid diagnostic test, RDT, or lateral flow assay) is a point-of-care immunoassay that detects a target antigen or antibody in a patient sample — typically whole blood, serum, urine, or nasal swab — and delivers a visual result within 5–20 minutes, without laboratory equipment.

Rapid tests use the lateral flow immunoassay (LFA) principle: a conjugated antibody migrates along a nitrocellulose membrane, capturing the target analyte at a test line and confirming assay validity at a control line. A second generation uses fluorescence immunoassay (FIA) readers for semi-quantitative results.

As an IVD rapid test manufacturer, Sekbio supplies both the antibody raw materials that go inside rapid tests and the finished OEM cassette kits ready for private labelling — serving diagnostics companies, NGOs, and government procurement agencies across Africa, Southeast Asia, the Middle East, and South America.

Lateral Flow Assay (LFA) Fluorescence Immunoassay (FIA) Point-of-Care Testing (POCT) Colloidal Gold OEM / Private Label CE Marking Support

Rapid Test Product Portfolio

OEM lateral flow assay cassettes available for private label. All products manufactured under ISO 13485 QMS. CE documentation available.

Infectious Disease

Product Target Sample Type Format Priority
MxA Rapid TestMxA protein (viral infection marker)Whole blood / Finger-prickColloidal gold LFA● High
HIV Ag/Ab 4th Generation Rapid TestHIV-1/2 antibody + p24 antigenWhole blood / Serum / PlasmaColloidal gold LFA● High
PCT Rapid TestProcalcitonin (sepsis marker)Whole blood / SerumFIA (quantitative)● High
Dengue Rapid TestDengue IgG / IgM / NS1Whole blood / SerumColloidal gold LFA● Mid
Tuberculosis IgG/IgM Rapid TestM. tuberculosis antibodiesWhole blood / SerumColloidal gold LFA● Mid
Strep A Rapid TestGroup A Streptococcus antigenThroat swabColloidal gold LFA● Mid
H. pylori Ag Rapid TestH. pylori antigenStoolColloidal gold LFA● Mid
Mycoplasma IgM Rapid TestMycoplasma pneumoniae IgMSerum / PlasmaColloidal gold LFA● Standard
Chlamydia Rapid TestChlamydia trachomatis antigenSwab / UrineColloidal gold LFA● Mid
Gonorrhea Rapid TestN. gonorrhoeae antigenSwab / UrineColloidal gold LFA● Standard

Cardiac & Inflammation

Product Target Sample Type Format Priority
HbA1C Rapid TestGlycated haemoglobin (diabetes monitoring)Whole blood / Finger-prickFIA (quantitative)● High
cTnI Rapid TestCardiac Troponin I (AMI marker)Whole blood / SerumFIA / Colloidal gold● High
CRP Rapid TestC-Reactive Protein (inflammation)Whole blood / SerumFIA (quantitative)● Mid
D-Dimer Rapid TestFibrin degradation (thrombosis)Whole blood / PlasmaFIA (quantitative)● Mid

Reproductive Health & Fertility

Product Target Sample Type Format Priority
AMH Rapid TestAnti-Müllerian Hormone (ovarian reserve)Serum / PlasmaFIA (quantitative)● Mid
HPV Ag Rapid TestHuman Papillomavirus antigenCervical swabColloidal gold LFA● Mid

Oncology & Metabolic

Product Target Sample Type Format Priority
PSA Rapid TestProstate-Specific AntigenWhole blood / SerumColloidal gold LFA● Mid
FOB Rapid TestFecal Occult BloodStoolColloidal gold LFA● Standard
25-OH Vitamin D Rapid TestVitamin D (nutritional status)Whole blood / SerumFIA (quantitative)● Mid
Ferritin Rapid TestFerritin (iron status / anaemia)Whole blood / SerumFIA (quantitative)● Standard

Tropical & Endemic Disease

Product Target Sample Type Format Priority
Malaria Rapid TestP. falciparum / P. vivax HRP2Whole bloodColloidal gold LFA● Mid
Leptospira IgG/IgM Rapid TestLeptospira antibodiesWhole blood / SerumColloidal gold LFA● Standard
Filariasis IgG/IgM Rapid TestFilarial antibodiesWhole blood / SerumColloidal gold LFA● Standard
Chikungunya IgG/IgM Rapid TestChikungunya virus antibodiesSerum / PlasmaColloidal gold LFA● Standard

Don't see the rapid test you need? We develop custom lateral flow assays from your target biomarker.

Request Custom Rapid Test Development →

OEM Rapid Test Manufacturing Capabilities

From antibody raw material to finished cassette — Sekbio supports every stage of rapid test OEM production.

Antibody Raw Materials

Proprietary monoclonal antibodies and colloidal gold conjugates optimised for lateral flow assay performance — batch-to-batch CV <10%.

Cassette Manufacturing

Automated nitrocellulose membrane dispensing, cassette assembly, and foil pouch packaging. MOQ 1,000 units per SKU.

Private Label & Packaging

Full white-label service: your brand name, logo, IFU, and secondary packaging. English, French, Spanish, Arabic available.

Regulatory Support

ISO 13485 QMS documentation. CE Marking technical file support. Export-ready with MSDS, CoA, and lot traceability records.

Serving Rapid Test Markets Worldwide

Sekbio supplies OEM rapid test cassettes to diagnostics distributors, NGOs, and national health programmes across high-growth markets.

Africa

HIV, malaria, tuberculosis, and typhoid rapid tests for Sub-Saharan markets. NGO and government tender supply experience.

Southeast Asia

Dengue, chikungunya, leptospira, and HbA1C rapid tests for Vietnam, Thailand, Indonesia, and the Philippines.

Middle East

Cardiac biomarker, diabetes monitoring (HbA1C), and fertility rapid tests for Gulf and MENA region distributors.

South America

Dengue, Zika, chikungunya, and STI rapid tests for Brazil, Colombia, Peru, and regional distributors.

Rapid Test OEM — Frequently Asked Questions

Common questions from distributors and diagnostics companies about Sekbio's rapid test manufacturing and OEM service.

What is a rapid test?
A rapid test (RDT) is a point-of-care lateral flow immunoassay that detects a target antigen or antibody in a patient sample and delivers a visual result within 5–20 minutes without laboratory equipment. It uses antibody-antigen interactions on a nitrocellulose membrane. Sekbio manufactures both colloidal gold LFA cassettes and fluorescence immunoassay (FIA) formats.
What is the minimum order quantity (MOQ) for OEM rapid tests?
Sekbio's MOQ for OEM rapid test cassettes is 1,000 units per SKU. Bulk orders of 10,000+ units qualify for preferential pricing. Contact info@sekbio.com for a custom quote with quantity-based pricing tiers.
How long does OEM rapid test production take?
For existing catalog products, OEM production lead time is 3–6 weeks after order confirmation and artwork approval. Custom rapid test development (new antigen, new format) requires 8–16 weeks from antibody selection to final validated product.
Does Sekbio provide private label (white label) rapid tests?
Yes. Sekbio offers full private label service — your brand name, logo, IFU, and outer packaging. We support English, French, Spanish, and Arabic IFU languages. CE Marking technical file documentation is available for European market registration.
Is Sekbio ISO 13485 certified for rapid test manufacturing?
Yes. Sekbio holds ISO 13485 certification covering the design, development, and manufacture of IVD rapid test kits. Full lot traceability, Certificate of Analysis (CoA), and MSDS documentation are provided with every shipment.
Can Sekbio develop a custom rapid test for a new biomarker?
Yes. Sekbio's antibody development team can develop custom lateral flow assay rapid tests from a new target biomarker. The process covers antibody discovery and selection, conjugate optimisation, membrane and reader validation, and transfer to OEM production — typically 8–16 weeks end-to-end. Contact us to discuss your target.

Ready to Source Rapid Tests OEM?

Tell us your target disease, required format, and annual volume. Our team will respond within 24 hours with product specifications and OEM pricing.