HBsAg Rapid Test Kits-Cassette-Based bulk supplier for pharma manufacturers

HBsAg Rapid Test Kits-Cassette-Based Suppliers & Bulk Manufacturers

Available Forms: Cassette-Based Rapid Test Kits

Available Strengths: sensitivity >95%, specificity >99%

Reference Brands: -

HBsAg cassette rapid tests, single-use lateral flow in vitro diagnostics for hepatitis B surface antigen, for laboratories, health programmes, hospital buyers and IVD distributors who need registered kits.

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Product Description:

These single-use lateral flow cassettes detect hepatitis B surface antigen (HBsAg), the marker of current hepatitis B infection. In this immunochromatographic assay, antibodies to HBsAg fixed on a membrane capture the antigen, and a coloured conjugate forms a visible test line; a control line shows the sample has run correctly. Depending on the kit, the sample is serum, plasma or whole blood. The cassette format suits clinics and outreach far from a laboratory. It is an in vitro diagnostic, not a medicine.

Rapid HBsAg tests are used in antenatal care, before vaccination or treatment, and in programmes following WHO hepatitis B testing guidance. Results are read within the time window in the instructions for use; late readings are invalid. A reactive result needs follow-up under the national testing algorithm. Sensitivity and specificity differ between products and must come from the instructions for use and independent evaluations. Blood services often require laboratory assays for donor screening, so check the intended use.

Sourcing notes. For UN and donor tenders, WHO prequalification of the IVD is the usual entry criterion; other buyers look for national IVD registration. In the EU, hepatitis B tests are Class D under the IVD Regulation. Ask for the instructions for use with performance data, the ISO 13485 certificate, a release record for each lot and real-time stability data. Cassettes come in sealed foil pouches with desiccant; confirm the storage range on the label. State tests per kit, sample type and shelf life on arrival.

HBsAg Rapid Test Kits-Cassette-Based — third party manufacturing & bulk supply

HBsAg Rapid Test Kits-Cassette-Based is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.

Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.

Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

Indicative minimum order quantity

HBsAg Rapid Test Kits-Cassette-Based is supplied as Cassette-Based Rapid Test Kits — a dosage form priced by order value, so the indicative MOQ is a minimum order value of USD 5,000 per product. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and shelf life.

Manufacturers of HBsAg Rapid Test Kits-Cassette-Based listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.

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Frequently Asked Questions

It is used for the qualitative detection of Hepatitis B Surface Antigen (HBsAg) in human blood samples to aid in the diagnosis and screening of Hepatitis B infection.

It is based on a lateral flow immunoassay technology using specific antibodies against HBsAg, nitrocellulose membrane strips, and labeled conjugates such as colloidal gold to detect the presence of the antigen in the sample.

It is marketed under multiple trade names globally such as Determine HBsAg, SD BIOLINE HBsAg, OnSite HBsAg Rapid Test, HEPACARD, and Vikia HBsAg.

It is manufactured by multiple companies worldwide including Abbott Diagnostics, SD Biosensor, CTK Biotech, bioMérieux, Nal von Minden, J Mitra & Co., Span Diagnostics, Tulip Diagnostics, and Meril Diagnostics.

The generic name is Hepatitis B Surface Antigen (HBsAg) Rapid Diagnostic Test (Lateral Flow Immunoassay).

Common brand names include Determine HBsAg, SD BIOLINE HBsAg, OnSite HBsAg Rapid Test, HEPACARD, and NADAL HBsAg Test.

These kits are manufactured globally across regions including the United States, European Union countries, India, China, and South Korea by various diagnostic companies.