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Covid 19 Rapid Antibody Test Kit bulk supplier for pharma manufacturers

Covid 19 Rapid Antibody Test Kit Suppliers & Bulk Manufacturers

Available Forms: Test Kits

Available Strengths: 1 test/kit, 10 tests/kit

Reference Brands: Cellex qSARS-CoV-2 IgG/IgM Rapid Test (USA), Roche SARS-CoV-2 Rapid Antibody Test (EU)

Category: Rapid Test Kits

The device is designed to aid in the rapid differential diagnosis of COVID-19 Virus infection. This assay is intended to be used for screening patients with suspected COVID-19 Ag infection having symptoms of respiratory infections or immediate contact with confirmed positive cases. Covid 19 Rapid Antibody Test Kit is available in Test Kits and strengths such as 1 test/kit, 10 tests/kit. Sourced from GMP-certified and ISO-compliant manufacturers, this API meets global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical formulation and commercial manufacturing, Covid 19 Rapid Antibody Test Kit is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.

Technical Specifications & Supply Details
Lead Time 7 to 60 days (depending on batch size & schedule)
MOQ As per manufacturer’s batch size
COA Available with every batch
Regulatory Dossier / DMF Available upon request
Export Documentation FSC, COA, Manufacturing License, Product Permission
Standards IP, BP, USP
Certifications WHO-GMP, EU-GMP, USFDA (as applicable)

Covid 19 Rapid Antibody Test Kit can be exported to over 30 countries across Asia, Africa, Europe, and Latin America. Flexible packaging, competitive pricing, and a verified supplier network make Pharmatradz a trusted sourcing partner for pharmaceutical companies and contract manufacturers worldwide.

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📘 Sourcing Guide

Product Description:

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus responsible for COVID-19, spread rapidly across more than 185 countries and regions, leading to a global health crisis. Within a short period, it resulted in millions of confirmed infections and a significant number of deaths, highlighting its high transmissibility and public health impact. The virus primarily targets the respiratory system, causing illnesses that range from mild symptoms such as fever, cough, and fatigue to severe complications including pneumonia, acute respiratory distress syndrome (ARDS), and multi-organ failure.

SARS-CoV-2 is transmitted mainly through respiratory droplets and close human contact, making containment challenging, especially in densely populated areas. Vulnerable populations, including the elderly and individuals with underlying health conditions, are at a higher risk of severe disease outcomes. The rapid spread and severity of infection have placed immense pressure on healthcare systems worldwide.

Respiratory diseases caused by SARS-CoV-2 continue to pose serious threats to human health, emphasizing the importance of early detection, preventive measures, vaccination, and effective diagnostic tools to control and manage the spread of infection.

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Frequently Asked Questions

It is used for the qualitative detection of IgG and IgM antibodies against SARS-CoV-2 in human blood samples to determine previous exposure to COVID-19 infection and to support epidemiological studies and immune response assessment.

It is based on a lateral flow immunoassay technology using recombinant SARS-CoV-2 antigens, colloidal gold or similar labeling systems, nitrocellulose membranes, and specific antibodies to detect IgG and IgM in blood samples.

It is marketed under multiple trade names globally such as Cellex qSARS-CoV-2 IgG/IgM Rapid Test, Healgen COVID-19 Rapid Test, Roche SARS-CoV-2 Rapid Antibody Test, and SD Biosensor STANDARD Q COVID-19 IgM/IgG Combo.

It is manufactured by multiple companies worldwide including Cellex Inc., Healgen Scientific LLC, Roche Diagnostics, SD Biosensor, Abbott Laboratories, BIOSYNEX, Meril Diagnostics, and GenBody Inc.

The generic name is SARS-CoV-2 IgG/IgM Rapid Antibody Diagnostic Test (Lateral Flow Immunoassay).

Some common brand names include Cellex qSARS-CoV-2 IgG/IgM Rapid Test, Healgen COVID-19 Rapid Test Cassette, Roche SARS-CoV-2 Rapid Antibody Test, and STANDARD Q COVID-19 IgM/IgG Combo.

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

Yes, Covid 19 Rapid Antibody Test Kit is available with DMF and other regulatory documents such as COA and MSDS. These can be provided upon request for qualified buyers.

Absolutely. Sample requests are accepted for formulation trials and quality checks. Please submit an enquiry to initiate the process.

Our manufacturing partners are GMP-certified and comply with ISO and WHO standards, ensuring global quality benchmarks.

Lead times vary based on quantity and destination, but most orders are fulfilled within 1–3 weeks. Express shipping options are available.

Yes, Covid 19 Rapid Antibody Test Kit is exported to over 30 countries across Asia, Africa, Europe, and Latin America. We support documentation for customs and regulatory clearance.

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