Malaria Rapid Test Kit

Description

Malaria Ag Pf/Pv Rapid Diagnostic Test (RDT) Kit

Healthy Inc is a specialized global supplier and exporter of advanced diagnostic, infectious disease, and emergency care solutions. We provide high-sensitivity, stable Malaria Rapid Test Kits, manufactured in ISO 13485 & WHO-GMP certified diagnostic facilities. This “Differential Antigen Test” is a massive-volume strategic export to National Health Programs, NGO procurement agencies, and international B2B distributors, serving as the globally preferred intervention for the rapid detection of Plasmodium falciparum and Plasmodium vivax.

Product Overview

This kit operates as a “Portable Immunological Laboratory.” It ensures patient safety by providing a definitive diagnosis in 15 minutes, allowing for the immediate administration of ACT (Artemisinin-based Combination Therapy).

• Mechanism 1 (HRP-II Capture – Pf): The test strip is physically coated with monoclonal antibodies against Histidine-Rich Protein II, which is chemically unique to P. falciparum.

• Mechanism 2 (pLDH Capture – Pv): It physically utilizes antibodies against Parasite Lactate Dehydrogenase, a chemical marker for P. vivax and other non-falciparum species, allowing for species-specific differentiation.

• Mechanism 3 (Capillary Action): Once a blood sample is physically applied with a buffer, it chemically migrates across the nitrocellulose membrane. If antigens are present, they physically bind to the “Test Line,” creating a visible colored band.

Kit Components & Features

We supply this product as a Complete Diagnostic Set, optimized for use in remote areas without electricity or specialized equipment.

Technical & Logistics Specifications

• HS Code: 3822.19.90 (Diagnostic Reagents / Malaria Test Kits)

• Target Antigens: HRP-II (Pf) and pLDH (Pv/Pan)

• Format: Cassette (Lateral Flow)

• Sensitivity/Specificity: >98% (Compared to Microscopy)

• Packaging: 25 Tests/Box or 50 Tests/Box. Our specialized moisture-proof packaging ensures 24-month stability in Zone IVb tropical climates ($2^{\circ}\text{C}$ to $30^{\circ}\text{C}$).

Manufacturing Authority & Compliance

• High-Affinity Antibody Loading: The accuracy of an RDT physically depends on the Antibody Density on the strip. Our manufacturing process utilizes Precision Stripping Technology to ensure the chemical signal is strong even at low parasitemia levels.

• Tropical Heat Stability: Malaria is prevalent in hot regions. Our kits are physically engineered with Desiccant-Optimized Pouches, chemically ensuring the antibodies do not degrade at high humidity—a critical commercial factor for Africa and SE Asia.

• Batch Consistency: Every lot physically undergoes National Reference Laboratory Testing, physically ensuring that the “Control Line” and “Test Line” perform with 100% reliability.

Primary Indications

• Public Health: Large-scale Screening in Endemic Zones (Africa, SE Asia, LATAM).

• Emergency Medicine: Rapid diagnosis of febrile patients in rural or mobile clinics.

• Travel Medicine: Diagnostic tool for travelers returning from malaria-endemic regions.

• NGO Programs: Ideal for “Test-Treat-Track” initiatives by the WHO and Global Fund.

Usage Instructions

1. Sampling: Physically clean the finger and use the lancet to obtain a blood drop.

2. Loading: Use the pipette to physically transfer the exact volume of blood (5μl-10μl) to the sample well (S).

3. Buffering: Physically add 2–3 drops of the assay buffer into the buffer well (B).

4. Reading: Wait exactly 15 minutes. It is physically critical not to read after 20 minutes, as chemical ghost lines may appear.

Safety Warning: For In Vitro Diagnostic Use Only. Disposal Note: Physically dispose of used lancets and cassettes in a Biohazard Sharps Container. Invalid Test: If the “Control Line” (C) does not appear, the test is physically invalid and must be repeated. Confirmation: In complex cases, RDT results should physically be confirmed by microscopy or PCR where available.

Global Export & Contract Manufacturing

Healthy Inc is a premier Diagnostic and Infectious Disease Solution Exporter in India. As a verified Medical Supplier in Mumbai, we offer flexible Third Party Manufacturing (OEM/Private Label) for high-volume Malaria RDTs. Whether you are a National Ministry of Health in Africa or a B2B Pharma Marketplace partner in the CIS or SE Asia, we ensure secure, ISO-compliant delivery.