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  • Malaria Pf/Pan Antigen Rapid Test
  • Malaria Pf/Pan Antigen Rapid Test

Malaria Pf/Pan Antigen Rapid Test

Usage
The Malaria Pf/Pan Antigen Rapid Test is a rapid, serological, lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of Plasmodium falciparum (Pf) antigen and P. vivax (Pv), P. ovale (Po), or P. malariae (Pm) antigen in human whole blood specimen. It is intended to be used by healthcare professionals as an aid in the diagnosis of infection with plasmodium. The test only provides preliminary analysis results but not critical diagnosis criteria. Any use or interpretation of the test must be analyzed and confirmed with alternative testing method(s) and clinical findings based on professional judgment of healthcare providers.

 

Background of Clinical Indications

Malaria is caused by a protozoan which invades human red blood cells.1 Malaria is one of the world's most prevalent diseases. According to the WHO, the worldwide prevalence of the disease is estimated to be 300-500 million cases and over 1 million deaths each year. Most of these victims are infants, young children. Over half of the world's population lives in malarious areas. Microscopic analysis of appropriately stained thick and thin blood smears has been the standard diagnostic technique for identifying malaria infections for more than a century.2 The technique is capable of accurate and reliable diagnosis when performed by skilled microscopists using defined protocols. The skill of the microscopist and use of proven and defined procedures, frequently present the greatest obstacles to fully achieving the potential accuracy of microscopic diagnosis. Although there is a logistical burden associated with performing a time-intensive, labor-intensive, and equipment-intensive procedure such as diagnostic microscopy, it is the training required to establish and sustain competent performance of microscopy that poses the greatest difficulty in employing this diagnostic technology.

The Malaria Pf/Pan Antigen Rapid Test is a rapid test which utilizes a pair of antibodies to qualitatively detect P. falciparum Histidine- rich protein II (pHRP-II), and a pair of antibodies to qualitatively detect the plasmodium Lactate Dehydrogenase (pLDH) for detection of P. falciparum, P. vivax, P. ovale and P. malariae, which enables simultaneous detection and differentiation of an infection with P. falciparum and/or any of the other three plasmodium species.3-6 The test can be performed without cumbersome laboratory equipment, and the results are available within 20 minutes.

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Packing specification

Principle of Inspection

The Malaria Pf/Pan Antigen Rapid Test is a qualitative membrane-based immunoassay for the detection of Plasmodium falciparum (Pf) antigen and P. vivax (Pv), P. ovale (Po), or P. malariae (Pm) antigen in human whole blood specimen. The membrane is pre-coated with specific monoclonal anti-pLDH antibodies in the Pan line and monoclonal anti-pHRP-II antibodies in the Pf line. During testing, the whole blood specimen reacts with the particle coated with pHRP-II-gold conjugates, pLDH-gold conjugates, and colloidal gold conjugates containing control antibody to form an antigen-antibody-gold complex. The mixture migrates upward on the membrane chromatographically by capillary action to react with anti-pHRP-II antibodies and anti-pLDH antibodies immobilized in the membrane and produce a colored line(s).

If pLDH is present in the specimen, a colored line will appear at the Pan line. In the presence of a Pf line, a Pan line indicates a positive result for Pf or a positive result for Pf and any of the other three Plasmodium species (Pv, Pm, Po). In the absence of a Pf line, a Pan line indicates a positive result for Pv, Po or Pm or a combination of any of these three Plasmodium species.

If pHRP-II is present in the specimen, a colored line will appear at the Pf line, indicating a Pf positive test result.

The absence of both the Pan line and the Pf line indicates a negative result.

An internal quality control is included in the test, in the form of a colored line appearing in the control line region (C), indicating that the test is functional, and proper and sufficient volume of specimen has been applied to enable migration through the test and control line, regardless of whether there is a test line or not. If the control line (C) does not appear within the testing time, test result is invalid and the test should be repeated with a new test device.

Specification packaging

1 Tests/Kit，25 Tests/Kit.

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About Kangte

Zhejiang Kangte Biotechnology Co., Ltd

Zhejiang Kangte Biotechnology Co., Ltd. was established in 2001 and is located in Zhejiang Xinchang Provincial High-tech Industrial Park. It is a national high-tech enterprise integrating R&D, production and sales of in vitro diagnostic reagents. Relying on the pioneering team spirit and scientific management, the company has repeatedly won the national advanced production unit in the in vitro diagnostic industry. 

The company has GMP standard workshops, clean workshops, R&D laboratories, equipped with high-precision testing equipment and fully automatic production equipment. In order to enhance the company's overall R&D strength, it has established a good "production-study-research" cooperative relationship with many colleges and universities. The company has obtained a number of invention patents and utility model patents and has passed ISO9001, ISO14001, ISO13485, and other system certifications. The company currently has more than 100 registered products, covering biochemical, immunological, and other fields, and many of the products have reached the leading domestic level in technology. 

The company adheres to the concept of "integrity, professionalism, efficiency and innovation" to serve customers, and constantly introduces products with higher technological content to provide customers. The company will, as always, position itself in "service technology, professionalism and efficiency, and achieve customers", and work hard to jointly shape the IVD industry and continuously improve the level of human health.

 

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