| Type: | Rapid Diagnostic Test |
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| Format: | Cassette |
| Specimen: | Whole Blood |
| Box Specification: | 40 Tests/Box |
| Quantity Per Carton: | 1000 Tests |
| Certificate: | CE / ISO 13485 |
| Samples: |
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| Customization: |
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Suppliers with verified business licenses
Audited Supplier | Format | Cassette |
| Specimen | Whole blood |
| Box Specification | 40 Tests/Box |
| Certificate | CE / ISO 13485 |
| Shelf Life | 24 Months |
| Usage | Professional Use |
| Instrument Classification | Class III |
| Box Size | 268*124*65mm |
| Carton Size | 66*36*56.5cm |
Background
Malaria rapid diagnostic tests (RDTs) assist in the diagnosis of malaria by providing evidence of the presence of malaria parasites in human blood. RDTs are an alternative to diagnosis based on clinical grounds or microscopy, particularly where good quality microscopy services cannot be readily provided.
Variations occur between products, such as targets and formats, though the principles of the tests are similar. Malaria RDTs detect specific antigens (proteins) produced by malaria parasites in the blood of infected individuals. Some RDTs can detect only one species (Plasmodium falciparum or P. vivax) while others detect multiple species (P. falciparum, P. vivax, P. malariae and P. ovale). Blood for the test is commonly obtained from a finger prick.
RDTs are lateral flow immuno-chromatographic antigen-detection tests, which rely on the capture of dye-labelled antibodies to produce a visible band on a strip of nitro-cellulose, often encased in plastic housing, referred to as cassettes. With malaria RDTs, the dye-labelled antibody first binds to a parasite antigen, and the resultant complex is captured on the strip by a band of bound antibody, forming a visible line (T-test line) in the results window. A control line (C- control line) gives information on the integrity of the antibody-dye conjugate but does not confirm the ability to detect parasite antigens.
Hangzhou Testsea Biotechnology Co., LTD. is a national high-tech enterprise, is located in Hangzhou. Testsea has lots of researchers and workers who graduated from Zhejiang University and overseas. Testsea is specialized in the research, development, production and sales of raw materials for medical diagnosis and food safety testing. We have applied for 28 kinds of patents which cover medical diagnosis, food safety rapid testing, food enzymatic immunoassay and new enzyme preparation. Testsea provides perfect raw material solutions for scientific research institutions, enterprises, research institutes and other institutions globally. Testsea total business area is more than 56,000 square meters, including 2,000 square meters of GMP 100,000-level purification workshop, our company is strictly following ISO13485 and ISO9001 quality management system operation with research, production, quality control, finance, domestic sales and international sales, etc. Our products are well accepted by many users domestic and abroad. In addition, we establish a good business relationship with many domestic universities and in vitro diagnostic production enterprises, even with southeast Asia, Europe, Africa, Latin America, and other countries.
Testsea has a research and development team led by doctors and masters with professional workers and a well-equipment facility. The production capacity of recombinant antigens has reached 18g/month.
Testsea pursuit of "integrity, quality, responsibility" concept and adhere to the quality, the purpose of serving the society and constantly developing new high-quality diagnostic materials efforts.
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