Rotavirus is a major cause of severe childhood gastroenteritis. Rotavirus, the most significant member of the Reoviridae family, is responsible for almost two million hospital admissions, around 25 million clinic visits, and more than 0.8 million deaths among children below the age of five globally each year. Rotavirus has a worldwide incidence, both in developed and developing countries; however, maximum deaths have been observed in the developing countries.
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It is difficult to differentiate gastroenteritis caused by rotavirus from other enteric pathogens. Hence, identification of the cause of gastroenteritis needs analysis of fecal specimens with commercially available assays. Rotaviruses are double-stranded, non-enveloped RNA viruses, which consist of 11 segments. Viral RNA is surrounded by a three-layer capsid: outer capsid, inner capsid, and core capsid. Based on antigenic protein VP6, the International Committee on Taxonomy of Viruses (ICTV) has subdivided rotaviruses into eight groups (A–H).
Majority of human rotaviruses belong to group A. VP4 and VP7 (proteinase sensitive protein), two structural proteins of the outer capsid, determine the P and G genotypes of a virus, respectively. Genomic segment changes may occur between strains due to the segmented structure of viral RNA, resulting in large number of P and G genotypes. Epidemiological studies reported that G9P, G3P, G2P, and G1P have been the most common genotypes causing diseases in children in the last 20 years.
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G12 is reported to be a recently emerged genotype. Nucleic acid amplification, cell culture, and electron microscopy tests are used in the laboratory diagnosis of rotavirus infections. ELISA, latex agglutination, and immune chromatographic are the most commonly used methods, as these are fast, do not require special technical expertise and tools, have high specificity and sensitivity, and are easy to use.
Rotarix and RotaTeq are the two oral attenuated rotavirus vaccines for rotavirus gastroenteritis. These have been used and licensed in large number of countries since 2006. Rotarix vaccine provides a high level of protection against rotavirus gastroenteritis caused by G1, G3, G4, and G9 types. However, its protection is low for G2 type. RotaTeq vaccine, which is used in three doses, provides a high level of protection against the G1–G4 and G9 types.
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Rotavirus vaccines are available globally; however, they have not been included in the national vaccination programs of the every country. The coverage ratio of current rotavirus vaccines for the genotypes detected is quite high. Wide availability of immunosuppressive drugs, advances in molecular diagnostic technologies, and rise in funding from government organizations and associations drive the rotavirus diagnostics market. However, high cost of vaccines is a major restraint of the global rotavirus diagnostics market.
The global rotavirus diagnostics market can be segmented based on type of diagnostic test, end-user, and region. In terms of type of diagnostic test, the market can be classified into enzyme immunoassay, ELISA, PCR, RT-PCR, and others. Based on end-user, the global rotavirus diagnostics market can be categorized into hospitals, commercial/private labs, physician offices, and public health labs. The global rotavirus diagnostics market can be segmented into five major regions: North America, Europe, Asia Pacific, Latin America, and Middle East & Africa.
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Major players operating in the global rotavirus diagnostics market are GlaxoSmithKline plc, Merck & Co., Inc., Abbott Laboratories, Affymetrix, Inc., Danaher Corporation, Becton, Dickinson and Company, bioMérieux SA, Bio-Rad Laboratories, Inc., Cepheid, Inc., Diamedix, Inc., DiaSorin, and Eiken Chemical Co., Ltd., among others.
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