Intended Use
For the qualitative determination of IgM antibodies against the serotype Hantaan of Hantavirus in Human Serum or plasma. The kit contains highly purified recombinant NP as an antigen and there are no virus or virus extracted antigens in the kits. For research use only (RUO), not for diagnosis, cure or prevention of the disease.
Performance Characteristics
In an in-house study, apparently healthy subjects showed the following results:

It is recommended that each laboratory establishes its own range of normal values.
General Description
Hantavirus is named for the Hantan River area in South Korea where an early outbreak occurred in 1970. Hantaviruses (HTNV) are single-stranded, enveloped, negative sense RNA viruses in the Bunyaviridae family. HTNV normally infect rodents. Humans may become infected with hantaviruses through contact with rodent urine, saliva, or feces. Some strains of hantaviruses cause potentially fatal diseases in humans, such as hantavirus hemorrhagic fever with renal syndrome (HFRS) and hantavirus pulmonary syndrome (HPS)—also known as hantavirus cardiopulmonary syndrome (HCPS), a "rare respiratory illness associated with the inhalation of aerosolized rodent excreta (urine and feces) contaminated by hantavirus particles.
The Bunyaviridae family is divided into five genera: Orthobunyavirus, Nairovirus, Phlebovirus, Tospovirus, and Hantavirus. Like all members of this family, hantaviruses have genomes comprising three negative-sense, single-stranded RNA segments. Members of other Bunyaviridae family genera are generally arthropod-borne viruses, but hantaviruses are thought to be transmitted to humans mainly through inhalation of aerosolized rodent excreta or rodent bites.
HTNV RNA segments designated S (small), M (medium), and L (large). The S RNA encodes the nucleocapsid (N) protein. The M RNA encodes a polyprotein that is cotranslationally cleaved to yield the envelope glycoproteins Gn (formerly G1) and Gc (formerly G2). The L RNA encodes the L protein, which functions as the viral transcriptase/replicase. Within virions, the genomic RNAs of hantaviruses are thought to complex with the N protein to form helical nucleocapsids. These are composed of many copies of the nucleocapsid protein N, which interact with the three segments of the viral genome to form helical structures. The virally encoded RNA polymerase is also found in the interior. By mass, the virion is greater than 50% protein, 20-30% lipid and 2-7% carbohydrate. There is no vaccine for hantavirus. A vaccine known as Hantavax, an inactivated vaccine that may not be effective against European hantaviruses like the Puumala (PUUV) virus. The vaccine is considered important as acute hantavirus infections are responsible for significant morbidity and mortality worldwide. It is estimated that about 1.5 million cases and 46,000 death happened in China from 1950 to 2007. The number of cases is estimated at 32,000 in Finland from 2005 to 2010 and 90,000 in Russia from 1996 to 2006.
The first hantavirus vaccine was obtained from formalin inactivated HTNV grown in rodent brain cells and adjuvanted in Alum. It is estimated that about two million doses of rodent brain or cell-culture derived vaccine are given in China every year. Other vaccines are being tested.