Cryptosporidium parvum ELISA Kit

Sample

Faecal

Species Reactivity

None

Intended Use

Cryptosporidium parvum ELISA Kit is an in-vitro-diagnostic device for direct detection of Cryptosporidium parvum in faecal samples.

Storage

Upon receipt, all test components have to be kept at 2…8 °C, preferably in the original kit box. After opening all kit components are stable for at least 2 months, provided proper storage.

Precision

Intra-Assay coefficient of variation (CV) in the Cryptosporidium parvum from 8-fold determinations of samples:

Inter-Assay coefficient of variation (CV) in the Cryptosporidium parvum in 8 different test runs from twofold determinations of samples:

Detection Limit

The lower detection limit of Cryptosporidium parvum antigen in the Cryptosporidium parvum kit was determined by titration of oocysts diluted in a negative stool sample: 1.6 x 105 Oocysts per ml stool suspension.

Sensitivity

0.969

General Description

The genus Cryptosporidium belongs to the phylum Apicomplexa, protozoan parasites characterized by secretory cell organells enabling the invasion of host cells. Among different human pathogenic species Cryptosporidium parvum represents the most important cause of diarrhea in man but also in several animal species (Zoonosis) (1, 2). The transmission of Cryptosporidium is effected by food or drinking water contaminated with faeces. Person to person transmission has also been described. After ingestion of the infective stage, the oocyst, the vegetative motile sporozoites will be released in the small intestine, where they invade into the enterocytes and stay in a parasitophorous vacuole beneath the microvilli. The sporozoites multiply by bisection (asexually) as well as sexually. In the course of sexual multiplication micro- and macrogamonts emerge and fuse to form the infective oocyst. The oocysts can be devided into thin-wall and thick-wall oocysts: the thin-wall oocysts are responsible for autoinfections within the same host whereas the thick-wall oocysts are excreted with the faeces and are therefore responsible for transmission to other hosts. The clinical picture of cryptosporidiosis is usually watery self-limiting diarrhea. However immunocompromised persons can develop prolonged and life-threatening diarrhea. In rare cases extraintestinal infections of e.g. the respiratory tract or bile-duct have been reported (1, 2). Cryptosporidium infections are usually diagnosed by direct pathogen detection from faecal specimens either by microscopy of dyed smears, immune fluorescence microscopy or by immunological methods like ELISA. Nucleic acid amplification techniques (PCR) are also established but still restricted to special laboratories. Enzyme immunoassays used for routine diagnostics are based on mono- or polyclonal antibodies directed to not further characterized antigens derived from the oocyst stage of the parasite (3, 4).