Mikrogen Diagnostik recomWell HEV IgM ELISA Kit

Enzyme immunoassay with antigens produced by recombinant techniques for the detection of IgG and IgM antibodies against hepatitis E Virus (HEV) in human serum or plasma.

Product is intended for research use.

10X Wash Buffer - 100 mL
Dilution Buffer - 125 mL
TMB Substrate - 12 mL
Stop Solution - 12 mL
Instructions for Use (Review) -1 Each
Evaluation Form -1 Each
Microplate Sealing Tape - 2 Each
Microtiter Plate - 12 x 8 Wells
Positive Control - 450 uL
Cut-Off Control - 450 uL
Negative Control - 450 uL
Anti-Human IgM Conjugate ( contains NaN3 (<0.1%), MIT (<0.01%) and chlorazetamide (<0.1%)) - 500 uL

Materials required but not supplied
• Deionised water (high quality)
• Test tube
• Vortex mixer or other rotators
• 8-channel pipette or washer with pump
• Clean measuring cylinders, 50 ml and 1000 ml
• Micropipettes with disposable tips, 10 µl and 1000 µl
• 10 ml pipette or dispenser
• Incubation chamber 37°C
• Microtitre plate photometer
• Timer
• Disposable protective gloves
• Waste container for bio-hazardous materials

 All blood products must be treated as potentially infectious.
 The microtitre wells have been coated with inactivated whole cell lysates, bacterial or viral antigens.
 After the addition of patient or control specimens the microtitre wells must be considered potentially infectious and treated accordingly.
 For the production of control specimens, blood from donors is used which does not contain antibodies to HIV 1/2, HCV and HBs antigen. The product must be treated with the same care as for a patient sample, as an infection cannot be excluded with certainty.
 Suitable disposable gloves must be worn throughout the entire test procedure.
 The conjugates contain the antimicrobial agents and preservatives sodium azide, MIT (methylisothiazolone), oxypyrion, chloroazetam ide and hydrogen peroxide. Avoid contact with the skin or mucous membrane. Sodium azide can form an explosive azide upon con tact with heavy metals such as copper and lead.
 Phosphoric acid is an irritant. It is mandatory to avoid contact with skin and mucous membranes.
 All fluids to be disposed must be collected. All collecting containers must contain suitable disinfectants for the inactivation of human pathogens. All reagents and materials contaminated with potentially infectious samples must be treated with disinfectants or disposed of according to your hygiene regulations. The concentrations and incubation periods stated by the manufacturer must be observed.
 Only use microtitre wells once.
 Do not substitute or mix the reagents with reagents from other manufacturers.
 Read through the entire instructions for use before carrying out the test and carefully follow them. Deviation from the test protocol provided in the instructions for use can lead to erroneous results.

Hepatitis E Virus (HEV): Epidemiology and Clinical Background
Pathogen and Transmission Hepatitis E Virus (HEV) is a leading cause of enterically transmitted acute viral hepatitis globally. While transmission in developing regions is primarily linked to fecal contamination of drinking water, cases in industrialized nations are increasingly zoonotic. In Europe and other developed areas, HEV Genotype 3 is the predominant strain, typically transmitted through the consumption of undercooked meat, particularly pork and wild game. Additionally, transmission routes involving blood products, transfusions, and organ transplantation have been documented.

Clinical Presentation and Symptoms Although many HEV infections may be subclinical, acute Hepatitis E presents with a clinical profile similar to Hepatitis A. The disease is characterized by an incubation period followed by a prodromal phase. Common symptoms include:

Flu-like symptoms (fever, arthralgia, headache)
Gastrointestinal distress (vomiting, diarrhea)
Elevated liver enzymes
Cholestatic jaundice (which may persist for several weeks)

High-Risk Populations While HEV infection is generally self-limiting in healthy individuals, it poses a severe threat during pregnancy. In endemic regions, HEV infection in pregnant women is associated with a high rate of fulminant hepatitis, resulting in a mortality rate of approximately 20%. In the general population (males and non-pregnant females), the mortality rate ranges between 0.5% and 4.0%.

1. Myint KS, Endy TP, Gibbons RV, Laras K, Mammen MP Jr, Sedyaningsih ER, Seriwatana J, Glass JS, Narupiti S, Corwin AL., Evaluation of diagnostic assays for hepatitis E virus in outbreak settings. J Clin Microbiol. 2006 44(4):1581-3.
2. Shrestha MP, Scott RM, Joshi DM, Mammen MP Jr, Thapa GB, Thapa N, Myint KS, Fourneau M, Kuschner RA, Shrestha SK, David MP, Seriwatana J, Vaughn DW, Safary A, Endy TP, Innis BL., Safety and efficacy of a recombinant hepatitis E vaccine. N Engl J Med. 2007 356(9):895-903.
3. Dalton HR, Bendall R, Ijaz S, Banks M. Hepatitis E: an emerging infection in developed countries. Lancet Infect Dis. 2008 8(11):698-709.
4. Pischke S, Potthoff A, Hauröder B, Schlué J, Manns MP, Cornberg M, We demeyer H., Hepatitis-E: Eine Infektionskrankheit erlebt einen Bedeutungswech sel. Dtsch Med Wochenschr. 2010 135(22):1129-33.