Rapid Test for IgM Antibody to Hepatitis E Virus

This test is a single use, rapid device intended for qualitative detection of IgM-class antibodies to hepatitis E virus (HEV) in serum or plasma samples. It is intended to be used in clinical laboratories for diagnosis of acute hepatitis E and management of patients related to infection with hepatitis E virus.

Release form

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Product Description

Producer:

Beijing Wantai Biological Pharmacy Enterprise Co., Ltd

Country of production:

China

Article:

WJ-1510, WJ-1550, WJ-151500

Brief description:

This test is a single use, rapid device intended for qualitative detection of IgM-class antibodies to hepatitis E virus (HEV) in serum or plasma samples. It is intended to be used in clinical laboratories for diagnosis of acute hepatitis E and management of patients related to infection with hepatitis E virus.

Appointment:

Qualitative detection of IgM-class antibodies to hepatitis E virus

Materials provided:

Test cartridge
1.5 ml sample tube
Disposable pipette

Materials required but not provided:

Clock or timer, lancets, alcohol wipes, micropipettes, disposable tips, sample container, centrifuge, biohazard container, sterile gauze or cotton cloth.

Performance characteristics

In a large-scale clinical evaluation conducted in China between April and August, 2011, total of 1228 serum and 225 plasma samples were tested with Wantai HEV-IgM Rapid Test.
- Sensitivity: 97.71%
- Specificity : 99.28%
- Overall agreement with the comparison test: 98.78%

Sample Type:

serum / plasma

Delivery

Implemented by Nova Poshta. If the order is above 1500 UAH, the sender pays the shipping cost

Instructions for use (PDF) Declaration of Conformity (PDF)