Rapid Test for IgM Antibody to Hepatitis A Virus

Producer:

Beijing Wantai Biological Pharmacy Enterprise Co., Ltd

Country of production:

China

Article:

WJ-1010, WJ-1050, WJ-101500

Brief description:

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

Appointment:

Qualitative detection of IgM-class antibodies to hepatitis A virus (HAV)

Materials provided:

Test cassette
Sample tube 1 ml
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 wipe

Performance characteristics

Within the group of negative samples, the negative agreement rate of Wantai HAV-IgM Rapid Test was 97.5%, the negative agreement rate of Wantai ELISA kit was 100.0%, and KHB ELISA kit was 99.5%. In conclusion, the overall agreement between Wantai HAV-IgM Rapid Test and Wantai ELISA kit was 98.2% (283/288) , and 97.9% (282/288) between Wantai HAV-IgM Rapid and KHB ELISA. These results confirm the high specificity and sensitivity of Wantai HAV-IgM rapid test and trueness in detection of this kit.

Sample Type:

serum / plasma