Rapid HAV IgM Test Card

Producer:

Xiamen Boson Biotech Co., Ltd

Country of production:

China

Article:

1H15C2

Brief description:

Rapid HAV IgM Test is a single use, rapid device intended for qualitative detection of IgM-class antibodies to hepatitis A virus (HAV) in serum, plasma or whole blood 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) in serum, plasma or whole blood samples.

Materials provided:

1. Rapid HAV IgM Test
2. Instructions for use
3. Sample bottle. Each sample bottle contains 2mL of sample buffer.
4. 2 uL capillary pipet

Materials required but not provided:

Clock or timer, safety lancets, alcohol prep-pad, specimen collection container, centrifuge, biohazard waste container, sterile gauze or cotton.

Performance characteristics:

In clinical evaluations of the performance of this HAV IgM Rapid Test, 750 confirmed negative and 304 positive samples were tested. A sensitivity of 96.4% (293/304) and a specificity of 99.3% (745/750) were obtained. Overall, agreement with the reference ELISA test is 98.5%.

Sample Type:

whole blood / serum / plasma