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U.S. Department of Health and Human Services

Medical Devices

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MONOLISA™ Anti-HBs and MONOLISA™ Anti-HBs Calibrator Kit - P050048

This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.


Product Name: MONOLISA™ Anti-HBs and MONOLISA™ Anti-HBs Calibrator Kit
PMA Applicant: Bio-Rad Laboratories
Address: 6565 185th Ave NE, Redmond WA 98052
Approval Date: August 25, 2006
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf5/p050048a.pdf

What is it? The Bio-Rad MONOLISA™ Anti-HBs EIA is used to detect antibodies associated with hepatitis B virus (HBV) infection.   Antibodies are substances produced by the body to fight against foreign substances called antigens, such as the hepatitis B virus surface antigen (HBsAg). The purpose of this test is to determine if the patient has been previously infected with HBV or is immune to HBV infection.

How does it work?

  • Patient serum/plasma specimen is incubated in microtiter wells coated with HBsAg. If antibodies to HBsAg (anti-HBs) are present in a specimen they bind to the HBsAg.
  • Excess patient sample is removed by a wash step. The conjugate is then added to the microwells and allowed to incubate.
  • The conjugate binds to any antigen-antibody complexes present in the microwells. After washing the well a chemical is added to the wells.
  • If a sample contains anti-HBs, the bound conjugate causes the well to change color. The color intensity, measured spectrophotometrically, is proportional to the amount of anti-HBs present in the specimen.

When is it used? The test is used to determine if the has been infected with HBV or to determine if a patient needs to be vaccinated with HBV vaccine.

What will it accomplish? Test results help determine whether a patient should be advised to receive the hepatitis B virus vaccine. Or results may help to show the stage of HBV infection. Depending on the stage of infection, doctors may recommend appropriate treatment.

When should it not be used? This test should not be used if it is not ordered by a physician. This test is a prescription device. This test has not been FDA licensed for screening blood donors. There are no other known patient exclusions.

Additional information: The Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p050048