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 Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: ARCHITECT HBsAg NEXT Qualitative Reagent Kit
ARCHITECT HBsAg NEXT Confirmatory Reagent Kit
ARCHITECT HBsAg NEXT Qualitative Calibrators
ARCHITECT HBsAg NEXT Qualitative Controls
ARCHITECT HBsAg NEXT Confirmatory Manual Diluent
PMA Applicant: Abbott Laboratories
Address: Abbott Diagnostics Division
100 Abbott Park Road
Abbott Park, IL 60064-3500
Approval Date: August 10, 2022
Approval Letter: Approval order
What is it?
- The ARCHITECT HBsAg NEXT Qualitative Reagent Kit is used to detect a protein called hepatitis B surface antigen (HBsAg) produced by the hepatitis B virus in a patient’s blood. This test is used with the ARCHITECT i System which runs the assay and analyzes the results.
- The HBsAg NEXT Confirmatory Reagent Kit is used to make sure that HBsAg is present in a sample that is initially reactive.
- The HBsAg NEXT Qualitative Calibrators and ARCHITECT HBsAg NEXT Qualitative Controls are used to make sure that the test is working properly.
- The HBsAg NEXT Confirmatory Manual Diluent is used to dilute the blood sample if the amount of HBsAg is too high to be used in the HBsAg Next Confirmatory Reagent Kit.
How does it work?
A sample of a patient’s blood is sent to a clinical laboratory. At the laboratory, the blood sample is processed to separate the serum or plasma. The serum or plasma containing HBsAg is then run using the ARCHITECT i System, where it is mixed with test chemicals. The system sends a signal if there is HBsAg detected in the sample. The ARCHITECT i System then measures the signal. A trained medical professional reviews the results and sends a report to the healthcare provider.
When is it used?
This is a laboratory test used for individuals, including pregnant women and children, who may be infected with the hepatitis B virus. The test results are used together with other clinical information and blood tests to help health care providers determine if someone with signs and symptoms of hepatitis B, or someone at risk for hepatitis B infection, has the virus.
What will it accomplish?
Detecting HBsAg, when combined with other clinical information and blood tests, helps health care providers determine whether someone is infected with hepatitis B. The presence of HBsAg can determine if a person is infected with hepatitis B, but not if it is a short-term (acute) or long-term (chronic) infection.
When should it not be used?
There are no known reasons not to use this test.
Additional information (including warnings, precautions, and adverse events):