The hepatitis B surface antigen (HBsAg) test provides results for hepatitis B utilizing a chemiluminescent microparticle immunoassay (CMIA) testing method.
Analyte(s)
Hepatitis B surface antigen
Test Code
0300
Testing Location
Testing Department
Serology
Pre-approval Required?
None
Required Forms
BPHL Test Requisition, DH1847
(not needed if orders are placed via electronic order)
Supply Ordering
Supplies may be requested from your servicing laboratory. Supplies ordered from BPHL should only be used for specimen sent to the BPHL for testing.
Turn Around time
4 business days after receipt at the laboratory.
Minimum Volume
At least 2 mL serum
Collection Media
“Tiger” or “yellow” top SST tube
Specimen Sources
Serum
Specimen Labeling
Specimen must be labeled with at least two unique patient identifiers, e.g., name and DOB, and the date of collection.
Information on the specimen must match the requisition and/or test order.
Special SPecimen Preparation
Centrifuge the SST within 8 hours of collection.
Storage Conditions
Specimens may be stored for up to 6 days after collection at 2-8° C.
If testing will be delayed more than 6 days after collection, remove serum from the clot, red blood cells, or separator gel and store at -20° C or colder. Avoid more than 3 freeze/thaw cycles.
Packaging and Shipping
Ship in a cooler with ice packs at 2-8° C to be received at the laboratory no more than 6 days from the collection date.
Specimens stored frozen should be shipped frozen to avoid additional freeze/thaw cycles.
unsatisfactory specimen
1) Incorrect source or incorrect collection device was used
2) Specimen was not labeled with 2 unique patient identifiers
3) Information on specimen does not match requisition/test order
4) Grossly hemolyzed
5) Leaked in transit
7) No specimen received with test order
9) Specimen not centrifuged
10) Quantity not sufficient (QNS)
11) Specimens that exceed the storage limitations listed above.
12) Specimens received at 2-8° C and greater than 6 days after collection will be cancelled.
Interferences and Limitations
1) 1.Liquid anticoagulants may have a dilution effect resulting in lower S/CO values for individual patient specimens.
2) For accurate results, specimen should be free of fibrin, red blood cells, and other particulate matter.
3) This assay is not verified for use in screening blood, plasma or tissue donors.
4) Current methods for the detection of HBsAg may not detect all potentially infected individuals. A nonreactive test result does not exclude the possibility of exposure to or infection with hepatitis B virus. A nonreactive test result in individuals with prior exposure to hepatitis B may be due to antigen levels below the detection limit of the assay or lack of antigen reactivity to the antibodies in this assay.
5) If the results are inconsistent with clinical evidence, additional testing is suggested to confirm this result.
6) For diagnostic purposes, results should be used in conjunction with patient history and other hepatitis markers for diagnosis of acute and chronic infection.
7) Results obtained with this assay may not be used interchangeably with values obtained with different manufacturers’ assay methods.
8) Patients routinely exposed to animals or to animal serum products can be prone to interference and anomalous results may be observed.
9) Specimens from patients who have received preparations of mouse monoclonal antibodies for diagnosis or therapy may contain human anti-mouse antibodies (HAMA). Specimens containing HAMA may produce anomalous values.
10) A reactive HBsAg result does not exclude co-infection by another hepatitis virus
Reference Range
Nonreactive
Result Indicator
Nonreactive
Reactive
Reference lab
None
Reflex testing
If HBsAg is reported as reactive, the specimen needs confirmation and will reflex to Test 0305 hepatitis B surface antigen confirmation. The result of the confirmatory assay, if done, is reported separately
Additional Information
Nonreactive: Specimen considered negative for HBsAg. A non-reactive test result does not exclude the possibility of exposure to or infection with hepatitis B virus. For individuals with prior exposure to hepatitis B, a nonreactive test result may be due to antigen levels below the detection limit of the assay or lack of antigen reactivity to the antibodies in the assay.
Reactive: Specimen considered repeatedly reactive; confirm using the ARCHITECT HBsAg qualitative confirmatory assay.