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Test Code HBsAg Hepatitis B Surface Antigen

Useful For

The Atellica® IM Hepatitis B surface Antigen II (HBsII) assay is an in vitro immunoassay for the qualitative detection of hepatitis B surface antigen (HBsAg) in human adult, adolescent, and pediatric serum and plasma (potassium EDTA, lithium heparin, and sodium heparin), and neonatal samples using the Atellica® IM Analyzer. The assay may be used in conjunction with other serological and clinical information to diagnose individuals with acute or chronic hepatitis B infection. The assay may also be used to screen for hepatitis B infection in pregnant women to identify neonates who are at risk of acquiring hepatitis B during the perinatal period.

Patient Preparation

No special patient preparation required

Collection Method

Venous collection

Minimum Volume

1 mL

Container

Gold Top / Serum Separator / Additive Free

Preferred Specimen

Gold Top SST Serum

Acceptable Specimens

Serum:

  • Gold Top SST
  • Red Top


Plasma:

  • Light Geen Top (Lithium heparin)
  • Purple or Pink Top(K2/K3 EDTA)
  • Dark Green (Sodium heparin)

 

Reference or Target Ranges

Nonreactive

Reportable Units

Reactive/Nonreactive

Critical Value

Not defined for this assay

Reasons for Rejection

 

Hemolysis Threshold >500 mg/dL
Icterus Threshold > 40 mg/dL
Lipemia Threshold >1000 mg/dL
Other QNS, contaminated, improperly Labeled, improper specimen type

Specimen Stability

 

Ambient 24 hrs
Refrigerated (4°C to 8°C) 6 hrs
Frozen(-40°C to 0°C) 6 months

Performance Information

 

Days and Time Performed 24/7
Expected Turn Around Time
Routine: 4 hours
Stat Availability No
Performing Bench UH Chemistry
Methodology/Method Description Siemens Atellica IM Sandwich immunoassay using direct chemiluminescence 

Additional Information/Important Notes

Result Clarification

 

Nonreactive: Samples with a value < 1.0 Index are considered nonreactive (negative) for hepatitis B surface antigen.  

 

Reactive: If the sample is > 50.0 Index or flagged as “> Index Range,” the specimen is reactive (positive) for hepatitis B surface antigen and no further testing is required. 

 

CPT Codes

87340