Hepatitis B Core IgM

Test Code: 5218619

Performed at multiple locations.

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Clinical and Procedure
Clinical Utility

Hepatitis B core IgM is an enzyme immunoassay for the qualitative detection of IgM antibodies to hepatitis B core antigen (anti-HBc IgM) in serum and plasma. Anti-HBc is the earliest antibody to develop in response to acute hepatitis B virus (HBV) infection, appearing predominantly as IgM anti-HBc at about 6 to 8 weeks after infection. The assay is intended to be used in conjunction with other hepatitis B virus serologic markers for diagnosis of hepatitis B disease associated with HBV infection.

Procedure

The Bio-Rad MONOLISATM Anti-HBc IgM assay system is a qualitative enzyme immunoassay for the detection of IgM antibodies to hepatitis B core antigen in serum and plasma. The test has been cleared or approved for diagnostic use by the U.S. Food and Drug Administration.

Specificity

For In Vitro Diagnostic Use. This assay has not been FDA cleared or approved for the screening of blood or plasma donors.

Turnaround Time

Same day (within 8 - 12 hours from receipt of specimen), Monday through Friday.

Specimen Information
Specimen Type Test Code CPT Code NY Approved Volume Assay Range Special Instructions
plasma 5218619 86705 Yes 2 mL (min. 0.5mL) Nonreactive
  • Collect 4-5 mL whole blood in EDTA.
  • Ship specimen on cold pack Monday through Thursday.
  • Specimens shipped at 2-8°C must be received within 7 days of collection.
  • Samples that will not be received within 7 days should have the plasma aliquoted, frozen and shipped on dry ice.
Serum 5218619 86705 Yes 2 mL (min. 0.5mL) Nonreactive
  • Collect 4-5 mL whole blood in red top tube, centrifuge and transfer 2 mL serum to sterile, screw top tube.
  • Can be shipped on cold pack or frozen Monday through Thursday.
  • Specimens shipped at 2-8°C must be received within days of collection.
  • If samples will not be received within 7 days, freeze and ship on dry ice.

Nonreactive.

Shipping

Lee's Summit Lab: Ship Monday through Friday.
Ship specimens FedEx Priority Overnight® to:

Eurofins Viracor
18000 W 99th St. Ste, #10
Lenexa, KS 66219
Ph: (800) 305-5198

Los Angeles Lab: Ship Monday through Friday.
Ship specimens FedEx Priority Overnight® to:

Eurofins Viracor Serology
2100 West 3rd Street, Suite 301
Los Angeles, CA 90057
Ph: (213)229-3654

Label Friday shipments with Saturday delivery. All specimens must be labeled with patients name and collection date. A Eurofins Viracor test requisition form must accompany each specimen. Multiple tests can be run on one specimen.

Causes for Rejection

Specimens beyond their acceptable length of time from collection as listed in the specimen handling, or specimen types other than those listed.

Disclaimer

Specimens are approved for testing in New York only when indicated in the Specimen Information field above. The CPT codes provided are based on Eurofins Viracor's interpretation of the American Medical Association's Current Procedural Terminology (CPT) codes and are provided for informational purposes only. CPT coding is the sole responsibility of the billing party. Questions regarding coding should be addressed to your local Medicare carrier. Eurofins Viracor assumes no responsibility for billing errors due to reliance on the CPT codes illustrated in this material.

References

Bio-Rad Monolisa™ package insert.

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