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OMEGA Coccidioides Antibody EIA

Test Code: 3400

Cpt Code:

86635 (x2)

Clinical Utility

The OMEGA Coccidioides Antibody Enzyme Immunoassay (EIA) is used for the qualitative detection of serum antibodies directed against TP and CF antigens from Coccidioides species as an aid in the diagnosis of coccidioidomycosis.

Procedure

The OMEGA Coccidioides Antibody EIA utilizes a proprietary mixture of recombinant and native Coccidioides antigens, including the CF and TP antigens, adsorbed to microwells. Diluted patient specimens and controls are incubated in both TP and CF microwells. Sample optical density (OD) readings are compared to calibrator cutoff OD readings to determine results. This test has been cleared or approved for diagnostic use by the U.S. Food and Drug Administration.

Assay Range

Positive/Negative/Indeterminate

Causes For Rejection

Specimens other than serum. Whole blood. Lipemic, icteric, or hemolyzed specimens. Specimens that have been stored at ambient temperature. Specimens that have been stored at 2 to 8°C for longer than 5 days. If storage longer than 5 days is needed, samples should be frozen at -20°C or colder. Unless indicated as stored frozen, the specimen will be rejected if the draw date is >5 days from receipt at Viracor-IBT.

Turnaround Time

Same day of receipt. (Set up and report Monday through Saturday).

Shipping

Ship Monday through Friday. Friday shipments must be labeled for Saturday delivery. All specimens must be labeled with patient's name and collection date. A Viracor-IBT test requisition form must accompany each specimen. Ship specimens FedEx Priority Overnight to: Viracor-IBT Laboratories, 1001 NW Technology Dr, Lee's Summit, MO 64086.

Specimen Information

3410 serum - NY approved. Collect 4-5 mL whole blood in serum separator tube, centrifuge, and freeze; or, collect 4-5 mL whole blood in serum separator tube, centrifuge and transfer 2 mL serum to sterile, screw top tube and freeze. Ship on dry ice Monday through Friday. Specimen may be stored up to 5 days at 2 to 8°C or serum may be frozen for longer at -20 to -80°C.

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 Viracor-IBT'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. Viracor-IBT assumes no responsibility for billing errors due to reliance on the CPT codes illustrated in this material.

 

References

Information derived from the OMEGA Cocci Ab EIA Test Kit package insert (Immuno-Mycologics, Inc.).

 

Pappagianis D, Zimmer BL. Serology of coccidioidomycosis. Clin Microbiol Rev. 1990 Jul;3(3):247-68.

 

Bronnimann DA, Galgiani JN. Coccidioidomycosis. Eur J Clin Microbiol Infect Dis. 1989 May;8(5):466–473.

 

Galgiani, JN. Coccidioides immitis. in Mandell, GL, Bennett, JE, Dolin, R, Eds., Principles and Practice of Infectious Diseases, Fifth Edition. Churchill Livingstone, New York, NY. 2000;2746-57.

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