3400 - OMEGA Coccidioides Antibody EIA | Clinical

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.

Turnaround Time

3 days from sample receipt. Testing performed at Eurofins DPT.

Specimen Information

Specimen Type	Test Code	CPT Code	NY Approved	Volume	Assay Range	Special Instructions
serum	3410	86635	Yes	2 mL (min. 0.5 mL)	Positive/Negative/Indeterminate	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.

Positive/Negative/Indeterminate

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 Eurofins test requisition form must accompany each specimen. Ship specimens FedEx Priority Overnight to: Viracor Eurofins, 18000 W 99th St. Ste, #10, Lenexa, KS 66219.

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 Eurofins.

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 Eurofins' 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 Eurofins 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.