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Zika Virus IgM (EUA)

Test ID: 

706672

CPT code:

86794

Clinical Use:

Presumptive (not definitive) evidence of Zika virus infection

Test Information:

• This test has not been FDA cleared or approved;

• This test has been authorized by FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories;

• This test has been authorized only for the diagnosis of Zika virus infection and not for any other viruses or pathogens; and

• This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

Specimen Type:

Serum

Requested Volume: 

2 mL

Minimum Volume: 

1 mL

Container Type: 

Gel-barrier tube is preferred. Red top tube is acceptable.

Collection:

Usual phlebotomy collection. Spin as quickly as possible after clot formation, remove serum, and refrigerate.

Storage Instructions:

Refrigerate

Stability Requirements:

Temperature

Period

Room temperature

Unstable

Refrigerated

14 days

Frozen

14 days

Freeze/thaw cycles

Stable x3

Rejection Criteria

Specimen submitted at room temperature; overly hemolyzed specimen; lipemia; gross bacterial contamination; mislabeled specimen

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