Zika Virus NAA Comprehensive

Test ID: 

706673

CPT code:

87662(x2)

Clinical Use:

Detection of Zika virus. This test is intended for the qualitative detection of RNA from the Zika virus in serum and urine from individuals meeting CDC Zika virus clinical criteria and/or CDC Zika virus epidemiological criteria.

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 detection of RNA from Zika virus and 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, frozen or refrigerated, and urine, frozen or refrigerated

Requested Volume: 

1.2 mL serum and 3 mL urine

Minimum Volume: 

0.7 mL serum and 2 mL urine. Note: This volume does not allow for repeat testing.

Container Type: 

Red-top tube or gel-barrier tube and Aptima® urine transport tube

Collection:

Transfer serum to a plastic transport tube; transfer urine to Aptima® urine transport tube; freeze both serum and urine preferred.

Storage Instructions:

Freeze preferred. Flash-freezing on dry ice is recommended. Serum and urine specimens are stable for 5 days at refrigerated temperatures.

Rejection Criteria

Specimen not shipped frozen or refrigerated; specimen greater than 5 days from collection at refrigerated temperature; whole blood; quantity not sufficient for analysis; gross specimen contamination; urine specimen in preservative other than Aptima® urine transport tube; leaking or broken tube; submission of only one of the two required specimen types