Zika Virus Comprehensive Profile, NAA, Serum and Urine

CPT: 87798(x2)
Print Share

Test Details

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.

Methodology

Nucleic acid amplification (NAA)

Additional 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 Requirements

Specimen

Serum, frozen or refrigerated, and urine, frozen or refrigerated

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

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.

Causes for Rejection

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

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
139600 Zika Virus NAA Comprehensive 139563 Zika Virus, NAA, Serum 85622-9
139600 Zika Virus NAA Comprehensive 139582 Zika Virus, NAA, Urine 85623-7

For Providers

Please login to order a test.

 

© 2017  Laboratory Corporation of America® Holdings and Lexi-Comp Inc. All Rights Reserved.

CPT Statement/Profile Statement

The LOINC® codes are copyright © 1994-2017, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee. Permission is granted in perpetuity, without payment of license fees or royalties, to use, copy, or distribute the LOINC® codes for any commercial or non-commercial purpose, subject to the terms under the license agreement found at https://loinc.org/license/. Additional information regarding LOINC® codes can be found at LOINC.org, including the LOINC Manual, which can be downloaded at LOINC.org/downloads/files/LOINCManual.pdf