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CMV

Test ID: I CMV CPT Code: 88342

Expected Turnaround Time
2 days
Stated turn-around-times (TATs) are for clinical use only and subject to change based on biopharma protocol requirements. Final TATs will be specified in the biopharma study contract.

Clinical Information
Cytomegalovirus (CMV) is a common viral member of the herpes family. Generally in a healthy adult, no symptoms are observed with latent infection. However, overtime, mononucleosis-like syndrome may develop in immunocompetent individuals, or tissue-invasive disease can develop in immunocompromised patients. Tissue-invasive disease commonly involves the gastrointestinal tract. This CMV antibody is a mixture of two monoclonal antibodies directed against CMV immediate early and early protein antigen


Specimen Requirements


Specimen Requirements
  • Fresh Tissues: Fixative should be at a 20:1 fixative to tissue ratio, 10% neutral buffered formalin (NBF) for 6-72 hours (48-72 hours PREFERRED)
  • Formalin-fixed Paraffin Embedded Tissue (FFPE blocks): FFPE Block, Formalin Fixed
  • Unstained slides: 2 slides (3-5 μM) per stain (min 1 slide per stain), Formalin Fixed

Specimen Stability
  • Fresh Tissue Tissues: ≤ 72 Hours
  • Formalin-fixed Paraffin Embedded Tissue (FFPE blocks): Indefinite
  • Unstained slides: Indefinite
  • Stained slides: Indefinite

Storage Requirements

15°C to 25°C


Shipping Conditions
Ambient

Shipping Recommendations
  • Fresh Tissues: AMBIENT
  • Formalin-fixed Paraffin Embedded Tissue (FFPE blocks) and unstained slides: AMBIENT, Use a refrigerated (NOT FROZEN) gel pack in the shipment to protect from extreme temperatures. Separate gel pack from specimen.
  • Specimens may be transferred to 70% alcohol for transportation purposes after fixation in 10% NBF or B plus.

Specimen Rejection Criteria

Specimens must be fixed in 10% NBF or B plus. All other fixatives will be rejected. 


Test Details


Synonyms

Cytomegalovirus, Human beta-herpesvirus 5, HCMV


Test Method
Immunohistochemistry

Methodology Category
IHC

Regulatory Status
ASR

Special Considerations
  • Fresh Tissues: Specimens may be fixed in formalin for 24-72 hours by collection sites, then transferred to 70% ethanol and stored at 2-8°C for longer term storage if needed. Samples must be tested 3 months after placing in ethanol.
  • Unstained slides: Positively charged glass slides required to prevent background staining and prevent tissue loss. Slides should be left unbaked.