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Alphabetical Index
CMV by Quantitative NAAT (8000100193 )
Test Mnemonic:

CMV-NAAT
Specimen Requirements:
Collection:

Plasma Pearl Top (PPT)- blood or Sterile Container- urine
Container:

PPT for blood; Sterile Container for urine
Minimum Volume:

3 mL plasma or 3 mL urine
Storage/Transport:

Refrigerate 2-8ºC up to 5 days. If there are delays, samples should be frozen at -20ºC and tested within 60 days.
Stability:

Refrigerate 2-8ºC up to 5 days. If there are delays, samples should be frozen at -20ºC and tested within 60 days.
Causes for Rejection:

Incomplete and/or incorrect sample identification, insufficient sample collection, gross hemolysis, clotted samples, incorrect tube type, non-sterile or leaking containers.
Specimen Preparation:

Within 24 hours of collection, centrifuge PPT tube. 

No specimen prep required for urine sample.
Methodology:

in vitro nucleic acid amplification (NAAT) that uses real-time transcription-mediated amplification (TMA) technology.
Performed:
Lab:

Clinical Microbiology
Turnaround Time:

Test is performed in batch, once per day, three days per week.
Reference Range:

Plasma <53 IU/mL

Urine <150 IU/mL
CPT 4 Code:

87497
Note:

The Aptima CMV Quant Dx Assay is a real-time transcription-amplification (TMA) used for quantification of Cytomegalovirus DNA in human plasma and urine.

The Quantitative range of this assay for plasma is 1.72 - 7.00 log IU/mL or 53 - 10,000,000 IU/mL.

The Quantitative range of this assay for urine is 2.18 - 7.00 log IU/mL or 150 - 10,000,000 IU/mL.

An interpretation of "Not Detected" does not rule out the presence of inhibitors in the patient specimen or CMV DNA concentartion below the level of detection of the test. Care should be taken when interpreting any single viral load determination.

Detected, not Quantifiable: CMV DNA detected, but at a level below the lower limit of quantitation of the assay.

Indeterminate: Error indicated in the generation of the result. please submit a new specimen for repeat testing if clinically indicated.

In general, testing urine specimens older than three weeks is not performed unless approved by a Laboratory Services Microbiology Director.
Synonyms:

CMV-PCR; CMV; NAAT
Patient Preparation :

Routine venipuncture for blood. Routine urine collection.
Clinical Indication:

Used for quantitation of Cytomegalovirus DNA in plasma or urine.
Effective Date: 02/02/2023
Reviewed By/Date: 0 - 01/01/1900
Approved By/Date: Williams-Bouyer, Natalie - 05/17/2024
When ordering tests for which Medicare or Medicaid reimbursement will be sought, physicians should only order tests that are medically necessary for the diagnosis or treatment of the patient. Components of the organ or disease panels may be ordered individually. The diagnostic information must substantiate all tests ordered and must be in the form of an ICD-10 code or its verbal equivalent.

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