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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:

4 mL plasma or 4 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.

Specimen Preparation:

Within 24 hours of collection, centrifuge PPT tube. 

No specimen prep required for urine sample.

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.

Reference Range:

Plasma <53 IU/mL

Urine <150 IU/mL

Turnaround Time:

Test is performed three days per week.

Methodology:

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

Performed:
Lab:

Clinical Microbiology

Synonyms:

CMV-PCR; CMV; NAAT

Clinical Indication:

Used for quantitation of Cytomegalovirus DNA in plasma or urine.

Patient Preparation :

Routine venipuncture for blood. Routine urine collection.

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.

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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