Name: CMV Qualitative by PCR, CSF
Test Name: CMV Qualitative by PCR, CSF
Health Link Test Code: HCCMVCF
LIS Test Code: CMVCF
CPT Code(s): 87496
Methodology: Real-Time PCR
Detect CMV in cerebrospinal fluid (CSF).
Days Performed: Mon-Fri.
In-Lab Turnaround Time: 2 - 3 days.
Stat In-Lab Turnaround Time: Not available stat.
Specimen: Cerebrospinal fluid (CSF)
Collection Container: Sterile container
Collection Volume: 2 mL
Pediatric Collection Volume: 2 mL
Indefinitely at -70°C or 7 days at -20°C.
Sample Analyzed: Cerebrospinal fluid (CSF) aliquot
Testing Volume: 2 mL
Pediatric Testing Volume: 1.2 mL
Transport to Laboratory within 2 hours of collection.
Interpretation Type: Expected Results
A "Not detected" result may be the result of PCR inhibitors, virus levels below the level of detection of this test, or virus diluted in a large sampling volume. Virus quantitation is not possible due to the nature of the specimen.
A "Detected" result indicates the presence of CMV DNA. A result of "Not Detected" does not rule out the presence of CMV DNA or the absence of infection. False negative results may be due to the suppression of viral replication to levels below the detection threshold, or to inhibitory substances that may be present in the specimen. Inadequate specimen collection, processing and storage may invalidate test results. This test should not be used as the only criterion to form a clinical conclusion, instead, results should be correlated with other test results, patient symptoms and clinical presentation.
The performance characteristics of this test were validated by UWHC Clinical Laboratories. The U.S. Food and Drug Administration (FDA) has not approved or cleared this test; however, FDA approval or clearance is currently not required for clinical use of this test. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions. The UWHC Clinical Laboratories is authorized under Clinical Laboratory Improvement Amendments (CLIA) to perform high-complexity testing.