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HelpTest Code CMVB Cytomegalovirus (CMV) DNA, Quantitative using Real Time PCR
Clinical Indications
Alinity m CMV assay is intended for use in conjunction with clinical presentation and other laboratory markers to provide clinicians with a means to assess CMV DNA levels in the management of CMV in solid organ transplant patients, hematopoietic stem cell transplant patients, and patients receiving anti-CMV therapy. This assay is not intended to be used in screening blood, blood products, tissue, or organ donors for CMV.
Additional Test Codes
Epic Order Name: CMV Quant PCR-Blood
Sunquest Order Code: CMVB
Epic Px Code: LAB2673
Specimen Collection Type
Preferred: Pearl
Acceptable: Lavender
Minimum Collection Volume
2 mL Plasma
Reference Range
Not Detected
Critical Value
N/A
Interpretation
This assay is FDA cleared to quantitate CMV from 30 IU/mL (1.48 Log IU/mL) to 100,000,000 IU/mL (8.00 Log IU/mL) in EDTA plasma specimens. The limit of detection of the assay in EDTA plasma specimens is 30 IU/mL (1.48 Log IU/mL). A "Not Detected" result indicates that CMV was not detected.
A result of <30 IU/mL (<1.48 log IU/mL) indicates that CMV is detected, but the CMV level present cannot be quantified accurately below this lower limit of quantification of this assay.
A numerical result is reported when CMV is detected. If detected, quantitative results will be reported in IU/mL and log IU/mL.
Rejection Criteria
Any unspun whole blood sample outside of specimen stability
Any plasma sample outside of specimen stability
Samples that do not comply with TUKHS Lab specimen requirements
Specimen Availability for Add-on Testing
24 hours
Specimen Stability
Prior to centrifugation: 24 hours room temp. (15 to 30°C), 5 days refrigerated (2 to 8°C)
After centrifugation: 24 hours room temp. (15 to 30°C), 5 days refrigerated (2 to 8°C)
Day(s) Performed
Monday-Friday
Performing Lab- Department
TUKHS-BH-MOLECULAR MICROBIOLOGY
CPT Code
87497
LOINC Code
29604-6
Test Alias
Cytomegalovirus PCR
Additional Information / Notes
N/A