CMV (DNA detection by Real time PCR Urine)

Immunity

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No Fasting Required

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Detects CMV viremia.

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CMV (DNA detection by Real time PCR Urine) - Comprehensive Medical Test Information Guide

Why is it done?
- Test Purpose: This test detects Cytomegalovirus (CMV) DNA in urine using Real-time PCR (Polymerase Chain Reaction) technology, identifying active viral infection and viral replication.
- Primary Indications: Diagnosis and monitoring of CMV infection in immunocompromised patients (HIV/AIDS, organ transplant recipients, cancer patients), suspected congenital CMV infection in newborns, and evaluation of CMV-related complications such as retinitis, nephritis, and colitis.
- Clinical Timing: Performed during acute infection symptoms, prior to and following organ/bone marrow transplantation, for immunocompromised patient surveillance, monitoring antiviral therapy effectiveness, and screening newborns with symptoms consistent with congenital infection.
Normal Range
- Reference Values: Negative / Not Detected (ND) or Below detection limit (<Lower Limit of Detection)
- Detection Limit: Typically 50-500 copies/mL or 50-500 IU/mL depending on laboratory methodology and assay sensitivity
- Units of Measurement: Copies/mL, IU/mL (International Units/mL), or log10 copies/mL
- Result Interpretation: Negative/Not Detected = No CMV DNA present, indicating no active viral replication; Positive/Detected = CMV DNA present, indicating active infection with quantification reflecting viral load burden
Interpretation
- Negative Result: Indicates absence of detectable CMV DNA in urine; suggests no active CMV infection or successful viral suppression with antiviral therapy; in immunocompromised patients, reduces likelihood of CMV disease manifestation
- Low Positive (≤1,000 copies/mL): Indicates early infection, viral shedding phase, or controlled viral replication; warrants close monitoring and possible antiviral therapy initiation in high-risk patients; may warrant repeat testing
- Moderate Positive (1,001-10,000 copies/mL): Indicates active CMV infection with significant viral replication; requires antiviral therapy initiation; necessitates vigilant clinical monitoring and follow-up viral load testing
- High Positive (>10,000 copies/mL): Indicates high-burden CMV infection with extensive viral replication; strongly suggests active CMV disease risk; requires immediate antiviral intervention and intensive monitoring; associated with increased risk of end-organ disease
- Factors Affecting Results: Immunosuppression degree, antiviral drug use and compliance, time since infection, specimen collection timing, urine quality/contamination, assay sensitivity variations between laboratories, CMV strain virulence, and presence of coinfections
- Clinical Significance: Positive results correlate with active infection and disease progression risk; trending viral load over time is crucial for therapy response assessment; serial monitoring helps guide treatment adjustments; negative conversion indicates therapeutic success
Associated Organs
- Primary Organ Systems: Urinary system (kidneys, bladder, ureters), immune system, central nervous system, gastrointestinal tract, ocular system, respiratory system, and bone marrow
- Associated Conditions - Immunocompromised Patients: CMV nephritis (kidney inflammation/dysfunction), CMV cystitis (bladder inflammation), CMV colitis (gastrointestinal inflammation), CMV retinitis (vision loss), CMV encephalitis (brain inflammation), CMV pneumonitis (lung infection)
- Associated Conditions - Transplant Patients: CMV disease post-solid organ transplantation, bone marrow transplant rejection risk, graft-versus-host disease complications, allograft nephropathy acceleration
- Associated Conditions - Other Populations: Congenital CMV infection in newborns causing hearing loss, developmental delays, intellectual disability, hepatosplenomegaly, thrombocytopenia
- High-Risk Patient Populations: HIV/AIDS patients (CD4 <50 cells/mm³), solid organ transplant recipients, hematopoietic stem cell transplant recipients, patients on chronic immunosuppression, cancer patients receiving chemotherapy, pregnant women with primary CMV infection
- Potential Complications: Acute kidney injury, chronic kidney disease progression, secondary infections, immune reconstitution inflammatory syndrome (IRIS), drug resistance development, tissue invasion complications, multi-organ involvement, severe immunosuppression-related secondary malignancies
Follow-up Tests
- Confirmatory and Complementary Tests: CMV blood (plasma) PCR for viremia assessment, CMV serology (IgM and IgG antibodies) for infection staging, CMV antigen detection (pp65 antigenemia assay), urine culture for CMV isolation, tissue biopsy with histopathology and immunohistochemistry for invasive disease confirmation
- Organ-Specific Diagnostic Tests: Ophthalmologic examination for retinitis; colonoscopy with biopsy for colitis; chest imaging (CT/X-ray) for pneumonitis; lumbar puncture with CSF analysis for CNS involvement; renal function tests (creatinine, BUN) for nephritis assessment
- Monitoring Tests for Therapy Response: Serial CMV urine PCR at 2-4 week intervals during treatment, CMV plasma PCR trending, CD4 count monitoring (in HIV patients), immune reconstitution assessment, toxicity markers (electrolytes, renal function for ganciclovir/foscarnet nephrotoxicity)
- Resistance Testing: CMV genotyping and phenotyping for antiviral resistance detection if viral loads remain elevated despite adequate therapy
- Recommended Monitoring Frequency: Transplant patients: weekly during high-risk period (post-transplant months 1-4), then monthly; HIV patients: every 1-2 weeks if positive, then weekly during treatment; stable patients: every 2-4 weeks while on therapy; post-therapy: periodic surveillance based on immune status
- Adjunctive Laboratory Tests: Complete blood count (WBC, platelets), comprehensive metabolic panel (renal/hepatic function, electrolytes), lactate dehydrogenase (LDH), albumin, inflammatory markers (CRP), immunoglobulin levels
Fasting Required?
- Fasting Status: NO - Fasting is NOT required for CMV urine DNA PCR testing
- Special Specimen Collection Instructions: Collect first morning urine specimen (ideally); alternatively, random urine collection is acceptable; minimum 10-15 mL required; use sterile collection container provided by laboratory; refrigerate specimen immediately after collection; transport to laboratory promptly (within 2 hours if not refrigerated; within 24 hours if refrigerated)
- Patient Preparation Requirements: No special fasting or dietary restrictions; maintain normal hydration status; no need to empty bladder before collection in most cases; ensure genital area cleaned with soap and water (females: front-to-back; uncircumcised males: retract foreskin) to minimize contamination
- Medications - No Special Restrictions: Continue all medications as prescribed, including antiviral agents (ganciclovir, foscarnet, cidofovir, valganciclovir); do not discontinue medications for test; inform laboratory of current antiviral therapy as it may affect viral load interpretation
- Contraindications/Cautions: Avoid contaminated or non-sterile collection containers; do not use preservatives unless specified by laboratory; do not mix urine with other specimens; avoid prolonged room temperature storage (promotes bacterial overgrowth and false results)
- Optimal Timing Considerations: Early morning first void specimens typically have highest viral concentration; schedule collections at consistent times for comparative trending; coordinate collection timing with laboratory processing schedules when possible

How our test process works!