Table 5.
General indication of use | Specific clinical utility | Commentsa |
---|---|---|
Prognostication | Assessment of CMV disease risk | Higher initial and peak viral loads are associated with a higher risk of CMV disease development (see the text); a rapid rise or upward trend in viral load is associated with a higher risk of CMV disease development (see the text) |
Assessment of CMV disease severity | Higher viral loads are associated with more severe CMV disease, tissue-invasive CMV disease, and potential multiorgan involvement (see the text) | |
Prevention | Guidance in the initiation and duration of preemptive therapy | Detection of a viral load above a predefined assay-specific threshold is an indication for the initiation of preemptive antiviral therapy; weekly NAT will guide in determining duration of preemptive therapy (see treatment below) |
Diagnosis | Rapid and sensitive diagnosis of CMV infection | Rapid and sensitive detection of CMV in the blood or tissue of patients with compatible clinical symptoms confirms the clinical suspicion of CMV disease; higher viral loads are associated with more severe CMV disease, tissue-invasive CMV disease, and potential multiorgan involvement; a negative CMV NAT in blood does not completely rule out CMV disease if the clinical suspicion is high—in this case, pursue other diagnostic tests |
Treatment | Assessment of efficacy of antiviral therapy | Weekly NAT will indicate the decline in viral load as a measure of the efficacy of antiviral therapy |
Assessment of treatment duration | Higher pretreatment viral loads (e.g., >18,200 [4.3 log10] IU/ml) have lower rates of CMV disease resolution; viral load suppression (e.g., <137 IU/ml or <2.1 log10 IU/ml) is associated with a shorter time to clinical CMV disease resolution | |
Assessment of risk of relapse | Detection of a viral load above a threshold at the end of antiviral treatment is significantly associated with clinical and virological relapse; viral decay (t1/2) in patients with successful antiviral treatment was 3.17 days, compared to 8.8 days for patients with subsequent CMV relapse | |
Assessment of risk of antiviral resistance | Persistent detection (or rise) of viral load in a patient receiving a prolonged course of antiviral therapy is a surrogate for the presence of a drug-resistant virus |
The viral load thresholds for most clinical indications have not been defined due to the lack of a standardized assay in most studies that have reported these clinical uses. See the text for examples of viral load thresholds specific to assays used and populations studied.