TABLE 1.

Characteristics of study population, infective episodes, and samples analyzed

	LMV-prophylaxis	LMV off-label treatment^b	Pre-emptive therapy^c	Total
No. of transplant recipients	23	7	14	44
Male sex	13	5	10	28
Age (mean ± SD)	49 ± 13.2	34 ± 16.1	45 ± 21.2	45 ± 17
Type of transplant
Hematopoietic stem cells	23	4	6	33
Liver	0	1	3	4
Heart	0	2	2	4
Kidney	0	0	3	3
CMV serostatus D/R^a
D+/R+	13	0	7	20
D−/R+	10	4	3	17
D+/R−	0	3	4	7
No. of CMV-DNAemia-positive episodes^d	25	7	15	47
CMV-DNAemia-positive/total samples	97/106	35/37	95/111	227/254
Median CMV DNAemia levels in whole blood (copies/mL^e, range)	3.9 × 10² (3 × 10²–1.9 × 10⁵)	1.4 × 10³ (3 × 10²–7.3 × 10⁴)	2.8 × 10³ (3 × 10²–2.4 × 10⁶)	9.8 × 10² (3 × 10²–2.4 × 10⁶)
No. of CMV-RNAemia-positive episodes^f	6	6	15	27
CMV-RNAemia-positive/total samples	14/106	9/37	50/111	73/254
Median CMV-RNAemia levels in plasma (copies/mL, range)	3 × 10 (3 × 10–1.9 × 10³)	5.1 × 10 (3 × 10–1.2 × 10³)	1.4 × 10² (3 × 10–9.1 × 10³)	8.1 × 10 (30–9.1 × 10³)
Correlation coefficient between CMV DNAemia and CMV-RNAemia levels	0.571^g	0.237^g	0.759^h	0.755^h
Sensitivity–specificity of CMV-RNAemia vs CMV-DNAemia	14.4%–100%	25.7%–100%	52.6%–100%	32.2%–100%ⁱ

^{^a}

D, donor; R, recipient; +, positive; −, negative.

^{^b}

LMV-off-label due to ganciclovir resistance (three patients receiving solid organ transplant), severe neutropenia (two pediatric hematopoietic stem cell transplant recipients), and positive CMV-DNAemia results when starting LMV (two adult hematopoietic stem cell transplant recipients).

^{^c}

The patients receiving therapy with (val)ganciclovir (n = 13) or foscarnet (n = 1).

^{^d}

CMV-DNAemia-positive episodes: at least two sequential positive CMV-DNAemia results in whole blood or one more than 300 copies/mL; a mean of 5.4 samples/episodes [±3.5 standard deviation (SD)] was analyzed.

^{^e}

Conversion factor from copies/mL to international units/mL is 0.46.

^{^f}

CMV-RNAemia-positive episodes: episodes with at least one positive result.

^{^g}

Spearman correlation, CMV-DNAemia and CMV RNAemia levels under the lower limit of quantification (300 and 30 copies/ml) were considered equal to 150 and 15 copies/ml, respectively.

^{^h}

Pearson correlation, CMV-DNAemia and CMV RNAemia levels under the lower limit of quantification (300 and 30 copies/ml) were considered equal to 150 and 15 copies/ml, respectively.

^ⁱ

The specificity of 100% was also found in 100 additional plasma samples from transplant patients for whom CMV reactivation was ruled out by negative CMV-DNAemia results (data not shown).