Table 2.
Test | Patients with “Definitive” PyVN N 2 |
Patients with “Definitive” PyVN -and- Positive Test 3 N |
Sensitivity (%) |
Patients without “Definitive” PyVN N |
Patients without “Definitive” PyVN -and- Negative Test 4 N |
Specificity (%) |
---|---|---|---|---|---|---|
Urine cytology/Decoys | ||||||
≥2 tests with ≥10 cells | 60 | 30 | 50 | 114 | 62 | 54 |
BKPy-viremia by PCR | ||||||
≥104 viral copies/mL | 61 | 40 | 66 | 102 | 82 | 80 |
≥250 viral copies/mL | 61 | 59 | 97 | 102 | 33 | 32 |
Urinary PyV-Haufen | 64 | 64 | 100 | 118 | 116 | 98 |
1 Cohort is limited to 182 patients with available PyV-Haufen test results -plus- either additional test results for decoy cell shedding and/or BKPy-viremia. The overall prevalence of PyVN in this cohort is 35%. 2 A patient is listed as “positive” if ≥ two samples tested positive for decoy cell shedding above threshold or ≥ one sample tested positive for BKPy-viremia above threshold or ≥ one sample tested positive for PyV-Haufen shedding. All test results collected between transplantation and index biopsy were considered in the group of 64 PyVN patients. 3 A patient is listed as “negative” if all available test results were negative or below threshold. 4 All test results collected within 74 weeks post transplantation were considered in the group of 118 patients without “definitive” PyVN.