Additional file 1: of Non-invasive diagnosis of acute rejection in renal transplant patients using mass spectrometry of urine samples - a multicentre phase 3 diagnostic accuracy study

Quality Assurance/Monitoring. (DOC 31 kb

Levels of parathyroid hormone (A), serum calcium (B) and vitamin D (C) are shown in NC patients and controls at the indicated time points.

<p>Patients with calcification are depicted in red. Data are shown as mean ± standard error of the mean (SEM).</p

Drug treatment and allograft status of patients and controls at biopsy time points.

<p>Values represent percentages.</p>*<p>p<0.05;</p>+<p>p = 0.056.</p>§<p>ARB’s: angiotensin receptor blockers; ACE-I’s: Angiotensin converting enzyme inhibitors,</p>$<p>any grade of hydronephrosis,</p>&<p>any cGrade>0 according to the BANFF classification.</p

Urinary concentrations of OPN are shown in NC patients and control transplant patients without signs of calcification at the indicated time points.

<p>Patients with calcification are depicted in red.</p

Serum concentrations of Fetuin A (A) as well as MGP (B) are shown in NC patients (n = 31) in comparison to control transplant patients without signs of calcification (n = 27) at the indicated time points.

<p>Patients with calcification are depicted in red.</p

Urinary phosphate levels in NC patients in comparison to control transplant patients without signs of calcification at the indicated time points are shown.

<p>Patients with calcification are depicted in red.</p

Demographics and transplant data of patients with and without (controls) calcification.

<p>Continuous data are given as mean±SD unless otherwise stated;</p>*<p>p = 0.011.</p

Representative images of Fetuin A (A), MGP (B) and OPN (C) expression are shown (red circle).

<p>The expression of the antigens is specifically localized in the vicinity of calcified plaques in patients with calcification. A representative control image is shown for Osteopontin (D). Original magnification: (Fetuin a and MGP x40; OPN x40 and x60).</p

Urinary mineral ions in patients and controls at biopsy time points.

<p>Urinary mineral ions in patients and controls at biopsy time points.</p

G-chart of Diagnosis Dates of Cancer.

<p>Cases marked with red dots and the number “1” above the upper control limit (UCL) indicate an unusually low rate of detected de novo malignancies (Test 1 result) which may raise concerns in regard to appropriate vigilance of doctors or possible decreased diagnostic sensitivity. Alternatively, this observation may also indicate decreased de novo cancer risk in these observed cases. Cases marked by the letter “B” and a red dot on the lower control limit (LCL) indicate a failed Benneyan test pointing to statistically relevant increases in the diagnostic event rate which should trigger clinical concerns in regard to causation, e.g. by intensified or uncontrolled immunosuppression. Alternatively, a more rigorous screening for cancer may also lead to an increased event rate.</p