A Unique Assay Panel to Support Diagnosis and Management of CKD-MBD.
Chronic Kidney Disease – Mineral Bone Disorder (CKD-MBD) is a systemic disorder of mineral and bone metabolism due to CKD manifested by either one or a combination of the following:
The KDIGO guidelines recommend monitoring of the following assays are to support CKD stage 3-5 and patients on dialysis, with the frequency based on stage, rate of progression and whether specific therapies have been initiated; Calcium, Phosphate, Alkaline Phosphatase, PTH, 25(OH)D.1 Immunodiagnostic Systems Limited (referred to hereafter as IDS) provides a CKD-MBD panel which comprises of a combination of bone and calcium metabolism markers including: Bone Specific Alkaline Phosphate, PTH and 25(OH)D.
This IDS portfolio provides laboratories with:
• Simplified workflow to manage CKD-MBD related testing
• Improved turn-around times for CKD related samples
• Reliable results through automation of unique assay panel
Chronic kidney disease (CKD) is an international public health problem affecting 5–10% of the world population.2 As kidney function declines, there is a progressive deterioration in mineral homeostasis, with a disruption of concentrations of phosphorus and calcium, and changes in circulating levels of parathyroid hormone (PTH), 25-hydroxyvitamin D (25(OH)D),1,25-dihydroxyvitamin D (1,25(OH)2D).
The ability of the kidneys to appropriately excrete a phosphate load is diminished with stage 3 CKD leading to hypophosphatemia, elevated PTH, and decreased 1,25(OH)2D. The conversion of 25(OH)D to 1,25(OH)2D is impaired, leading to reduced intestinal calcium absorption and increasing PTH. The kidney fails to respond adequately to PTH, which normally promotes phosphaturia and calcium reabsorption.
The mineral and endocrine functions disrupted in CKD are critically important in the regulation of both initial bone formation during growth (bone modelling) and bone structure and function during adulthood (bone remodelling). As a result, bone abnormalities are found almost universally in patients with CKD requiring dialysis (stage 5D), and in the majority of patients with CKD stages 3–5.
Building on our expertise in calcium and bone testing, we can provide laboratories with a unique panel for CKD-MBD testing. These markers can be measured on our IDS-iSYS Multi-Discipline Automated System from a single serum sample tube, to maximise work-flow efficiency. A selection of CKD-MBD tests are also available as traditional Enzyme Immunoassay (EIA) or Radioimmunoassay (RIA) formats.
1. Moe S, et al. Kidney Disease: Improving Global Outcomes (KDIGO). Definition, evaluation, and classification of renal osteodystrophy: a position statement from Kidney Disease: Improving Global Outcomes (KDIGO). Kidney Int. 2006 Jun;69(11): 1945-53.
2. Eknoyan G, Lameire N, Barsoum R et al. The burden of kidney disease: improving global outcomes. Kidney Int 2004; 66: 1310–1314.
3. Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Work Group. KDIGO clinical practice guideline for the diagnosis, evaluation, prevention, and treatment of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD). Kidney Int Suppl. 2009 Aug;(113):S1-130.
| Portfolio | Certification | Clinical Area | Product Type | RUO/IVD |
|---|---|---|---|---|
| 25 VitDS | CE Marked |
Automated | IVD | |
| 1,25 VitDXp | CE Marked |
Automated | IVD | |
| Intact PTH | CE Marked |
Automated | IVD | |
| 1,25-Dihydroxy Vitamin D | CE Marked |
Automated | IVD | |
| Intact PINP | CE Marked |
Automated | IVD | |
| Ostase® BAP | CE Marked |
Automated | IVD | |
| TRAcP 5b (BoneTRAP®) | CE Marked |
Automated | IVD | |
| InaKtif MGP (dp-ucMGP) | CE Marked |
Automated | IVD, RUO in USA |
