This test should be regarded as 'Research Use Only'. This test has not been cleared or approved by the U.S. Food and Drug Administration. It may not be covered by insurance and providers need to inform all patients of this prior to ordering.
For Medicare patients, an Advanced Beneficiary notice (ABN) is required; for Medicaid patients, a Noncovered Services Waiver is required, and for commercial payers, prior authorization should be obtained.
Retinol-binding protein is a low-molecular-weight protein of 21 kDa that transports retinol (vitamin A alcohol) from the liver to peripheral tissues. Retinol-binding protein is most often found bound to transthyretin, but a small, unbound fraction (<10%) passes freely through glomerular membranes and is reabsorbed by renal proximal tubules cells where it is catabolized. Due to extensive tubular reabsorption, under normal conditions very little of the filtered retinol-binding protein appears in the final excreted urine. Therefore, an increase in the urinary excretion of retinol-binding protein indicates proximal tubule injury and/or impaired proximal tubular function. Measurement of retinol-binding protein in urine is, therefore, a useful aid in the monitoring and/or diagnosis of kidney disease.
Elevated excretion rates can indicate tubular damage associated with renal tubulointerstitial nephritis or tubular toxicity from heavy metal or nephrotoxic drug exposure. Glomerulonephropathies and renal vasculopathies also are often associated with coexisting tubular injury and so may result in elevated retinol-binding protein excretion. Measurement of urinary excretion of alpha-1-microglobulin, another low-molecular-weight protein, is an alternative to the measurement of retinol-binding protein. To date, there are no convincing studies to indicate that 1 test has better clinical utility than the other.
Urinary excretion of retinol-binding protein can be determined from either a 24-hour collection or from a random urine collection. The 24-hour collection is traditionally considered the gold standard. For random or spot collections, the concentration of retinol-binding protein is divided by the urinary creatinine concentration. This corrected value adjusts retinol-binding protein for variabilities in urine concentration.