INTENDED USE

The Micro-Albumin Semi-quantitative Rapid Test is a rapid chromatographic immunoassay for the semi-quantitative detection of micro-albumin in human urine.

INTRODUCTION

This product is used to obtain a visual, semi-quantitative result and is intended for professional use only. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result.
The steady expulsion of small quantities of albumin with the urine can be the first sign of kidney damage. In the healthy kidney albumin is usually glomerular filtrated and tubular reabsorbed, so that it is hardly detectable in urine. With a damaged kidney this process is disordered. The expulsion of albumin in the range of 20 – 200 mg/L is as microalbuminuria. With this microalbumin test such small concentrations are already securely captured. Especially with diabetics positive results could point to a beginning diabetic nephropathy. Without appropriate therapeutic intervention it will lead for a high percentage of patients to a progression of this complication. The expulsion of albumin increases continuously (= macroalbuminuria) and ends finally after several years in a renal failure, which makes dialysis or a kidney transplant inevitable. In the USA and Europe diabetes is the main cause for terminal kidney failure. A study (DEMAND), accomplished world-wide, shows that approx. 41% of type-2 diabetics exhibit a microalbuminuria. The frequency of microalbuminuria increases with age, blood pressure and diabetes duration, and is the rarer, the better the blood sugar is adjusted. The high prevalence of the illness reveals how important a microalbuminuria annual screening is for diabetics. For type- 1 diabetics the first measurements are usually recommended 5 years after initiation of the illness. For type-2 diabetics the screening should start directly with the first outset of the diagnosis, since it is unknown, how long the illness already exists. The diagnosis of a microalbuminuria is also of special importance, since it can be not only the first sign of a beginning nephropathy but also an indicator for an increased risk for cardiovascular illnesses for type-2 diabetics. An increase of albumin expulsion can be due, beside damages of renal structures, to additional factors physical activity, infections of the urinary tract, high blood insufficiency or surgical interferences.
If the increased albumin expulsion disappears after removal of concerns only a transient albuminuria without any pathological reason.
Since the albumin expulsion can vary substantially from day to day, at least 2 of 3 urine samples, which were collected over a period of 3-6 months, should show increased albumin values, before a microalbuminuria is diagnosed.

PRINCIPLE

The Micro-Albumin Semi-quantitative Rapid Test is an immunoassay based on the principle of competitive binding. Human albumins may be present in the urine specimen compete against the albumin conjugate for binding sites on the antibody.
During testing, a urine specimen migrates upward by capillary action. Albumin, if present in the urine specimen below 20ug/mL, will not saturate the binding sites of the antibody in the test. The antibody coated particles will then be captured by immobilized human albumin and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the Albumin level exceeds 20ug/mL because it will saturate all the binding sites of anti-albumin antibodies.
An albumin-positive urine specimen will not generate a colored line in the test line region because of albumin competition, while an albumin-negative urine specimen or a specimen containing a albumin concentration less than the 20ug/mL will generate a line in the test line region. To serve as a procedural control, a colored line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.