Rapid Diagnostic Test Kits For Micro - Albumin Semi Quantitative Detection

A rapid test for the semi-quantitative detection of Micro-Albumin in urine CE certified

Applications: 

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

Description: 

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 characterized 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 of influence like physical activity, infections of the urinary tract, high blood pressure, heart insufficiency or surgical interferences.

If the increased albumin expulsion disappears after removal of these factors, it 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.

How to use? 

1. Remove the test dipstick from the sealed foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed immediately after opening the foil pouch.
2. With arrow towards the urine specimen, immerse the test dipstick vertically in the urine specimen in such a way that urine does not cross “MAX” line on the test dipstick for 10-15 seconds. See the illustration below.
3. Read the results after 5 minutes, by comparing the color intensity of the test result line within the T-range with the color scale. The evaluation should take place no later than 10 minutes after the test. Please adhere strictly. Longer or shorter response times affect the color intensity of the test result line and obstruct a safe semi-quantitative evaluation.

INTERPRETATION OF RESULTS

(Please refer to the illustration above)

POSITIVE: Two lines appear or only one line. One colored line should be in the control line region (C) and another apparent colored line should be in the test line region (T) or no line apparent in the test region (T).The color intensity of the test result line is identical or paler than the color for 20 mg/L on the color scale (see inner plate of the box). A match with the color intensity of the color scale makes the classification of the result into the different concentration ranges possible. At concentrations above 100 mg/L no test line develops anymore. Such samples are to be considered in any case as positive, even if they are not semi-quantitative evaluable.

NEGATIVE: Two lines appear. One colored line should be in the control line region (C) and another apparent colored line should be in the test line region (T). The color intensity of the test result line is equivalent to the color for 0 mg/L on the color scale. In this case the sample does not contain traceable quantities of albumin. If the color intensity of the test result line is paler than the 0 mg/L value but more intensive than the color for 20 mg/L on the color scale, the albumin concentration is in a range which can be considered harmless. Such results are to be likewise considered as negative test results.

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the diagnostic test immediately and contact your local distributor.

QUALITY CONTROL

appearing in the control region (C) is an internal valid procedural control. It confirms sufficient specimen volume and correct procedural technique. Control standards are not supplied with this kit; however, it is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance.