Micro-Albumin Rapid Test

A rapid test for the qualitative detection of Micro-Albumin in urine.  For professional in vitro diagnostic use only.

  • Description
  • Specifications
  • INTRODUCTION】 

    The Micro-albumin dipstick is a lateral flow, one-step immunoassay for the qualitative detection of low  concentrations of albumin at a cut-off of 20 μg/mL urine. This product is used to obtain a visual, qualitative result and is intended for professional use, only.  The assay was developed for the first screening of urine samples and provides a preliminary  analytical result. A positive result indicates elevated levels of albumin above the cut-off but does not  correct for alterations in the urine concentration. Positive results should therefore be confirmed by a  more specific quantitative method. Clinical consideration and professional judgment should be applied  to any Micro-albumin test result, particularly when preliminary positive results are indicated.


    PRINCIPLE】 

    The Micro-albumin dipstick is a one-step competitive immunoassay in which immobilized human  albumin from the assay competes with albumin which may be present in urine for limited antibody  binding sites. The membrane of the strip has been pre-coated with human albumin in the test result line region (Tregion). A pad containing a color-labelled anti-albumin antibody is placed at the right end of the  membrane. With the urine the antibodies move towards the test result line region by capillary action. If  no albumin is present in the urine it will attach to the immobilized albumin. This can be seen by the  formation of a red test result line. Therefore, a line in the T-region indicates that no albumin is present  in the urine or that the albumin concentration is below the cut-off. If albumin is present in the urine, it competes with the immobilized albumin in the T-region for the  limited antibody sites. With increasing concentrations of albumin in the sample the binding of the  antibody is more and more inhibited and the color of test result line becomes weaker. When the  amount of albumin is equal or more than the cut-off, 20 µg/ml, it will prevent the binding of the  antibody to the immobilized albumin and the line vanishes. Therefore, the absence of a colored band  in the T-region indicates a positive test result. A control line with a different antigen/antibody reaction is also added to the immunochromatographic  membrane strip at the control region (C-region) to indicate that the test has been performed properly.  The presence of the control line serves as 1) verification that sufficient volume has been added, and 2)  that proper flow was obtained. The control line should always appear, regardless of the presence or  absence of albumin.  This means that negative urine will produce two colored lines, whereas positive urine with elevated  levels of albumin will produce only one colored line.


    TEST PROCEDURE】 

    Tests that have been stored refrigerated should be brought to room temperature prior to opening in order  to avoid a condensation of humidity on the test strips. After removing the test strip, run the test  immediately. 

    1. Open the pouch and remove the dipstick by holding it at the colored end. Discard the pouch and  desiccant inside. Mark the test for identification reasons if necessary. Avoid touching the white  membrane in the middle of the test strip.  

    2. Dip the other end of the dipstick into the urine sample for at least 10 seconds. Make sure that the test  is not submerged beyond the MAX mark. The urine should not have any direct contact to the white  membrane because this would destroy the assay. To ensure that the liquid uptake was sufficient we  recommend waiting for the release of the colored antibodies before removing the test from the liquid.  That can be either seen by a pink front moving across the membrane or by the formation of the  control line.

    3. Remove the dipstick and place it horizontally on a flat non-adsorbent surface that does not withdraw  any liquid from the assay. Start the timer. 

    4. At the end of five minutes read the result. Do not interpret result later than 10 minutes after starting the assay.


    ORDER INFORMATION 

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