Semi-quantitative 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.



    IMPLEMENTATION OF THE TEST

    After opening the tube the required amount of tests should be carried out immediately. Tests, which have  been stored refrigerated, should be equilibrated to room temperature before opening to avoid  condensation of humidity on the test. 

    1. Open the tube and remove the test strip at the handle. Mark the strip if necessary for identification  purposes. Avoid direct contact of the white membrane in the center of the test strip. Close the tube  immediately afterwards. 

    2. Dip the other end of the test strip for at least 10 seconds into the urine sample. Make sure that the  test is not submerged deeper than the MAX mark. The urine may not have direct contact with the  white membrane, since this makes the test useless. To make sure the absorbed amount of liquid is  sufficient, it is recommended to wait for the release of the color-marked antibodies. This can be  recognized by the moving of the red liquid front along the membrane, or by the development of the  control line. 

    3. Remove the test strip and place it on a clean surface which does not extract humidity (e.g. on the test  pouch). Start the timer. 

    4. Read the test result 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 to this time. Longer or shorter response times affect the color intensity of the  test result line and obstruct a safe semi-quantitative evaluation.


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