ImmunoDip® Rapid Test for the Detection of Microalbumin in Urine
Introduction
Almost half of
all insulin dependent diabetics develop a diabetic nephropathy (DNP), with
protein in the urine and a decline in the filtration rate, during the course
of their disease. If a DNP remains undetected, it can lead to irreversible
kidney failure, necessitating dialysis treatment or kidney transplant.
Additionally, high blood pressure, through atherosclerotic changes in the
blood vessels that supply the kidneys, can lead to inadequate blood supply
and to nephropathy. Microalbuminuria, is defined as a slight increase
in urinary albumin (20 – 200 mg/L), caused by a disturbance in the
glomerular filtration barrier. Microalbuminuria may have various
causes; it may be the concomitant product of profound physical stress,
fever, cardiac insufficiency or poor regulation of hypertension. After the
elimination of the causative factors, the levels can return to normal.
However, a constant, detectable, prolonged microalbuminuria suggests damage
to the glomerular filter. The risk of progression to kidney damage can be
greatly reduced by means of metabolic adjustment, blood pressure control and
early pharmaceutical intervention. The increased risk of cardiovascular
disease that accompanies a nephropathy can, at the same time, also be
reduced.
Test Principle
The ImmunoDip® Microalbumin rapid test measures
the concentration of urinary Albumin by utilization of a self-contained,
immunochromatographic, lateral flow membrane test strip containing specific
monoclonal antibody against human albumin. The test strip contains labeled
antibody conjugate, immobilized antigen and immobilized antibody. When
Albumin present in the urine binds with antibody coated latex beads on the
test strip, a maximum of two blue colored bands are formed. The resulting
intensity of these bands corresponds to the concentration of Albumin in the
urine sample.
Key
Benefits and Features
Simple &
Fast –- An easy five (5) step testing procedure allows you to
obtain test results in only three (3) minutes.
Cost
Effective – Generate accurate, reliable test results without the
need for expensive reagents, calibrators and instrumentation.
Testing
Versatility – Able to use in virtually any clinical setting...
24 hours a day, 7 days a week.
Minimal
Interferences – No significant cross-reactivity with common
medications and other human proteins.
Stable
Results – Able to obtain either qualitative or semi-quantitative
test results eight (8) hours after testing.
Built-In
Testing Control – Provides utmost confidence in test results.
Convenient
Storage & Shelf-Life – Able to store at either refrigerated or
ambient temperatures for eighteen (18) months after date of manufacture.
Proven
Performance – A documented and published history of testing in
some of the most demanding clinical environments worldwide.
Testing & Interpretation
To perform the
test:
-
Remove test
device from pouch.
-
Place into urine
sample, preferably using a first morning void.
-
Check that urine
sample is up to, or above, vent hole.
-
Let sit in
sample a minimum of three (3) minutes.
-
Read the result
within eight (8) hours after placing the strip in the urine sample.
Read the result
within eight (8) hours after placing the strip in the urine sample. To
read the test, compare the relative intensity of the two bands. The top band
also functions as a built in control:
-
If the bottom
band is darker than the top band, the result is NEGATIVE (<12
mg/L).
-
If the bottom
band and top band are of equal color intensity, the result is NEGATIVE (12-18 mg/L).
-
If the bottom
band is lighter than the top band, the result is POSITIVE (>18
mg/L).
-
If only a top
band is present, the result is POSITIVE (>18 mg/L).
Ordering Information
Product
|
Catalogue
Number |
Package
Configuration |
ImmunoDip® Qualitative Test
(Complexity Rating: CLIA Waived) |
790-25 |
25 Test Strips/Kit |
ImmunoDip® Semi-Quantitative Test(Complexity Rating:
Moderate) |
700-25 |
25 Test Strips/Kit |
Two-Level Microalbumin Urine
Quality Control Materials |
SM-252 |
4 X 8 mL |
References
1. Mogensen,
CE, et al. Prevention of Diabetic Renal Disease with Special Reference to
Microalbuminuria. Lancet 346: 1080-1084 (1995).
2. Tobe, SW, et al. Microalbumin in Diabetes Mellitus. CMAJ 167:
499-503 (2002).
3. National Kidney Foundation. K/DOQI Clinical Practice Guidelines for
Chronic Kidney Disease: Evaluation, Classification and Stratification. Kidney Disease Outcome Quality Initiative. Am J Kidney Dis 39: (2 Suppl
1): 1-246 (2002).
4. American Diabetes Association, Inc. (ADA). Position Statement: Nephropathy in Diabetes. Diabetes Care 27:S79-83, 2004.
REFER TO PACKAGE INSERT AND/OR MSDS FOR
ADDITIONAL TECHNICAL INFORMATION
© Diagnostic Chemicals Limited. All rights reserved 2005.
ImmunoDip® is a registered trademark of Diagnostic Chemicals Limited
