EASY TO USE
• Simply place test device into the urine sample
• Results in 3 minutes
• Albumin <18mg/L indicates a negative result
• Albumin >18mg/L indicates a positive result
• Sensitivity >99%; Specificity 98%
EASY TO READ
• A top line darker than the bottom line indicates a positive result.
• Color bands remain stable for 8 hours.
• Room temperature storage; 18-month shelf life.
25 x Individually Packaged Test Devices
1 x Package Insert
The OSOM ImmunoDip devices are provided ready to use and are stable until the expiry date indicated on the box and device pouch. Store at 18°C/65°F–26°C/79°F. The device is stable for four hours after being removed from the foil pouch.
MATERIALS REQUIRED BUT NOT PROVIDED
Timer or watch
Clean specimen collection container
The user may wish to purchase and utilize Genzyme Microalbumin Controls (Cat. No. SM-252) for external quality control.
Summary and explanation of test
There are several kidney disease conditions that can produce high levels of albumin in urine(1). Detecting albumin in urine at the low levels measured by this test will aid in early detection and treatment of patients at risk for renal (kidney) disease. Slightly elevated levels of human protein albumin in urine, >18 mg/L, is known as microalbuminuria. Levels above 18 mg/L are not normally found in healthy individuals. These low, but significant levels are not detectable with older dipstick assays. The OSOM ImmunoDip Urinary Albumin.
Test classifies a sample as positive if it is above a level of 18 mg/L. Conditions in which elevated levels of albumin in urine may be present include: Type 1 and Type 2 diabetes(2-8); hypertension(9, 10); and renal disease found in pregnancy(11). There are other less common causes as well. Diabetes is the largest single cause. One study found 45% of the insulin-dependent diabetics developed serious kidney disease(3). Testing for elevated levels of albumin in urine helps to identify those diabetics who are prone to kidney disease. Scientific studies indicate that proper control of blood glucose (blood sugar) levels and blood pressure help slow down or prevent kidney damage (1, 9).
Principles of the test
The OSOM ImmunoDip Urinary Albumin Test is a lateral flow immunochromatographic test strip which measures the concentration of urinary albumin. Contained in the device are labelled antibody conjugate, immobilized antigen and immobilized antibody. The albumin present in the urine binds with blue colored latex beads present in the test device. This binding is caused by monoclonal antibodies against human albumin attached to the beads. When the device is placed into urine, these beads mix with the urine
sample and are carried up the test device by a wicking action. Human albumin is fixed in a band at the bottom half of the testing region. Goat anti-mouse antibodies are fixed in a band at the top half of the testing region.The test also contains buffer and stabilizing components on strip substrates. At low levels of albumin in the sample, these blue beads bind to the band of albumin. This produces a blue colored band in the lower half of the test window. The test window has a second band that can bind the colored beads. The colored beads are bound by the second band even if they have reacted with albumin in the urine. When there is a low level of albumin in the urine, most of the beads will bind to the lower band.
However, some of the beads will react with the small amount of albumin present. These beads will pass through the lower band and will be bound at the upper band. This produces a second blue band. As the amount of albumin in the urine increases, more beads pass through the lower band and are bound by the upper band. After three minutes, the darkness or intensity of the two blue bands in the test window is compared.
If the band in the upper half of the test window is lighter than or equal to the lower band, the test is negative. Negative means there is a normal level of albumin in the test urine sample. If the band in the upper half of the test window is darker than the lower band, the test is positive. Positive means there is more albumin in the test urine sample than is found in normal urine. Detailed instructions for reading the results are in the Procedure/Result Interpretation Guide in this insert.
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