The Microalbumin Test Cassette (Urine) is based on Fluorescence Immunoassay to
measure Microalbumin in Urine.
【SUMMARY】
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.1 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, to additional factors of influence like physical activity, infections of the
urinary tract, high blood pressure, heart insufficiency or surgical interferences(besides
damages of renal structures).
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.
【PRINCIPLE】
The Microalbumin Test Cassette (Urine) detects Microalbumin based on
Fluorescence Immunoassay. The sample moves through the strip from sample pad to
absorbent pad. Microalbumin in the urine will compete with the Microalbumin antigen
coated on the membrane. The less Microalbumin in the sample, the more chance that
fluorescent microspheres-conjugated anti-Microalbumin antibodies can be captured
by the Microalbumin antigen coated on the membrane (Test line). The concentration
of microalbumin in the sample is inversely related to the intensity of the fluorescent
signal captured on the T line. According to the fluorescence intensity of the test and
the standard curve, the concentration of Microalbumin in the sample can be calculated
by FIATESTTM Analyzer to show Microalbumin concentration in specimen.
【REAGENTS】
The test includes anti-Microalbumin antibody coated fluorphores and Microalbumin
antigen coated on the membrane.
【PRECAUTIONS】
1. For professional in vitro diagnostic use only.
2. Do not use after the expiration date indicated on the package. Do not use the test
if the foil pouch is damaged. Do not reuse.
3. Avoid cross-contamination of specimens by using a new specimen collection
container for each specimen obtained.
4. Do not eat, drink or smoke in the area where the specimens and tests are
handled. Handle all specimens as if they contain infectious agents. Observe
established precautions against microbiological hazards throughout the procedure
and follow standard procedures for proper disposal of specimens. Wear protective
clothing such as laboratory coats, disposable gloves and eye protection when
specimens are assayed.
5. Do not interchange or mix reagents from different lots.
6. Humidity and temperature can adversely affect results.
7. Used testing materials should be discarded in accordance with local regulations.
8. Read the entire procedure carefully prior to any testing.
9. The Novatrend Plus Microalbumin Test Cassette (Urine) should only be used with the
Novatrend Plus Analyzer by approved medical professionals.
【STORAGE AND STABILITY】
1. The kit should be stored at 4-30°C before the expiry date printed on the sealed
pouch.
2. The test must remain in the sealed pouch until use.
3. Do not freeze.
4. Care should be taken to protect the components of the kit from contamination. Do
not use if there is evidence of microbial contamination or precipitation. Biological
contamination of dispensing equipment, containers or reagents can lead to false
results.
【SPECIMEN COLLECTION AND PREPARATION】
Use preferably only fresh morning urine for testing since physical effort can lead to an
increase in albumin expulsion. Urine sample should be stored at 2-8°C if the test is to
be run within 2 days of collection. For long term storage, specimens should be kept
below -20°C. Samples that have been refrigerated must be equilibrated to room
temperature before testing. Avoid repeated freezing and thawing of urine samples.
【MATERIALS】
• Test Cassettes • Package Insert Materials Provided
• ID Card
• Specimen Collection Tubes with Buffer
Materials Required But Not Provided
• Timer
• Centrifuge • Novatrend Plus Fluorescence Immunoassay Analyzer
• Pipette • Specimen Collection Containers
【DIRECTIONS FOR USE】
Refer to Novatrend Plus Fluorescence Immunoassay Analyzer Operation Manual for the
complete instructions on use of the Test. The test should be conducted in room
temperature.
Allow the test, specimen and/or controls to reach room temperature (15-30°C)
prior to testing.
1. Turn on the Analyzer power. Then according to the need, select “Standard test” or
“Quick test” mode.
2. Take out the ID card and insert it into the Analyzer port.
3. Pipette 75μL of urine into the buffer tube, mix the specimen and the buffer well.
4. Transfer 75μL diluted sample into the sample well of the test cassette.
5. There are two test modes for Novatrend Plus Fluorescence Immunoassay Analyzer,
Standard Test mode and Quick Test mode. Please refer to the user manual of
Novatrend Plus Fluorescence Immunoassay Analyzer for details.
“Quick test” mode: After 10 minutes of adding sample,Insert the test cassette into
the Analyzer, click “QUICK TEST”, fill the test information and click "NEW TEST"
immediately. The Analyzer will automatically give the test result after a few seconds.
“Standard test” mode: Insert the test cassette into the Analyzer immediately after
adding specimen, click “STANDARD TEST”, fill the test information and click "NEW
TEST" at the same time, The Analyzer will automatically countdown 10 minutes.
After the countdown, the Analyzer will give the result at once.
