mAlb Test Cassette t Use By Fiatest fluorescence Immunoassay Analyzer with CE
The Microalbumin Test Cassette is based on Fluorescence Immunoassay to measure Microalbumin in Urine as an aid in kidney damage diagnosis.The test result is calculated by Fluorescence Immunoassay Analyzer.
| Product Name: | MAlb Test Cassette T Use By Fiatest Fluorescence Immunoassay Analyzer With CE |
| Format: | Cassette |
| Certificate: | CE |
| Pack: | 10T/25T |
| Shelf Life: | 2 Years |
| Linearity Range: | 5 ~ 300 Mg/L , R≥0.990 |
| Principle: | Fluorescence Immunoassay |
| Specimen: | Urine |
| Reading Time: | 15 Minutes |
| Storage Temperature: | 4-30℃ |
| Cut-Off: | 20mg/L |
A rapid test for measuring Microalbumin in Urine with the use of Fiatest TM fluorescence Immunoassay Analyzer. For professional in vitro diagnostic use only.
Application:
The Microalbumin Test Cassette (Urine) is based on Fluorescence Immunoassay to measure Microalbumin in Urine.
Description:
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 (besidesdamages 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.
How to use?
Refer to Fiatest TM 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 Fiatest TM Fluorescence Immunoassay Analyzer, Standard Test mode and Quick Test mode. Please refer to the user manual of Fiatest TM 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.
INTERPRETATION OF RESULTS
Results read by Fiatest TM Fluorescence Immunoassay Analyzer.
The result of tests for Microalbumin is calculated by FluroLitTM Fluorescence Immunoassay
Analyzer and display the result on the screen. For additional information, please refer to the usermanual of Fiatest TM Fluorescence Immunoassay Analyzer.
Linearity range of FluroLitTM Microalbumin Test is 5~300 mg/L.
Reference range:＜20 mg/L
| Catalogue Number | Item Name | Sample | Test Range | KIT size |
| FI-ALB-102 | mAlb Test Cassette | Urine | 5-300mg/L | 10T/25T
|
