NewScen Coast Bio-Pharmaceutical Co., Ltd

INTENDED USE
This mAlb Quantitative Test Cassette is intended for use in the detection of microalbumin in human urine, at a cutoff concentration of 10 mg/L. It is for health care professional use only. 

PRINCIPLE OF THE PROCEDURE
The mAlb Quantitative Test is a chromatographic immunoassay (CIA) for the detection of antigens to mAlb in human urine. mAlb antibody are precoated onto membrane as a capture reagent on the test region. During the test, specimen is allowed to react with the colloidal gold particles, which have been labeled with mAlb antibodies. Antigen to mAlb, if present, absence of red colored band will develop on the membrane in proportion to the amount of mAlb antigens presented in the specimen. A red colored band in the test region suggests a negative result.To serve as a procedural control, red colored band in the control region will always appear regardless the presence of antigens to mAlb.

STORAGE
The kits should be stored at temperature 4-30°C, the sealed pouch for the duration of the shelf life (24months).

ASSAY PROCEDURE
1.Collect urine specimen with a clean dry container either plastic or class.
2.Remove the test cassette from pouch by tearing.
3.Carefully apply 70ul of urine sample into the S well.
4.Read the result in to 5 -10 minutes following the reader.

INTERPRETATION OF RESULTS
 

 
Result: If the test result shows < 20 mg/L, that means normal; If the test result shows 20-200mg/L, means some microalbumin in the urine, higher value means more serious. And test again after one week, if the test result shows 20-200mg/L in several test, can be diagnosed to microalbumin; If the test result shows > 200 mg/L, If the test result shows>200mg/L, it may be proteinuria, and it need other methods for further testing.
Invalid: If no band appears in the control region(C), regardless of the presence or absence of band in the test region (T). It indicates a possible error in performing the test. The test should be repeated using a new device.