Diagnostic Kit for Urine microalbumin

(Fluorescence Immunochromatographic Assay)

For in vitro diagnostic use only

Please read this package insert carefully prior to use and strictly follow the instructions. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert.

INTENDED USE

Diagnostic Kit for Urine microalbumin (Fluorescence Immunochromatographic Assay) is suitable for the quantitative detection of microalbumin in human urine by fluorescence immunochromatographic assay, which is mainly used for the auxiliary diagnosis of kidney disease.All positive sample must be confirmed by other methodologies. This test is intended for healthcare professional use only.

SUMMARY

Microalbumin is a normal protein found in the blood and is extremely rare in urine when metabolized normally. If there’s a trace amount in the urine Albumin in more than 20 micron /mL, belongs to urinary microalbumin, if can be timely treatment, can completely repair the glomeruli, eliminate proteinuria, if not timely treatment, may enter the uremia phase.The increase of urinary microalbumin is mainly seen in diabetic nephropathy, hypertension and preeclampsia in pregnancy. The condition can be accurately diagnosed by the value of urinary microalbumin, combined with the incidence, symptoms and medical history. Early detection of urinary microalbumin is very important to prevent and delay the development of diabetic nephropathy.

PRINCIPLE OF THE PROCEDURE

The membrane of the test device is coated with ALB antigen on the test region and goat anti rabbit IgG antibody on the control region. Marker pad are coated by fluorescence mark anti ALB antibody and rabbit IgG in advance. When testing sample, ALB in sample combine with fluorescence marked anti ALB antibody, and form immune mixture. Under the action of the immunochromatography, the complex flow in the direction of absorbent paper, when complex passed the test region, The free fluorescent marker will be combined with ALB on the membrane.The concentration of ALB is negative correlation for fluorescence signal, and the concentration of ALB in sample can be detected by fluorescence immunoassay assay.

REAGENTS AND MATERIALS SUPPLIED

25T package components：

Test card individually foil pouched with a desiccant 25T

Package insert 1

MATERIALS REQUIRED BUT NOT PROVIDED

Sample collection container,timer

SAMPLE COLLECTION AND STORAGE

1. The samples tested can be urine.
2. Fresh urine samples can be collected in a disposable clean container. It is recommended to test the urine samples immediately after collection. If the urine samples cannot be tested immediately, please store them at 2-8 ℃, but it is recommended not to store them for more than 12 hours. Do not shake the container. If there is sediment at the bottom of the container, take supernatant for testing.
3. All sample avoid freeze-thaw cycles.
4. Thaw samples to room temperature before use.