| Customization: | Available |
|---|---|
| Type: | IVD Reagent |
| Transport Package: | Carton or Customized Package |
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Intended Use
The Microalbuminuria (MAU) Rapid Test Kit (Colloidal Gold) is an in vitro diagnostic device for the qualitative determination of albumin levels in human urine. It serves as an auxiliary aid in the diagnosis of chronic kidney injury (CKI).
Composition
Main Test Components: Individually packaged test Strip, Cassette, or Midstream device. Key components include MAU antigen, anti-MAU antibody, Goat Anti-Chicken IgY, Chicken IgY, Chloroauric acid, and NC membrane.
Accessory: Dropper (for use with test cassette).
Other Contents: Instructions for Use (IFU), Standard Color Card.
Storage and Expiry Date
Store the kit at 4-30°C in a cool, dry place, protected from light. Do not freeze.
The expiry date is printed on the package. Do not use the product after this date.
Once the vial containing test strips is opened, the strips are valid for 30 days. Ensure the cap is tightly closed after each use.
Specimen Collection
Collect urine specimens using conventional laboratory procedures into a clean, dry, disposable plastic or glass container without preservatives.
Avoid excessive fluid intake for 2 hours prior to collection to prevent inaccurate results.
If sediment is present, centrifuge, filter, or allow it to settle, and use the supernatant.
If not tested immediately, specimens can be refrigerated (2-8°C) for up to 48 hours. For long-term storage, freeze below -20°C and avoid repeated freeze-thaw cycles.
Before testing, bring refrigerated specimens to room temperature and ensure frozen specimens are completely thawed.
Treat all specimens as potentially infectious. Wear disposable gloves and masks during handling to avoid contact.
Procedure
Testing
Read all instructions before starting. Bring the test kit and specimen to room temperature (20-30°C).
Remove the test device from the foil pouch immediately before use. Use it promptly, especially in environments with high temperature (>30°C) or humidity.
For Strip: Immerse the strip vertically into the urine sample up to the MAX line for 10-15 seconds. Remove, and place it on a clean, non-absorbent, flat surface.
For Cassette: Place the cassette on a clean, level surface. Use the dropper to transfer 2 full drops (approx. 80 μL) of urine into the specimen well (S). Start the timer. Avoid air bubbles.
For Midstream: Dip the absorbent tip vertically into the urine for 10-15 seconds, without submerging the plastic body. Remove and place on a clean, non-absorbent, flat surface.
Wait for colored line(s) to appear. Read the results between 3 and 5 minutes. Do not interpret results after 10 minutes.
Pack Fomats
| Strip | 1test/box, 2tests/box, 5tests/box, 20tests/box,100tests/box |
| Cassette | 1test/box, 2tests/box, 5tests/box, 20tests/box,50tests/box |
| Midstream | 1test/box, 2tests/box, 5tests/box,10tests/box, 20tests/box |
Result Interpretation
Negative (-)
Two red lines are visible. One is located in the test line region (T), and the other is in the control line region(C). A negative result with the test indicates the albumin in the urine is less than the cut-off value.
Positive (+)
One colored line appears in the control line region (C). No line appears in the test line region (T). A positive result with the test indicates the albumin in the urine is more than then cut-off value.
It should be considered positive even if there is a faint line in the T line region, like G3-G4 shown in the Standard Color Card below. It indicates the concentration of albumin present in the urine is around the cut-off value.
Invalid
There is no red line in the control region (C). Incorrect operation or the product has been damaged are the most likely reasons. Please repeat the test with a new test. If the problem still exists, should stop using this batch of products immediately and contact local suppliers.
Precautions
For in vitro diagnostic use only. Do not reuse any component.
Do not use if the foil pouch is damaged.
Perform the test within 15 minutes of removing the device from the pouch to avoid moisture absorption affecting results.
Do not touch the nitrocellulose (NC) membrane. Use a new sample container for each test to prevent cross-contamination.
Contaminated specimens (e.g., containing bleach or alum) or improper operation may yield incorrect results.
Use the product before the expiry date.
Dispose of all specimens, used products, and packaging as biohazardous waste according to local regulations. Do not discard indiscriminately.
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