| Customization: | Available |
|---|---|
| Type: | IVD Reagent |
| Transport Package: | Carton or Customized Package |
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Microalbuminuria (MAU) Rapid Test Kit (Colloidal Gold)
For Self-testing Use
Intended Use
The Microalbuminuria (MAU) Rapid Test Kit (Colloidal Gold) is intended for the qualitative determination of albumin levels in human urine, for in vitro diagnostic use only. It serves as an auxiliary method in the diagnosis of chronic kidney injury (CKI).
Pack Fomats
| Strip | 1 test/box, 2 tests/box, 5 tests/box, 20 tests/box, 100 tests/box |
| Cassette | 1 test/box, 2 tests/box, 5 tests/box, 20 tests/box, 50 tests/box |
| Midstream | 1 test/box, 2 tests/box, 5 tests/box, 10 tests/box, 20 tests/box |
Strip: 1 test/box, 2 tests/box, 5 tests/box, 20 tests/box, 100 tests/box
Cassette: 1 test/box, 2 tests/box, 5 tests/box, 20 tests/box, 50 tests/box
Midstream: 1 test/box, 2 tests/box, 5 tests/box, 10 tests/box, 20 tests/box
Composition
Each test is individually packaged and may be in the form of a Strip, Cassette, or Midstream device. Main components include: MAU antigen, anti-MAU antibody, Goat Anti-Chicken IgY, Chicken IgY, Chloroauric acid, and NC membrane.
A dropper is provided for the Cassette format.
Storage and Expiry Date
Store at 4-30°C in a cool, dry place, protected from light. Do not freeze.
Refer to the package for the expiry date. Do not use beyond this date.
Once opened, the strips in the container are valid for 30 days. Ensure the cap is tightly closed after each use.
Specimen Collection
Collect urine specimens using standard laboratory procedures.
Use a clean, dry, disposable plastic or glass container without preservatives.
Avoid excessive fluid intake 2 hours prior to collection to prevent inaccurate results.
If sediment is present, centrifuge, filter, or allow precipitation and use the supernatant.
Specimens can be refrigerated at 2-8°C for up to 48 hours. For longer storage, keep below -20°C and avoid repeated freeze-thaw cycles.
Bring refrigerated or frozen specimens to room temperature before testing.
Handle all specimens as potentially infectious. Wear disposable gloves and masks during collection and handling.
Procedure
Read all instructions before use. Allow the test kit to reach room temperature (20-30°C).
Remove the test device from the foil pouch. Use immediately, especially in environments with high temperature (>30°C) or humidity.
Strip: Immerse the strip into the urine sample along the arrow direction up to the MAX line for 10-15 seconds. Remove and place on a non-absorbent flat surface.
Cassette: Place the cassette on a clean, level surface. Using the dropper, add 2 full drops (approx. 80 µL) of urine into the specimen well (S). Avoid air bubbles. Start the timer immediately.
Midstream: Dip the absorbent tip vertically into the urine for 10-15 seconds. Do not immerse past the plastic handle. Remove and place on a non-absorbent flat surface.
Read results between 3-5 minutes. Do not interpret after 10 minutes.
Result Interpretation
Limitation
This test provides qualitative results only. A positive result (albumin >20 mg/L) does not confirm kidney injury.
For in vitro diagnostic use only. Do not reuse.
Read results within 10 minutes.
This test provides a preliminary diagnosis. Confirmatory evaluation must be conducted by a physician using all clinical and laboratory findings.
Precautions
For in vitro diagnostic use only. Single use only.
Do not use if the pouch is damaged.
Perform the test within 15 minutes after removal from the pouch to avoid moisture affecting results.
Avoid touching the NC membrane. Use a new container for each sample to prevent cross-contamination.
Contaminated specimens or improper operation may lead to inaccurate results.
Use before the expiry date printed on the pouch.
Dispose of all specimens, used products, and accessories as biohazardous waste.
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