| 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 tool in the diagnosis of chronic kidney injury (CKI).
Storage and Expiry Date
Store 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 after this date.
Once opened, the strips in the cassette are valid for 30 days. Always close the cap tightly after use.
Specimen Collection
Collect urine according to standard laboratory procedures using 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 it to settle, and use the supernatant.
Specimens can be refrigerated at 2-8°C for up to 48 hours. For long-term storage, keep below -20°C and avoid repeated freeze-thaw cycles.
Before testing, bring refrigerated or frozen specimens to room temperature and ensure frozen samples are completely thawed.
Treat all specimens as potentially infectious. Wear disposable gloves and masks during handling to avoid contact.
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 in urine 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), avoiding bubbles. Start the timer.
Midstream: Dip the absorbent tip vertically into urine for 10-15 seconds, without submerging the plastic part. Remove and place on a non-absorbent flat surface.
Wait for colored lines to appear. Read results at 3-5 minutes. Do not interpret after 10 minutes.
Result Interpretation
Limitation
This test is for qualitative determination 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.
The test provides a preliminary result. Final diagnosis must be made by a physician based on comprehensive clinical and laboratory evaluation.
Precautions
For in vitro diagnostic use only. Single use.
Do not use if the foil pouch is damaged.
Perform the test within 15 minutes after opening to avoid moisture affecting results.
Avoid touching the NC membrane. Use a new sample container for each test to prevent cross-contamination.
Contaminated specimens or improper operation may yield inaccurate results.
Use before the expiry date on the pouch.
Dispose of all specimens, used products, and accessories as biohazard waste.
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