| 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 a qualitative in vitro diagnostic device for the detection of albumin in urine. It is intended to be used as an auxiliary tool in the diagnosis of chronic kidney injury (CKI).
Composition
Each kit contains individually packaged test strips, cassettes, or midstream devices. Key components include:
MAU antigen and anti-MAU antibody
Goat Anti-Chicken IgY and Chicken IgY
Chloroauric acid and NC membrane
Dropper (for cassette type)
Standard color card
Storage and Expiry
Store at 4-30°C in a cool, dry place away from light. Do not freeze.
Refer to the packaging for the expiry date. Do not use expired products.
Once opened, strips stored in the container are valid for 30 days. Ensure the cap is tightly closed after each use.
Specimen Collection
Collect urine in a clean, dry, disposable plastic or glass container without preservatives.
Avoid excessive fluid intake within 2 hours prior to collection.
If sediment is present, centrifuge, filter, or allow it to settle before testing.
If testing cannot be performed immediately, refrigerate the sample at 2-8°C for up to 48 hours. For longer storage, freeze at -20°C and avoid repeated freeze-thaw cycles.
Bring refrigerated or frozen specimens to room temperature before testing.
Wear protective gloves and a mask when handling specimens to avoid potential biohazards.
Test Procedure
Read all instructions carefully before starting. Allow the test kit to reach room temperature (20-30°C).
Remove the test device from the foil pouch. Use immediately after opening, especially in humid or hot conditions.
Apply the specimen as follows:
Strip: Immerse into urine up to the max line for 10-15 seconds. Place on a flat, non-absorbent surface.
Cassette: Add 2 drops (~80 µL) of urine into the sample well (S) using the provided dropper. Avoid air bubbles.
Midstream: Immerse the absorbent tip in urine for 10-15 seconds. Do not submerge beyond the plastic handle.
Read results at 3-5 minutes. Do not interpret after 10 minutes.
Result Interpretation
A negative result indicates albumin levels are below the cutoff.
A positive result (even a faint T line similar to G3-G4 on the standard color card) indicates albumin is at or above the cutoff.
Invalid results may be due to improper procedure or product damage. Repeat with a new device. If the issue persists, discontinue use and contact the local supplier.
| Result | Appearance | Interpretation |
| Negative (-) | Two red lines (C & T) | Albumin < cutoff value |
| Positive (+) | One line at C, no T line | Albumin > cutoff value |
| Weak Positive | Faint T line with C line | Albumin near cutoff value |
| Invalid | No C line | Test error or damaged kit |
Limitation
This kit 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.
Interpret results within 3-5 minutes. Do not read after 10 minutes.
Results are preliminary. Final diagnosis should be made by a physician based on comprehensive clinical evaluation.
Precautions
For single-use in vitro diagnostics only.
Do not use if the foil pouch is damaged.
Perform the test within 15 minutes after opening.
Avoid touching the NC membrane. Use a new container for each specimen.
Contaminated samples (e.g., with bleach or alum) may yield false results.
Use only before the expiry date.
Dispose of all used products and specimens as biohazardous waste.
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