| Customization: | Available |
|---|---|
| Type: | IVD Reagent |
| Certificate: | Ivdd |
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Microalbuminuria (MAU) Rapid Test Kit (Colloidal Gold)
For Self-testing Use
Intended Use
Microalbuminuria (MAU) Rapid Test Kit (Colloidal Gold) is an in vitro diagnostic device intended for the qualitative determination of albumin levels in urine. It serves as an auxiliary tool in the diagnosis of chronic kidney injury (CKI).
Pack fomats
Product superiority
Visual interpretation for convenient self-testing;
Non-invasive urine sample collection, easy to obtain;
High accuracy;
Suitable for continuous monitoring in individuals with underlying diseases.
Composition
Individually packed Strip/Cassette/Midstream
Main test components: MAU antigen, anti-MAU antibody, Goat Anti-Chicken lgY, Chicken lgY, Chloroauric acid, NC membrane
Dropper (for test cassette)
Instructions for use
Standard Color Card
Desiccant
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 are valid for 30 days if stored in the original container with the cap tightly closed after each use.
Specimen Collection
Collect urine samples according to standard laboratory protocols.
Use a clean, dry, preservative-free disposable plastic or glass container.
Avoid excessive liquid intake 2 hours before collection to prevent inaccurate results.
If sediment is present, centrifuge, filter, or allow it to settle; use only the clear supernatant.
Refrigerate at 2-8°C for up to 48 hours if testing is not immediate. 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 complete thawing.
Treat all specimens as potentially infectious. Wear disposable gloves and masks during handling.
Testing Procedure
Read the instructions thoroughly before use. Allow the test kit to reach room temperature (20-30°C).
Remove the test from the foil pouch and use immediately, especially in environments above 30°C or with high humidity.
Proceed based on kit type:
Strip: Immerse the strip into the urine sample up to the "MAX" line for 10-15 seconds. Remove and place on a flat, non-absorbent surface.
Cassette: Place the cassette on a clean, level surface. Add 2 full drops (approx. 80 µL) of urine into the specimen well (S) using the dropper. Start the timer immediately; avoid air bubbles.
Midstream: Dip the device vertically into the urine for 10-15 seconds without submerging the plastic handle. Remove and place on a flat, non-absorbent surface.
Result Interpretation
| Negative (-) | Two red lines appear (test line T and control line C). Indicates albumin level below the cut-off value. |
| Positive (+) | One line appears in the control region (C), and no line or a faint line in the test region (T). A faint line (e.g., as shown in G3-G4 of the Standard Color Card) indicates albumin concentration around or above the cut-off value. |
| Invalid | No line in the control region (C). Repeat with a new test. If the issue persists, discontinue use and contact the local supplier. |
Limitations
Qualitatively detects albumin in urine. A positive result indicates albumin >20 mg/L but does not confirm kidney damage.
For in vitro diagnostic use only. Do not reuse.
Read results within the specified time; do not interpret after 10 minutes.
Provides preliminary results only. A physician should make a definitive diagnosis using additional clinical and laboratory data.
Precautions
For in vitro diagnostic use only. Do not reuse.
Do not use if the pouch is damaged.
Perform the test within 15 minutes after opening to avoid moisture effects.
Avoid touching the NC membrane. Use a new specimen container for each test.
Contaminated samples or improper handling may yield inaccurate results.
Do not use beyond the expiration date.
Dispose of all used materials as biohazardous waste according to local regulations.
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