| Type: | IVD Reagent |
|---|---|
| Transport Package: | Carton or Customized Package |
| Specification: | 1pc/box; 25 pcs/box; 50 pcs/box; 100 pcs/box |
| Trademark: | Singclean or Customized brand |
| Origin: | China |
| Customization: |
|---|
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Intended Use
Microalbuminuria (MAU) Rapid Test Kit (Colloidal Gold) is intended for qualitative determination of albuminuria levels in urine in vitro diagnostic. It is used as a supplementary method in the diagnosis of chronic kidney injury(CKI).
Composition
Individually packed Strip/ Cassette/ Midstream
The main components of the test included MAU antigen, anti-MAU antibody, Goat Anti-Chicken lgY, Chicken lgY, Chloroauric acid, and NC membrane.
Dropper(for test cassette)
Introductions for use
Standard Color Card,
Specification
| High sensitivity | 20mg/L |
| Small sample size | two drops urine |
| Shelf life | 24 months |
Storage and Expiry Date
· Store the Kit at 4~30°ºC, and keep it in a cool and dry place, protected from light. Do not freeze.
· See the package with an expiry date. Do not use it after the expiry date.
· It is valid for 30 days for the strips packaged in a cask after opening. Close the cap after use, and keep the cap tightly Use
Specimen Collection
· Collect urine specimens according to the conventional laboratory procedures.
· Collect urine specimens in a disposable plastic or glass container that is clean, dry, and does not contain any preservatives.
· 2 hours before collecting the urine specimens, should not consume a large amount of liquid or drinks to prevent getting inaccurate results.
· if there is sediment at the bottom of the container, please centrifuge, filter, or precipitation and use the supernatant.
· if there is no time to test, urine specimens can be refrigerated at 2 ~ 8°C for 48 hours. For long-term storage, specimens should be kept below -20°C, to avoid repeated freezing and thawing of specimens.
· Before testing, refrigerated specimens should reach room temperature, and the frozen specimens should be complete.
· All the specimens may be infectious agents or have potential biological hazards, when collecting or using someone's urine, one should pay attention to wearing disposable gloves and masks to prevent contact with others' urine.
Procedure
Testing
1. Please read all the information in this IFU before performing the test. Allow the test kit to reach room temperature before use. (20~30°C).
2. Remove the test kit from the foil pouch. The test kit should be used as soon as possible, especially at temperatures higher than 30°C
or a highly humid environment.
3. Strip: Put the test strip in the urine sample in the direction of the arrow till the max line is at least 10-15 seconds. Do not pass the max line.
Take the strip out of the specimen and place it on a non-absorbent flat surface.
Cassette: Place the cassette on a clean and level surface. Hold the dropper vertically and transfer 2 full drops of urine (approx.80 μL) to the specimen well (S), and then start the timer. Avoid trapping air bubbles in the specimen well (S).
Midstream: Dip the midstream vertically in the urine specimen for at least 10-15 seconds. Do not pass the plastic part of the midstream when immersing the midstream. Take the midstream out of the specimen and place it on an anon-absorbent flat surface.
4. Wait for the colored line(s) to appear. Read the result for 3-5 minutes and then read the result. Don't read the result after 10 minutes.
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
1. Only used for in vitro diagnostic, and cannot reused.
2. Do not use it if the pouch is damaged, avoid influencing the test results of the judgment.
3. Please test in 15 minutes after unpacking to avoid the paper getting damp and influencing the test results.
4. To avoid the cross-contamination of samples, don't touch the nitrocellulose(NC) membrane on the product and each test should use a new sample container
5. Contaminated urine specimen (e.g. containing bleach or alum) or improper operation cause incorrect results
6. Use the product before the expiry date printed in a foil pouch.
7. Handle all specimens, used products, packages, and droppers as biological activity waste, please do not arbitrarily discard them.
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