| 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
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 component of the test included MAU antigen, anti-MAU antibody, Goat Anti-Chicken lgY, Chicken lgY, Chloroauric acid, NC membrane.
Dropper(for test cassette)
Introductions for use
Standard Color Card,
Storage and Expiry Date
·Store the Kit at 4~30°ºC, keep in a cool and dry place, protected from light. Do not freeze.
·See the package with expiry date. Do not use it after the expiry date.
· It is valid for 30 days for the strips packaged in a cask after opened. And close the cap after used, keep the cap tightly Use
Specimen Collection
·Collect urine specimen according to the conventional laboratory procedures.
·Collect urine specimen by a disposable plastic or glass container which is clean, dry and 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 result.
·lf there is sediment at the bottom of the container, please centrifuge, filter, or precipitation and use the supernatant.
·lf there is no time to test, urine specimen can be refrigerated in 2 ~ 8°C for 48 hours. For long term storage, specimens should be kept below -20°C, avoid repeated freezing and thawing of specimens.
·Before testing, refrigerated specimen should be reach to the room temperature, and frozen specimen should be completely.
·All the specimens may be infectious agent or have potentially biological hazard, when collecting or using someone's urine, should pay attention to wear disposable gloves and masks to prevent contacting 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 temperature higher than 30°C
or highly humid environment.
3.strip: Put the test strip in the urine sample at the direction of arrow till the max line at least 10-15 seconds. Do not pass 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 anon-absorbent flat surface.
4. Wait for the colored line(s) to appear. Read the result at 3-5 minutes and then read the resut. 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), the other is in control line region(C).A negative result with the test indicates the albumin in urine is less then 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 urine is more then cut off value.
It should be considered positive even there is a faint line in T line region, like G3-G4 showed in the Standard Color Card bellow. It indicates the concentration of albumin present in the urine is around the cut off value.
Invalid
There is no red line in 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 product immediately and contact with local suppliers.
Limitation
1.The test is only used for qualitative determination of albumin in urine. A positive result with the test indicates the albumin concentration in urine is more than 20mgL, and does not necessarily indicate kidney injury.
2.Only use for in vitro diagnostic, and cannot reused.
3.Please read the result in time, don't read the result after 10 minutes.
4.The test kit provides a presumptive diagnosis. A conformed diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.
Precautions
1.Only use for in vitro diagnostic, and cannot reused.
2.Do not use if the ponch is damaged, avoiding influence the test results of judgment.
3.Please test in 15 minutes after unpacking to avoid paper get damp and influence 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 new sample container
5.Contaminated urine specimen (e.g. containing bleach or alum) or improper operation cause incorrect results
6.Use the product before expiry date printed in foil pouch.
7.Handle all specimens, used products, packages and droppers as biological activity waste, please do not arbitrarily discard.
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