Other In Vitro Diagnostic Test
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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).
Mechanism：
MAU Rapid Test Kit utilizes colloidal gold labeling and immune chromatography based on the principle of competitive binding to detect of albumin in human urine. During testing, a urine specimen migrates upward by capillary action. Albumin, if present in the urine specimen at an insufficient concentration, will not saturate the binding sites of antibody coated particles in the test strip. The antibody coated particles will then be captured by immobilized albumin conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the albumin concentration is sufficient because it will saturate all the binding sites of anti- Albumin antibodies. So, a positive urine specimen will not generate a colored line in the test line region because of competition, while a negative urine specimen will generate a line in the test line region.
To serve as an internal procedural control, the control line region (C) is coated with polyclonal Goat Anti-Chicken lgY antibody which will always conjugate binds to Chicken IgY-colloidal gold, so a colored line will always appear in the control line region(C). It is indicated that proper volume of specimen has been added, membrane wicking has occurred and procedural technique is corrected.
Test Procedure
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.
Interpretation of results
1
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.
2
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.
3
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.
Introduction of Singclean Neutrophil Gelatinase-Associated Lipocalin (NGAL) Rapid Test Kit (Colloidal Gold)
Singclean Neutrophil Gelatinase-Associated Lipocalin (NGAL) Rapid Test Kit (Colloidal Gold) is intended for qualitative determination of NGAL levels in urine in vitro diagnostic. It is used as a supplementary method in the early diagnosis of acute kidney injury (AKI), as NGAL is an early and sensitive biomarker of AKI.
Mechanism：
NGAL Rapid Test Kit utilizes colloidal gold labeling and immune chromatography based on the principle of double-antibody sandwich method to selectively detect elevated levels of NGAL in urine. During testing, a urine specimen migrates upward by capillary action. For a positive, NGAL is captured by anti-NGAL antibody 2-colloidal gold particles, forming antigen-anti-NGAL antibody 2-colloidal gold particles complex, then this complex reacted with anti-NGAL antibody 1 immobilized on the test line region(T), forming anti-NGAL antibody 1-antigen-anti-NGAL antibody 2-colloidal gold particles complex, and produces a pink color band when NGAL concentration is equal to or greater than 20 ng/mL. For a negative, no colored line appears in the test line region(T).
To serve as an internal procedural control, the control line region (C) is coated with monoclonal antibody which will always conjugate binds to antibody 2-colloidal gold, so a colored line will always appear in the control line region(C). It is indicated that proper volume of specimen has been added, membrane wicking has occurred and procedural technique is corrected.
Test Procedure
1. Allow the test kit to reach room temperature before use. (20~ 30℃).
2. Remove the test kit from the foil pouch. The test kit should be used in 15 mins, and it should be tested as soon as possible especially at temperature higher than 30℃ or highly humid environment.
3. Strip: Put the test strip in the urine 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 a non-absorbent flat surface.
4. Wait for the colored line(s) to appear. Read the result at 12-15 minutes and then read the result. Don't read the result after 20 minutes.
1
Two colored lines are visible. One is located in the test line region (T), the other is in control line region (C). A positive result with the test indicates the NGAL in urine is more than cut off value.
2
One colored line appears in the control line region (C). No line appears in the test line region (T). A negative result with the test indicates the NGAL in urine is less than cut off value.
3
There is no colored 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.
The schematic for result interpretation is showed below. The result interpretation of midstream format is the same as the strip format.
Industry Information
What is Microalbuminuria?
When a patient has high blood pressure or diabetes or both (often at the same time), changes in the kidney's blood vessels alter the way the kidney filters proteins (especially albumin), which allow proteins to leak into the urine. Microalbuminuria is an early sign of diabetic nephropathy.
What is NGAL?
NGAL is the abbreviation of Neutrophil gelatinase-associated lipocalin, and NGAL is one of the lipid carrier proteins. Recent studies have found that NGAL is an early marker of acute kidney injury as well as an early marker of diabetic nephropathy. NGAL has many functions, including binding and transporting hydrophobic small molecules,
The production process of in vitro diagnostics
Interpoint Membrane
Class 100,000 Cleanroom
Carry out Sheet Scribing
For Colloidal Gold and Fluorescent Products
Gold Spray
Class 100,000 Cleanroom
Carry out Gold Label Spraying
For Colloidal Gold and Fluorescent Products
Inner Packing
Automatic Inner Packaging Machine
Strips Cutting
Precision Program Control
Pressure Plate
CCD Electronic Eye Detection
Bagging and Sealing
CCD Electronic Eye Detection
Outer Packing
Automatic Outer Packaging Machine
Folding Boxes and Packaging
Precise Packaging of Products
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