CE

Instruction for use

For professional in vitro diagnostic use only.

Please read all the information in this lFU before performing the test.

【Product Name】

Neutrophil Gelatinase-Associated Lipocalin (NGAL) Rapid Test Kit (Colloidal Gold)

【Pack Formats and Size】

Strip: 1 pc/box, 25 pcs/cask, 100 pcs /box

Cassette: 1 pc/box, 5 pcs/box, 50 pcs/box

Midstream: 1 pc/box, 20 pcs/box

【Intended Use】

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.

【Background】

NGAL (neutrophil gelatinase-associated lipocalin, lipocalin-2,siderocalin) is a small protein expressed in neutrophils and certain epithelia, including the renal tubules. Under normal conditions NGAL levels are low in urine and plasma, but rise sharply

from basal levels in response to AKl to reach diagnostic levels within 2-4h, making NGAL an early and sensitive biomarker of acute kidney injury.

【Principle】

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.

【Composition】

Individually packed / Strip / Cassette / Midstream   The main component of the test included anti- antibody 1, anti-NGAL antibody 2, Goat Anti-Chicken lgY, Chicken lgY, Chloroauric acid, NC membrane.

Dropper(for test cassette)

Instructions for use

【Materials Required but Not Provided】

Timer, Single use specimen collection container

【Storage and Expiry Date】

· Store the Kit at 4~30℃, 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 device packaged in a cask after opened. And close the cap after used, keep the cap tightly.

【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.

· If there is no time to test, urine specimen can be refrigerated in 2~8°℃ 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. 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.

【Result Interpretation】

Positive (+)：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.

Negative (-)：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.

Invalid：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.

【Limitations】

1.The test is only used for qualitative determination of NGAL in urine. A positive result with the test indicates the NGAL concentration in urine is more than 20ng/mL, and does not necessarily indicate kidney injury as a single clinical sign.

2. Only use for in vitro diagnostic, and cannot reuse.

3.Please read the result in time, may cause an incorrect result after 20 minutes.

Latest version 8.28.04.006 A1 Issued Date:2020.11.04