Accu-Tell^® Microalbumin Rapid Test Cassette (Urine)

Product Description

CATALOG

KEY POINTS

Detection for: microalbuminuria (MAU) in urine

Reading time: 5-10 minutes

Accuracy: >98% agreement

Sensitivity: 20mg/L

INTRODUCTION

The steady expulsion of small quantities of albumin with the urine can be the first sign of kidney damage. In the healthy kidney albumin is usually glomerular filtrated and tubular reabsorbed, so that it is hardly detectable in urine.

With a damaged kidney this process is disordered. The expulsion of albumin in the range of 20 - 200 mg/L is characterized as microalbuminuria.

INTENDED USE

ACCU-TELL^® Microalbumin Cassette (Urine) is a simple，One-Step immunochromatographic assay for the rapid detection of microalbuminuria (MAU) in urine.

This product is used to obtain visual semi- quantitative result and is intended for professional in vitro use. This assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result.

TEST PROCEDURE

If stored refrigerated, ensure that the pouched device ,and specimen is brought to room temperature（about 20 minutes） before use. Do not open the pouch until you are ready to perform the test.

1.Open the aluminum foil bag and take out the test reagent.

2.Use plastic dropper to drop gradually 2 drops of samples (60～80μL）into the sampling window, and start timing.

3.When start timing, result should be observed within 5-10 minutes. Result after 10minutes is invalid.

PERFORMANCE CHARACTERISTICS

Accuracy：

The accuracy of ACCU-TELL^® Microalbumin Cassette (Urine) was evaluated in comparison to a commercially available immunoassay at a cut-off of 20 g/mL. 250 urine samples, collected from volunteers, have been tested by both procedures with >98% agreement.

Sensitivity:

Use  human  albumin  comparative  tests  for  detection.  Sensitivity of the test Cassette is 20mg/L.

Specificity:

Results of 100mg/L human albumin and human IgG samples should be negative.

Interference：

Potentially interference of common medications and various human proteins, and other substances that are likely to be present in urine was studied. All substances were spiked into negative and positive controls and tested with Urine Microalbumin Test Cassette. No interference was observed at substance concentrations listed below:

Acetaminophen 20mg/l, Acetylsalicylic acid 20mg/l, Ascorbic acid 20mg/l,Atropine 20mg/l, Caffeine 20mg/l,Glucose 2mg/l, Hemoglobin 500mg/l,vitamin C 20mg/l.

LIMITATIONS

1.The assay is designed for use with human urine only.  Other fluids have not been evaluated.

2.The test only provides a primary analysis result. If necessary, the  second  analysis method should be used for result determination.

3.Positive  result  only  means  that  the  albumin  exists  in  urine  samples,  but it cannot reports course of diabetes and other diseases.

4.There is a possibility that technical or procedural errors may interfere with the test and cause false results. If questionable results are obtained or abnormal level of MAU is suspected, the test should be repeated using a fresh urine specimen..

5.Several clinical conditions, such as urinary tract infection, acute febrile illnesses, and heart failure, may transiently increase urinary albumin excretion. Screening of MAU should be postponed in these situations.

6.Same as all the test reagents, final result must be determined by  clinical  doctors with clinical symptoms.

Note: The above information is for reference use only. Please refer to the product insert provided with the products before use.