MAU FIA Test

The Microalbumin Fluorescence ImmunoAssay (FIA) Test is a lateral flow chromatographic immunofluorescent assay for the quantitative detection of MicroAlbumin in human Urine (MAU), using the RaFIA system. This test is intended for in vitro diagnostic use only.
A urine microalbumin test is a test to detect very small levels of a blood protein (albumin) in urine. In healthy individuals, the kidney filters waste from the blood and retain healthy components, such as albumin. However, microalbumin may be detected in the urine in the early stages of kidney disease. This is frequently seen in chronic diseases, such as diabetes or high blood pressure. Kidney damage can cause proteins to leak through your kidneys and exit your body in your urine. MicroAlbumin in Urine (MAU) is one of the first clinically identifiable markers for risk of kidney damage. Identifying kidney disease at an early stage can help prevent serious complications.
The MAU FIA Test was developed to detect microalbumin in human urine within 10 minutes, without the use of cumbersome laboratory equipment, and requiring minimally trained laboratory personnel.

  • Quantitative, non-subjective results
  • Increased sensitivity and broader detection range compared to rapid tests

RANGES:

  • Working range: 2.0-300.0 mg/L

PRECISION:

  • Intra-lot Precision: Intra-lot precision was determined by testing of MAU reference materials using 10 test devices from the same lot. CV ≤ 15%.
  • Inter-lot Precision: Inter-lot precision was determined by testing of MAU reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.

ACCURACY:

  • MAU control materials with three different concentrations were tested by every lot of test device, and the deviations were within ±15%.

LINEARITY:

  • A serial concentration of MAU reference materials at 2.0-300.0 mg/L was tested, and the correlation coefficient (R) is ≥0.9900.

REAGENTS AND MATERIALS PROVIDED:

  1. Individually sealed foil pouches containing:
    a. One test device
    b. One desiccant
  2. Detection buffer tubes
  3. SD card
  4. Instructions for Use

MATERIALS REQUIRED BUT NOT PROVIDED:

  1. Clock or timer
  2. RaFIA Immunofluorescence Analyzer
  3. RaFIA Immunofluorescence Incubator

Instructions for use

 

Catalog #

Product

Quantity

Specimen

F2020Mau FIA Test25/kitUrine

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Materials required but not provided:

Catalog #

Product

FIA-100Immunofluorescence Analyzer

Catalog #

Product

FIA-101Immunofluorescence Incubator

To learn about distribution opportunities or for additional product information, please contact info@ctkbiotech.com

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