For In Vitro Diagnostic Use Microalbumin · 2018-07-27 · Microalbumin Turbidimetric Immunoassay...

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Microalbumin Turbidimetric Immunoassay • Extensive linear range (10-500 μg/mL) • No significant effects from common interferents • Simple, fast, ready to use reagents Because microalbuminuria may be reversible if diabetes is well controlled, its early detection may be very beneficial. However, microalbuminuria is not generally measurable by the simple test ordinarily used to detect proteinuria because it lacks sensitivity. For the detection of microalbuminuria, RIA, ELISA and nephelometry assay are used. However they have complicated procedures and are time consuming. Wako’s Microalbumin is a turbidimetric immunoassay using polyclonal antibodies against human albumin and allows accurate and reproducible measurement of microalbuminuria with a simple procedure. Catalog No. Product Name Pkg Size Storage 999-06001 * Autokit Micro Albumin Buffer 2 x 45 mL 2-10°C Antibody 1 x 15 mL 2-10°C 995-06101 * Autokit Micro Albumin Calibrator Set 5 conc x 2mL 2-10°C 991-06201 * Autokit Micro Albumin Control Set 2 x 2 conc x 2 mL 2-10°C * Product is available as a special purchase only. For In Vitro Diagnostic Use

Transcript of For In Vitro Diagnostic Use Microalbumin · 2018-07-27 · Microalbumin Turbidimetric Immunoassay...

Page 1: For In Vitro Diagnostic Use Microalbumin · 2018-07-27 · Microalbumin Turbidimetric Immunoassay • Extensive linear range (10-500 ˜g/mL) • No significant effects from common

MicroalbuminTurbidimetric Immunoassay

• Extensive linear range (10-500 μg/mL)

• No significant effects from common interferents

• Simple, fast, ready to use reagents

Because microalbuminuria may be reversible if diabetes is well controlled, its early

detection may be very beneficial. However, microalbuminuria is not generally measurable

by the simple test ordinarily used to detect proteinuria because it lacks sensitivity. For the

detection of microalbuminuria, RIA, ELISA and nephelometry assay are used. However

they have complicated procedures and are time consuming.

Wako’s Microalbumin is a turbidimetric immunoassay using polyclonal antibodies against

human albumin and allows accurate and reproducible measurement of microalbuminuria

with a simple procedure.

Catalog No. Product Name Pkg Size Storage

999-06001* Autokit Micro Albumin

Buffer 2 x 45 mL 2-10°C

Antibody 1 x 15 mL 2-10°C

995-06101* Autokit Micro Albumin Calibrator Set 5 conc x 2mL 2-10°C

991-06201* Autokit Micro Albumin Control Set 2 x 2 conc x 2 mL 2-10°C

* Product is available as a special purchase only.

For In Vitro Diagnostic Use

Page 2: For In Vitro Diagnostic Use Microalbumin · 2018-07-27 · Microalbumin Turbidimetric Immunoassay • Extensive linear range (10-500 ˜g/mL) • No significant effects from common

Performance characteristics

Principle

When a sample is mixed with the antibody solution in the buffer, albumin in the sample combines specifically with the anti-human albumin antibody to yield immune complexes resulting in increased turbidity. Since the degree of turbidity is proportional to the amount of albumin in the sample, the amount of albumin can be determined by measuring the turbidity.

Prozone Phenomenon

Correlation:

For additional information, please contact customer service at:Email: wakodx-customerservice@fuji�lm.comPhone: 877-714-1924

© 2018 FUJIFILM Wako Diagnostics U.S.A. Corporation

WLS-1952-3

InstrumentsVarious automated analyzer applications are available.

Accuracy

The accuracy of this method was demonstrated by a recovery study.

Prozone phenomenon not observed up to 10000 μg/mL

No. Expected value (μg/mL)

Obtained value (μg/mL)

Recovery (%)

1 33.1 32.6 98.4

2 58.1 56.9 97.8

3 118.1 117.6 99.6

PrecisionWithin-run precision

Sample # Replicates Mean (μg/mL) SD CV (%)

1 21 4.97 0.09 1.81

2 21 105.81 0.79 0.75

3 21 510.84 3.91 0.77

Total precisionNumber of assay days

Mean (μg/mL) SD CV (%) SWT ST

21 4.90 0.14 2.86 0.23 0.23

21 511.21 7.68 1.50 7.65 9.78

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y = 1.0179x - 0.9619r = 0.9992

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Micro Albumin expected conc., μg/mL

1025 Terra Bella Ave. Mountain View, CA 94043www.wakodiagnostics.com