Kamiya Biomedical Company - Clinical Diagnostics

Clinical Diagnostics - Immunoassay Reagents
For Use on Automated Chemistry Analyzers

Microalbumin

Cat. No.:

KAI-019 or KAI-057

Type:

Reagent

Method:

Immunoturbidimetric

Format:

Liquid

Linearity:

0.2 - 30.0 mg/dL

Sample:

Urine

KIT COMPOSITION

Cat. No. KAI-019 R1: 4 X 20 mL buffer R2: 2 X 10 mL antibody Tests / Kit: 200 (Hitachi 717) (Can Vary Based On Analyzer Model)		Click Image To Enlarge
Click here for an example package insert. Click here for the Safety Data Sheets (SDS): Reagent-1 (R-1) Reagent-2 (R-2) Click here for information about recommended calibrators and controls.

Cat. No. KAI-057 R1: 3 X 80 mL buffer R2: 1 X 80 mL antibody Tests / Kit: 800 (Hitachi 717) (Can Vary Based On Analyzer Model)		Click Image To Enlarge
Click here for an example package insert. Click here for the Safety Data Sheets (SDS): Reagent-1 (R-1) Reagent-2 (R-2) Click here for information about recommended calibrators and controls.

INTENDED USE

For the quantitative determination of human albumin in urine by immunoturbidimetric assay. Measurement of albumin in urine aids in the diagnosis of kidney dysfunction.
FOR IN VITRO DIAGNOSTIC USE.

REAGENT PREPARATION

The reagents are ready to use and do not require reconstitution.

STORAGE AND HANDLING

All reagents should be stored refrigerated (2-8°C). Return all reagents to 2-8°C promptly after use. Unopened reagents can be used for one year from the date of manufacture, as indicated by the expiration date on the package and bottle labels. Opened reagents can be used for one month if stored at 2-8°C.

PERFORMANCE

Precision
The within-run, between-run, and total precision for the K-ASSAY ® Microalbumin assay was determined using packaged reagents, human urine samples, and a Roche / Hitachi 917 analyzer in accordance with CLSI EP5-A2.

	Sample 1	Sample 2	Sample 3
N	80	80	80
Mean (mg/dL)	0.311	0.987	27.250

Within Run S.D.	0.019	0.021	0.126
Within Run C.V.	6.007 %	2.168 %	0.463 %

Between Runs S.D.	0.012	0.014	0.063
Between Runs C.V.	3.840 %	1.411 %	0.229 %

Total S.D.	0.021	0.024	0.166
Total C.V.	6.914 %	2.407 %	0.608 %

Accuracy / Correlation
Testing was performed on a Roche / Hitachi 917 analyzer using unaltered, natural human urine samples and in accordance with the CLSI EP9-A2 guideline. A comparison of the K-ASSAY ® Microalbumin and the Roche Tina-Quant Albumin assay was performed with the following results:

Linear Regression: y = 0.9155x + 0.0084
r = 0.9964
n = 93
x = Roche Tina-Quant Albumin
y = K-ASSAY ® Microalbumin

x	min	=	0.33 mg/dL	y	min	=	0.14 mg/dL
	max	=	33.04 mg/dL		max	=	30.24 mg/dL
	mean	=	6.778 mg/dL		mean	=	6.213 mg/dL

Assay Range

0.1 - 30.0 mg/dL

INTERFERENCE

Testing was performed on a Roche / Hitachi 917 analyzer in accordance with the CLSI EP7-A2 guideline with the following results.
Criteria: Recovery within ± 10% of initial value

Acetone :	No interference ≤ 350 mg/dL
Ascorbic Acid :	No interference ≤ 100 mg/dL
Bilirubin :	No interference ≤ 66 mg/dL
Calcium :	No interference ≤ 160 mg/dL
Creatinine :	No interference ≤ 500 mg/dL
Glucose :	No interference ≤ 2,000 mg/dL
Hemoglobin :	No interference ≤ 300 mg/dL
Urea :	No interference ≤ 4,200 mg/dL
Uric Acid :	No interference ≤ 70 mg/dL
Urobilinogen :	No interference ≤ 20 mg/dL

Bence-Jones Proteins
Kappa Light Chain :	No interference ≤ 30 mg/dL
Lambda Light Chain :	No interference ≤ 30 mg/dL

Administered Diuretics
Furosemide :	No interference ≤ 400 µg/mL
Trichlormethiazide :	No interference ≤ 20 µg/mL

Analgesic Medications
Acetaminophen :	No interference ≤ 0.2 mg/mL
Ibuprofen :	No interference ≤ 2.0 mg/mL

Oral Diabetes Medications
Gilbenclamide :	No interference ≤ 15 µg/mL
Metformin Hydrochloride :	No interference ≤ 4.0 µg/mL

Immunoassay Reagents for Chemistry Analyzers

Research ELISAs

Animal / Preclinical ELISAs

Antibodies

Biochemicals

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