Snibe Maglumi 600 User Manual (English)

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059130729

-V2.3-EN 1/4

MAGLUMI Aldosterone (CLIA)

130206007M

100

Shenzhen New Industries

Biomedical Engineering Co., Ltd

4/F,Wearnes Tech Bldg,

Science & Industry Park,

Nanshan,Shenzhen,518057CHINA

Tel. + 86-755-86028224

Fax.+ 86-755-26654850

Lotus Global Co., Ltd

15 Alexandra Road

London

NW8 0DP

Tel. + 44-20-75868010

Fax.+ 44-20-79006187

FOR PROFESSIONAL USE ONLY

Store at 2-8 °C

COMPLETELY READ THE INSTRUCTIONS BEFORE

PROCEEDING

SYMBOLS EXPLANATIONS

Authorized Representative in the

European community

Manufacturer

Consult instructions for use

Contents of kit

In vitro diagnostic medical device

Batch code

Catalogue number

Use by

Temperature limitation

( store at 2-8 °C)

Sufficient for

Keep away from sunlight

Keep upright for storage

INTENDED USE

The kit has been designed for the quantitative determination of

Aldosterone (ALD) in human serum or plasma.

The method can be used for samples over the range of 5-1000

pg/ml.

The test has to be performed on the Fully-auto

chemiluminescence immunoassay (CLIA) analyzer MAGLUMI

(Including Maglumi 600,Maglumi 1000,Maglumi 1000 Plus,

Maglumi 2000,Maglumi 2000 Plus,Maglumi 3000 and Maglumi

4000).

SUMMARY AND EXPLANATION OF THE TEST

Aldosterone (ALD) is a steroid hormone produced by the adrenal

cortex, which controls salt and water balance in the kidney.

Abnormally high levels of this hormone cause sodium retention,

high blood pressure, heart rhythm irregularities and possibly

paralysis. Normally, aldosterone is mediated by renin-angiotensin

system. Moreover, sodium and potassium level, ACTH, adrenal

glands and dopamine also regulate the secretion of aldosterone.

Human blood aldosterone mainly bounds to plasma albumin,

seldom bounds to CBG. Therefore, aldosterone has a relatively

short half life (35min) and higher metabolized clearance. The

non-metabolized aldosterone in human urine accounts for 6% of

the secretion amount and contains hormone activity. The

determination of aldosterone in human plasma or urine is of great

value for diagnosis and identification of some disease.

PRINCIPLE OF THE TEST

Competitive immunoluminometric assay;

Use a purified ALD antigen to label FITC, and use an anti-ALD

monoclonal antibody to label ABEI. Sample, Calibrator or Control,

with ABEI Label, FITC Label, and magnetic microbeads coated

with anti-FITC are mixed thoroughly and incubated at 37℃,

forming antibody-antigen complexes; after sediment in a

magnetic field, decant the supernatant, then cycle washing for 1

time. Subsequently, the starter reagents are added and a flash

chemiluminescent reaction is initiated. The light signal is

measured by a photomultiplier as RLU within 3 seconds and is

proportional to the concentration of ALD present in samples.

KIT COMPONENTS

Material Supplies

Reagent Integral for 100 determinations

Nano magnetic microbeads: TRIS buffer,

1.2% (W/V), 0.2%NaN

, coated with sheep

anti- FITC polyclonal antibody.

2.5ml

Calibrator Low: bovine serum, 0.2%NaN

3.0ml

Calibrator High: bovine serum, 0.2%NaN

3.0ml

Displacing Reagent: bovine serum, 1%ANS

6.0ml

FITC Label: purified ALD antigen labeled

FITC, containing BSA, 0.2%NaN

6.5ml

ABEI Label: anti-ALD polyclonal antibody

labeled ABEI, containing BSA, 0.2%NaN

6.5ml

All reagents are provided ready-to-use.

Reagent Vials in kit box

Internal Quality Control: containing BSA,

0.2%NaN

. (target value refer to Quality

Control Information date sheet)

2.0ml

Internal quality control is only applicable with MAGLUMI system.

Instructions for use and target value refer to Quality Control

Information date sheet. User needs to judge results with their own

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Do you have a question about the Snibe Maglumi 600 and is the answer not in the manual?

Snibe Maglumi 600 Specifications

General

Model	Maglumi 600
Sample Types	Serum, Plasma, Whole Blood
Type	Chemiluminescence Immunoassay Analyzer
Weight	Approximately 150 kg
Power Supply	220V, 50/60Hz
Time to first result	Approximately 15 minutes
Assay Method	CLIA
Reagent Cooling	2-8°C
Sample Capacity	60 samples
Reagent Capacity	15 reagents on board
Detection Method	Photomultiplier Tube (PMT)
Throughput	180 tests/hour
Test Menu	Wide range of infectious diseases, tumor markers, thyroid function, hormones, cardiac markers, etc.