Snibe Maglumi 600 Manual

MAGLUMI Aldosterone (CLIA)
130206007M
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
FOR PROFESSIONAL USE ONLY
Store at 2-8 ° C
COMPLETELY READ THE INSTRUCTIONS BEFORE
PROCEEDING
SYMBOLS EXPLANATIONS
Authorized
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
059130729-V2.3-EN
100
Lotus Global Co., Ltd
15 Alexandra Road
London
UK
NW8 0DP
Tel. + 44-20-75868010
Fax.+ 44-20-79006187
Representative in the

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
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
3
anti- FITC polyclonal antibody.
Calibrator Low: bovine serum, 0.2%NaN
Calibrator High: bovine serum, 0.2%NaN
Displacing Reagent: bovine serum, 1%ANS
FITC Label: purified ALD antigen labeled
FITC, containing BSA, 0.2%NaN
ABEI Label: anti-ALD polyclonal antibody
labeled ABEI, containing BSA, 0.2%NaN
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
3
Control Information date sheet)
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
performed on the Fully-auto
2.5ml
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3.0ml
3
3.0ml
3
6.0ml
6.5ml
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3
6.5ml
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3
2.0ml
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