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bioMrieux Immunoassay Systems

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V ITEK I MMUNO D IAGNOSTIC A SSAY S YSTEM


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VIDAS - The Concept

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VIDAS - Disposables
1 SPR + 1 strip = 1 patient
SPR coated with antibodies or antigens, serving also as pipeting device strip containing all the ready-to-use reagents

UNIQUE and original unitary concept, avoiding any cross contamination.


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VIDAS STRIP : all information printed


1 2 3 4 5 S/N 6834 FRANCE
VIDAS

TOXO IgM

LOT 960307-0 EXP 7-MAR-96 bioMrieux 69200 Marcy l'Etoile


2-8C IN VITRO

TXM

CC59U277

SAMPLE I.D.

1 - alphanumeric barcode

2 - assay code

3 - lot number
4 - expired date of the reagent 5 - strip sequence number (production number)
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VIDAS : an easy loading

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VIDAS : a dynamic process

SPR

Strip

Time & delays Movements Volumes

depend on the PROTOCOL


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Example of a reaction

Washing buffers

Substrate

Diluent Sample (Pre-wash)

Conjugate

Photo diode

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Antigen detection : example of procedure


Cycled in and out

SPR
E E E
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Target organism
E

ECHANTILLON sample

TAMPON washing buffer DE LAVAGE

CONJUGUE conjugate

SUBSTRAT substrate
ENZYMATIC REACTION

IMMUNOLOGICAL REACTION

Principle for an antigen detection test


sandwich principle

4-methyl umbelliferyl phosphate

Bound Ab

Alkaline phosphataselabeled Ab

Ag to be detected
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VIDAS : reading in fluorescence

Filters
Lenses

Xenon Flash Lamp

Photodiode
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COMPETITION
Detection of haptens

4-methyl umbelliferyl phosphate


Bound Ab

Alkaline phosphataselabeled hapten Hapten to be detected


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ELISA INDIRECT
Serologies 4-methyl umbelliferyl phosphate Ab to be detected

Bound Ag

Alkaline phosphataselabeled Ab
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IMMUNOCAPTURE
Detection of specific IgM 4-methyl umbelliferyl phosphate

Ab to be detected Anti-IgM

alkaline phosphataselabeled Ab
Ag in liquid medium
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A memorized calibration

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Calibration (of quantitative tests)


1 - The Master Curve (reference curve) is performed by QC Lab
+ + + +
+ + +

6000

5000

R F V

4000

3000

2000

+ + + + + + + + ++
0

+ + + +

+ + + +

1000

+ + +
6

+ + + +

12

18

24

30

36

42

48

54

Concentration
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 AQ8TE5K J21QY3Y 6VO6HJ6 N65CHD JFK355 4 4G54 C


07714_A
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Strip lot : 030929-0 149, 635,2215,5061 7 48.2 mUI/ml 5.27 -7.37mUI/ml Assay : LH Standard RFV Values : Calibration method : Calibration (S1) Dose Value : Control C1 Dose Value Range : Calibrator (S1) RFV range :
1858 --3318 Max. CV % :10.0

1 - Results are summarized on a card

30406 VIDAS LH
bioMrieux sa 69280 Marcy l'Etoile France

MLE card description

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2 The MLE is to be read by VIDAS, to store the master curve

Assay : LH Standard RFV Values : Calibration method : Calibration (S1) Dose Value : Control C1 Dose Value Range : Calibrator (S1) RFV range :

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 AQ8TE5K J21QY3Y 6VO6HJ6 N65CHD JFK355 4 4G54 C


Strip lot : 030929-0 149, 635,2215,5061 7 48.2 mUI/ml 5.27 -7.37mUI/ml
1858 --3318 Max. CV % :10.0

07714_A

30406 VIDAS LH
bioMrieux sa 69280 Marcy l'Etoile France

The theoretical calibration curve is stored in memory


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3 The theoretical Curve needs to be readjusted with S1


3000 2500

R F V

2000 1500 1000 500 0 0

S1 reading

Validation 14 days

75

150

225

300
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IU / ml

Calibration When to perform what ?


New Lot of Reagent : 1. MLE card 2. Adjustment with S1 (or S2)

Every 14 Days : 1. Adjustment with S1 (or S2)

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THE CURRENT VIDAS MENU

Immunochemistry Infectious diseases Immunocoagulation Antigen detection Industry

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VIDAS : more than 90 parameters


Infectious diseases HIV : early screening and confirmation : HIV duo , Ag P24...
Hepatitis diagnosis : HAV IgM, Ag HBs, HBc IgM, anti HBs... Toxoplasmosis, Rubella , CMV...and confirmation with avidity Antigen detection : Chlamydia, clostridium difficile toxin A...

Immunochemistry
Fertility : hCG, Estradiol, FSH, LH, Prolactine, Progesteron, Testo.. Thyroid :TSH, T3, T4... Tumor markers : ACE, AFP, TPSA, CA... Allergy : IgE, Stallertest, Stallertroph, Stallergy

Immunocoagulation exclusion of deep venous thrombosis : D Dimer

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VIDAS and mini VIDAS : 2nd immunoassay system sold in the world

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