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The Value of Using Third Party Quality Control Products

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Trends of today

 “Third Parties”  Main business is control materials  Instrument manufacturers´  Main business is reagents

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Trends of today  Integration/consolidation!

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Integration of Quality Management

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Integration of Quality Management

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Integration of Quality Management

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Integration of Quality Management

• Chemistry LYPHOCHEK ASSAYED CHEMISTRY CONTROL LIQUID MULTIQUAL CONTROL • 80 ANALYTES !!

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Integration of Quality Management

• Immuno LYPHOCHEK LIQUICHEK

IMMUNOASSAY PLUS CONTROL IMMUNOASSAY PLUS CONTROL

• 100 + ANALYTES • 1100 + METHODS • 35 + INSTRUMENTS

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Bio-Rad provides over 230 controls

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Bio-Rad controls for over 500 analytes

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Bio-Rad inserts provide values for thousands of methods

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Regulatory  „Controls independent of those produced by the manufacturer of the test or analyser should be used. The laboratory must have a system of long-term monitoring of internal quality control results to assess method performance“

NATA (National Association of testing Authorities) AS 4663 (ISO 15189), Australia, 5,6,1, Internal Quality Control

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Bio-Rad Control Products  Chemistry (Serum, Urine)

 Hemoglobin

 Immunoassay

 Hematology

 Therapeutic Drug Monitoring

 Coagulation

 Cardiac Assessment

 Urinalysis

 Immunology/Serum Protein Testing

 Blood Gas  Infectious Disease  Autoimmune

 Drugs of Abuse

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Bio-Rad QC: discovering new oportunities virology controls

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VIROTROL Infectious Disease Controls

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Complete line of infectious disease controls



18 – 36 months shelf life



Liquid


Bio-Rad Serology/Virology Products

 Hepatitis & Retrovirus Controls Virotrol I : anti-HIV-1, anti –HTLV-I, anti-HCV, anti-CMV, anti HBc, HBsAg

Virotrol II : anti-HBs, anti-HAV

Virotrol III : anti- HAV, anti-HAV IgM, anti-HBc IgM, HBeAg

Virotrol IV : anti-HBe

Virotrol HIV-2 : anti-HIV-2

Viroclear : Negative Control Slide 16


Bio-Rad Serology/Virology Products



Congenital Diseases Controls

VirotrolToRCH : anti-Toxo IgG, a-Rubella IgG, a-CMV IgG, a-HSV-1 IgG, a-HSV-2 IgG

Virotrol ToRCH-M : a-Toxo IgG & IgM, a-Rubella IgG & IgM, a-CMV IgG & IgM, a-HSV-1 IgG, a-HSV-2 IgG

Viroclear ToRCH : Negative Control

Virotrol MuMZ : Mumps-IgG, Measles-IgG, VZV-IgG Slide 17


Bio-Rad Serology/Virology Products

 Other Diseases Controls Virotrol EBV : anti-VCA IgG, anti-VCA IgM, anti EBNA IgG

Viroclear EBV : Negative Control

Pyloritrol : anti-Helicobacter Pylori IgG

Syphilis Total : anti-Syphilis IgG, anti-Syphilis IgM, RPR

AmpliTRol CT/GC : NAT for Chlamidia & N.Gonorrhoeae Slide 18


Bio-Rad Quality Control Systems

Providing an up-to-date service for modern laboratories

ISO 15189; accreditation

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ISO 15189 Accreditation Requirements

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Must participate in an EQA program – For all analytes performed/required



Must have solution to establish acceptability for tests not available through an EQA program


UNITY Interlaboratory Program



Software for statistical evaluation of daily iQC



Can be used with independent Bio-Rad controls

Interlaboratory comparison of daily iQC results with „peer“ group daily or monthly

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UNITY Interlaboratory Program

How often would you like to be compared to the peer group – If you had a choice? …Ideally daily…. With Unity you can !

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BIOBIO-RAD LYPHOCHEK

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Second funcion of Unity – Interlaboratory Comparison Statistics displayed on www.QCNet.com

Calculation in UNITY Central Database in U.S.

Internal QC: Statistics and documentation

Sending QC data via internet Monthly /Daily Reports Slide 24


UNITY: Confidence in results ANALYTES TSH

10886

Free T3

873

T3 TOTAL

555

Free T4

6495

T4TOTAL

5619

TESTOSTERONE

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LAB. PARTICIPANTS

4957

PSA

8381

FSH

1383

LH

8657

HCG

6499

HGH

929


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UNITY QC DATA ANALYSIS

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Westgard Advisor

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Westgard Advisor™ 

Bio-Rad patented - technology for automatic SPC rules selection



Principle: – Automaticly chooses optimal Westagrd rules depending on  Lab results so far for given analyte  Tea selected by laboratory – Automatically applies those rules

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http://www.westgard.com

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Bio-Rad Westgard Advisor Program

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Conclusions

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www.qcnet.com

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