EQASs for TTI Diagnostics
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H. Zeichhardt 1,3 , V. Lindig 1,2 and H.-P. Grunert 1,2,3 PowerPoint PPT Presentation


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EQASs for TTI Diagnostics as Tool for Elucidating and Solving Problems of Commercial and In-house Tests. H. Zeichhardt 1,3 , V. Lindig 1,2 and H.-P. Grunert 1,2,3 1 CharitéCentrum für diagnostische und präventive Labormedizin, Institut für Virologie, Campus Benjamin Franklin, Berlin

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H. Zeichhardt 1,3 , V. Lindig 1,2 and H.-P. Grunert 1,2,3

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H zeichhardt 1 3 v lindig 1 2 and h p grunert 1 2 3

EQASs for TTI Diagnosticsas Tool for Elucidating and Solving Problemsof Commercial and In-house Tests

H. Zeichhardt1,3, V. Lindig1,2 and H.-P. Grunert1,2,3

1CharitéCentrum für diagnostische und präventive Labormedizin,

Institut für Virologie, Campus Benjamin Franklin, Berlin

2Institut für Biotechnologische Diagnostik (GBD), Berlin

3INSTAND e.V., Düsseldorf

Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien

Collaborating Centers of

International Consortium for Blood Safety (ICBS), New York

Koch-Metchnikov-Forum of the Petersburg Dialogue


National and who international eqass in immunology virology

Serology

PCR/NAT

HIV-1/2

Cytomegalovirus

HIV-1 (RNA)

HPV

HIV-1 p24 Ag

Epstein-Barr Virus

Hepatitis B Virus

Enteroviruses

Hepatitis A Virus

Varicella Zoster V.

Hepatitis C Virus

Enterov. (WHO/RKI)

Hepatitis B V. Prg. I

Herpes simplex V.

HCV Genotyping

Adenoviruses

Hepatitis B V. Prg. II

Measlesvirus

Cytomegalovirus

Hepatitis C Virus

Mumpsvirus

Varicella Zoster V.

Hepatitis D Virus

Resp. Sync. V. Ag

Herpes simpl. V. 1

Hepatitis E Virus

Influenzav. A/H5N1/B Ag

Herpes simpl. V. 2

Rubellavirus

TBE Virus

Influenzav. A/H5N1/B

Parvovirus B19

BSE (PrPsc)

Parvovirus B19

National and WHO International EQASsin Immunology/Virology

Samples total: > 702.000 (since 1988)


H zeichhardt 1 3 v lindig 1 2 and h p grunert 1 2 3

Partnership for National andInternational Quality Control Systems in Virus Diagnostics and Safety Testing of Blood

  • CharitéCentrum für diagnostische und präventive LabormedizinCampus Benjamin Franklin, Institut für Virologie, Berlin

  • Institute for Standardization and Documentation in Medical Laboratories (INSTAND), Düsseldorf

    WHO Collaborating Center for Quality Assurance and Standardization in Laboratory Medicine

  • Institut für Biotechnologische Diagnostik der GBD, Berlin

  • German Medical Association (Bundesärztekammer)

  • German Association against Virus Diseases (DVV)

  • Society of Virology (GfV)

  • Paul Ehrlich Institute

  • Robert Koch Institute

  • National and International Reference Institutes

  • Friedrich-Loeffler-Institute

  • World Health Organization, Geneva and Lyon

  • International Consortium for Blood Safety (ICBS), New York

Diagnostic Council

of DVV and GfV


Instand eqas reference laboratories

INSTAND EQAS - Reference Laboratories

  • Prof. Braun / Prof. Enders, Stuttgart

  • Prof. Doerr / Prof. Rabenau / Dr. Berger, Frankfurt

  • Prof. Fleckenstein / Dr. Huber / Dr. Korn, Erlangen

  • Prof. Gerlich / Dr. Willems, Gießen

  • Prof. Gürtler, Greifswald

  • Dr. Heckler, Hannover

  • Dr. Heim, Hannover

  • Prof. Klenk / Prof. Radsak, Marburg

  • Prof. Krüger / Dr. Meisel / Dr. Hofmann, Berlin

  • Prof. Kurth / Prof. Pauli / Prof. Schreier / Dr. Mankertz / Dr. Schweiger / Dr. Tischer, RKI, Berlin

  • Prof. Liebert / Prof. Pustowoit, Leipzig

  • Prof. Löwer / Dr. Chudy / Dr. Nick / Dr. Nübling / Dr. Scheiblauer / Dr. Unger, PEI, Langen

  • Prof. Mettenleiter / Prof. Groschup / Dr. Buschmann / PD Dr. Harder / Dr. Ziegler, FLI, Greifswald - Insel Riems

  • Prof. Müller-Lantzsch / Dr. Gärtner, Homburg/Saar

  • Prof. Neumann-Haefelin / Dr. Huzly, Freiburg

  • Prof. Pfister / Dr. Wieland, Köln

  • Prof. Roggendorf / PD Dr. Ross / Dr. Fiedler, Essen

  • Dr. Vornwald, Berlin

  • Prof. Wutzler / Prof. Faber / Dr. Sauerbrei, Jena


Eqas for qualitative pcr nat hcv detection and solving of performance problems

EQAS for Qualitative PCR/NAT HCV Detection and solving of performance problems

Problems:

  • False negative results in inexperienced laboratories

    Consequences:

  • EQAS surplus samples for daily run controls and training


Eqas for hcv qualitative pcr nat 1

Date

Participants

Correct results

(for 4 samples)

July 1997

102

96-100%

November 1997

103

95-100%

April 1998

156

92-99%

New participants

November 1998

140

98-100%

April 1999

194

98-100%

November 1999

171

98-99%

April 2000

201

99-100%

November 2000

176

99-100%

April 2001

206

99%

November 2001

183

99-100%

April 2002

217

99-100%

EQAS for HCV: Qualitative PCR/NAT (1)


Eqas for hcv qualitative pcr nat 2

Date

Sample No.

Participants (P)

Correct results

Jul. 1997

1

102

98%(100/102)

4

101

95%(97/101)

Nov. 1997

6

103

95%(98/103)

7

103

96%(99/103)

Apr. 1998

12002

156

92%(143/156)

divided in

103 continuous P

94%(97/103)

53 new P

87%(46/53)

12004

156

94%(147/156)

divided in

103 continuous P

96%(99/103)

53 new P

91%(48/53)

EQAS for HCV: Qualitative PCR/NAT (2)

Results of new participants


H zeichhardt 1 3 v lindig 1 2 and h p grunert 1 2 3

EQAS for Quantitative PCR/NAT HIV and HCV Good lab performancewith robust test:Benefit of EQAS samples run in dublicate in one scheme


Quantitative pcr nat confidence interval median 0 5 log

Quantitative PCR/NAT Confidence Interval: Median +/- 0.5 log


Eqas for hiv 1 lab performance

EQAS for HIV-1: Lab Performance


Eqas for hiv 1 differentiation of methods

EQAS for HIV-1: Differentiation of Methods


Quantitative pcr nat confidence interval median 0 5 log1

Quantitative PCR/NAT Confidence Interval: Median +/- 0.5 log

* withoutresultsfor bDNA forsamples <200,000 copies/ml (Nov. 1999 - Nov. 2000)

& without results for bDNA for samples <3,000 copies/ml (Apr. 2004; Mrz. 2007)

without results for bDNA for samples <1,220 IU/ml (Apr. 2004; Mrz 2007)


H zeichhardt 1 3 v lindig 1 2 and h p grunert 1 2 3

EQAS for Quantitative PCR/NAT HBV Training with reliable tests:Benefit of identical EQAS samplesfor multiple testing


Improvement of lab performance by 2 years training

Improvement of Lab Performanceby 2 Years Training

EQAS Nov 04, Nov 05 and Mar 07, HBV PCR/NAT (361)

IU/ml

Copies/ml


Quantitative pcr nat confidence interval median 0 5 log2

Quantitative PCR/NAT Confidence Interval: Median +/- 0.5 log

# withoutresultsfor bDNA andhybridizationforsamples <1,000,000 copies/ml (Nov. 1999 - Apr. 2003)

$ without results for hybridization for samples <1,000,000 copies/ml (Nov. 2003 - Apr. 2004)

§ without results for bDNA for samples <500,000 IU/ml (Apr. 2002 - Apr. 2003)


Eqas for quantitative pcr nat cytomegalovirus performance of commercial and in house tests

EQAS for Quantitative PCR/NATCytomegalovirus  Performance ofcommercial and in-house tests


Eqas for cmv quantitative pcr nat

EQAS for CMV: Quantitative PCR/NAT


Eqas performance of commercial and in house tests

EQAS: Performance ofCommercial and In-house Tests


Global network for external quality control and training

Global Network for External Quality Control and Training


Contact

Contact

Hans-Peter Grunert

Heinz Zeichhardt

CharitéCentrum für diagnostische

und präventive Labormedizin

Institut für Virologie

Campus Benjamin Franklin

Hindenburgdamm 27

12203 Berlin

Tel.:+49-30-8445 3624 or 3625

Fax:+49-30-8445 3626

Email:[email protected]

[email protected]


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