INSTAND e.v. in cooperation with:
|
|
- Delphia Gregory
- 5 years ago
- Views:
Transcription
1 Pre-evaluation of the EQA Schemes in Virus Diagnostics June 2015 Corrected version: 10 August 2015 (See Table 3; program 346) INSTAND e.v. in cooperation with: Deutsche Vereinigung zur Bekämpfung der Viruskrankheiten (DVV) Gesellschaft für Virologie (GfV) Deutsche Gesellschaft für Hygiene und Mikrobiologie (DGHM) Prof. Dr. Heinz Zeichhardt Priv.-Doz. Dr. Oliver Donoso Mantke Issued by: INSTAND e.v. Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laborarien e.v. Düsseldorf/Berlin,
2 EQAS Adviser: Assistant EQAS Adviser: Prof. Dr. Heinz Zeichhardt Priv.-Doz. Dr. Oliver Donoso Mantke Charité - Universitätsmedizin Berlin c/o INSTAND e.v. Institut für Virologie, Campus Benjamin Franklin Ubierstr. 20, Düsseldorf Hindenburgdamm 27, Berlin Tel.: +49-(0) ; Fax: +49-(0) Tel.: +49-(0) ; Fax: +49-(0) donoso@instand-ev.de Heinz.Zeichhardt@charite.de Organisation and Logistics: INSTAND e.v. Ubierstr Düsseldorf Tel.: +49 (0) Fax: +49 (0) instand@instand-ev.de Internet: Pre-evaluation Virology June corr EN.doc 2 von 11
3 Dear colleagues, Pre-Evaluation and Mailing of Participation Documents INSTAND External Quality Assessment Schemes June 2015 Virus Immunology Virus Genome Detection by PCR/NAT You have participated in one or several of the INSTAND external quality assessment (EQA) schemes in diagnostics of June Today you receive the pre-evaluation. By mail, you receive the following participation documents of those EQA schemes in which you have participated this time and which are performed with a frequency of four times a year, i.e. also in September 2015 (see Table 1): certificate of successful participation statement of participation statement of individual results VIRUS IMMUNOLOGY: Cymegalo (351) Hepatitis A (343) Hepatitis B Prog. 1 (344) Hepatitis B Prog. 2 (345) Hepatitis C (346) HIV-1/HIV-2 (335) HIV-1 p24 Ag (337) Table 1: EQA schemes performed with a frequency of four times per year VIRUS GENOME DETECTION: Cymegalo (365) Hepatitis A (377) Hepatitis B (361) Hepatitis C (362) HIV-1 (360) Parvo B19 (367) Please note: The participation documents of those INSTAND EQA schemes in diagnostics performed twice a year or with lower frequency are mailed in due time before the next run of the corresponding EQA schemes (see Table 2). VIRUS IMMUNOLOGY: Table 2: EQA schemes performed twice per year or with lower frequency (EQA schemes having been performed in June 2015 are highlighted in bold) Dengue es (Ab/NS1-Ag) (350) Epstein Barr (352) TBE (FSME) (358) Hantaes (355) Hepatitis D (347) Hepatitis E (348) Herpes simplex es (354) HTLV-1/HTLV-2 (339) Measles (357) Mumps (356) Parvo B19 (342) Rubella (341) Rabies (Tollwut) (336) Varicella zoster (353) VIRUS GENOME DETECTION: Adenoes (371) BK (364) Chikungunya (392) Coronaes (340) Cymegalo training program (368) Cymegalo resistance determination (349) Dengue es (369) Enteroes (372) RKI-Entero-Surveillance (every two years) (374) Epstein Barr (376) Hepatitis B training program (378) Hepatitis B genotyping (396) Hepatitis B resistance determination (397) Hepatitis C training program (379) Hepatitis C geno-/subtyping (once a year) (375) Hepatitis C resistance determination (399) Hepatitis D (400) Hepatitis E (380) Herpes simplex type 1/2 (363) HIV-1 training program (382) HIV-1 drug resistance determ. (standard progr.) (383) HIV-1 drug resistance determ. (additional progr.) (384) HIV-2 (395) Human Metapneumo (385) Human Papilloma es (373) Human Rhinoes (393) Influenza es (genome/ag) (370) JC (394) Measles (386) Mumps (387) Noro (381) Parainfluenza es (388) Respirary syncytial (Ag/genome) (359) Rotaes (401) Rubella (389) Rabies (Tollwut) (390) Varicella zoster (366) West Nile (391) Pre-evaluation Virology June corr EN.doc 3 von 11
4 Please see the following Tables 3, 4 and 5 for details on sample properties and the expected target values for this EQA scheme June You received information on sample properties already per on 16 July The reports of all EQA schemes will be released on the INSTAND homepage immediately after completion. For details please see the INSTAND homepage under "EQAS / Reports / Year and Category (Virus immunology / Virus genome detection)" in English language: and in German language: Please note: RiliBÄK A compilation of the "Guideline of the German Medical Association (Bundesärztekammer / RiliBÄK = Richtlinie der Bundesärztekammer zur Qualitätssicherung laborariumsmedizinischer Untersuchungen)" with all Sections including Section "Qualitative determinations in laborary medicine = Qualitative laborariumsmedizinische Untersuchungen" and Section "Direct detection and characterization of infectious diseases pathogens = Direkter Nachweis und Charakterisierung von Infektionserregern" has recently been published (in German language: Deutsches Ärzteblatt, Jg. 111, Heft 38, 19. September 2014, A A 1618) (please see link). An English version of the guideline translated by INSTAND e.v. with the consent of the Executive Board of the German Medical Association has been published in "German Medical Science" (in English language: Bundesärztekammer (German Medical Association), Instand e.v., Guidelines of the German Medical Association on quality assurance in medical laborary testing. GMS Z Forder Qualitatssich Med Lab. 2015;6:Doc03. DOI: /lab000018, URN: urn:nbn:de:0183- lab ) (please see link). Note for German laboraries: The requirements laid down in Specified Section - effective since and with a transition period until should be fulfilled now. New INSTAND EQA schemes in diagnostics and INSTAND ordering documents 2015 We may inform you that 10 new EQA schemes for genome detection will be launched in 2015 after we have introduced 20 additional EQA schemes in diagnostics in For details please see the INSTAND ordering documents 2015 incl. brochure and order form (please see link). Surplus samples of the current and previous EQA schemes in diagnostics are available for test assessment of your diagnostics. Please contact INSTAND for details. Thank you for your kind cooperation Prof. Dr. H. Zeichhardt Priv.-Doz. Dr. O. Donoso Mantke Pre-evaluation Virology June corr EN.doc 4 von 11
5 Table 3: EQA Schemes Virus Immunology - June pre-evaluation Program Group RiliBÄK Analyte Sample Cymegalo Epstein Barr Tick-borne encephalitis (TBE = FSME) # Hepatitis A Hepatitis B (prog. 1) (HBsAg anti-hbs anti-hbc) anti-cmv-igg anti-cmv-igm anti-cmv-igg anti-cmv-igm anti-ebv-igg anti-ebv-igm anti-ebv-igg anti-ebv-igm anti-tbe-igg anti-tbe-igm anti-tbe-igg anti-tbe-igm qualitative dilution sample source The accepted results will be shown in the report. anti-hav miu/ml anti-hav miu/ml (4 miu/ml target anti-hav-igm : 18.5 past CMV infection (one healthy blood donor) past CMV infection (one healthy blood donor) past EBV infection (three healthy blood donors) past EBV infection (two healthy blood donors) healthy blood donor with indication of a past TBE infection/vaccination healthy blood donor with indication of a past TBE infection/vaccination anti-hav-igg healthy blood donor healthy blood donor healthy blood anti-hav-igm : 25 acute hepatitis A infection HBsAg HBsAg HBsAg HBsAg anti-hbs anti-hbs anti-hbs anti-hbs IU/ml (7.54 IU/ml target IU/ml (0.00 IU/ml target IU/ml (0.84 IU/ml target IU/ml (2.52 IU/ml target IU/l (53 IU/l target IU/l (200 IU/l target 0-9 IU/l (0 IU/l target IU/l (103 IU/l target (a) 1 : acute hepatitis B infection (a) 1 : (a) 1 : (b) 1 : 700 (b) 1 : 175 (b) 1 : 350 healthy blood acute hepatitis B infection anti-hbs healthy blood donor healthy blood anti-hbs healthy blood donor anti-hbc (c) 1 : 300 chronic hepatitis B ( for HBeAg, antianti-hbc (c) 1 : 150 HBc-IgM ) anti-hbc healthy blood anti-hbc (c) chronic hepatitis B 1 : 600 ( for HBeAg, anti- HBc-IgM ) a, b, c: Marked samples represent dilutions from the corresponding sck materials. # FSME = Frühsommer-Meningoenzephalitis Pre-evaluation Virology June corr EN.doc 5 von 11
6 Table 3 (contd.): EQA Schemes Virus Immunology - June pre-evaluation Program Group RiliBÄK Analyte Sample Hepatitis B (prog. 2) (anti-hbc-igm HBeAg anti-hbe) Hepatitis C (Ab and HCV-Ag) Hepatitis D Hepatitis E Herpes simplex es HIV-1/ HIV anti-hcv qualitative dilution sample source anti-hbc-igm (d) 1 : 70 anti-hbc-igm (d) 1 : 140 acute hepatitis B infection HBeAg = HBeAg = : 600 chronic hepatitis B anti-hbe healthy blood anti-hbe chronic hepatitis B 1 : 70 ( for HBeAg) anti-hcv HCV antigen anti-hcv HCV antigen anti-hcv HCV antigen anti-hcv HCV antigen anti-hdv-igg anti-hdv-igm anti-hdv-igg anti-hdv-igm anti-hev-igg anti-hev-igm anti-hev-igg anti-hev-igm anti-hsv-igg anti-hsv-igm anti-hsv-igg anti-hsv-igm $ = $ = not evaluated not evaluated 1 : 1.7 chronic hepatitis C 1 : 6 1 : 6 Condition after chronic hepatitis C (successful therapy) healthy blood Condition after chronic hepatitis C (successful therapy) 1 : chronic hepatitis D healthy blood donor healthy blood donor 1 : 2 acute hepatitis E infection healthy blood past HSV-1 infection (two healthy blood donors) anti-hiv-1/ healthy blood anti-hiv : 80 HIV-1 infection anti-hiv-1/ healthy blood anti-hiv : 60 HIV-2 infection HCV Ag healthy blood p24 Ag HIV-1 HIV-1 infection p24 Ag 337 (spiked pool of p24 Ag : blood donors; HIV-1 heat inactivated) HTLV-1/ anti-htlv-1/ * blood donor HTLV-2 anti-htlv * 1 : 300 HTLV-1 infection 339 anti-htlv-1/ ** blood donor * ** anti-htlv ** 1 : 4 HTLV-2 infection d: Marked samples represent dilutions from the corresponding sck materials. The samples and are identical. $ The samples and are identical. corrected on 10 August Pre-evaluation Virology June corr EN.doc 6 von 11
7 Table 3 (contd.): EQA Schemes Virus Immunology - June pre-evaluation Program Group RiliBÄK Analyte Sample Measles Mumps Parvo B19 Rubella Varicella zoster anti-measles-igg avidity: low anti-measles-igm anti-measles-igg anti-measles-igm anti-mumps-igg anti-mumps-igm anti-mumps-igg anti-mumps-igm anti-parvo B19-IgG * =342044* anti-parvo B19-IgM anti-parvo B19-IgG anti-parvo B19-IgM anti-parvo B19-IgG anti-parvo B19-IgM ** ** qualitative dilution sample source acute measles infection healthy blood donor with indication of a past measles infection/vaccination healthy blood donor with indication of a past mumps infection/vaccination healthy blood donor with indication of a past mumps infection/vaccination past parvo B19 infection (sera of two healthy blood donors) past parvo B19 infection (sera of one healthy blood donor) avidity: low 1 : 2 acute parvo-b19 infection anti-parvo B19-IgG * =342041* anti-parvo B19-IgM titer Hi test / HiG anti-rubella-igg anti-rubella-igm titer Hi test / HiG anti-rubella-igg anti-rubella-igm anti-vzv-igg anti-vzv-igm anti-vzv-igg anti-vzv-igm The samples and are identical IU/ml (350 IU/ml target IU/ml (141 IU/ml target past parvo B19 infection (sera of two healthy blood donors) sera of two healthy blood donors with indication of a past rubella infection or vaccination sera of two healthy blood donors with indication of a past rubella infection or vaccination past VZV infection (two healthy blood donors) past VZV infection (two healthy blood donors) Pre-evaluation Virology June corr EN.doc 7 von 11
8 Table 4: EQA Schemes Virus Genome Detection by PCR/NAT - June pre-evaluation Program Group RiliBÄK Sample CMV EBV HAV spiked HBV HCV HEV * suspension of feces** HIV-1 spiked HIV-2 spiked HMPV qualitative Target value of all methods (note on dilution (provisional data) geno-/subtype) copies/ml IU/ml : approx approx (e) 1 : approx approx : approx approx (e) 1 : approx approx (f) 1 : 800 approx approx (f) 1 : 200 approx approx (f) 1 : 50 approx approx (g) 1 : not evaluated # not evaluated # (g) 1 : not evaluated # not evaluated # not evaluated # not evaluated # (g) 1 : not evaluated # not evaluated # not evaluated # (h) 1 : not evaluated # approx (h) 1 : not evaluated # approx (h) 1 : not evaluated # approx (subtype 2a/2c) (i) 1 : 600 not evaluated # approx not evaluated # (subtype 2a/2c) (i) 1 : 300 not evaluated # approx (subtype 2a/2c) (i) 1 : not evaluated # approx * (j) 1 : 28 not evaluated # not evaluated # ** 1 : not evaluated # not evaluated # * not evaluated # not evaluated # * (j) 1 : 14 not evaluated # not evaluated # (k) 1 : 7 approx not evaluated # (k) 1 : 700 approx. 602 not evaluated # : 100 approx not evaluated # (k) 1 : 70 approx not evaluated # (l) 1 : 900 not evaluated # not evaluated # : 9 not evaluated # not evaluated # e (l) 1 : 90 not evaluated # not evaluated # (l) 1 : 9 not evaluated # not evaluated # (subtype A) (m) 1 : not evaluated # not evaluated # (subtype A) (m) 1 : 64 not evaluated # (subtype A) (m) 1 : 320 not evaluated # # The quantitative results are not evaluated due the low number of analyses (without disadvantage for the certificate). e, f, g, h, i, j, k, l, m: Marked samples derive from corresponding sck materials diluted in consecutive steps. Pre-evaluation Virology June corr EN.doc 8 von 11
9 Table 4 (contd.): EQA Schemes Virus Genome Detection by PCR/NAT - June pre-evaluation Program Group RiliBÄK Sample Measles FTA cards Mumps FTA cards Parvo B19 Respirary syncytial (antigen/ genome) Rubella FTA cards VZV qualitative (note on geno-/subtype) Target value of all methods dilution (provisional data) copies/ml IU/ml (genotype B3) undiluted not evaluated # (genotype D8) undiluted not evaluated # (genotype A) undiluted not evaluated # (genotype D4) undiluted not evaluated # (genotype F) (n) undiluted not evaluated # (genotype F) (n) 1 : 10 not evaluated # (genotype G) (o) undiluted not evaluated # (genotype G) (o) 1 : 10 not evaluated # : not evaluated # approx not evaluated # (p) 1 : not evaluated # approx (p) 1 : not evaluated # approx RSV A (q) 1 : 60 not evaluated # RSV B 1 : 20 not evaluated # RSV A 1 : 80 not evaluated # RSV A (q) 1 : 180 not evaluated # (genotype 1G) (r) undiluted not evaluated # (genotype1g) (r) 1 : 2 not evaluated # (genotype 2B) (s) undiluted not evaluated # (genotype 2B) (s) 1 : 2 not evaluated # (t) 1 : 200 approx (t) 1 : 100 approx (t) 1 : 800 approx # The quantitative results are not evaluated due the low number of analyses (without disadvantage for the certificate). n, o, p, q, r, s, t: Marked samples derive from corresponding sck materials diluted in consecutive steps. Pre-evaluation Virology June corr EN.doc 9 von 11
10 Table 5: EQA Schemes Virus Genome Detection by PCR/NAT - June 2015 incl. Typing - pre-evaluation Program Group RiliBÄK Sample Adenoes Coronaes Enteroes HSV-1/ HSV-2 Human papilloma es * qualitative Target value of all methods copies/ml species type (note on dilution) Quantitative results will be discussed in Adeno 31 the final report. A 1 : diluted B Adeno 11 1 : diluted (u) CoV OC43 1 : diluted (v) B Adeno 11 1 : diluted (u) Quantitative results MERS-CoV will be discussed in : 100 diluted (w) the final report. CoV OC : 100 diluted (v) MERS-CoV : diluted (w) Quantitative results ---- will be discussed in the final report approx = Entero 68 1 : 1000 diluted Coxsackie B3 1 : diluted Coxsackie A21 1 : diluted HSV-1 1 : diluted (x) approx approx = HSV-2 1 : 5 00 diluted (y) HSV-1 1 : diluted (x) approx High Risk High Risk HSV-2 1 : 4000 diluted (y) HPV 18 1 : 15 diluted (z) HPV 16 1 : 5 diluted High Risk High Risk u, v, w, x, y, z: Marked samples derive from corresponding sck materials diluted in consecutive steps. : The samples and are identical. HPV 18 1 : 30 diluted (z) HPV 16 1 : 20 diluted Pre-evaluation Virology June corr EN.doc 10 von 11
11 Table 5 (contd.): EQA Schemes Virus Genome Detection by PCR/NAT - June 2015 incl. Typing - pre-evaluation Program Group RiliBÄK Sample Human rhinoes * Rotaes suspension of feces aa, bb: = qualitative Target value of all methods copies/ml species type (note on dilution) Quantitative results will be discussed in HRV A Typ the final report : 100 diluted (aa) = HRV A Typ : 10 diluted (aa) G2P[4] : diluted (bb) ---- HRV A Typ 30 1 : 10 diluted (aa) Quantitative results will be discussed in G2P[4] the final report : 100 diluted (bb) G2P[4] : diluted (bb) Marked samples derive from corresponding sck materials diluted in consecutive steps. : The samples and are identical. Pre-evaluation Virology June corr EN.doc 11 von 11
June Pre-evaluation of the External Quality Assessment Schemes in Virus Diagnostics. Prof. Dr. Heinz Zeichhardt. Dr.
June 2018 Pre-evaluation of the External Quality Assessment Schemes in Virus Diagnostics Prof. Dr. Heinz Zeichhardt Dr. Martin Kammel Issued by: INSTAND Gesellschaft zur Förderung der Qualitätssicherung
More informationINSTAND e.v. in cooperation with:
Pre-evaluation of the EQA Schemes in Virus Diagnostics November/December 2014 INSTAND e.v. in cooperation with: Deutsche Vereinigung zur Bekämpfung der Viruskrankheiten (DVV) Gesellschaft für Virologie
More informationJune EQA schemes closed. Information on sample properties. Prof. Dr. Heinz Zeichhardt. Dr. Martin Kammel
June 2018 EQA schemes closed Information on sample properties Prof. Dr. Heinz Zeichhardt Dr. Martin Kammel Issued by: INSTAND Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laborarien
More informationINSTAND e.v. in cooperation with:
Pre-evaluation of the EQA Schemes in Virus Diagnostics November/December 2015 INSTAND e.v. in cooperation with: Deutsche Vereinigung zur Bekämpfung der Viruskrankheiten (DVV) Gesellschaft für Virologie
More informationSeptember Pre-evaluation of the External Quality Assessment Schemes in Virus Diagnostics
September 2016 of the External Quality Assessment Schemes in Virus Diagnostics Prof. Dr. Heinz Zeichhardt Priv.-Doz. Dr. Oliver Donoso Mantke Issued by: INSTAND Gesellschaft zur Förderung der Qualitätssicherung
More informationSeptember Pre-evaluation of the External Quality Assessment Schemes in Virus Diagnostics
September 2018 Corrected version: 20 November 2018 (See Table 3; page 9, program 344) of the External Quality Assessment Schemes in Virus Diagnostics Prof. Dr. Heinz Zeichhardt Dr. Martin Kammel Issued
More informationNovember/ December 2016
November/ December 2016 Pre-evaluation of the External Quality Assessment Schemes in Virus Diagnostics Prof. Dr. Heinz Zeichhardt Dr. Martin Kammel Issued by: INSTAND Gesellschaft zur Förderung der Qualitätssicherung
More informationNovember/ December 2016
November/ December 2016 Corrected version: 02 February 2017 (See Table 3; page 11; program 401) EQA schemes closed Information on sample properties Prof. Dr. Heinz Zeichhardt Dr. Martin Kammel Issued by:
More informationMarch Pre-evaluation of the External Quality Assessment Schemes in Virus Diagnostics
March 2018 Pre-evaluation of the External Quality Assessment Schemes in Virus Diagnostics deadline postponed : 23 March 2018 only for program 374: 06 April 2018 Prof. Dr. Heinz Zeichhardt Dr. Martin Kammel
More informationI N S T A N D e. V. Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (vormals Hämometerprüfstelle)
I N S T A N D e. V. Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (vormals Hämometerprüfstelle) WHO Collaborating Centre for Quality Assurance and Standardization
More informationI N S T A N D e. V. Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (vormals Hämometerprüfstelle)
I N S T A N D e. V. Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (vormals Hämometerprüfstelle) WHO Collaborating Centre for Quality Assurance and Standardization
More informationReport External Quality Assessment Scheme Group 346 Virus Immunology - Hepatitis C Virus November/December INSTAND e.v. in cooperation with:
Report External Quality Assessment Scheme Group 346 Virus Immunology - Hepatitis C Virus November/December 2014 INSTAND e.v. in cooperation with: Deutsche Vereinigung zur Bekämpfung der Viruskrankheiten
More informationReport External Quality Assessment Scheme Group 346 Virus Immunology - Hepatitis C Virus September INSTAND e.v. in cooperation with:
Report External Quality Assessment Scheme Group 346 Virus Immunology - Hepatitis C Virus September 2014 INSTAND e.v. in cooperation with: Deutsche Vereinigung zur Bekämpfung der Viruskrankheiten (DVV)
More informationHindenburgdamm 27, Berlin Tel.: +49-(0) ; Fax: +49-(0)
I S T A D e. V. Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (vormals Hämometerprüfstelle) Deutsche Vereinigung zur Bekämpfung der Viruskrankheiten (DVV) Gesellschaft
More informationReport on External Quality Assessment Scheme Survey no. 253 Autoimmun Diseases 02 March 2015
Report on External Quality Assessment Scheme Survey no. 253 Autoimmun Diseases 2 March 15 INSTAND e.v. Dr. M. Blüthner Prof. Dr. Hans-Peter Seelig issued by: Instand e.v. Gesellschaft zur Förderung der
More informationControls & Calibrators. Disease Quality Controls
Controls & Calibrators Infectious Disease Quality Controls Infectious Disease Quality Controls A broad selection of controls designed to monitor assay precision of hepatitis, retrovirus, sexually transmitted
More informationSchedule of Accreditation
Schedule of Accreditation Organisation Name National Virus Reference Laboratory INAB Reg No 326MT Contact Name Eimear Malone Address University College Dublin, Belfield, Dublin Contact Phone No 01-7161319
More informationDS-EIA-ANTI-HIV-UNIF (Ab) I DS-EIA-ANTI-HIV-UNIF (Ab) I DS-EIA-ANTI-HIV-UNIF (Ab) I
* Sensitivity HIV DS-EIA-ANTI-HIV-UNIF (Ab) I-153 96 115 24 DS-EIA-ANTI-HIV-UNIF (Ab) I-150 192 115 24 DS-EIA-ANTI-HIV-UNIF (Ab) I-155 480 115 24 DS-EIA-HIV-AG-SCREEN I-1452 96 115 12 0.025 IU/ml DS-EIA-HIV-AGAB-SCREEN
More informationEC CERTIFICATE. National Institute for Biological Standards and Control (NIBSC) Blanche Lane South Mimms Potters Bar Hertfordshire EN6 3QG UK
National Institute for Biological Standards and Control (NIBSC) EC Certificate - Full Quality Assurance System Approval Certificate Annex IV (excluding sections 4 and 6) of Council Directive 98/79/EC on
More informationSchedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK
Schedule of Accreditation 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK National Infection Service, Public Health England Colindale 61 Colindale Avenue London NW9 5EQ Contact: Dr Sanjiv
More informationELISA kits for infections (HIV; Hepatitis A, B, C, D, E; Syphilis, ToRCH and others), hormone pathologies and tumor markers.
DSI S.r.l. DSI S.r.l. is one of the European leaders in the field of immunodiagnostic tests manufacturing. We are a research-focused company with the long-term microbiological scientific traditions. Our
More informationViral Structure Herpes virus. Pathology of viral disease. Viral Structure. Topics for the first lecture. Virus size
Pathology of viral disease Viral Structure Herpes virus Ila Singh, MD, PhD Department of Pathology P & S 14-453 is132@columbia.edu Envelope Tegument Spikes Nucleocapsid Genome Principles of Virology: Molecular
More informationJAJ International, Inc./LuSys Laboratories, Inc.
JAJ International, Inc./LuSys Laboratories, Inc. 10054 Mesa Ridge Court, Suite #120 San Diego, California 92121 USA Tel: 1(858) 866-0788, Fax: 1(858) 866-1688 Email: info@jajinternational.com Website:
More informationVIROLOGY INTRODUCTION SAMPLE LABELLING & COMPLETION OF REQUEST FORMS GENERAL GUIDELINES FOR VIRUS ISOLATION
VIROLOGY INTRODUCTION Virological tests are usually costly and labour-intensive, therefore they should be undertaken only when good clinical indications for doing so exist, and after thoughtful consideration
More informationMultiple Choice Questions - Paper 1
Multiple Choice Questions - Paper 1 Instructions for candidates The examination consists of 30 multiple choice questions, each divided into 5 different parts. Each part contains a statement which could
More informationالحترمونا من خري الدعاء
الحترمونا من خري الدعاء Instructions for candidates The examination consists of 30 multiple choice questions, each divided into 5 different parts. Each part contains a statement which could be true or
More informationImage of Ebola viruses exiting host cells HUMAN VIRUSES & THE LIMITATION OF ANTIVIRAL DRUG AGENTS
Image of Ebola viruses exiting host cells HUMAN VIRUSES & THE LIMITATION OF ANTIVIRAL DRUG AGENTS APRIL 2017 Infectious viruses are a global health threat Since the approval of the first antiviral drug
More informationImage of Ebola viruses exiting host cells HUMAN VIRUSES & THE LIMITATION OF ANTIVIRAL DRUG AGENTS
Image of Ebola viruses exiting host cells HUMAN VIRUSES & THE LIMITATION OF ANTIVIRAL DRUG AGENTS MAY 2017 1 Infectious viral pathogens are a significant global health threat to mankind 2 Since the approval
More informationLaboratory Evidence of Human Viral and Selected Non-viral Infections in Canada
Canada Communicable Disease Report ISSN 1188-4169 Date of publication: October 1998 Volume 24S7 Supplement Laboratory Evidence of Human Viral and Selected Non-viral Infections in Canada 1989 to 1996 Our
More informationLaboratory Diagnosis of Viral Infections. G. Jamjoom 2005
Laboratory Diagnosis of Viral Infections G. Jamjoom 2005 Five Main Techniques: Virus Culture and Isolation Serology Rapid Detection of Viral Antigens Detection of Viral Nucleic Acid Electron Microscopy
More informationMemo No: Date: 25-Nov NEW Serology and Virology Testing
Memo No: 2014-61 Date: 25-Nov-2014 www.hicl.on.ca Re: NEW Serology and Virology Testing In Common Laboratories has been working hard to expand our test menu. We are pleased to announce the availability
More informationNon-reproductive tissues and cells
Colour key Tested pathogen VIRAL Minimum requirements as set out in Directive 2004/23/EC More stringent testing - legy binding on national level More stringent testing - recommended on national level Not
More informationMicrobiology EQA Product Portfolio
Labquality EQAS Microbiology EQA Product Portfolio Clinically relevant external quality assessment program for microbiology Bacterial serology Bacteriology Mycology Parasitology Preanalytics Virology Labquality
More informationNon-reproductive tissues and cells
Colour key Minimum requirements as set out in Directive 2004/23/EC and its technical Directives (particularly 2006/17/EC) More stringent -legally binding, applies for all donations and all donor profiles
More informationNon-reproductive tissues and cells
Colour key Minimum requirements as set out in Directive 2004/23/EC More stringent - legy binding on national level More stringent - recommended on national level Not legy binding and not recommended on
More informationUpdate on the development of clinical diagnostic run controls at NIBSC. Neil Almond Division of Virology
Update on the development of clinical diagnostic run controls at NIBSC Neil Almond Division of Virology BACKGROUND Molecular techniques are increasingly being used for microbiological diagnoses Assays
More informationViral Diseases. T Bamdad, PhD, Tarbiat Modares University
Viral Diseases 1 Categorizing viral infections by the organ system most commonly affected (eg, lungs, GI tract, skin, liver, CNS, mucous membranes) can be clinically useful, although certain viral disorders
More informationon the road to harmonisation?
on the road to harmonisation? Prof. Dr.med.Michael Spannagl Munich- Heart of? 1 O zapft is - Oktoberfest 1 Key facts Date: September - October (1 days) Location: Munich - Theresenwiese 6,3 Mio. Visitors
More informationTel: Tel: Web: CODE DESCRIPTION UNITS
New Instruments MICROPLATE ANALYZERS DESCRIPTION UNITS MDIMOD2 Modulus2 2-4 Microplate Analyzer 1 Refurbished Instruments MICROPLATE ANALYZERS DESCRIPTION UNITS MDINXGMI Refurbished Nexgen 4-Microplate
More informationQUALITY CONTROL Infectious Disease
QUALITY CONTROL Infectious Disease 1 Infectious Disease Quality Control The human based material used in the production of our Quality Controls is sourced from the Taiwan Blood Services Foundation (TBSF).
More informationSchedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK
2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK West of Scotland Specialist Virology Centre New Lister Building Level 5 Glasgow Royal Infirmary 10-16 Alexandra Parade Glasgow G31 2ER Contact:
More informationREAD HIGHLIGHTED CHANGES
BIO-FLASH anti-hbs 3000-8581 100 tests The BIO-FLASH anti-hbs is a fully automated chemiluminescent simultaneous immunoassay for quantitative measurement of antibodies to Hepatitis B surface antigen (anti-hbs)
More informationNon-reproductive tissues and cells
Ministry of Health: Institute for Transplantation and Biomedicine / Colour key VIRAL HIV 1 and HIV 2 Hepatitis B Minimum requirements as set out in Directive 2004/23/EC More stringent - legy binding More
More informationELISA. AccuDiag Autoimmune Diseases and Others. ANA Screen Qualitative ~135 min 90.4% 100%
/ AccuDiag Autoimmune Diseases and Others ANA Screen 5102-2 96 ~135 min 90.4% 100% ENA Profile-6 (Sm/RNP, Sm, Jo-1, Scl-70, SS-A, SS-B) 2506-2 96 ~ 60 min 96% 100% ENA Combined Screen (6 antigens) Sm/RNP,
More informationNon-reproductive tissues and cells Recommending authority/ association
Colour key Minimum requirements as set out in Directive 2004/23/EC More stringent - legy binding More stringent - recommended Not legy binding and not recommended Tested pathogen Donor test/ technique
More informationThe use of QCMD proficiency testing panels in clinical virology.
The use of QCMD proficiency testing panels in clinical virology. Prof.dr. Bert Niesters Department of Medical Microbiology Division of Clinical Virology UMC Groningen Disease Disease Management Viral Load
More informationDEPARTMENT OF MICROBIOLOGY IMPORTANT NOTICE TO USERS Turnaround Times (TATs) for Microbiology Investigations
Dear User, ISSUE: M008 DEPARTMENT OF MICROBIOLOGY IMPORTANT NOTICE TO USERS Turnaround Times (TATs) for Microbiology Investigations In order to comply with national quality guidance and as part of our
More informationViral Hepatitis Diagnosis and Management
Viral Hepatitis Diagnosis and Management CLINICAL BACKGROUND Viral hepatitis is a relatively common disease (25 per 100,000 individuals in the United States) caused by a diverse group of hepatotropic agents
More informationViral hepatitis. Supervised by: Dr.Gaith. presented by: Shaima a & Anas & Ala a
Viral hepatitis Supervised by: Dr.Gaith presented by: Shaima a & Anas & Ala a Etiology Common: Hepatitis A Hepatitis B Hepatitis C Hepatitis D Hepatitis E Less common: Cytomegalovirus EBV Rare: Herpes
More informationSize nm m m
1 Viral size and organization Size 20-250nm 0.000000002m-0.000000025m Virion structure Capsid Core Acellular obligate intracellular parasites Lack organelles, metabolic activities, and reproduction Replicated
More informationNon-reproductive tissues and cells Recommending authority/ association
Colour key Minimum requirements as set out in Directive 2004/23/EC More stringent - legy binding More stringent - recommended Not legy binding and not recommended Non-reproductive tissues and cells VIRAL
More informationPurification of viral nucleic acid from serum, plasma, cell-free biological fluids MACHEREY- NAGEL
Purification of viral nucleic acid from serum, plasma, cell-free biological fluids Purification of viral nucleic acid from serum, plasma, cell-free biological fluids viral RNA: viral DNA: NucleoSpin RNA
More informationOfficial Journal of the European Communities COMMISSION
16.5.2002 EN Official Journal of the European Communities L 131/17 COMMISSION COMMISSION DECISION of 7 May 2002 on common technical specifications for in vitro-diagnostic medical devices (notified under
More informationDiagnostic Methods of HBV infection. Zohreh Sharifi,ph.D of Virology Research center, Iranian Blood Transfusion Organization (IBTO)
Diagnostic Methods of HBV infection Zohreh Sharifi,ph.D of Virology Research center, Iranian Blood Transfusion Organization (IBTO) Hepatitis B-laboratory diagnosis Detection of HBV infection involves
More informationStructure and duties of Blood service
NATIONAL CENTER FOR TRANSFUSION MEDICINE Prevalence of infectious diseases among Mongolian blood donors Namjil Erdenebayar General director of The National Center for Transfusion Medicine, Mongolia NCTM,
More informationNon-reproductive tissues and cells Recommending authority/ association
Colour key Minimum requirements as set out in Directive 2004/23/EC More stringent testing - legy binding on national level More stringent testing - recomd on national level Not legy binding and not recomd
More informationHAV HBV HCV HDV HEV HGV
Viral Hepatitis HAV HBV HCV HDV HEV HGV Additional well-characterized viruses that can cause sporadic hepatitis, such as yellow fever virus, cytomegalovirus, Epstein-Barr virus, herpes simplex virus, rubella
More informationSchedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK
2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK Royal Liverpool & Broadgreen University Hospitals NHS Trust Department of Virology Liverpool Clinical Laboratories Royal Liverpool and Broadgreen
More informationVersion number CAT 2016/01
Version number CAT 2016/01 Contents An Introduction to the QCMD EQA Schemes 4 Disease Groups Blood Borne Virus 5 Central Nervous System 5 Congenital Infections 6 Drug Resistance 6 Exotic/Emerging Diseases
More informationViral Antigens Recombinant Proteins. Life Science, Inc. Large Scale Manufacturing, R&D and Custom Services.
Viral Antigens Recombinant Proteins Large Scale Manufacturing, R&D and Custom Services Life Science, Inc. www.meridianlifescience.com Life Science, Inc. Meridian Life Science, (MLS) is an industry leader
More informationINSTAND-Proficiency-Testing Program ACCOMPANYING BOOKLET
INSTAND-Proficiency-Testing Program ACCOMPANYING BOOKLET Testing Information Bacteriologic Infection Serology May 2014 I N S T A N D e. V. Gesellschaft zur Förderung der Qualitätssicherung in medizinischen
More informationPotential etiologies of infection in these patients are diverse, including common and uncommon opportunistic infections.
In the name of God Principles of post Tx infections 1: Potential etiologies of infection in these patients are diverse, including common and uncommon opportunistic infections. Infection processes can progress
More informationNon-reproductive tissues and cells
Colour key Minimum requirements as set out in Directive 2004/23/EC More stringent testing - legally binding on national level More stringent testing - recommended on national level Not legally binding
More informationDo Viruses Play a Role in Childhood Leukaemia?
CHILDREN with LEUKAEMIA, 6 September 2004 Do Viruses Play a Role in Childhood Leukaemia? Robin A. Weiss Natural Bioweapons of Mass Destruction A Richter Scale of Viruses and Global Mortality HIV HBV +
More informationIncrease in Locally-Acquired Cyclosporiasis Cases in Ontario
Increase in Locally-Acquired Cyclosporiasis Cases in Ontario Update to York Region health care providers as of July 31, 2018 Ontario is experiencing an increase in the number of Cyclospora infections.
More informationHEPATITIS VIRUSES. Other causes (not exclusively hepatitis v.)also called sporadic hepatitis: HEPATITIS A(infectious hepatitis)
Dept.of Microbiology/Virology Assist.prof. Shatha F. Abdullah HEPATITIS VIRUSES Medically important hepatitis v. (liver)are: 1.HAV 2.HBV 3.HCV 4.HDV 5.HEV 6.HGV Other causes (not exclusively hepatitis
More informationRepetitorium of selected human viruses HIV
Repetitorium of selected human viruses HIV Chair and Department of Medical Microbiology Poznan University of Medical Sciences Chairman: prof. dr hab. Andrzej Szkaradkiewicz Wieniawskiego Street 3, 61-712
More informationCERTIFICATE OF ACCREDITATION
CERTIFICATE OF ACCREDITATION In terms of section 22(2)(b) of the Accreditation for Conformity Assessment, Calibration and Good Laboratory Practice Act, 2006 (Act 19 of 2006), read with sections 23(1),
More informationTEST REQUEST INFORMATION- VIROLOGY
Chlamydia/ Gonorrhea Nucleic Acid Amplification VC75 Qualitative Nucleic Acid Amplification SPECIMEN: Genital swab or first catch urine CONTAINER:GEN-PROBE APTIMA 2 Combo swab transport tube or urine transport
More informationvirology MCQs 2- A virus commonly transmitted by use of contaminated surgical tools & needles produces a disease called serum hepatitis.
virology MCQs 1- A virus which causes AIDS is: a- Small pox virus. b- Coxsackie B virus. c- Mumps virus. d- Rubella virus. e- HIV-III virus. 2- A virus commonly transmitted by use of contaminated surgical
More informationStorage conditions. roomtemperature or incubator at 36 C. Other: 2-8 C Blood: roomtemperature or incubator at. A.s.a.p. max 24h. A.s.a.p.
Extract Vademecum Department of Medical Microbiology Status: Code: Version: Approval date: Geldig MMB-PR-04/1 1 Juni 2017 Name request Specimen Material needed Transport Bacteriology Bacterial culture
More information: New graphic materials for bioelisa and bioblot product lines
1 NEWS BK NEWS # 385 /BE/ MKT DATE : 24-05-2016 TITLE : New graphic materials for bioelisa and bioblot product lines Dear colleagues, We are pleased to present the new materials for bioelisa and bioblot
More informationLIAISON Measles IgG The fully automated solution for quantitative antibody detection
LIAISON Measles IgG The fully automated solution for quantitative antibody detection FOR OUTSIDE THE US AND CANADA ONLY LIAISON Measles IgG Number of tests 100 Key assay features Method Assay range Solid
More informationTest Definition: FMCPS Meningoencephalitis Comprehensive Panel (Serum)
Reporting Title: Meningoencephalitis Comp Panel, S Performing Location: Focus Diagnostics, Specimen Requirements: Draw blood in a plain, red-top tube(s). (Serum gel tube is acceptable.) Spin down and send
More informationSeite Infektionsserologie Infectious serology 142
142 Infectious serology Infectious serology 143 Bacteria Bordetella Borrelia Treponema Chlamydia For more information on this subject scan the QR code or enter the Quick Link code q008 at www.euroimmun.com
More informationto be notified: all parties involved in the graduated plan procedure. Annexes
Paul-Ehrlich-Institut Postfach 63207 Langen, Germany To all marketing authorisation holders of cellular blood preparations and therapeutic single plasmas as well as authorisation holders of stem cells
More informationInfectious Disease Controls for Serology Testing
Infectious Disease Controls Infectious Disease Controls for Serology Testing A comprehensive guide for monitoring testing for Hepatitis, Retrovirus, Sexually Transmitted and Congenital Diseases Table of
More informationNon-reproductive tissues and cells Recommending authority/ association
Colour key Minimum requirements as set out in Directive 2004/23/EC More stringent - legally binding More stringent - recommended Not legally binding and not recommended Non-reproductive tissues and cells
More informationBioPlex 2200 Infectious Disease Panels
BioPlex 2200 System BioPlex 2200 Infectious Disease Panels An Expanding Multiplexed Assay Menu Lyme HIV Ag-Ab MMV IgM Syphilis Total & RPR MMRV EBV HSV-1 & HSV-2 EBV IgM ToRC IgM ToRC Leading the way with
More informationThe Alphabet Soup of Viral Hepatitis Testing
The Alphabet Soup of Viral Hepatitis Testing August 18, 2011 Patricia Slev, PhD, DABCC Medical Director, Serologic Hepatitis and Retrovirus Laboratory, ARUP Laboratories Assistant Professor of Pathology,
More informationEssential Vaccinations for HIV-Positive Adults and Adolescents
Essential Vaccinations for HIV-Positive Adults and Adolescents Janak A. Patel, MD Professor & Director, Pediatric Infectious Diseases Director, Maternal-Child Program University of Texas Medical Branch
More informationObjectives. Acute Hepatitis: Symptoms. Acute Hepatitis: Signs HIHIM 409. Acute Viral Hepatitis by Type, United States,
Objectives Viral Hepatitis: ABCD&E HIHIM 409 Describe the Clinical Syndromes of Viral Hepatitis List the modes of Transmission Understand and be able to interpret Diagnostic (laboratory) tests Know the
More informationWard Manual. PHC Diagnostic Virology & Reference Laboratory
PHC Diagnostic Virology & Reference Laboratory I. General Information The SPH Virology Laboratory is located at St. Paul s Hospital 1081 Burrard Street, Room 625, Burrard Building, Vancouver, B.C. V6Z
More informationAnswering your daily challenges. in the ELISA technology I N FECTI OUS DISEASES. bioelisa
Answering your daily challenges in the ELISA technology I N FECTI OUS DISEASES bioelisa RETROVIRUS HIV is the cause of the most important global pandemic. Due to the lack of vaccination, early diagnosis
More informationThe Study of Congenital Infections. A/Prof. William Rawlinson Dr. Sian Munro
The Study of Congenital Infections A/Prof. William Rawlinson Dr. Sian Munro Current Studies SCIP Study of Cytomegalovirus (CMV) Infection in Pregnancy ASCI Amniotic Fluid Study of Congenital Infections
More informationProposed 1 st IS for Hepatitis E Virus RNA WHO/BS/
www.pei.de Proposed 1 st IS for Hepatitis E Virus RNA WHO/BS/09.2126 S. Baylis, Division of Virology, Paul-Ehrlich-Institut, Langen, Germany SoGAT XXII 14 th -15 th April 2011, Rome, Italy Presented at:
More informationFor information only: all participants in the graduated plan procedure. 7 January 2013
Paul-Ehrlich-Institut P.O. Box 63207 Langen, Germany To: All marketing authorisation holders of cellular blood products and therapeutic single plasma as well as holders of an authorisation for stem cells
More informationThe ABCs of Viral Hepatitis Diagnosis. Ila Singh, M.D., Ph.D. P & S Viral Hepatitis. Hepatitis A, B, C, D, E and G viruses
The ABCs of Viral Hepatitis Diagnosis Ila Singh, M.D., Ph.D. P & S 14-453 is132@columbia.edu Viral Hepatitis Hepatotropic viruses Hepatitis A, B, C, D, E and G viruses Generalized infection plus infection
More informationMP Biomedicals Asia Pacific Pte. Ltd. (formerly Genelabs Diagnostics Pte. Ltd.)
Revision: 12 May 2005 1 WESTERN BLOT / IMMUNOBLOT HIV-1 BLOT Version 1.3* 11010-018 HIV-1 viral lysate Western Blot assay for the 11010-036 detection of antibodies to HIV-1 with serum 11010-108 108 strips
More informationChapters 21-26: Selected Viral Pathogens
Chapters 21-26: Selected Viral Pathogens 1. DNA Viral Pathogens 2. RNA Viral Pathogens 1. DNA Viral Pathogens Smallpox (pp. 623-4) Caused by variola virus (dsdna, enveloped): portal of entry is the respiratory
More informationHalton Region Health Department Vol 13, Issue 2 Summer 2006 To all Halton Physicians The following topics are included in this update: West Nile Virus Update Update on Mumps Hepatitis B Immunization for
More informationSerology for Biochemists
Serology for Biochemists Dr Ronda Greaves Diagram from: http://www.cdc.gov/hepatitis/resources/professionals/training/serology/training.htm Overview Part A: GENERAL SEROLOGY IgG vs IgM Definitions The
More informationSchedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK
2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK Clinical Microbiology QMC Campus Derby Road Nottingham NG7 2UH Contact: Jil Bowskill Tel: +44 (0) 1905 760192 Ext 30659 E-Mail: jilean.bowskill@nuh.nhs.uk
More informationAccuSet HBV Worldwide Performance Panel
PACKAGE INSERT 0805-033 INTENDED USE The is intended for use by diagnostic manufacturers, researchers, and clinical laboratories to develop, evaluate, or troubleshoot HBV test methods. Characterized samples
More informationAcute Hepatitis: An Approach to Infectious and Other Causes. Mary Anne Cooper MSc, MD, MEd, FRCPC
: An Approach to Infectious and Other Causes Mary Anne Cooper MSc, MD, MEd, FRCPC Faculty: Dr. Mary Anne Cooper Relationships with commercial interests: Consulting Fees: Lupin Pharmaceuticals, Canada Objectives
More informationINTERPRETING HEPATITIS B SEROLOGY
INTERPRETING HEPATITIS B SEROLOGY RECOMMENDED WORDING FOR NATIONAL LABORATORIES TO REPORT HEPATITIS B DIAGNOSTIC TEST RESULTS THIS DOCUMENT HAS BEEN ENDORSED BY: Australasian Society for HIV Medicine,
More informationEQA PROGRAMME CATALOGUE. Version number CAT2019/01
2019 EQA PROGRAMME CATALOGUE www.qcmd.org Version number CAT2019/01 Contents An Introduction to the QCMD EQA Schemes 5 EQA Groups Blood Borne Virus 6 Central Nervous System 6 Congenital Infections 7 Drug
More informationManagement of Viral Infection during Pregnancy
Vaccination Management of Viral Infection during Pregnancy JMAJ 45(2): 69 74, 2002 Takashi KAWANA Professor of Obstetrics and Gynecology, Teikyo University Mizonokuchi Hospital Abstract: Viral infection
More informationSingle donator specimens as advantage in external quality control assessments of infectious diseases
Single donator specimens as advantage in external quality control assessments of infectious diseases MD, PhD Maija Lappalainen and MD Jukka Suni HUSLAB, Department of Virology Labquality Days 10.2.2007
More informationThis document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
2002D0364 EN 01.07.2012 002.001 1 This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents B COMMISSION DECISION of 7 May 2002 on common technical
More information