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ISTITUTO SUPERIORE DI SANITA’Department of Infectious,
Parasitic and Immunomediated Diseases
IL RUOLO DELL’ISTITUTO SUPERIORE DI SANITA’ COME ORGANO TECNICO: IL CONTRIBUTO DEL DIPARTIMENTO
DI MALATTIE INFETTIVE, PARASSITARIE, ED IMMUNOMEDIATE
Dr. Maria Rapicetta
Dirigente di ricerca – DIRETTORE DEL REPARTO EPATITI VIRALI DIP. MIPI
1° CORSO DI AGGIORNAMENTO SUI DISPOSITIVI MEDICI: ASPETTI REGOLATORI E APPLICATIVI
ROMA, 18-19 MAGGIO 2009
ISTITUTO SUPERIORE DI SANITA’Department of Infectious,
Parasitic and Immunomediated Diseases
DPR 13/3/1986, n. 128 – Regolamento di esecuzione delle norme di cui all’art.189 del testo unico delle leggi sanitarie, approvato con regio decreto 24/7/1934, n. 1265, e successive modificazioni, in materia di produzione e commercio dei presidi medico-chirurgici. G.U. Serie Gen. n. 98 del 29/4/1986.
DM 3/3/1987, n. 133 - Assoggettamento alla disciplina dei presidi medico-chirurgici dei Kit per la rilevazione di anticorpi anti HIV. G.U. Serie Gen. n. 80 del 6/4/1987.
DM 12/12/1991 - Assoggettamento dei reagenti per il rivelamento di HBsAg ed anti HCV alla disciplina dei presidi medico-chirurgici. G.U. Serie Gen. n. 41 del 19/2/1992.
DPR 6/10/1998, n. 392 - Regolamento recante norme per la semplificazione dei procedimenti di autorizzazione alla produzione ed all’immissione in commercio di presidi medico-chirurgici, a norma dell’art. 20, comma 8, della legge 15/3/1997 n. 59. G.U. Serie Gen. n. 266 del 13/11/1998.
Provvedimento ministeriale 5/2/1999 – Approvazione dei requisiti della domanda e relativa documentazione da presentare ai fini dell’autorizzazione all’immissione in commercio ed alla variazione di autorizzazioni già concesse per i presidi medico-chirurgici. G.U. Serie Gen. n. 34 del 11/2/1999.
Circolare ministeriale 30/10/2000, n. 17 – Adeguamento dei livelli di sicurezza trasfusionale in presenza di metodiche atte alle indagini sui costituenti virali per HCV. G.U. Serie Gen. n. 258 del 4/11/2000.
Circolare ministeriale 19/12/2001, n. 14 – Indicazioni integrative alla Circolare 30/10/2000 n. 17, recante: “Adeguamento dei livelli di sicurezza trasfusionale in presenza di metodiche atte alle indagini sui costituenti virali per HCV”. G.U. Serie Gen. n. 300 del 28/12/2001.
DL 9/5/2003, n. 103 - Disposizioni urgenti relative alla sindrome respiratoria acuta severa (SARS). G.U. Serie Gen. n. 108 del 12/5/2003.
Direttiva 98/79/CE del Parlamento Europeo e del Consiglio del 27/10/1998 relativa ai dispositivi medico-diagnostici in vitro. G.U. C.E. n. L.331 del 7/12/1998.
DL 8/9/2000, n. 332 – Attuazione della Dir. 98/79/CE relativa ai dispositivi medico-diagnostici in vitro. G.U. Serie Gen. n. 269 del 17/11/2000.
RIFERIMENTI NORMATIVI
ISTITUTO SUPERIORE DI SANITA’Department of Infectious,
Parasitic and Immunomediated Diseases
NATIONAL CONTROLS OF HIV AN HEPATITIS TEST KITS IN EC MEMBER STATES*
EC Member State National control authority
licensing control and/or
evaluation
National control authority batch
release
Monitoring of kits in use and
other evaluation systems
None
Austria
Belgium
Denmark
Finland
France
Germany
Greece
Ireland
Italy
Luxembourg
Netherlands
Portugal
Spain
Sweden
UK
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
* from CPMP Biotechnology working group
ISTITUTO SUPERIORE DI SANITA’Department of Infectious,
Parasitic and Immunomediated Diseases
ATTIVITA’ DI CONTROLLO E CONSULENZA DEL DIPARTIMENTO MIPI
DELL’ISS NEL SETTORE DEI KIT DIAGNOSTICI IN VITRO
● Controllo di kit di tipo immunometrico per determinazioni qualitative e quantitative di marcatori di infezioni
● Controllo e validazione di kit per determinazione qualitativa e quantitativa di acidi nucleici (NAT) quali marcatori di infezioni
● Controlli di kit diagnostici post-marketing su segnalazione
● Allestimento di pannelli sierici e Preparazioni Standard per controlli interni di qualità
● Attuazione di programmi nazionali di valutazione esterna di qualità (VEQ) per laboratori del SSN
● Partecipazione a commissioni EU ed a Comitati Tecnici associati alla Direttiva 98/79/CE
● Organizzazione di convegni sulle specifiche tematiche rivolti a personale tecnico del SSN
ISTITUTO SUPERIORE DI SANITA’Department of Infectious,
Parasitic and Immunomediated Diseases
Gruppo di lavoro CdG/DMDV - Direttiva 98/79/CE (7 dicembre 1998)
SISTEMA DI GESTIONE DELL’AUTORIZZAZIONE (SGA)Il sistema è articolato in modo da definire, per le varie fasi delle attività:
a) Politica e conduzione della certificazione;
b) Organizzazione tecnica, amministrativa e delle risorse umane;
c) Pianificazione delle attività interessate, ivi comprese l’assegnazione delle risorse e la documentazione;
d) Misura delle prestazioni conseguite con l’adozione del sistema, ivi incluse le verifiche ispettive (audit);
e) Verifica e riesame del sistema.
La struttura generale dell’ SGA risponde allo stato dell’arte in materia ed è schematizzabile nel seguente modello logico:
Verifica delle
soluzioni adottate
Pianificazione
delle attività
Controlli e azioni
correttiveAttuazione
dell’ SGA
Politica per la
Certificazione di dispositivi
medico-diagnostici in vitro
Miglioramento
continuo
ISTITUTO SUPERIORE DI SANITA’Department of Infectious,
Parasitic and Immunomediated Diseases
Gruppo di lavoro CdG/DMDV - Direttiva 98/79/CE (7 dicembre 1998)
ARTICOLAZIONE DEL SISTEMA DI GESTIONE DELL’AUTORIZZAZIONE
Rif. SEZIONI Cod. SOTTOSEZIONI
1. Politica dell’Istituto1.1 Politica per la certificazione
1.2 Piano di attuazione della politica
2.Controllo dell’organizzazione
2.1 Organizzazione
2.2 Personale
3.Controllo delle valutazioni di conformità
3.1 Richiesta di valutazione
3.2 Preparazione della valutazione
3.3 Conduzione della valutazione
3.4 Rapporto sulla valutazione
3.5 Modifiche ai requisiti della valutazione
3.6 Sorveglianza e rinnovo della certificazione
4.Controllo delle prestazioni
4.1Analisi e valutazione delle non conformità
4.2 Verifiche ispettive interne
4.3 Reclami
5. Revisione del sistema5.1 Misura delle prestazioni del sistema
5.2 Riesame del sistema
L’ SGA è articolato nelle seguenti Sezioni e Sottosezioni:
ISTITUTO SUPERIORE DI SANITA’Department of Infectious,
Parasitic and Immunomediated Diseases
ORGANIGRAMMA NOMINATIVO DEI RESPONSABILI DEL COMITATO DI GESTIONE DEI DMDV
(CdG/DMDV - Dipartimento Malattie Infettive, Parassitarie ed Immunomediate - MIPI)
Direttiva 98/79/CE (7 dicembre 1998)
ISTITUTO SUPERIORE DI SANITA’Department of Infectious,
Parasitic and Immunomediated Diseases
• Licensing after the evaluations of technical documentation and of
sample kit by the Istituto Superiore di Sanità and by the Ministry of
Health*
• Batch release procedure by the Istituto Superiore di Sanità
• External quality control (NEQAS) by the Istituto Superiore di Sanità
* Any variation of components, expire date and production procedure must be authorised
PROCEDURES FOR DIAGNOSTIC KITS CONTROL IN ITALY
(Decrees: 3 March 1987 (anti-HIV), 12 December 1991 (HBsAg, Anti-HCV)
ISTITUTO SUPERIORE DI SANITA’Department of Infectious,
Parasitic and Immunomediated Diseases
REQUIREMENTS FOR TECHNICAL DOCUMENTATION
THE TECHNICAL DOCUMENTATION PROVIDED BY THE MANUFACTURERS MUST BE BASED, FOR LICENSING PROCEDURE ON:
• biological principles of methodology• production methods & characterization of each reagent• type of reagents and their shelf life including their assessment• description of testing procedures• adapted procedures for result assessment• sensitivity, specificity and accuracy (with description of the assessment methods)• information sheet, also in Italian, as an integral part of the kit, reporting the elements listed above, handling precautions and limitation on the physical, biological and clinical aspects, and the list of necessary but not provided materials
FOR BATCH RELEASE PROCEDURE, ON:
• series number of the batch and of the individuals components• expire date of the batch and the individual reagents (which must comply with the registration documentation)
• the number of kits in the batch• quality control certificate and quality control assays performed by the manufacturer
ISTITUTO SUPERIORE DI SANITA’Department of Infectious,
Parasitic and Immunomediated Diseases
Tradename Brand
Screening tests
Method Manufacturer
AXSYM HIV 1/2 gO EIA
VIDAS HIV DUO
HIV COMBI EIA COBAS CORE
VITROS ANTI HIV 1+2
ENZYGNOST ANTI HIV 1/2 PLUS
ORTHO HIV-1/HIV-2 Ab CAPTURE ELISA TEST
BIOTEST ANTI-HIV TETRA ELISA
GENSCREEN HIV 1/2 versione 2
VIRONOSTIKA HIV UNI-FORM II PLUS O
ImX HIV-1/HIV-2 III PLUS
ACCESS HIV-1/2 NEW
ENZYGNOST HIV Integral
MUREX HIV- 1.2.O
COBAS CORE ANTI HIV 1-2-O EIA
ABBOTT HIV 1/2 gO EIA
MEIA 3 Gen
ELFA (FluorescenzaI Indirect sandwich 4 Gen
ECLIA (ElettroChemiLunescenza) sandwich 4 Gen
Immunometric luminescence 3 Gen
ELISA 3 Gen
ELISA 3 Gen
ELISA (sandwich) 3 Gen
ELISA (sandwich) 3 Gen
ELISA 3 Gen
MEIA 3 Gen
ChLIA (Immunometrico Chemioluminescenza)
ELISA (sandwich) 4 Gen
ELISA 3 Gen
ELISA 3 Gen
ELISA 3 Gen
ABBOTT
BIOMERIEUX
ROCHE
ORTHO
DADE BEHRING
ORTHO
BIOTEST
BIO-RAD
ORGANON
ABBOTT
BIO-RAD
DADE BEHRING
ABBOTT
ROCHE
ABBOTT
ANTI-HIV TESTING KITS (VEQ 2004)
ISTITUTO SUPERIORE DI SANITA’Department of Infectious,
Parasitic and Immunomediated Diseases
Tradename Brand
Screening tests
Method Manufacturer
AXSYM HCV
COBAS CORE ANTI-HCV EIAS
ORTHO HCV 3.0 ELISA Test System with Enhanced SAVe
VITROS HCV
ARCHITECT ANTI HCV
IMX HCV v.3.0
INNO-TEST HCV Ab IV
ABBOTT HCV EIA 3.0
MONOLISA ANTI-HCV PLUS
ACCESS HCV PLUS
AXSYM HBsAg V. 2
COBAS CORE HBsAg EIA II
VIDAS HBsAg
VITROS HBsAg
ARCHITECT HBsAg
ELECSYS HBsAg
ETI MAK 4
ORTHO ANTIBODY TO HBsAg ELUSA TEST SYSTEM 3
ENZYGNOST HBsAg 5.0
IMX HBsAg
HEPANOSTIKA HBsAg UNIFORM II
SUPERMIK HBsAg
MONOLISA Ag HBs PLUS
ACCESS HBsAg
MEIA
ELISA (indirectI
ELISA
Immunometric luminescence
CMIA
MEIA
ELISA
ELISA
ELISA (indirect)
Enzyme Immunoassay (chemiluminescence)
MEIA 3 Gen
ELISA sandwich
ELFA (Enzyme Linked Fluorescent assay)
Immunometric luminescence
CMIA (chemiluminescent microparticle immunoassay)
ECLIA (ElettroChemiLuminescenza)
ELISA direct sandwich
ELISA 3 Gen
ELISA
MEIA
ELISA sandwich
ELISA sandwich
ABBOTT
ROCHE
ORTHO
ORTHO
ABBOTT
ABBOTT
INNOGENETICS
ABBOTT
BIO-RAD
BIO-RAD
ABBOTT
ROCHE
BIOMERIEUX
ORTHO
ABBOTT
ROCHE
DIASORIN
ORTHO
DADE BEHRING
ABBOTT
ORGANON
MED. SYSTEM
BIO-RAD
BIO-RAD
ANTI-HCV and HBsAg TESTING KITS (VEQ 2004)
ISTITUTO SUPERIORE DI SANITA’Department of Infectious,
Parasitic and Immunomediated Diseases
Tradename Brand
Screening tests
Manufacturer
COBAS AMPLISCREEN HCV TEST v. 2.0
COBAS AMPLISCREEN HIV-1 TEST v. 1.5
COBAS AMPLISCREEN HBV TEST
PROCLEIX HIV-1/HCV
PROCLEIX ULTRIO ASSAY
HIV, HBV, HCV CONFIRMATORY TESTS
CHIRON RIBA HCV 3.0 SIA
INNO-LIA HCV Ab III UPDATE
DECISCAN HCV PLUS
HIV BLOT 2.2
NEW LAV BLOT I Ac Ab Ak
CHIRON RIBA HIV-1/HIV-2 SIA
INNO-LIA HIV K1036 IT
INNOLIA HIV CONFIRMATION
BIOBLOT HIV-1 PLUS
ELECSYS HBsAG CONFIRMATORY
COBAS CORE HBsAg II CONFIRMATORY EIA
ROCHE
ROCHE
ROCHE
CHIRON
CHIRON
CHIRON
INNOGENETICS
SANOFI-PASTEUR
ALFA BIOTECH
BIO-RAD
ORTHO
ONNOGENETICS
INNOGENETICS
INSTRUMENTATION LAB.
ROCHE
ROCHE
HIV, HBV, HCV NAT TESTS
ISTITUTO SUPERIORE DI SANITA’Department of Infectious,
Parasitic and Immunomediated Diseases
DISTRIBUZIONE CENTRI PARTECIPANTI NEL 1994 E NEL 2003
ISTITUTO SUPERIORE DI SANITA’Department of Infectious,
Parasitic and Immunomediated Diseases
TIPOLOGIA DEI CAMPIONI POSITIVI INVIATI
ISTITUTO SUPERIORE DI SANITA’Department of Infectious,
Parasitic and Immunomediated Diseases
DISTRIBUZIONE GEOGRAFICA E PERCENTUALE DI
COPERTURA DEI CENTRI PARTECIPANTI
ISTITUTO SUPERIORE DI SANITA’Department of Infectious,
Parasitic and Immunomediated Diseases
CHARACTERISTICS OF POSITIVE SAMPLES OF CHARACTERISTICS OF POSITIVE SAMPLES OF EACH SHIPMENT PANEL, BY YEAREACH SHIPMENT PANEL, BY YEAR
ISTITUTO SUPERIORE DI SANITA’Department of Infectious,
Parasitic and Immunomediated Diseases
ISTITUTO SUPERIORE DI SANITA’Department of Infectious,
Parasitic and Immunomediated Diseases
EU IVD DIRECTIVEEU IVD DIRECTIVE
Directive 98/79/EC of the European Parliament and of the Council on Directive 98/79/EC of the European Parliament and of the Council on in in vitrovitro Diagnostic Medical Devices Diagnostic Medical Devices
- adopted on 5 October 1998- adopted on 5 October 1998
- published in Official Journal of EU Committees on 7 December 1998- published in Official Journal of EU Committees on 7 December 1998
- published in Italian GU n. 269 on 17 November 2000- published in Italian GU n. 269 on 17 November 2000
■ ■ has introduced at EU level common regulatory requirements for safety quality and has introduced at EU level common regulatory requirements for safety quality and performance of IVDsperformance of IVDs
■ ■ applies to: applies to:reagents and reagent products, calibrator materials or instruments including specimen reagents and reagent products, calibrator materials or instruments including specimen receptacles intended by the manufacturer for the in vitro examination of human tissue, receptacles intended by the manufacturer for the in vitro examination of human tissue, blood or fluid samples for the purpose of providing information about a patient’s state of blood or fluid samples for the purpose of providing information about a patient’s state of healthhealth
ISTITUTO SUPERIORE DI SANITA’Department of Infectious,
Parasitic and Immunomediated Diseases
Directive 98/79/CE (7 December 1998)Directive 98/79/CE (7 December 1998)ANNEX IANNEX I
ESSENTIAL REQUIREMENTSESSENTIAL REQUIREMENTS
The manufacturer has to demonstrate that the The manufacturer has to demonstrate that the in vitroin vitro diagnostic medical devices: diagnostic medical devices:
■■ do not compromise the health and safety of patients and users do not compromise the health and safety of patients and users
■■ are designed and manufactured to be suitable for the stated medical purpose, taking into account of are designed and manufactured to be suitable for the stated medical purpose, taking into account of
the generally acknowledged state of the artthe generally acknowledged state of the art
■■ are able to achieve the performance, where appropriate, in terms of: analytical sensitivity, diagnostic are able to achieve the performance, where appropriate, in terms of: analytical sensitivity, diagnostic
sensitivity, analytical specificity, diagnostic specificity, accuracy, repeatability, reproducibility, sensitivity, analytical specificity, diagnostic specificity, accuracy, repeatability, reproducibility,
including control of known relevant interferences, and limits of detection.including control of known relevant interferences, and limits of detection.
■■ possess the elements of traceability, i.e.: possess the elements of traceability, i.e.:
aa - The values assigned to calibrators and/or control materials, are assured through available - The values assigned to calibrators and/or control materials, are assured through available
reference measurement procedures and/or available reference materials of a higher order.reference measurement procedures and/or available reference materials of a higher order.
bb - are designed, manufactured and packed in such a way that their characteristics and - are designed, manufactured and packed in such a way that their characteristics and
performances during their intended use will not be adversely affected under storage and transport performances during their intended use will not be adversely affected under storage and transport
conditionsconditions
cc - labeling information and instructions for use, both for devices intended for professional use - labeling information and instructions for use, both for devices intended for professional use
and for self-tests are addressed to lay persons.and for self-tests are addressed to lay persons.
■■ Is characterized by risk analysis including the identification and demonstration of acceptability of Is characterized by risk analysis including the identification and demonstration of acceptability of
risks related with their use.risks related with their use.
ISTITUTO SUPERIORE DI SANITA’Department of Infectious,
Parasitic and Immunomediated Diseases
Directive 98/79/CE (7 December 1998)Directive 98/79/CE (7 December 1998)
CLASSIFICATION OF IVDS INTO CATEGORIESCLASSIFICATION OF IVDS INTO CATEGORIES
1 - Devices listed in Annex II-List A1 - Devices listed in Annex II-List AReagents and reagent products for detection of infections by HIV 1 and 2, HTLV-I and II or by Reagents and reagent products for detection of infections by HIV 1 and 2, HTLV-I and II or by
hepatitis B, C and D viruses. Reagents for determination of ABO system, Rhesus-C, c, D, E, e, hepatitis B, C and D viruses. Reagents for determination of ABO system, Rhesus-C, c, D, E, e,
anti-Kell.anti-Kell.
2 -2 - Devices listed in Annex II-List B Devices listed in Annex II-List BReagents and reagent products for determination of anti-Duffy, anti-Kidd, irregular anti-Reagents and reagent products for determination of anti-Duffy, anti-Kidd, irregular anti-
erythrocytic antibodies, tumor marker PSA, HLA tissue groups DR, A, B, detection of erythrocytic antibodies, tumor marker PSA, HLA tissue groups DR, A, B, detection of
phenylketonuria, detection of the infectious diseases: rubella, toxoplasmosis, cytomegalovirus phenylketonuria, detection of the infectious diseases: rubella, toxoplasmosis, cytomegalovirus
and chlamydia, detection of trisomy 21. Self-testing devices for the measurement of blood and chlamydia, detection of trisomy 21. Self-testing devices for the measurement of blood
glucose.glucose.
3 -3 - Devices for self-testingDevices for self-testing
4 - All other devices not listed in Annex II and not intended for self-testing4 - All other devices not listed in Annex II and not intended for self-testing
ISTITUTO SUPERIORE DI SANITA’Department of Infectious,
Parasitic and Immunomediated Diseases
Document GHTF/SG1/N045: 2008Document GHTF/SG1/N045: 2008
PROPOSED GENERAL CLASSIFICATION SYSTEMPROPOSED GENERAL CLASSIFICATION SYSTEM FOR IVD MEDICAL DEVICES FOR IVD MEDICAL DEVICES
ISTITUTO SUPERIORE DI SANITA’Department of Infectious,
Parasitic and Immunomediated Diseases
Directive 98/79/CE (7 December 1998)Directive 98/79/CE (7 December 1998)
CONFORMITY ASSESSMENT ROUTES FOR CONFORMITY ASSESSMENT ROUTES FOR IN VITROIN VITRO DIAGNOSTIC DIAGNOSTIC MEDICAL DEVICES LISTED IN ANNEX II-LIST-AMEDICAL DEVICES LISTED IN ANNEX II-LIST-A
ISTITUTO SUPERIORE DI SANITA’Department of Infectious,
Parasitic and Immunomediated Diseases
Directive 98/79/CE (7 December 1998)Directive 98/79/CE (7 December 1998)
CONFORMITY ASSESSMENT ROUTES FOR CONFORMITY ASSESSMENT ROUTES FOR IN VITROIN VITRO DIAGNOSTIC DIAGNOSTIC MEDICAL DEVICES LISTED IN ANNEX II-LIST-BMEDICAL DEVICES LISTED IN ANNEX II-LIST-B
ISTITUTO SUPERIORE DI SANITA’Department of Infectious,
Parasitic and Immunomediated Diseases
Directive 98/79/CE (7 December 1998)Directive 98/79/CE (7 December 1998)
CONFORMITY ASSESSMENT ROUTES FOR CONFORMITY ASSESSMENT ROUTES FOR IN VITROIN VITRO DIAGNOSTIC DIAGNOSTIC MEDICAL DEVICES TO BE USED FOR SELF-TESTINGMEDICAL DEVICES TO BE USED FOR SELF-TESTING
ISTITUTO SUPERIORE DI SANITA’Department of Infectious,
Parasitic and Immunomediated Diseases
Directive 98/79/CE (7 December 1998)Directive 98/79/CE (7 December 1998)
CONFORMITY ASSESSMENT ROUTE FOR GENERAL CONFORMITY ASSESSMENT ROUTE FOR GENERAL IN VITROIN VITRO DIAGNOSTIC MEDICAL DEVICESDIAGNOSTIC MEDICAL DEVICES
ISTITUTO SUPERIORE DI SANITA’Department of Infectious,
Parasitic and Immunomediated Diseases
Document GHTF/SG1/N045: 2008Document GHTF/SG1/N045: 2008
CONCEPTUAL ILLUSTRATION OF REGULATORY REQUIREMENTS CONCEPTUAL ILLUSTRATION OF REGULATORY REQUIREMENTS INCREASING WITH DEVICE RISK CLASSINCREASING WITH DEVICE RISK CLASS
ISTITUTO SUPERIORE DI SANITA’Department of Infectious,
Parasitic and Immunomediated Diseases
COMMON TECHNICAL SPECIFICATIONCOMMON TECHNICAL SPECIFICATIONSS (CTS) 2009/108/EC amending 2002/364/EC (CTS) 2009/108/EC amending 2002/364/EC
SCREENING ASSAYS: ANTI-HIV 1 AND 2, ANTI-HTLV I AND II, SCREENING ASSAYS: ANTI-HIV 1 AND 2, ANTI-HTLV I AND II, ANTI-HCV, HBSAG, ANTI-HBCANTI-HCV, HBSAG, ANTI-HBC
ISTITUTO SUPERIORE DI SANITA’Department of Infectious,
Parasitic and Immunomediated Diseases
COMMON TECHNICAL SPECIFICATIONCOMMON TECHNICAL SPECIFICATIONSS (CTS) 2009/108/EC amending 2002/364/EC (CTS) 2009/108/EC amending 2002/364/EC
NAT ASSAYS FOR HIV 1, HCV, HBV, HTLV I/IINAT ASSAYS FOR HIV 1, HCV, HBV, HTLV I/II(QUALITATIVE AND QUANTITATIVE; NOT MOLECULAR TYPING)(QUALITATIVE AND QUANTITATIVE; NOT MOLECULAR TYPING)
1
ISTITUTO SUPERIORE DI SANITA’Department of Infectious,
Parasitic and Immunomediated Diseases
COMMON TECHNICAL SPECIFICATIONCOMMON TECHNICAL SPECIFICATIONSS (CTS) 2009/108/EC amending 2002/364/EC (CTS) 2009/108/EC amending 2002/364/EC
2
ISTITUTO SUPERIORE DI SANITA’Department of Infectious,
Parasitic and Immunomediated Diseases
COMMON TECHNICAL SPECIFICATIONCOMMON TECHNICAL SPECIFICATIONSS (CTS) 2009/108/EC amending 2002/364/EC (CTS) 2009/108/EC amending 2002/364/EC
For quantitative NATs a study shall be performed on at least 100 positive specimens reflecting the routine conditions of users (e.g. no pre-selection of specimens). Comparative results with another NAT test system shall be generated in parallel.
For qualitative NATs a study on diagnostic sensitivity shall be performed using at least 10 seroconversion panels. Comparative results with another NAT test system shall be generated in parallel.
3
ISTITUTO SUPERIORE DI SANITA’Department of Infectious,
Parasitic and Immunomediated Diseases
COMMON TECHNICAL SPECIFICATIONCOMMON TECHNICAL SPECIFICATIONSS (CTS) 2009/108/EC amending 2002/364/EC (CTS) 2009/108/EC amending 2002/364/EC
RAPID TESTS: ANTI- HIV 1 AND 2, ANTI-HCV, HBSAG,RAPID TESTS: ANTI- HIV 1 AND 2, ANTI-HCV, HBSAG,ANTI-HBC, ANTI-HTLV I AND IIANTI-HBC, ANTI-HTLV I AND II
ISTITUTO SUPERIORE DI SANITA’Department of Infectious,
Parasitic and Immunomediated Diseases
COMMON TECHNICAL SPECIFICATIONCOMMON TECHNICAL SPECIFICATIONSS (CTS) 2009/108/EC amending 2002/364/EC (CTS) 2009/108/EC amending 2002/364/EC
HIV 1 ANTIGENHIV 1 ANTIGEN
SEROTYPING AND SEROTYPING AND GENOTYPING ASSAYGENOTYPING ASSAY: HCV: HCV
ISTITUTO SUPERIORE DI SANITA’Department of Infectious,
Parasitic and Immunomediated Diseases
DEFINITION OF THE “STATE OF ART” FOR HIV DETECTION DEVICES DEFINITION OF THE “STATE OF ART” FOR HIV DETECTION DEVICES INCLUDING HIV AG/AB COMBINATION ASSAYS, INCLUDING HIV AG/AB COMBINATION ASSAYS,
ANTI-HIV-1/2 ASSAYS AND HIV RAPID TESTSANTI-HIV-1/2 ASSAYS AND HIV RAPID TESTS
Common Technical Specifications (CTS, 3 February 2009 amending Decision 2002/364/EC)Common Technical Specifications (CTS, 3 February 2009 amending Decision 2002/364/EC) “diagnostic tests sensitivity during the early infection phase (sero-conversion) has to “diagnostic tests sensitivity during the early infection phase (sero-conversion) has to represent the state of art”. Furthermore, two categories of samples are defined:represent the state of art”. Furthermore, two categories of samples are defined:
Early sero-conversion HIV samples:Early sero-conversion HIV samples: - p24 antigen and/or HIV RNA positive and; - p24 antigen and/or HIV RNA positive and; - not recognised by all of the antibody screening tests and; - not recognised by all of the antibody screening tests and; - indeterminate or negative confirmatory assays - indeterminate or negative confirmatory assays
Sero-conversion HIV:Sero-conversion HIV: - p24 antigen and/or HIV RNA positive and; - p24 antigen and/or HIV RNA positive and; - recognised by all of the antibody screening tests and; - recognised by all of the antibody screening tests and; - positive or indeterminate confirmatory assays - positive or indeterminate confirmatory assays
HIV tests shall identify all sero-conversion HIV samples as positive; and at least 40 early HIV tests shall identify all sero-conversion HIV samples as positive; and at least 40 early sero-conversion HIV samples shall be tested. Results should conform to the state of the sero-conversion HIV samples shall be tested. Results should conform to the state of the art.art.
ISTITUTO SUPERIORE DI SANITA’Department of Infectious,
Parasitic and Immunomediated Diseases
SERO-CONVERSION PANELS USEDSERO-CONVERSION PANELS USED
ISTITUTO SUPERIORE DI SANITA’Department of Infectious,
Parasitic and Immunomediated Diseases
DETECTION DELAY IN RECOGNITION OF HIV INFECTION DETECTION DELAY IN RECOGNITION OF HIV INFECTION RELATIVE TO NAT (DAYS)RELATIVE TO NAT (DAYS)
ISTITUTO SUPERIORE DI SANITA’Department of Infectious,
Parasitic and Immunomediated Diseases
DETECTION DELAY OF HCV INFECTION (DAYS)DETECTION DELAY OF HCV INFECTION (DAYS)
ISTITUTO SUPERIORE DI SANITA’Department of Infectious,
Parasitic and Immunomediated Diseases
DETECTION DELAY OF HBSAG INFECTION (DAYS)DETECTION DELAY OF HBSAG INFECTION (DAYS)
ISTITUTO SUPERIORE DI SANITA’Department of Infectious,
Parasitic and Immunomediated Diseases
SUMMARY RESULTS OF THE SERO-CONVERSION STUDYSUMMARY RESULTS OF THE SERO-CONVERSION STUDYHIV 1/2, Ab TEST KITHIV 1/2, Ab TEST KIT
Test kit
ISTITUTO SUPERIORE DI SANITA’Department of Infectious,
Parasitic and Immunomediated Diseases
ISTITUTO SUPERIORE DI SANITA’Department of Infectious,
Parasitic and Immunomediated Diseases
ISTITUTO SUPERIORE DI SANITA’Department of Infectious,
Parasitic and Immunomediated Diseases
Directive 98/79/CE (7 December 1998)Directive 98/79/CE (7 December 1998)ANNEX III sect. 3ANNEX III sect. 3
TECHNICAL DOCUMENTATIONTECHNICAL DOCUMENTATION
Must include:Must include:
1 -1 - General description of the product General description of the product
2 -2 - Documentation of the quality system Documentation of the quality system
3 -3 - Design information including origin of material; drawings and diagrams and the Design information including origin of material; drawings and diagrams and the
operation of the product; description of the procedures used for sterile products; labels operation of the product; description of the procedures used for sterile products; labels
and instructions for useand instructions for use
4 -4 - Results of the risk analysis Results of the risk analysis
5 -5 - Results of the design calculations and of the inspections carried out Results of the design calculations and of the inspections carried out
6 -6 - The test reports The test reports
7 -7 - The results of stability studies The results of stability studies
ISTITUTO SUPERIORE DI SANITA’Department of Infectious,
Parasitic and Immunomediated Diseases
SUMMARY RESULTS OF THE SERO-CONVERSION STUDYSUMMARY RESULTS OF THE SERO-CONVERSION STUDYHIV 1/2 Ag/Ab TEST KITHIV 1/2 Ag/Ab TEST KIT
Test kit