ISTITUTO SUPERIORE DI SANITA Department of Infectious, Parasitic and Immunomediated Diseases IL RUOLO DELLISTITUTO SUPERIORE DI SANITA COME ORGANO TECNICO:

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



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



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



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



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



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:



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)



• 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)



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



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 3 Gen

MEIA 3 Gen

ChLIA (Immunometrico Chemioluminescenza)


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)



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)



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



DISTRIBUZIONE CENTRI PARTECIPANTI NEL 1994 E NEL 2003



TIPOLOGIA DEI CAMPIONI POSITIVI INVIATI



DISTRIBUZIONE GEOGRAFICA E PERCENTUALE DI

COPERTURA DEI CENTRI PARTECIPANTI



CHARACTERISTICS OF POSITIVE SAMPLES OF CHARACTERISTICS OF POSITIVE SAMPLES OF EACH SHIPMENT PANEL, BY YEAREACH SHIPMENT PANEL, BY YEAR





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



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.



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



Document GHTF/SG1/N045: 2008Document GHTF/SG1/N045: 2008

PROPOSED GENERAL CLASSIFICATION SYSTEMPROPOSED GENERAL CLASSIFICATION SYSTEM FOR IVD MEDICAL DEVICES FOR IVD MEDICAL DEVICES




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




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




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




CONFORMITY ASSESSMENT ROUTE FOR GENERAL CONFORMITY ASSESSMENT ROUTE FOR GENERAL IN VITROIN VITRO DIAGNOSTIC MEDICAL DEVICESDIAGNOSTIC MEDICAL DEVICES



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



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




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




2




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




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




HIV 1 ANTIGENHIV 1 ANTIGEN

SEROTYPING AND SEROTYPING AND GENOTYPING ASSAYGENOTYPING ASSAY: HCV: HCV



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.



SERO-CONVERSION PANELS USEDSERO-CONVERSION PANELS USED



DETECTION DELAY IN RECOGNITION OF HIV INFECTION DETECTION DELAY IN RECOGNITION OF HIV INFECTION RELATIVE TO NAT (DAYS)RELATIVE TO NAT (DAYS)



DETECTION DELAY OF HCV INFECTION (DAYS)DETECTION DELAY OF HCV INFECTION (DAYS)



DETECTION DELAY OF HBSAG INFECTION (DAYS)DETECTION DELAY OF HBSAG INFECTION (DAYS)



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







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



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

Documents

ISTITUTO SUPERIORE DI SANITA Department of Infectious, Parasitic and Immunomediated Diseases IL RUOLO DELLISTITUTO SUPERIORE DI SANITA COME ORGANO TECNICO: