Kit di Test Antigenico Rapido per SARS-CoV-2

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DOCUMENTAZIONE

Kit di Test Antigenico Rapido per SARS-CoV-2

(IMMUNOCROMATOGRAFIA CON ORO COLLOIDALE)

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Kit di Test Antigenico Rapido per SARS-CoV-2

(IMMUNOCROMATOGRAFIA CON ORO COLLOIDALE)

Il prodotto è volto al rilevamento qualitativo di antigeni contro il SARS-COV-2 in campioni clinici (tampone nasale).

Disponibile in formato 25 test/kit e 1 test/kit 1

^Test/kit

25

^Test/kit

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FUNZIONI DESCRIZIONE CARATTERISTICHE

INDICAZIONI

Il Kit di Test Antigenico Rapido per SARS-CoV-2 (Immunocromatografia con oro colloidale) è un test immunoenzimatico per uso professionale, di grande rapidità e facilità d’uso (15 minuti), destinato alla determinazione qualitativa dell'antigene di SARS-Co- V-2 a partire da tampone nasofaringeo.

Sensibilità diagnostica: 92,00 % (percentuale di soggetti malati correttamente identificati) Specificità diagnostica: 99,26 % (percentuale di soggetti sani correttamente identificati)

Il prodotto è composto da schede di prova, Istruzioni per l’uso, soluzione di trattamento del campione. Inoltre, in ogni busta di scheda di prova vi è una scheda di rilevamento dell'antigene SARS-COV-2 e una confezione di essiccante.

La scheda di prova è composta da un tappetino standard dorato (rivestito con anticorpo monoclonale della proteina del SARS-CoV-2 N con etichetta oro colloidale), tappetino del campione, membrana di nitrocellulosa. (l'area di test (T) è rivestita con un anticorpo monoclonale della proteina della SARS-COV-2 N; l'area di controllo (C) è rivestita con anticorpo di capra anti-topo), carta assorbente e carta rigida idrofoba.

Il test è adatto solo a professionisti per una diagnosi in vitro ausiliare. Non congelare o utilizzare dopo la data di scadenza (riportata sulla confezione). Il test tessera va usato entro un’ora dall’apertura della busta sigillata in alluminio.

Evitare temperature eccessive e umidità nell’ambiente di laboratorio. La temperatura di reazione dovrebbe essere 15-30°C e l’umidità dovrebbe essere sotto il 70%.

Durante la fase di test indossare indumenti di protezione, mascherina medica, guanti e occhiali. Non utilizzare schede di test con una singola confezione rotta, segni poco chiari, né dopo la data di scadenza. Durante il test la scheda di prova deve essere posta sul piano orizzontale. La scheda di prova deve essere fissata e non deve essere rimossa.

Disporre di campioni usati, tessere test e altri rifiuti nel bidone di raccolta indifferenziata all’interno di un sacchetto di plastica.

Conservare a 4°C~ 30°C, C, in ambiente asciutto, lontano dalla luce solare diretta. Shelf life pari a 12 mesi.

Kit di Test Antigenico Rapido per SARS-CoV-2

(IMMUNOCROMATOGRAFIA CON ORO COLLOIDALE)

IL KIT INCLUDE:

DISPOSITIVO MEDICO CLASS

E 1 E’ un dispositivo medico-diagnostico in vitro.

Leggere le avvertenze e le istruzioni per l’uso.

Autorizzazione del 31/10/2020

Formato 1 test/kit 25 test/kit Ogni busta

1 test 25 test

1 1

1ml x 1 3ml x 2

Tessere test Manuale d’uso Soluzione per il trattamento del campione

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Il prodotto è composto da schede di prova, Istruzioni per l’uso, soluzione di trattamento del campione. Inoltre, in ogni busta di scheda di prova vi è una scheda di rilevamento dell'antigene SARS-COV-2 e una confezione di essiccante.

La scheda di prova è composta da un tappetino standard dorato (rivestito con anticorpo monoclonale della proteina del SARS-CoV-2 N con etichetta oro colloidale), tappetino del campione, membrana di nitrocellulosa. (l'area di test (T) è rivestita con un anticorpo monoclonale della proteina della SARS-COV-2 N; l'area di controllo (C) è rivestita con anticorpo di capra anti-topo), carta assorbente e carta rigida idrofoba.

Kit di Test Antigenico Rapido per SARS-CoV-2

(IMMUNOCROMATOGRAFIA CON ORO COLLOIDALE)

Prelevare il campione nasofaringeo

TEST POSITIVO TEST NEGATIVO TEST INVALIDO

1

Aggiungere 6 gocce di diluente nell’incavo A.

Routare il fusto 2 volte in entrambe le direzioni (orario e antiorario)

4

Rimuovere la copertura della colla fissante.

2 Inserire il campione di

tampone attraverso il fondo del pozzetto B nel pozzetto A.

3

Fare aderire i due lati assieme.

Il risultato sarà visibile entro 15/20 minuti

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DESCRIZIONE

INTERPRETAZIONE DEI RISULTATI DEL TEST

DISPOSITIVO MEDICO CLASS

E 1 E’ un dispositivo medico-diagnostico in vitro.

Leggere le avvertenze e le istruzioni per l’uso.

Autorizzazione del 31/10/2020

Barcode 1 test/kit Barcode 25 test/kit

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Certificazioni / Test report

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9/11/2020 Elenco dei dispositivi medici

www.salute.gov.it/interrogazioneDispositivi/RicercaDispositiviServlet?action=ACTION_RICERCA 1/1

Area tematica Dispositivi medici | Archivio banche dati

Stampa | Scarica il dataset Elenco dei dispositivi medici

Criteri di ricerca:

Denominazione fabbricante:

Codice fiscale fabbricante:

Partita IVA / VAT number fabbricante:

Codice nazione fabbricante:

Denominazione mandatario:

Codice fiscale mandatario:

Partita IVA / VAT number mandatario:

Codice nazione mandatario:

Tipologia dispositivo:

Identificativo di registrazione attribuito dal sistema BD/RDM: 2021437 Codice attribuito dal fabbricante:

Nome commerciale e modello:

Classificazione CND:

Descrizione CND:

Classe CE (valida solo per dispositivi medici di classe, impiantabili attivi e IVD):

Elenco dispositivi individuati Dati aggiornati al:07/11/2020

DISPOSITIVO MEDICO/ASSEMBLATO FABBRICANTE/ASSEMBLATORE

TIPOLOGIA DISPOSITIVO

IDENTIFICATIVO DI REGISTRAZIONE BD/RDM

ISCRITTO AL REPERTORIO

CODICE ATTRIBUITO DAL FABBRICANTE/ASSEMBLATORE

NOME COMMERCIALE E

MODELLO CND CLASSE

CE

DATA PRIMA PUBBLICAZIONE

DATA FINE IMMISSIONE IN COMMERCIO

RUOLO

AZIENDA DENOMINAZIONE CODICE FISCALE

PARTITA IVA/VAT NUMBER

NAZIONE

Dispositivo 2021437 N

SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography)

TEST RAPIDO PER DOSAGGIO DELL?

ANTIGENE DEL SARS-COV- 2 (IMMUNOCROMATOGRAFIA

CON ORO COLLOIDALE)

W0105099099 - VIROLOGIA - TEST RAPIDI E "POINT OF CARE" - ALTRI

IVD - Altro tipo di

IVD

31/10/2020

FABBRICANTE

LEPU MEDICAL TECHNOLOGY (BEIJING) CO.

LTD.

CN

MANDATARIO

LEPU MEDICAL (EUROPE) COOPERATIEF

U.A.

851526019B01 NL

<< < Pagina:1 > >> Num. Pagine:1 Num. Dispositivi:1

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Subject: Performance of Beijing Lepu Medical Technology Co., Ltd’s SARS-CoV-2 Antigen Rapid Test Kit are theoretically not be affected by recently discovered variants including the United Kingdom variant and the South African variant.

Dear valued customers:

We, Beijing Lepu Medical Technology Co., Ltd, would like to inform you that our SARS-CoV-2 Antigen Rapid Test Kit remain suitable for the detection of SARS-CoV- 2 antigen even in the emergence of newly discovered variants including the United Kingdom variant and the South African variant.

According to our investigation, several site mutations have occurred of the spike protein at positions of N501Y, E484K, K417N/T for SA mutant strain B.1.351(501Y.V2), and of N501Y, P681H, 69-70del、E484K for UK mutant strain b.1.1.7(501Y.V1), (From Guangdong Provincial Center for Disease Control and Prevention) and of N501Y、E484K、K417N/T for Brazil mutant strain P.1(501Y.V3). Since the recognition site of the raw materials used in our antigen test are the nucleocapsid protein different from mutation sites, we expect our products are theoretically able to detect variants including UK, Brazil, and SA.

Meanwhile, we will promptly communicate any updates regarding SARS- CoV-2 Antigen Rapid Test Kit. In addition, we will continue our efforts to comply with high quality management standards and to maintains a consistent high quality management system to ensure customer’s satisfaction and product safety. If you have any questions, please contact our sales representative.

Beijing Lepu Medical Technology Co., Ltd 2021-02-19

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federfarma

federazione nazionale unitaria dei titolari di farmacia italiani

Notizie, informazioni, aggiornamenti sul mondo della farmacia ogni giorno su la web TV di Federfarma

Via Emanuele Filiberto, 190 - 00185 ROMA

Tel. (06) 70380.1 - Telefax (06) 70476587 - e-mail:box@federfarma.it Cod. Fisc. 01976520583

Roma, 23 febbraio 2021

Uff.-Prot.n° URI.ML/EP/2863/108/PE Oggetto: UE: i test antigenici riconosciuti.

ALLE ASSOCIAZIONI PROVINCIALI ALLE UNIONI REGIONALI

SOMMARIO:

Lo scorso 17 febbraio 2021 il Comitato per la sicurezza sanitaria dell'UE ha concordato un elenco comune di test rapidi antigenici COVID-19, ovvero una selezione di test antigenici per i quali gli Stati membri riconosceranno reciprocamente i risultati. Alla base di tale elenco comune vi è la condivisione di una serie standardizzata di dati da includere nei certificati dei test COVID- 19.

Efficaci strategie comuni europee di screening sono un aspetto essenziale della preparazione e della risposta alla pandemia da COVID-19. Mentre è noto come il test molecolare (RT-PCR) rimanga ancora il migliore per la diagnosi del COVID-19, è altrettanto noto come i test antigenici rapidi siano sempre più utilizzati dagli Stati membri come un modo per rafforzare ulteriormente la loro capacità complessiva di effettuare screening di massa alla popolazione.

Per tale ragione il 21 gennaio 2021, gli Stati membri hanno approvato all’unanimità una Raccomandazione del Consiglio UE che stabilisce un quadro comune per l’uso dei test antigenici rapidi ed il riconoscimento reciproco dei risultati di tali test in tutta l’UE.

Tale raccomandazione invitava gli Stati membri a raggiungere tre risultati concreti:

1. Un elenco comune di test antigenici rapidi COVID-19 considerati appropriati per l’uso delle situazioni descritte nella raccomandazione e che soddisfino tre condizioni: a) portino il marchio CE; b) soddisfino i requisiti minimi di prestazione di sensibilità ≥ 90% e specificità ≥ 97

%; c) siano stati convalidati da almeno uno Stato membro come appropriati per il loro uso fornendo dettagli sulla metodologia e sui risultati degli studi.

2. Una selezione di test antigenici rapidi di cui gli Stati membri riconoscano reciprocamente i risultati per le misure di sanità pubblica.

3. Una serie comune standardizzata di dati da includere nei certificati dei risultati dei test COVID-19, facilitando il riconoscimento reciproco dei risultati dei test.

I tre risultati suddetti sono stati raggiunti dal Comitato per la sicurezza sanitaria dell’UE grazie all’approvazione di un documento approvato lo scorso 17 febbraio (EU health preparedness:

A common list of COVID-19 rapid antigen tests, including those of which their test results are mutually recognised, and a common standardised set of data to be included in COVID-19 test result certificates - cfr. all. n.1). Di seguito si analizzano i risultati raggiunti sui 3 punti suddetti da tale documento.

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I. Elenco comune dei test antigenici rapidi

Il documento fissa, nell’allegato I, i test presenti sul mercato europeo che gli Stati membri si impegnano a riconoscere reciprocamente. I test riportati nell’allegato evidentemente recano tutti il marchio CE; soddisfano i requisiti minimi di prestazione di ≥ 90% di sensibilità e ≥ 97 % di specificità; sono stati convalidati da almeno uno Stato membro come appropriati per il loro uso nel contesto del COVID-19, fornendo dettagli sulla metodologia e sui risultati di tali studi (quali il tipo di campione utilizzato per la convalida, il contesto in cui è stato valutato l’uso del test e se si sono verificate difficoltà per quanto riguarda i criteri di sensibilità richiesti o altri elementi di prestazione).

L’elenco suddetto dovrà essere condiviso con l’ECDC e la Commissione UE. A quel punto il Centro comune di ricerca (JRC) lo utilizzerà per aggiornare la banca dati "COVID-19 Dispositivi diagnostici in vitro e metodi di prova " ed elaborerà un elenco comune di test antigenici rapidi e dei loro usi disponibile online.

L’elenco sarà regolarmente rivisto dagli Stati membri nel contesto delle riunioni del Comitato per la sicurezza sanitaria e, se necessario, sarà aggiornato inserendo nuovi test che entreranno nel mercato e rimuovendo quelli non più ritenuti efficaci.

II. Test antigenici rapidi i cui risultati sono riconosciuti reciprocamente

Gli Stati membri si sono accordati su una selezione di test antigenici rapidi di cui riconoscono reciprocamente i risultati per le misure di sanità pubblica. Affinché i risultati dei test antigenici rapidi siano reciprocamente riconosciuti, tali test devono essere utilizzati da almeno tre Stati.

Sulla base di questo criterio, gli Stati membri hanno convenuto che i risultati dei seguenti test antigenici saranno reciprocamente riconosciuti per le misure di sanità pubblica, in quanto soddisfano tutti i criteri stabiliti:

- Abbott Rapid Diagnostics, Panbio™ COVID-19 Ag Rapid Test;

- AMEDA Labordiagnostik GmbH, AMP Rapid Test SARS-CoV-2 Ag;

- Becton Dickinson, BD Veritor System for Rapid Deteciton os SARS-CoV-2;

- Beijing Lepu Medical Technology, SARS-CoV-2 Antigen Rapid Test Kit (Immunocromatografia in oro colloidale);

- BIOSYNEX SWISS SA, BIOSYNEX COVID-19 Ag BSS;

- CerTest Biotect S.L., CerTest SARS-CoV-2 CARD TEST;

- Hangzhou Clongene Biotech, Clungene COVID-19 Antigen Rapid Test Kit;

- Healgen Scientific Limited, Coronavirus Ag Rapid Test Cassette (Swab);

- LumiraDX UK LTd, LumiraDx SARS-CoV-2 Ag Test;

- nal von minden GmbH, NADAL COVID -19 Ag Test;

- Quidel Corporation, Sofia 2 SARS Antigen FIA;

- SD BIOSENSOR, Inc., STANDARD F COVID-19 Ag FIA;

- SD BIOSENSOR, Inc., STANDARD Q COVID-19 Ag Test;

- Siemens Healthineers, CLINITEST Rapid COVID-19 Antigen Test - Xiamen Boson Biotech Co, scheda test rapido SARS-CoV-2 Antigen;

- Zhejiang Orient Gene Biotech Co.,Ltd, Coronavirus Ag Rapid Test Cassette (Swab).

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Come detto, il JRC specificherà nella sua banca dati aggiornata i test rapidi specifici per l’antigene di cui gli Stati membri riconoscono reciprocamente i risultati. In sede di revisione dell’elenco comune, gli Stati membri valuteranno se alcuni test antigenici rapidi debbano essere rimossi o aggiunti alla selezione dei test i cui risultati vengono riconosciuti reciprocamente informando il JRC che aggiornerà il suo database di conseguenza.

III. Serie di dati comuni standardizzati per i certificati dei test COVID-19

Per facilitare il riconoscimento reciproco dei risultati dei test rapidi antigenici gli Stati membri hanno concordato una serie comune standardizzata di dati (cfr. Allegato II del documento) da includere nel modulo per i certificati dei risultati dei test. Gli Stati membri hanno convenuto che i risultati dei test COVID-19 debbano essere resi nella lingua o nelle lingue nazionali del Paese in cui è stato effettuato il test, oltre che in inglese.

Il set di dati è stato concordato prendendo in considerazione le linee guida pubblicate dalla eHealth Network sulla vaccinazione per scopi medici, linee guida che hanno fornito indicazioni sui dati minimi utili per rappresentare le informazioni di base in un modo strutturato che ne faciliti la condivisione e l’interpretazione, anche in vista della standardizzazione dei risultati del test COVID- 19 e della vaccinazione COVID-19.

L’utilizzo di tale elenco comune potrà essere utile per le Regioni che decideranno di fare campagne pubbliche di screening anche attraverso le farmacie. Tali risultati potranno essere utilizzati, ad esempio, per ricerche comuni europee.

Inoltre, l’utilizzo di un test riconosciuto reciprocamente in tutta l’Unione Europea potrebbe essere molto utile per le farmacie che potranno offrire un prodotto che, nel breve periodo, potrà enormemente facilitare la libera circolazione delle persone all’interno del territorio europeo.

Ogni altra informazione utile sull’argomento - in particolare in merito alla decisione finale del Centro comune di ricerca (JRC) sulla messa a disposizione dell’elenco online dei test reciprocamente riconosciuti dagli Stati membri - verrà prontamente fornita dalla scrivente alle Associazioni in indirizzo.

Cordiali saluti.

IL SEGRETARIO IL PRESIDENTE Dott. Roberto TOBIA Dott. Marco COSSOLO

All.n.1

Questa circolare viene resa disponibile per le sole organizzazioni territoriali sul sito internet www.federfarma.it contemporaneamente all’inoltro tramite e-mail.

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EUROPEAN COMMISSION

DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY

Public health, country knowledge, crisis management Health Security and Vaccination

EU health preparedness:

A common list of COVID-19 rapid antigen tests, including those of which their test results are mutually

recognised, and a common standardised set of data to be included in COVID-19 test result certificates

Agreed by the Health Security Committee

on 17 February 2021

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2

I. Introduction

Robust testing strategies are an essential aspect of preparedness and response to the COVID- 19 pandemic, allowing for early detection of potentially infectious individuals and providing visibility on infection rates and transmission within communities. Moreover, they are a prerequisite to adequate contact tracing to limit the spread through prompt isolation. Also in the context of the circulation of SARS-CoV-2 variants of concern, surge testing in addition to existing testing deployment has proven to be key for controlling and suppressing further spread of the virus.

While the reverse transcription real-time polymerase chain reaction (RT-PCR) assay, which is a nucleic acid amplification test (NAAT) remains the ‘gold standard’ for COVID-19 diagnosis, new tests are rapidly entering the market, allowing faster and cheaper ways to detect ongoing infection. Rapid antigen tests, which detect the presence of viral proteins (antigens), are increasingly being used by Member States as a way of further strengthening countries’ overall testing capacity, particularly in case of limited NAAT capacities or where prolonged testing turnaround times results in no clinical utility.

The Health Security Committee agreed on 17 September 2020 on Recommendations for a common EU testing approach for COVID-19¹, setting out various actions for consideration by countries when updating or adapting their testing strategies. The Recommendations included Member States’ first experiences with rapid antigen tests and their deliberations concerning the settings and situations in which these tests should be used. Since then, the Committee has been discussing the use and application of rapid antigen tests in great depth, and has brought together a wealth of (technical) information on the types of tests used in European countries and the conditions applied.

On 21 January 2021, Member States unanimously agreed on a Council recommendation setting a common framework for the use of rapid antigen tests and the mutual recognition of COVID-19 test results across the EU². The Council recommendation called on Member States to agree on three concrete deliverables:

1. A common list of COVID-19 rapid antigen tests that are considered appropriate for use in the context of the situations described in the Council Recommendation, that are in line with countries’ testing strategies and that:

a. carry CE marking;

b. meet the minimum performance requirements of ≥ 90% sensitivity and ≥ 97%

specificity; and

c. have been validated by at least one Member State as being appropriate for their use in the context of COVID-19, providing details on the methodology and results of such studies, such as the sample type used for validation, the setting in which the use of the test was assessed, and whether any difficulties occurred as regards the required sensitivity criteria or other performance elements.

1 https://ec.europa.eu/health/sites/health/files/preparedness_response/docs/common_testingapproach_covid- 19_en.pdf

2 https://data.consilium.europa.eu/doc/document/ST-5451-2021-INIT/en/pdf

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3 2. A selection of rapid antigen tests of which Member States will mutually recognise

the test results for public health measures.

3. A common standardised set of data to be included in COVID-19 test result certificates, further facilitating the mutual recognition of COVID-19 test results.

Based on the information collected by the Health Security Committee, and taking into consideration the current epidemiological situation and the testing strategies and approaches that have been put in place across the EU, this document sets out the three deliverables as agreed by Member States. Its content is prepared based on the criteria set out in the Council Recommendation and considers the relevant recommendations published by the Commission³ and technical guidance issued the European Centre for Disease Prevention and Control (ECDC)⁴ and the World Health Organization (WHO)⁵.

II. Common list of rapid antigen tests

Point 11 of the Council Recommendation of 21 January 2021, calls on Member States to, without prejudice to Directive 98/79/EC, agree on and maintain a common and updated list of COVID-19 rapid antigen tests that are considered appropriate for use in the context of the situations described under point 6 and are in line with countries’ testing strategies. Moreover, the antigen tests included in the list should:

(a) Carry CE marking;

(b) Meet the minimum performance requirements of ≥ 90% sensitivity and ≥ 97%

specificity; and

(c) Have been validated by at least one Member State as being appropriate for their use in the context of COVID-19, providing details on the methodology and results of such studies, such as the sample type used for validation, the setting in which the use of the test was assessed, and whether any difficulties occurred as regards the required sensitivity criteria or other performance elements.

This list should be shared with ECDC and the Commission to prevent duplication of work and to feed into ongoing initiatives, particularly in the context of the redevelopment of the

“COVID-19 In Vitro Diagnostic Devices and Test Methods” database⁶, hosted by the Joint Research Centre (JRC). As referred to in the Commission Communication of 19 January⁷, the JRC will play a role in establishing a common list of rapid antigen tests and their uses, as agreed by Member States and with support from the Health Security Committee.

Annex I to this document sets out a common list of rapid antigen tests that, as of 17 February 2021 meet the criteria as specified above. This list will serve as a basis for the JRC to redevelop and update its COVID-19 testing database, with the aim of incorporating the

3 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32020H1595 and https://eur-lex.europa.eu/legal- content/EN/TXT/PDF/?uri=CELEX:32020H1743&from=EN

4 https://www.ecdc.europa.eu/en/publications-data/options-use-rapid-antigen-tests-covid-19-eueea-and-uk

5 https://www.who.int/publications/i/item/9789240017740

6 https://covid-19-diagnostics.jrc.ec.europa.eu/devices

7 https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52021DC0035&from=EN

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4 information in this platform and ensuring that the common list as agreed by Member States will be publicly available online.

The common list of rapid antigen tests will be regularly reviewed by Member States in the context of Health Security Committee meetings, and, if necessary, be updated in line with new results from independent validation studies becoming available and new tests entering the markets. Future updates to the list should also take into account how mutations of the SARS-CoV-2 virus may affect the efficacy of any particular rapid antigen tests, allowing for the removal of tests no longer deemed effective. The effect of mutations of the SARS-CoV-2 virus on the efficacy of NAAT, in particular RT-PCR assays, will also be kept under review.

Future updates to the common list of rapid antigen tests will be published as an update to the JRC database on COVID-19 In Vitro Diagnostic Devices and Test Methods.

III. Rapid antigen tests of which the test results are mutually recognised

As stipulated in point 15 of the Council Recommendation of 21 January 2021, Member States will agree on a selection of rapid antigen tests of which they will mutually recognise the test results for public health measures, based on the information included in the common list (see Annex I).

The Health Security Committee agrees that, for rapid antigen test results to be mutually recognised, at least three Member States should be using a rapid antigen tests in practice.

Based on this criterion, Member States agree that the results of the following rapid antigen tests will be mutually recognised for public health measures:

 Abbott Rapid Diagnostics, Panbio™ COVID-19 Ag Rapid Test

 AMEDA Labordiagnostik GmbH, AMP Rapid Test SARS-CoV-2 Ag

 Becton Dickinson, BD Veritor System for Rapid Deteciton os SARS-CoV-2

 Beijing Lepu Medical Technology, SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold immunochromatography)

 BIOSYNEX SWISS SA, BIOSYNEX COVID-19 Ag BSS

 CerTest Biotect S.L., CerTest SARS-CoV-2 CARD TEST

 Hangzhou Clongene Biotech, Clungene COVID-19 Antigen Rapid Test Kit

 Healgen Scientific Limited, Coronavirus Ag Rapid Test Cassette (Swab)

 LumiraDX UK LTd, LumiraDx SARS-CoV-2 Ag Test

 nal von minden GmbH, NADAL COVID -19 Ag Test

 Quidel Corporation, Sofia 2 SARS Antigen FIA

 SD BIOSENSOR, Inc.; Roche, STANDARD F COVID-19 Ag FIA

 SD BIOSENSOR, Inc.; Roche, STANDARD Q COVID-19 Ag Test

 Siemens Healthineers, CLINITEST Rapid COVID-19 Antigen Test

 Xiamen Boson Biotech Co, Rapid SARS-CoV-2 Antigen Test card

 Zhejiang Orient Gene Biotech Co.,Ltd,Coronavirus Ag Rapid Test Cassette (Swab)

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5 The JRC will specify in its updated database the specific rapid antigen tests of which Member States mutually recognise their test results.

Whenever Member States will review the common list of rapid antigen tests and consider whether any tests should be added or deleted, they will also take into account – also based on new results from independent national validation studies - whether any rapid antigen tests should be removed from or added to the selection of rapid antigen tests of which their results are being mutually recognised. This information will be provided to the JRC, who will update its database accordingly.

Future updates to the agreed list of rapid antigen tests of which the results are mutually recognised, will be published as an update to the JRC database on COVID-19 In Vitro Diagnostic Devices and Test Methods.

IV. Common standardised set of data for COVID-19 test certificates

In order to facilitate in practice the mutual recognition of results of rapid antigen tests as well as NAAT, including RT-PCR assays, point 18 of Council Recommendation 2020/1475 defines that Member States should agree on a common standardised set of data to be included in the form for test result certificates.

Based on information that was submitted by members of the Health Security Committee in response to a survey on mutual recognition on COVID-19 test results and further discussions that took place in the context of the Health Security Committee, Member States agree on the common standardised set of data for COVID-19 test result certificates as presented in Annex II.

Member States agree that COVID-19 test results should be made available in the national language(s) of the country where the test was taken, as well as English.

The dataset was agreed by taking into consideration the guidelines that were published by the eHealth Network on proof of vaccination for medical purposes, setting out basic interoperability elements⁸. While these guidelines aim to support interoperability between vaccination certificates rather than COVID-19 test results, they provided helpful input regarding minimum data that would enable basic information to be captured and represented in a structured manner that facilitates sharing and interpretation. Moreover, should Member States wish to standardise COVID-19 test results and COVID-19 vaccination, streamlining of datasets facilitates such processes.

The Health Security Committee will discuss, whenever relevant, possible updates to the agreed common standardised set of data for COVID-19 test certificates, and publish, if necessary, an updated agreed document.

8 https://ec.europa.eu/health/sites/health/files/ehealth/docs/vaccination-proof_interoperability-guidelines_en.pdf

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6

V. Continuous discussions and further work on the common rapid antigen tests list and common dataset for COVID-19 test result certificates

As described in the sections above, the content of this document, as agreed by the Health Security Committee on 17 February 2021, will continue to be discussed by Member States and updated whenever deemed relevant.

Whenever updates are required, these will either be published as an update to this current document or as an update to the JRC database on COVID-19 In Vitro Diagnostic Devices and Test Method, depending on scope of the required update and when the redeveloped database by JRC will be available.

In the context of the ongoing discussions and, if relevant, future updates to the current document, Member States have raised the following points that require particular attention:

Common RAT list

 Harmonised methodology for national validation studies on the clinical performance of rapid antigen tests

This will be addressed by future guidelines to be developed by the JRC and the ECDC, also taking into consideration the implementation guide published by WHO on 21 December 2020 on SARS-CoV-2 antigen-detecting rapid diagnostic tests⁹.

Moreover, Member States will continue sharing details via the HSC on the implementation of national validation studies, particularly concerning the validation methodologies and protocols applied.

 Quality of data produced through independent validation studies

It is key that the sensitivity levels of the rapid antigen tests, as reported by independent national validation studies, reflect clinical performance as measures in practice, rather than the sensitivity reported by the manufacturer. In this context, the JRC is planning to verify the science behind the validation data that has been made available from the Member States through the Health Security Committee, and to verify the findings (eventually in laboratory settings). For the validation of rapid antigen tests, the JRC plans to use the “gold standard”

method of NAAT, in particular RT-PCR, by benchmarking the antigen test samples against qPCR and digital PCR.

Moreover, Member States will continue sharing details via the HSC on the results produced by national validation studies, particularly concerning the sample type used for validation, the setting in which the use of the test was assessed, and whether any difficulties occurred as regards the required sensitivity criteria or other performance elements.

9 https://www.who.int/publications/i/item/9789240017740

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 Occurrence of SARS-CoV-2 variants of concern

Future updates to the common rapid antigen tests list should also take into account how mutations of the SARS-CoV-2 virus may affect the efficacy of any particular rapid antigen tests, allowing for the removal of tests no longer deemed effective. The effect of mutations of the SARSCoV-2 virus on the efficacy of RT-PCR tests should also be kept under review. In particular, in the current context of circulation of variants of concern, the use of rapid antigen tests does not allow samples to be used for subsequent detection of new variants (by NAAT and/or sequencing).

Mutual recognition of COVID-19 test results

 Criteria to be used for the mutual recognition of rapid antigen test results

At the moment, the extent to which rapid antigen tests are being used in practice by Member States differs greatly. In this context, Member States have agreed that, for now, the criterion that at least 3 Member States should be using a specific type of rapid antigen test in practice for it to be mutually recognised, applies. Member States will further discuss and explore whether other criteria should be used in the future. It is key that such discussions are held in the context of quality assurance measures.

 Context in which mutual recognition should be applied

Member States should further discuss the situation in which there is a need for mutual recognition of rapid antigen test results (as well as other COVID-19 test results). In addition to the context of travel, it is relevant to further discuss between countries when the list of rapid antigen tests of which their results will be mutually recognised should be applied.

COVID-19 test result certificates

 Possible creation of a digital platform

As also called for by the Council Recommendation of 21 January, Member States will explore the need and possibility, including time and cost considerations, for the creation of a digital platform, that can be used to validate the authenticity of standardised COVID-19 test certificates. Member States that are developing or that have already such digital systems in place will share their experiences in this regards. In the context of these discussions, the eHealth Network and in particular their semantic experts in Member States, will be closely involved.

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ANNEX I: Common list of rapid antigen tests, as agreed by Member States on 17 February 2021

Manufacturer RAT commercial name CE marking

Clinical performance (JRC database)

Clinical performance (FIND database)

Clinical performance (Data used in BE)

Clinical performance (Data used in DE)

Clinical performance (Data used in SI)

MS using in practice

Other countries using in practice

Countries that have completed practical validation studies

MS that are currently validating this RAT

In JRC database

In FIND database

Abbott Rapid Diagnostics

Panbio™ COVID-19 Ag Rapid

Test Yes

91.4%

sensitivity, 99.8% specificity NP swab

FIND Evaluation - Studies in DE and CH, NP swab, 10 Dec 2020

93.3% sensitivity 99.4% specificity NP Swab 98.1% sensitivity 99.8% specificity Nasal swab

91.4% sensitivity 99.8% specificity

AT, BE, BG, CY, CZ, DE^[2], EL, ES, FR^[1], HR, IT, MT, NL^[5], PL, PT, RO, SE, SK

CH, ME, MK, NO, UK, UA

DE, ES, NL^[5], CH, NO

CY, ES, HR, HU,

IE, LU, PT, SE Yes Yes

AMEDA Labordiagnostik GmbH

AMP Rapid Test SARS-CoV-2

Ag Yes

97.3% sensitivity 100% specificity NP swab 97.3% sensitivity 98.8% specificity Nasal swab

97.3% sensitivity 100% specificity NP swab

BE, BG, DE^[2]

HR, SI, CH, UA DE HR Yes Yes

Becton Dickinson

BD Veritor System for Rapid Deteciton os SARS-CoV-2 Yes

93.5% sensitivity 99.3% specificity Nasal swab

DE^[2], ES,

NL^[5], SE CH, UA DE, ES, NL^[5] SE^[3] Yes Yes

Beijing Lepu Medical Technology

SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold immunochromatography)

Yes

92% sensitivity unknown specificity Nasal swab

92% sensitivity 99.3% specificity Nasal swab

92% sensitivity 99.2% specificity NP swab

BE, DE^[2], SI UA DE Yes Yes

Beijing Wantai Biological Pharmacy Enterprise Co Ltd

WANTAI SARS-CoV-2 Ag

Rapid Test (FIA) Yes

96.6% sensitivity unknown specificity Nasal swab

DE^[2] DE Yes Yes

BIONOTE NowCheck® COVID-19 Ag

Test Yes

89.2% sensitivity 97.6% specificity NP/Nasal swab

FIND Evaluation - Study in Brazil, NP swab, 10 Dec 2020

DE^[2] CH DE Yes Yes

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BIOSYNEX

SWISS SA BIOSYNEX COVID-19 Ag BSS Yes Not specified 96% sensitivity 100% specificity NP swab

BE, DE^[2], FR,

NL^[5] CH DE, NL^[5] Yes Yes

CerTest Biotect S.L.

CerTest SARS-CoV-2 CARD

TEST Yes

92.9% sensitivity 99.6% specificity NP swab

92.9% sensitivity 98.4% specificity NP/OP swab

DE^[2], ES, SI ES Yes No

GenBody Inc GenBody COVID-19 Ag Test Yes

90% sensitivity 98% specificity NP/OP swab

Withdrawn DE^[2] UA DE Yes Yes

Guangdong Wesail Biotech Co. Ltd

COVID-19 AG Test Kit Yes

90% sensitivity 98% specificity NP/Nasal swab

DE^[2], SI DE Yes No

Hangzhou Clongene Biotech

Clungene COVID-19 Antigen

Rapid Test Kit Yes

98.5% sensitivity unknown specificity Nasal swab

91.4% sensitivity

100% specificity NP/OP swab

91.4% sensitivity 100% specificity NP/OP swab

BE, DE^[2], FR,

SI CH DE HR Yes No

Healgen Scientific Limited

Coronavirus Ag Rapid Test

Cassette (Swab) Yes

DE^[2], NL^[5],

SE, SI NL^[5] SE^[3] No No

Joinstar Biomedical Technology

COVID-19 Antigen Rapid Test (Colloidal Gold) Yes

96.1% sensitivity 98.1%

specificity Nasal swab

DE^[2], SI DE Yes Yes

LumiraDX UK LTd

LumiraDx SARS-CoV-2 Ag

Test Yes

DE^[2], ES, SI CH DE, ES Yes No

MEDsan GmbH MEDsan® SARS-CoV-2

Antigen Rapid Test Yes

92.5% sensitivity

99.8% specificity Nasal/OP swab

BE, DE^[2] CH DE Yes No

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MP Biomedicals Germany

Rapid SARS-CoV-2 Antigen

Test Card Yes

96.39%

sensitivity 99.03%

96.4% sensitivity

99% specificity NP/OP swab

BE, DE^[2] CH DE Yes No

nal von minden

GmbH NADAL COVID -19 Ag Test Yes

97.6% sensitivity

99.9% specificity NP/OP swab

AT, BE, DE^[2],

SI DE HR Yes No

Precision Biosensor Inc (Axon Lab SG)

Exdia COVI-19 Ag Test Yes

93.9% sensitivity 98% specificity NP swab

SI CH DE Yes Yes

Qingdao Hightop Biotech Co Ltd

SARS-CoV-2 Antigen Rapid

Test Yes

95% sensitivity unknown specificity Nasal swab

DE^[2] DE Yes No

Quidel

Corporation Sofia 2 SARS Antigen FIA Yes

96.7% sensitivity 100% specificity NP/Nasal swab

96.7% sensitivity

100% specificity NP/nasal swab

96.7% sensitivity 100% specificity NP/Nasal swab

AT, BE, DE^[2],

FI, NL^[5], SI CH DE, NL^[5] SI Yes Yes

Safecare Biotech Hangzhou Co

COVID-19 Ag Rapid Test Kit

(Swab) Yes

97.04%

sensitivity unknown specificity Nasal swab

DE^[2], FR CH DE Yes No

SD BIOSENSOR, Inc.; Roche

STANDARD F COVID-19 Ag

FIA Yes

FIND Evaluation - Studies in DE and Brazil, 10 Dec 2020

BE, BG, DE^[2], IT , LU, LV, NL^[5], PT, RO, SK

DE, IT, NL^[5] LU, PT No Yes

SD BIOSENSOR, Inc.; Roche

STANDARD Q COVID-19 Ag

Test Yes

96.52%

sensitivity 99.68%

specificity NP swab

FIND Evaluation - Studies in DE, CH and Brazil, 10 Dec 2020

AT, BE, BG, CY, DE^[2], ES, FI, FR, HR, IT, LU, LV, MT, NL^[5], RO, SE, SK, SI

ME, NO, CH DE, ES, IT, NL^[5], CH, UA

HR, IE, LU, SI,

SE Yes Yes

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Siemens Healthineers

CLINITEST Rapid COVID-19

Antigen Test Yes

96.72%

sensitivity 96.72%

98.32%

sensitivity 99.6% specificity NP swab 97.25%

sensitivity 100% specificity Nasal swab

AT, BE, DE^[2], FR, HR, NL^[5], SE, SI

DE, NL^[5] ES, HR, PT,

SE^[3] Yes Yes

Xiamen Boson Biotech Co

Rapid SARS-CoV-2 Antigen

Test card Yes Not specified 93.8% sensitivity

100% specificity NP swab

BE, BG, DE^[2],

FR CH DE Yes Yes

Zhejiang Orient Gene Biotech Co.,Ltd

Coronavirus Ag Rapid Test

Cassette (Swab) Yes

96.72%

sensitivity unknown specificity Nasal swab

98.32%

sensitivity 99.6% specificity NP swab 97.25%

sensitivity 100% specificity Nasal swab

AT, BE, BG,

DE^[2] UK DE SE^[3] Yes No

Notes:

[1] FR: Reference to validation study (not specifying which specific RAT is being recommended or was tested in practice): https://www.has- sante.fr/upload/docs/application/pdf/2020-10/synthese_tests_antigeniques_vd.pdf

[2] DE: Rapid antigen tests that fulfils the defined minimum criteria for reimbursement in Germany. See: https://antigentest.bfarm.de/ords/antigen/r/antigentests-auf-sars-cov- 2/liste-der-antigentests?session=13130597074531

[3] SE: Smaller evaluations ongoing in some of the regions.

[4] BE: In the clinical performance study performed in three different clinical laboratories during the ascendant phase of the epidemiological curve, we found an overall sensitivity and specificity of 57.6 and 99.5%, respectively with an accuracy of 82.6%.

[5] NL: Collected validation data from accredited laboratories in the Netherlands. The report includes evaluations of various RAT that labs performed at their own initiative.

https://lci.rivm.nl/antigeensneltesten

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ANNEX II: Common standardised set of data to be included in COVID-19 test result certificates, as agreed by Member States on 17 February 2021

Section Data element Description Preferred Code

System

Person identification

Person name The legal name of the tested person

Person identifier (optional)

An identifier of the tested person, according to the policies applicable in each country. It should be captured what type of identifier is used.

Examples: citizen ID card or identifier within the health system/IIS/e-registry.

Person date of birth Tested person’s date of birth.

Mandatory if no Person identifier is provided.

Complete date, without time, following the ISO 8601.

Test information

Type of test

Description of the type of test that was conducted, e.g. RT-PCR or rapid antigen test.

In the case of a rapid antigen tests, the form should provide details on the manufacturer and commercial name of the test used.

Disease or agent targeted

Specification that it concerns the detection of SARS-CoV-2 infection

Sample origin (optional)

The type of sample that was taken (e.g.

nasopharyngeal swab, oropharyngeal swab, nasal swab, saliva)

Date and time

Date and time when the test was taken.

In case of NAAT, e.g. RT-PCR, the certificate should also specify when the test result was produced.

Complete date, without time, following ISO 8601

Result of the test Negative or positive

Testing centre or facility

Name/code of testing centre, facility or a health authority responsible for the testing event.

Optional: address of the testing facility

Health Professional identification (optional)

Name or health professional code responsible for conducting (and validating) the test

Country where the test

was taken The country in which the individual was tested ISO 3166 Country Codes

Test certificate metadata

Test result issuer Entity that issued the COVID-19 test result certificate (allowing to check the certificate)

Certificate identifier (optional)

Reference of the COVID-19 test result certificate (unique identifier)

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Document No.: CE-DOC-CG27 Rev.: 1/0

Beijing Lepu Medical Technology Co., Ltd.

Building 7-1 No.37 Chaoqian Road, Changping District, Beijing, 102200, P.R. China Manufacture Address: Beijing Lepu Medical Technology Co., Ltd.

Building 7-1 No.37 Chaoqian Road, Changping District, Beijing, 102200, P.R. China

European Representative: Lepu Medical (Europe) Cooperatief U.A.

Abe Lenstra Boulevard 36, 8448 JB, Heerenveen, The Netherlands

Product information: SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography)

Model:

1 test/kit; 5 tests/kit; 10 tests/kit; 25 tests/kit; 50 tests/kit Classification: Others (not in List A and List B)

Conformity Assessment Route: Section 2 to 5 in annex III of IVDD 98/79/EC

We herewith declare that the above mentioned products meet the provisions of the following EC Council Directives and Standards.

All supporting documentations are retained under the premise of the manufacturer.

General Applicable Directive: DIRECTIVE 98/79/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 October 1998 on in vitro diagnostic medical devices

Standards Applied: All applicable harmonized standards (published in the official journal of the European Communities on 25^thMarch 2020).

The applicable standards are listed in Annex 1.

Place, date of issue Beijing, P.R. China, 3^th, Sept., 2020 Signature of Management

Representative

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Annex 1

EN ISO 13485:2016 Medical devices – quality management systems - requirements for regulatory purposes

EN ISO 14971:2019 Medical devices – application of risk management to medical devices

EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices EN ISO 18113-1:2011 In vitro diagnostic medical devices – information supplied by the manufacturer (labelling) – Part 1: terms, definitions and general requirements EN ISO 18113-2:2011 In vitro diagnostic medical devices – information supplied by the manufacturer (labelling) – Part 2: in vitro diagnostic reagents for professional use EN ISO 23640:2015 In vitro diagnostic medical devices – evaluation of stability of in vitro diagnostic regents

EN 13612:2002/AC: 2002 Performance evaluation of in vitro diagnostic medical devices

IEC 62366-1:2015 Application of usability engineering to medical devices

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Revision history:

Version Revision history Author Date

1/0 First procedure Wenna Li 3^th, Sept., 2020

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My Beneﬁt s.r.l.

Via Giacomo Leopardi, 46/A- 41123 Modena (MO) Tel. 059 828941 - email: info@mybenefit.it www.mybeneﬁt.it