IN VITRO TEST

6C21-10
34-3523/R4
SYSTEM
FINALIDAD DE USO FINALIT
D’USO

Total ␤-hCG
Los controles ARCHITECT Total -hCG se utilizan para la verificacin de la exactitud y la precisin del sistema I controlli ARCHITECT ␤-hCG totale vengono utilizzati per la verifica dell’accuratezza e della precisione del sistema
ARCHITECT i en la determinacin cuantitativa y cualitativa de gonadotropina corinica humana fraccin beta (-hCG) en ARCHITECT i nella determinazione quantitativa e qualitativa della subunit beta della gonadotropina corionica umana
suero y plasma humanos. Si desea m
s informacin, consulte el prospecto del ensayo ARCHITECT correspondiente. (␤-hCG) in campioni di siero e plasma umano. Per specifiche pi dettagliate, fare riferimento al foglietto illustrativo del
relativo dosaggio ARCHITECT.
CONTENIDO
3 frascos (8 ml cada uno) de controles ARCHITECT Total -hCG que contienen hCG preparada en suero humano sin
reactividad para el HBsAg, ni para el antgeno del VIH-1 o el RNA del VIH, ni reactividad de anticuerpos antiVHC ni
VIH-1/VIH-2. Conservante: azida sdica.
Los intervalos de concentracin siguientes se pueden utilizar para las especificaciones de estos controles en el sistema
ARCHITECT:
CONTENUTO
3 flaconi (8 ml ciascuno) di controlli ARCHITECT ␤-hCG totale contenenti hCG preparata in siero umano, non reattivo per
l’HBsAg, per l’antigene HIV-1 o l’HIV RNA e per gli anticorpi anti-HCV e anti-HIV-1/HIV-2. Conservante: Sodio azoturo.
I seguenti range di concentrazione possono essere utilizzati come specifiche del controllo analizzato in singolo sul
sistema ARCHITECT:

Concentracin esperada/ Concentracin esperada/ Concentrazione prevista/Range Concentrazione prevista/Range

Control Intervalo mIU/ml
25 16 - 34 25
Intervalo IU/I
16 - 34
Controllo
25
mIU/ml
16 - 34 25
IU/l
16 - 34
Controls
750 488 -1 013 750 488 -1 013 750 488 -1013 750 488 -1013
5 000 3 250 -6 750 5 000 3 250 -6 750 5000 3250 -6750 5000 3250 -6750
Cada laboratorio debe establecer sus propios intervalos de concentracin aceptable para cada lote de controles y para Ogni laboratorio deve stabilire i propri range di concentrazione per nuovi lotti dei controlli analizzando ciascun livello
Kontrollen / Contr
les
todos los niveles de los controles. Para ello, se debe analizar un mnimo de 20 replicados durante varios das (de 3 a 5
das). Entre las causas de variaciones que se pueden dar y que se deben incluir en este estudio para que sea
come minimo in replicato di 20 per diversi (3-5) giorni. Per essere rappresentativo della futura prestazione del sistema, lo
studio deve tenere conto delle cause di eventuali variabili, tra cui le seguenti: Controles / Controlli
representativo del funcionamiento futuro del sistema se incluyen: • Calibrazioni multiple memorizzate
• Mltiples calibraciones almacenadas • Lotti multipli di reagenti
• Mltiples lotes de reactivos • Lotti multipli di calibratori
• Mltiples lotes de calibradores • Moduli multipli di analisi
• Mltiples mdulos de procesamiento • Dati raccolti in diversi momenti della giornata
• Datos recogidos en diferentes momentos del da Questi risultati devono essere inclusi nelle procedure di controllo di qualit vigenti nel proprio laboratorio.
Estos resultados se deben utilizar en los procesos de control de calidad de su laboratorio.
STANDARDIZZAZIONE
ESTANDARIZACIN La concentrazione dei controlli
calcolata utilizzando calibratori standardizzati in base al Terzo Standard Internazionale
La concentracin de los controles se evala a trav
s de calibradores que se correlacionan con el tercer patrn (75/537) dell’Organizzazione Mondiale della Sanit (WHO) per la ␤-hCG.
internacional (3rd IS 75/537) para -hCG de la Organizacin Mundial de la Salud (OMS).
PRECAUZIONI
PRECAUCIONES • Per uso diagnostico in vitro.
• Para uso en diagnstico in vitro. • Se trattati e conservati secondo le istruzioni, i controlli ARCHITECT ␤-hCG totale si mantengono stabili fino alla data
• Si se almacenan y se manejan segn las instrucciones, los controles ARCHITECT Total -hCG se mantienen di scadenza. Non usare oltre tale data. Key to symbols used
estables hasta la fecha de caducidad. No los utilice transcurrida dicha fecha.
Erl
uterung der verwendeten Symbole/Lgende des symboles utiliss/Clave de los
• ATTENZIONE: Questo prodotto contiene componenti di origine umana e/o potenzialmente infettivi. Per
• ATENCI
N: este producto contiene componentes de origen humano o potencialmente infecciosos. Si desea un’elencazione specifica, fare riferimento alla sezione “Contenuto” del presente inserto. Nessuno dei metodi analitici smbolos utilizados/Legenda dei simboli utilizzati
una enumeracin m s detallada consulte el apartado “Contenido” de este prospecto. Al no existir m
todos de an lisis conosciuti pu garantire in modo assoluto che prodotti di origine umana o derivati da microrganismi inattivati non
que garanticen la inocuidad de materiales de origen humano o de microorganismos inactivados, todos los materiales possano trasmettere infezioni. Pertanto tutti i materiali di origine umana devono essere considerati potenzialmente
de origen humano se deben considerar potencialmente infecciosos. Maneje los reactivos y las muestras de origen infettivi. Si raccomanda di trattare i reagenti ed i campioni dei pazienti in accordo con quanto descritto nella List Number / Nr. / R
f
rence / Nmero de Expiration Date / Verwendbar bis / Date d’expiration
humano de acuerdo con las instrucciones especificadas en la publicacin “OSHA Standard on Bloodhorne pubblicazione OSHA Standard relativa agli agenti patogeni di origine ematica.1 I materiali contenenti o sospettati di referencia / Numero di listino Fecha de caducidad / Data di scadenza
Pathogens”. En el caso de materiales que contengan o que pudieran contener agentes infecciosos, se deben seguir contenere agenti infettivi devono essere trattati in accordo con quanto descritto nella pubblicazione Biosafety For In Vitro Diagnostic Use /
las pr cticas de seguridad biolgica “Biosafety Level 2” u otras normativas equivalentes.3,4 Level 2,2 o linee guida equivalenti.3-4 In-vitro-Diagnostikum / Pour diagnostic in vitro / Lot Number / Ch.-B. / Num
ro de lot
• Los controles contienen azida sdica como conservante. Para informacin sobre la eliminacin correcta de los • I controlli contengono sodio azoturo come conservante. Per informazioni sullo smaltimento dei materiali contenenti Para uso en diagnstico in vitro / Nmero de lote / Numero di lotto
materiales que contienen azida sdica, consulte el captulo 8 del Manual de Operaciones del sistema ARCHITECT. sodio azoturo in conformit alle norme di sicurezza, fare riferimento al capitolo 8 del Manuale d’Impiego del Sistema Per uso diagnostico in vitro

• Los componentes de este producto contienen azida sdica y han sido clasificados segn las directivas de la ARCHITECT. CAUTION: Handle human sourced materials as
Control Low, Medium, High (L, M, H)
Comunidad Europea (CE) como: nocivo (Xn). A continuacin se indican las frases relativas a los riesgos (R) y • I componenti di questo prodotto contengono sodio azoturo e sono classificati secondo le direttive della Comunit Kontrolle Niedrig, Mittel, Hoch (L, M, H)
potentially infectious. Consult instructions for
Contrle bas, moyen, haut (L, M, H)
medidas de seguridad (S). Europea (CE) nel modo seguente: Nocivo (Xn). Qui di seguito sono elencate le frasi appropriate relative ai rischi (R) use. (Infection Risk) / ACHTUNG:
Control bajo, medio, alto (L, M, H)
ed alle misure di sicurezza (S). Humanmaterial gilt als potentiell infektis und
R22 Nocivo por ingestin. Controllo basso, medio, alto (L, M, H)
muss mit der entsprechenden Vorsicht
R32 En contacto con cidos libera gases muy txicos. R22 Nocivo per ingestione. gehandhabt werden. Siehe Packungsbeilage.
S35 Elimnense los residuos del producto y sus recipientes con todas las precauciones posibles. R32 A contatto con acidi libera gas molto tossico. (Infektionsrisiko) / ATTENTION : Manipuler les Authorized Representative
S36 sese indumentaria protectora adecuada. S35 Non disfarsi del prodotto e del recipiente se non con le dovute precauzioni. produits d’origine humaine comme s’ils
taient Bevollmchtigter / Mandataire
S46 En caso de ingestin, acuda inmediatamente al m
dico y mu
strele la etiqueta o el envase. S36 Usare indumenti protettivi adatti. potentiellement infectieux. Consulter les Representante autorizado
S46 In caso d’ingestione consultare immediatamente il medico e mostrargli il contenitore o l’etichetta. instructions d’utilisation. (Risque d’infection) / Mandatario
ATENCIN: maneje los productos de origen
humano como potencialmente infecciosos.
Consulte las instrucciones de uso.(Riesgo de Legal Manufacturer
Almacnese entre 2 °C y 8 °C infeccin) / ATTENZIONE: Trattare i materiali Hersteller
di origine umana come potenzialmente infettivi. Fabricant
Conservare a 2-8 °C
BIBLIOGRAFA Consultare le istruzioni per l’uso.
(Rischio d’infezione)
Fabricante legal
Fabbricante
1. US Department of Labor, Occupational Safety and Health Administration, 29 CFR Part 1910.1030, Occupational Exposure to BIBLIOGRAFIA
Bloodborne Pathogens. 1. US Department of Labor, Occupational Safety and Health Administration, 29 CFR Part 1910.1030, Occupational Exposure to Store at 2-8°C / Lagerung bei
2. US Department of Health and Human Services. Biosafety in Microbiological and Biomedical Laboratories, Fourth Edition. Bloodborne Pathogens. Conserver  / Almac
nese entre
Washington, DC: US Government Printing Office, May 1999. 2. US Department of Health and Human Services. Biosafety in Microbiological and Biomedical Laboratories, Fourth Edition. Conservare a 2-8°C
3. World Health Organization. Laboratory Biosafety Manual. Geneva: World Health Organization; 2004. Washington, DC: US Government Printing Office, May 1999.
4. National Committee for Clinical Laboratory Standards. Protection of Laboratory Workers from Occupationally Acquired Infections: 3. World Health Organization. Laboratory Biosafety Manual. Geneva: World Health Organization; 2004.
Approved Guideline - Second Edition. NCCLS Document M29-A2. Wayne, PA: NCCLS, 2001. 4. National Committee for Clinical Laboratory Standards. Protection of Laboratory Workers from Occupationally Acquired Infections:
Approved Guideline - Second Edition. NCCLS Document M29-A2. Wayne, PA: NCCLS, 2001. ABBOTT
Max-Planck-Ring 2
65205 Wiesbaden
Germany
+49-6122-580 ©1998, 2005 Abbott Laboratories

6C21-1C-10_Mul_AcIn.p65 1 6/14/2005, 2:24 PM

COLOR: PMS 329 CVC
SIZE: 14” x 8.5”
SIZE: 12.59 x 35.56 cm
FILE: Alms
CONTROL VERSION 2 TEMPLATE, Human-Sourced Controls EDITOR: Mary
DTP: Joe
 INTENDED USE VERWENDUNGSZWECK DOMAINE D’APPLICATION
The ARCHITECT Total ␤-hCG Controls are for the verification of the accuracy and precision of the ARCHITECT i System Die ARCHITECT Gesamt--hCG Kontrollen dienen zur berprfung der Richtigkeit und Przision des ARCHITECT i Les contrles ARCHITECT ␤-hCG totale sont utilis
s pour la v
rification de l’exactitude et de la reproductibilit
de
when used for the quantitative and qualitative determination of beta human chorionic gonadotropin (␤-hCG) in human Systems bei der quantitativen und qualitativen Bestimmung von humanem Beta-Choriongonadotropin (-hCG) in l’ARCHITECT i lors de la d
termination quantitative et qualitative de la gonadotrophine chorionique humaine (mol
cule
serum and plasma. Refer to the ARCHITECT assay-specific reagent package insert for additional information. Humanserum und -plasma. Weitere Informationen entnehmen Sie bitte der entsprechenden ARCHITECT enti
re et sous-unit
s bta libres) dans le s
rum ou le plasma humain. Pour de plus amples informations, se r
f
rer  la
Packungsbeilage. notice du dosage.
CONTENTS
3 Bottles (8 mL each) of ARCHITECT Total ␤-hCG Controls contain hCG prepared in human serum nonreactive for INHALT COMPOSITION
HBsAg, HIV-1 Ag or HIV RNA, anti-HCV and anti-HIV-1/HIV-2. Preservative: Sodium Azide. 3 Flschchen (je 8 ml) ARCHITECT Gesamt--hCG Kontrollen enthalten hCG in Humanserum, nicht reaktiv fr HBsAg, 3 flacons (8 ml chacun) de contrles ARCHITECT ␤-hCG totale contenant de l’hCG pr
par
e dans du s
rum humain non
The following concentration ranges may be used for individual replicate control specifications on the ARCHITECT HIV-1 Ag oder HIV RNA, anti-HCV und anti-HIV-1/HIV-2. Konservierungsmittel: Natriumazid. r
actif pour l’AgHBs, l’Ag VIH-1 ou l’ARN VIH et pour les anticorps anti-VHC et anti-VIH-1/VIH-2.
System: Die folgenden Konzentrationsbereiche knnen fr das ARCHITECT System als Kontrollspezifikationen fr Conservateur : azide de sodium.
Einzelbestimmungen verwendet werden: Les limites de concentration suivantes peuvent servir de sp
cifications pour chaque r
plique des contrles sur
Target Concentration/Range Target Concentration/Range l’ARCHITECT :
Control mIU/mL IU/L Richtkonzentration/ Bereich Richtkonzentration/ Bereich
Kontrolle mIU/ml IU/l Concentration cible / Limites Concentration cible / Limites
25 16 - 34 25 16 - 34 Contrle mUI/ml UI/l
750 488 -1013 750 488 -1013 25 16 - 34 25 16 - 34
750 488 -1.013 750 488 -1.013 25 16 - 34 25 16 - 34
5000 3250 -6750 5000 3250 -6750
5.000 3.250 -6.750 5.000 3.250 -6.750 750 488 - 1013 750 488 - 1013
Each laboratory should establish its own concentration ranges for new control lots at each control level. This can be 5000 3250 - 6750 5000 3250 - 6750
accomplished by assaying a minimum of 20 replicates over several (3-5) days. Sources of variation that can be expected Jedes Labor sollte seine eigenen Konzentrationsbereiche fr neue Kontrollchargen und jede Kontrollkonzentration
should be included in this study in order to be representative of future system performance. These may include: durch mindestens Zwanzigfachbestimmung ber mehrere (3 - 5) Tage hinweg bestimmen. Die Ursachen fr mgliche Chaque laboratoire doit
tablir ses propres limites de concentration pour chaque contrle provenant d’un nouveau lot.
• Multiple stored calibrations Abweichungen sollten in dieser Untersuchung bercksichtigt werden, damit sie reprsentativ fr die knftige Leistung des Ceci peut tre effectu
en analysant un minimum de 20 r
pliques sur plusieurs jours (3  5). Cette
tude devra prendre
Systems ist. Dies knnen folgende Ursachen sein: en compte les sources de variation potentielles afin de rendre compte de la future performance du syst
me. Ces
• Multiple reagent lots
• Mehrfach gespeicherte Kalibrierungen variations peuvent tre dues entre autres aux facteurs suivants :
• Multiple calibrator lots
• Verschiedene Reagenzienchargen • Calibrations m
moris
es multiples
• Multiple processing modules
• Verschiedene Kalibratorchargen • Lots de r
actifs multiples
• Data points collected at different times of the day
• Mehrfach-Bearbeitungsmodule • Lots de calibrateurs multiples
These results should be applied to your laboratory’s quality control practices.
• Datenpunkte von verschiedenen Zeitpunkten des Tages • Modules d’analyse multiples
STANDARDIZATION Diese Ergebnisse sollten in die Verfahren zur Qualittskontrolle Ihres Labors eingehen. • Donn
es obtenues  diff
rents moments de la journ
e
The concentration of the controls are evaluated using calibrators referenced to the World Health Organization (W.H.O.) Ces r
sultats doivent tre utilis
s pour le contrle de qualit
dans votre laboratoire.
3rd International Standard 75/537 for ␤-hCG. STANDARDISIERUNG
Die Kontrollkonzentrationen wurden mittels Kalibratoren berprft, die auf den “3rd International Standard 75/537” fr STANDARDISATION
PRECAUTIONS hCG der Weltgesundheitsorganisation (WHO) eingestellt sind. La concentration des contrles est
valu
e  l’aide de calibrateurs correspondant au 3
me Standard International 75/537
• For In Vitro Diagnostic Use. de l’Organisation Mondiale de la Sant
(OMS) relatif  la ␤-hCG.
VORSICHTSMASSNAHMEN
• ARCHITECT Total ␤-hCG Controls are stable until the expiration date when stored and handled as directed. Do not PRECAUTIONS
use past expiration date. • In-vitro-Diagnostikum.
• CAUTION: This product contains human sourced and/or potentially infectious components. For a specific
listing, refer to the CONTENTS section of this package insert. No known test method can offer complete assurance
that products derived from human sources or inactivated microorganisms will not transmit infection. Therefore, all
human sourced materials should be considered potentially infectious. It is recommended that these reagents and
• Die ARCHITECT Gesamt--hCG Kontrollen sind bis zum Verfallsdatum haltbar, sofern sie vorschriftsgem gelagert
und gehandhabt werden. Nicht ber das Verfallsdatum hinaus verwenden.
• ACHTUNG: Dieses Produkt enthlt Humanmaterial und/oder potentiell infektise Komponenten. Eine
detaillierte Auflistung entnehmen Sie bitte dem Abschnitt “Inhalt” in dieser Packungsbeilage. Keine derzeit bekannte
• Pour diagnostic in vitro.
• Les contrles ARCHITECT ␤-hCG totale sont stables jusqu’ la date d’expiration s’ils sont conserv
s et manipul
s
selon les indications du fabricant. Ne pas utiliser au-del de la date d’expiration.
• ATTENTION : Ce produit contient des composants d’origine humaine et/ou potentiellement infectieux. Se
human specimens be handled in accordance with the OSHA Standard on Bloodborne Pathogens1. Biosafety Level 22 Testmethode kann mit absoluter Sicherheit ausschlieen, dass Infektionen durch Humanmaterial oder inaktivierte r
f
rer au paragraphe “Composition” de cette notice pour une liste d
taill
e. Aucune des m
thodes d’analyse
or other appropriate biosafety practices3,4 should be used for materials that contain or are suspected of containing Mikroorganismen bertragen werden knnen. Daher gelten alle Humanproben und Reagenzien als potentiell infektis actuellement connues ne peut garantir de faon absolue que les composants d’origine humaine ou d
riv
s de
infectious agents.
• Controls contain sodium azide as a preservative. For information on safe disposal of sodium azide containing
materials, refer to the ARCHITECT System Operations Manual, Section 8.
gles “OSHA Standard on Bloodborne Pathogens”.1 Les mat
riaux contenant ou
gles de s
curit
biologique de
und mssen gem den entsprechenden Sicherheitsvorschriften gehandhabt werden.1-4 microorganismes inactiv
s ne transmettront pas d’infections. En cons
quence, tous les mat
riaux d’origine humaine
• Die Kontrollen enthalten Natriumazid als Konservierungsmittel. Weitere Informationen zur sicheren Entsorgung devront tre consid
r
s comme potentiellement infectieux. Il est recommand
de manipuler ces r
actifs et les
Natriumazid-haltiger Materialien entnehmen Sie bitte Kapitel 8 der ARCHITECT Bedienungsanleitung.
chantillons humains selon les r
susceptibles de contenir des agents infectieux doivent tre manipul
s selon les r
• Components of this product contain sodium azide and are classified per applicable European Community (EC) • Die Komponenten dieses Produktes enthalten Natriumazid und werden gem den Richtlinien der Europischen
niveau 22 ou autres r
gles de s
curit
biologique en vigueur.3,4
Directives as: Harmful (Xn). The following are the appropriate Risk (R) and Safety (S) phrases. Gemeinschaft (EG) wie folgt eingestuft: Gesundheitsschdlich (Xn). Nachfolgend sind die entsprechenden Risiko- (R)
R22 Harmful if swallowed. und Sicherheitsstze (S) aufgefhrt. • Les contrles contiennent de l’azide de sodium comme conservateur. Pour de plus amples informations sur
R32 Contact with acids liberates very toxic gas. R22 Gesundheitsschdlich beim Verschlucken.
l’
limination appropri
e des produits contenant de l’azide de sodium, se r
f
rer au chapitre 8 du Manuel Technique
S35 This material and its container must be disposed of in a safe way. R32 Entwickelt bei Berhrung mit Sure sehr giftige Gase. ARCHITECT.
S36 Wear suitable protective clothing. S35 Abflle und Behlter mssen in gesicherter Weise beseitigt werden. • Des composants de ce produit contiennent de l’azide de sodium et sont classifi
s, selon les directives de la
S46 If swallowed, seek medical advice immediately and show this container or label. S36 Bei der Arbeit geeignete Schutzkleidung tragen. Communaut
Europ
enne (CE), comme : nocifs (Xn). Les risques particuliers (R) et les conseils de prudence (S)
S46 Bei Verschlucken sofort rztlichen Rat einholen und Verpackung oder Etikett vorzeigen. attribu
s  ces substances sont les suivants :
R22 Nocif en cas d’ingestion.
R32 Au contact d’un acide, d
gage un gaz tr
s toxique.
S35 Ne se d
barrasser de ce produit et de son r
cipient qu’en prenant toutes pr
cautions d’usage.
Store at 2-8°C.
S36 Porter un vtement de protection appropri
.
Lagerung bei 2 - 8 °C. S46 En cas d’ingestion, consulter imm
diatement un m
decin et lui montrer l’emballage ou l’
tiquette.
BIBLIOGRAPHY
1. US Department of Labor, Occupational Safety and Health Administration, 29 CFR Part 1910.1030, Occupational Exposure to LITERATUR
Bloodborne Pathogens. 1. US Department of Labor, Occupational Safety and Health Administration, 29 CFR Part 1910.1030, Occupational Exposure to
2. US Department of Health and Human Services. Biosafety in Microbiological and Biomedical Laboratories, Fourth Edition. Bloodborne Pathogens.
Washington, DC: US Government Printing Office, May 1999. 2. US Department of Health and Human Services. Biosafety in Microbiological and Biomedical Laboratories, Fourth Edition. Conserver entre 2 et 8 °C
3. World Health Organization. Laboratory Biosafety Manual. Geneva: World Health Organization; 2004. Washington, DC: US Government Printing Office, May 1999.
4. National Committee for Clinical Laboratory Standards. Protection of Laboratory Workers from Occupationally Acquired Infections: 3. World Health Organization. Laboratory Biosafety Manual. Geneva: World Health Organization; 2004. BIBLIOGRAPHIE
Approved Guideline - Second Edition. NCCLS Document M29-A2. Wayne, PA: NCCLS, 2001. 4. National Committee for Clinical Laboratory Standards. Protection of Laboratory Workers from Occupationally Acquired Infections:
1. US Department of Labor, Occupational Safety and Health Administration, 29 CFR Part 1910.1030, Occupational Exposure to
Approved Guideline - Second Edition. NCCLS Document M29-A2. Wayne, PA: NCCLS, 2001.
Bloodborne Pathogens.
2. US Department of Health and Human Services. Biosafety in Microbiological and Biomedical Laboratories, Fourth Edition.
Washington, DC: US Government Printing Office, May 1999.
3. World Health Organization. Laboratory Biosafety Manual. Geneva: World Health Organization; 2004.
4. National Committee for Clinical Laboratory Standards. Protection of Laboratory Workers from Occupationally Acquired Infections:
Approved Guideline - Second Edition. NCCLS Document M29-A2. Wayne, PA: NCCLS, 2001.

6C21-1C-10_Mul_AcIn.p65 2 6/14/2005, 2:24 PM