RDT Dengue IgA/IgGfrom asymptomatic or undifferentiated mild fever to Dengue Fever (DF), Dengue Hemorrhagic Fever (DHF) or even Dengue Shock Syndrome potentially fatal. Efficient and

RDT Dengue IgA/IgG

25 70701Rapid assay for the simultaneous detection of IgA and IgG antibodies directed against Dengue virus in human serum, plasma or venous whole blood

881105 - 2015/11

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Table of Content

1. INTENDED USE ...............................................................................3

2. SUMMARY AND EXPLANATION OF THE TEST ............................3

3. PRINCIPLES OF THE PROCEDURE ...............................................3

4. REAGENTS ......................................................................................4

5. WARNING AND PRECAUTIONS .....................................................4

6. SPECIMENS ....................................................................................5

7. PROCEDURE ...................................................................................6

8. TEST LIMITATIONS .........................................................................8

9. PERFORMANCE CHARACTERISTICS ...........................................8

10. QUALITY CONTROL OF THE MANUFACTURER ...........................9

11. BIBLIOGRAPHY REFERENCES ....................................................10

ANNEX: TESTING PROCEDURE ..................................................32

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1- INTENTED USERDT Dengue IgA/IgG is an individual test for qualitative and differential detection of IgA and IgG antibodies directed against Dengue virus NS1 antigen in human serum, plasma or venous whole blood as an aid in the diagnosis of acute dengue infection.

2. SUMMARY AND EXPLANATION OF THE TESTIn tropical and subtropical regions, dengue is the most important arbovirosis in terms of morbidity and mortality. Clinical course of the Dengue infection varies from asymptomatic or undifferentiated mild fever to Dengue Fever (DF), Dengue Hemorrhagic Fever (DHF) or even Dengue Shock Syndrome potentially fatal.Efficient and accurate diagnosis of dengue is of primary importance for clinical care, i.e. early detection of severe cases, case confirmation and differential diagnosis with other infectious diseases. During the early stages of the diseases, virus isolation, nucleic acid or NS1 antigen detection can be used to diagnose the infection. At the end of the acute phase of infection, serology is the method of choice for diagnosis (1, 2).Dengue IgA antibodies are detectable 3-6 days after onset of illness (3), at a period where circulating dengue viruses and NS1 antigen disappear from the blood. It is recommended to use RDT Dengue IgA/IgG rapid test in conjunction with dengue NS1 antigen detection assays to warrant an accurate diagnosis of the patient in the whole window of the acute phase of the disease. Recently, dengue specific IgA have been described to be efficient markers especially in secondary infections (4, 5) or in case of primary infections leading to severe outcome (6). Dengue IgG detection provides complementary information that, depending on the sampling time after fever onset, can help orientating the diagnosis towards infections with higher risk of complications (6).

3. PRINCIPLE OF THE PROCEDURERDT Dengue IgA/IgG is a unitary disposable test based on lateral flow immuno-chromatography principle on a strip in a cassette.5 µl of specimen to be tested (serum or venous whole blood) are distributed in the sample identified well. Then 3 drops of migration buffer are added to buffer well and sample and conjugate are drawn along the membrane strip. Results are read after 20 minutes of migration.When present in the sample, Dengue specific IgA and/or IgG will complex with corresponding capture anti Immunoglobulin at the Test Line on the strip and with antigen associated to anti-NS1 antibodies coated to gold colloidal particles. There, a purple line will appear. Whatever is the patient status, the Control Line must turn from a light blue color to a purple color otherwise, the test is considered invalid and should be repeated using fresh sample and new cassette.For detailed procedure and results interpretation, refer to the scheme at the end of this insert.

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4. REAGENTS

4.1. Description

4.2. Storage and handling requirementsThe RDT Dengue IgA/IgG should be stored at 2-30°C in a dry environment. Reagents can be used until expiry date mentioned on the package.

5. WARNING AND PRECAUTIONSFor in vitro diagnostic use. For healthcare professional use.

5.1. Health and Safety• This kit should be handled only by qualified personnel trained in laboratory

procedures and familiar with their potential hazards. Wear appropriate protective clothing, gloves and eye/face protection and handle appropriately to with the Good Laboratory Practices.

• Handle patient samples and any material that comes directly in contact with them as potentially able to transmit infectious diseases.

Label Nature of reagents Presentation

Cassette Individually foil pouched test device with desiccant.Test strip includes one sample pad, one conjugate pad composed of Dengue Ag and antibody coated colloid gold and one celluloid membrane coated with anti-human IgG antibody (Test Line IgG) and anti-human IgA antibody (Test Line IgA) and anti-mouse IgG antibody (Control Line).

25 x 1Ready-to-use

Migration Buffer

Borate buffer Preservative: ProClin™ 300

1 x 3 mlReady-to-use

Identification Conservation

Cassette In individual sealed pouch, until expiry date at 2-30°C

Migration buffer Until expiry date at 2-30°C before opening, and 2 months at 2-30°C after opening

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• Avoid spilling samples. Spills must be rinsed with bleach diluted to 10%. The material used for cleaning must be discarded in a contaminated residue container.

• Patient samples and contaminated material should be discarded after decontamination.

• For hazard and precaution recommendation related to some chemical components in this test kit, please refer to the pictogram(s) mentioned on the labels and the information supplied at the end of the Instructions for Use. The safety Data Sheet is available on www.bio-rad.com.

5.2. Precautions related to the procedure• For single use only.• Do not use any part of the test beyond the expiration date.• Always follow recommended storage conditions.• Do not open the pouch until performing the assay.• Do not touch the reaction zone with fingers.• Strictly follow the assay procedure.• DO NOT HEAT THE SAMPLE.• Hold the pipette vertically when distributing the sample into the sample

well (”S”).• Test should be performed at 18°C – 37°C.• If stored refrigerated, wait 30 min before use for the reagents to stabilize

at room temperature.• Do not mix reagent from different lot number of kits.• Do not use test device if the pouch is damaged.• Do not use test device if desiccant is missing from the pouch.• Do not process the test under direct ventilation that could dry the strip.

6. SPECIMENS Serum, plasma (EDTA, heparin or citrate) or whole blood on anticoagulant (EDTA, heparin or citrate) is the recommended sample type. Observe the following recommendations for handling, processing and storage of blood samples:• Collect all blood samples observing routine precaution for venipuncture.• For whole blood, samples should be stored at 2-4°C and tested within 7 days.

Do not freeze whole blood samples.• For serum, allow samples to clot.• Keep tubes stoppered at all times.• After centrifugation, separate the serum from the clot or red cells in a

tightly stoppered storage tube.

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• Serum specimens can be stored at +2-8°C if test is performed within 7 days. If test is not completed within 7 days, or for shipment, freeze the samples at -20°C or colder.

• Do not freeze/thaw serum samples more than 3 times. Previously frozen specimens should be thoroughly mixed (vortex) after thawing prior to testing.

• Do not heat the samples.

7. PROCEDURE

7.1. Material required

7.1.1. Materials providedEach RDT Dengue IgA/IgG kit contains:• Twenty-five (25) individually foil pouched cassettes with desiccant for

individual testing.• One (1) migration buffer dropper (3 ml).• One (1) instruction leaflet.

7.1.2. Materials required but not provided• Automatic or semi-automatic, adjustable or preset, pipettes or multi-

pipettes, to measure and dispense 5 µl.• Disposable tips.• Disposable gloves.• Goggles or safety glasses.• Sodium hypochlorite (bleach) and sodium bicarbonate.• Container for biohazard waste.

7.2. Reagents preparationAll reagents are ready-to-use.

7.3. Assay procedureRefer to figure at the end of the document.• Remove the cassette from its pouch and place it on a flat surface.• Label the test device with Patient ID or identification number.• Using a laboratory pipette, distribute 5 µl of sample into the sample well

(“S”) of the cassette holding the pipette vertically.• Using Migration Buffer dropper bottle, immediately add 3 drops of

Migration Buffer in round shape Diluent Well of the cassette.• Read the results after 20 to 30 minutes of migration at room temperature

(18-37°C).• Do not read the results before 20 minutes of migration.

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7.4. Interpretation of the ResultsConsider all bands even faint as reactive.• REACTIVE RESULT: presence of purple band at the Test Line A (IgA) and/

or the Test Line G (IgG) and the Control Line (C).• NON REACTIVE RESULT: presence of a purple band at the Control Line

(C) only.

NEGATIVEPresence of C Control band and absence of G and A bands

No detection of IgA or IgG; In case of Dengue suspicion, retest after 3-5 days.

POSITIVEIgA: Presence of C Control and A bands and absence of G band

Presence of IgA against Dengue virus. Indicative of an acute primary or secondary Dengue Infection.

IgG: Presence of purple C Control and G bands and absence of purple A band

Presence of IgG against Dengue virus. Indicative of current or past Dengue Infection.

IgA and IgG: Presence of purple C Control, A and G bands

Presence of IgA and IgG against Dengue virus. Indicative of acute primary or secondary Dengue Infection.

INVALIDAbsence of purple C Control band.

A wrong procedure is the most frequent cause of invalid result. Test should be repeated on fresh sample with a new cassette.

7.5. Test Validation CriteriaTest is considered INVALID if the Control Line (C) is absent, and should be repeated using a new cassette.

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8. TEST LIMITATIONSDiagnosis of recent infection by dengue virus can only be established on the basis of a combination of clinical and biological data.• A negative test result cannot exclude a recent infection.• Serological cross reactions with other Flaviviruses (Japanese encephalitis,

West Nile, yellow fever viruses) have been described• The RDT Dengue IgA/IgG is a qualitative test and does not indicate the

amount of IgA or IgG antibody in the specimen.• IgG and IgA antibodies can persist after the convalescence phase • Results should not be interpreted before 20 minutes of migration.

9. PERFORMANCE CHARACTERISTICS

9.1. Clinical performance

9.1.1 Relative specificityThe relative specificity was evaluated on sera or venous whole blood samples from blood donors or sera from febrile patients clinically diagnosed as negative for Dengue infection. Calculation was done using clinical status as reference.

IgA IgG

Population Total Negative Positive Specificity 95% Cl Negative Positive Specificity 95% Cl

French blood donors

115 115 0 100.0% 96.8%-100% 115 0 100.0% 96.8%-100%

Healthy Indian donors

50 48 2 96.0% 86.3%-99.5% 41 9 82.0% 68.5%-91.4%

Febrile Guiana patients

49 44 5 89.8% 77.7%-96.6% 40 9 81.6% 68.0%-91.2%

TOTAL 214 207 7 96.7% 93.4%-98.7% 196 18 91.6% 87.0%-95.0%

9.1.2. Relative sensitivityThe relative sensitivity was evaluated on sera from patients clinically diagnosed as positive for Dengue infection. Calculation was done using clinical status as reference.

Population N IgA positive 95% Cl IgG positive 95% ClIgA or NS1

positive95% Cl

India 31 100.0% 88.8%-100% 83.9% 66.3%-94.5% 100.0% 88.8%-100%

Singapore 50 50.0% 35.5%-64.5% 38.0% 24.6%- 52.8% 94.0% 83.4%-98.7%

French Guiana 133 76.7% 68.5%-83.6% 64.7% 55.9%-72.7% 93.8% 88.1%-97.3%

TOTAL 214 73.8% 67.4%-79.6% 61.2% 54.3%-67.8% 94.8% 90.8%-97.4%

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9.2. Cross Reactivity studies36 sera containing HAMA (12), ANA (12), or Rheumatoid Factor (12) were tested with RDT Dengue IgA IgG and did not show any non-specific reaction.A collection of 44 specimens from patients with infections other than Dengue, were tested with RDT Dengue IgA/IgG.

Population N IgA negative IgG negative

Malaria 25 24 96.0% 24 96.0%

Yellow Fever 11 11 100.0% 11 100.0%

West Nile Virus 8 7 87.5% 8 100.0%

9.3. PrecisionPrecision was tested using 3 positive samples including 2 low positive for IgA ,1 low positive for IgG and 1 negative sample. Interpretation was 100% in agreement with the status except for one low positive point giving 98% and 95% agreement for IgG and IgA, respectively.

9.4. Interferences studySamples containing 0.2 g/l of unconjugated bilirubin, hemolysed samples containing 2 g/l of hemoglobin, lipemic samples containing the equivalent of 30 g/l of triolein (triglyceride) or 5g/L of cholesterol, protein rich serums containing 120 g/l of total proteins do not affect the results.

10. QUALITY CONTROL OF THE MANUFACTURERAll manufactured reagents are prepared according to our Quality System, starting from reception of raw material to commercialization of the final product. Each lot is submitted to quality control assessments and is released to the market only after conforming to pre-defined acceptance criteria. The records related to production and controls of each single lot are kept within Bio-Rad.

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11. BIBLIOGRAPHY REFERENCES1. World Health Organization and the Special Programme for Research and

Training in Tropical Diseases (TDR) ; Dengue guidelines for diagnosis, treatment, prevention and control: new edition ; 2009

2. Centers for Disease Control and Prevention ; Dengue Laboratory Guidance and Diagnostic Testing ; http://www.cdc.gov/dengue/clinicallab/laboratory.html

3. Nawa M., Takasaki T., Ito M., Inoue S., Morita K., Kurane I. 2005. Immunoglobulin A an Antibody Response in Dengue Patients: a Useful Marker for Serodiagnosis of Dengue Virus Infection. Clin. Diagn. Lab. Immunol. 12 (10): 1235-1237

4. Jadhav SM, Deoshatwar AR.,2015. A meta-analysis of the diagnostic accuracy of dengue virus-specific IgA antibody-based tests for detection of dengue infection. Epidemiol Infect. 20:1-11

5. De Decker S, Vray M, Sistek V, Labeau B, Enfissi A, Rousset D., Matheus S. Evaluation of the Diagnostic Accuracy of a New Dengue IgA Capture Assay (Platelia Dengue IgA Capture, Bio-Rad) for Dengue Infection Detection; 2015; PLoS Negl Trop Dis 9(3).:

6. Rupali B, Kalichamy A, Anand S, Asha S, Paresh S, Dayaraj C; 2015;Higher levels of dengue-virus-specific IgG and IgA during pre-defervescence associated with primary dengue hemorrhagic fever. Arch. Virol. 2015; ;160;2435-2443.

ANNEX: TESTING PROCEDUREANEXO: PROCEDIMIENTO DE PRUEBAANEXO: PROCEDIMENTO DO TESTE

u

v

• Remove the cassette from its pouch and place it on a flat surface.

• Sacar el casete de su envase y colocarlo sobre una superficie plana.

• Remova o cassete da bolsa e coloque-o numa superfície plana.

• Using a laboratory pipette, distribute 5 µl of sample (serum, plasma or venous whold blood) into the sample well (“S”) holding the pipette vertically.

• Usando una pipeta de laboratorio, dispensar 5 µl de muestra (suero, plasma o sangre entera venosa) en el pocillo para muestras (“S”) sujetando la pipeta verticalmente.

• Utilizando uma pipeta de laboratório, distribua 5 µl da amostra (sangue total venoso, soro ou plasma) no poço de amostras («S») mantendo a pipeta na posição vertical.

PREPARING THE DEVICEPREPARACIÓN DEL DISPOSITIVOPREPARAÇÃO DO DISPOSITIVO

SAMPLE DISTRIBUTION (5 µl) DISTRIBUCIÓN DE LA MUESTRA (5 µl) DISTRIBUIÇÃO DE AMOSTRA (5 µl)

w• Using Migration Buffer dropper bottle,

immediately add 3 drops of Migration Buffer into round shape diluent well of the cassette.

• Utilizando el cuentagotas de solución de migración, añadir inmediatamente 3 gotas de solución de migración en el pocillo redondo de solución diluyente del casete.

• Utilizando o conta-gotas do tampão de migração, adicione imediatamente 3 gotas de tampão de migração no poço de diluente redondo do cassete.

MIGRATION BUFFER DISTRIBUTION (3 DROPS) DISTRIBUCIÓN DE LA SOLUCIÓN DE MIGRACIÓN (3 GOTAS)DISTRIBUIÇÃO DO TAMPÃO DE MIGRAÇÃO (3 GOTAS)

x • Read the results after 20 to 30 minutes of migration at room temperature (18 -37°C).

• Leer los resultados transcurridos de 20 a 30 minutos de migración a temperatura ambiente (18-37°C).

• Leia os resultados 20 a 30 minutos após a migração e na temperatura ambiente (18 - 37 °C).

MIGRATION INCUBATION STEP (20-30 MIN) FASE DE INCUBACIÓN DE LA MIGRACIÓN (20-30 MIN.)PASSO DE INCUBAÇÃO DE MIGRAÇÃO (20-30 MIN)

20-30 min.

(BG) •Този продукт съдържа човешки или животински компоненти. Бъдете внимателни при работа с него.

(CZ) • Tentovýrobekobsahujelidskénebozvířecíkomponenty.Zacházejtesnímopatrně.(DE) • Dieses Produkt enthält Bestandteile menschlichen oder tierischen Ursprungs. Vorsichtig

handhaben.(DK) • Dette produkt indeholder humane og animalske komponenter. Skal behandles med forsig-

tighed.(EE) • Käesolev toode sisaldab inim-või loomseid komponente. Käsitseda ettevaatlikult.(EN) • This product contains human or animal components. Handle with care.(ES) • Este producto contiene componentes humanos o animales. Manejar con cuidado.(FI) • Tässä tuotteessa on ihmisestä tai eläimistä peräisin olevia osia. Käsittele varovasti.(FR) • Ce produit contient des composants d’origine humaine ou animale. Manipuler avec précau-

tion.(GR) • Αυτό το προϊόν περιέχει ανθρώπινα ή ζωικά στοιχεία. Χειριστείτε το με προσοχή.(HR) • Ovaj proizvod sadrži ljudske ili životinjske sastojke. Pažljivo rukovati.(HU) • A készítmény emberi vagy állati eredetű összetevőket tartalmaz. Óvatosan kezelendő.(IT) • Questo prodotto contiene componenti umane o animali. Maneggiare con cura.(LT) •Šiameprodukteyražmogiškosiosarbagyvūninėskilmėssudėtiniųdalių.Elgtisatsargiai.(MT) • Dan il-prodott fih komponenti umani jew tal-annimali. Uża b’attenzjoni.(NL) • Dit product bevat menselijke of dierlijke bestanddelen. Breekbaar.(NO) • Dette produktet inneholder humane eller animalske komponenter. Håndteres med forsikti-

ghet.(PL) • Niniejszy produkt zawiera składniki pochodzenia ludzkiego lub zwierzęcego. Należy

obchodzić się z nim ostrożnie.(PT) • Este medicamento contém componentes de origem humana ou animal. Manuseie com

cuidado.(RO) •Acestprodusconţinematerialedeorigineumanăsauanimală.Manevraţi-lcugrijă.(SE) • Denna produkt innehåller beståndsdelar från människa eller djur. Hantera produkten

varsamt.(SI) • Izdelek vsebuje človeške ali živalske sestavine. Rokujte previdno.(SK) • Tentovýrobokobsahujeľudskéalebozvieraciezložky.Narábajtesnímopatrne.

H317P280 - P302+P352 - P333+P313 - P501

(BG)вниманиеМоже да причини алергична кожна реакция. Използвайте предпазни ръкавици/предпазно облекло/предпазни очила/предпазна маска за лице. ПРИ КОНТАКТ С КОЖАТА: Измийте обилно със сапун и вода. При поява на кожно дразнене или обрив на кожата: Потърсете медицински съвет/помощ. Изхвърлете съдържанието/контейнера в съответствие с местните/регионалните/националните/международните разпоредби.

(CZ)VarováníMůže vyvolat alergickou kožní reakci. Používejte ochranné rukavice/ochranný oděv/ochranné brýle/obličejový štít. PŘI STYKU S KŮŽÍ: Omyjte velkým množstvím vody a mýdla. Při podráždění kůže nebo vyrážce: Vyhledejte lékařskou pomoc/ošetření. Obsah/nádobu likvidujte v souladu s místními/regionálními/národními/mezinárodními předpisy.

(DE)AchtungKann allergische Hautreaktionen verursachen. Schutzhandschuhe/Schutzk le idung/Augenschutz/Gesichtsschutz tragen. BEI KONTAKT MIT DER HAUT: Mit viel Wasser und Seife waschen. Bei Hautreizung oder -ausschlag: Ärztlichen Rat einholen/ärztliche Hilfe hinzuziehen. Entsorgung des Inhalts / des Behälters gemäß den örtlichen / regionalen / nationalen/ internationalen Vorschriften.

(DK)AdvarselKan forårsage allergisk hudreaktion. Bær beskyttelseshandsker/beskyttelsestøj/øjenbeskyttelse/ansigtsbeskyttelse VED KONTAKT MED HUDEN: Vask med rigeligt sæbe og vand. Ved hudirritation eller udslet: Søg lægehjælp. Bortskaffelse af indholdet/beholderen i henhold til de lokale/regionale/nationale/internationale forskrifter.

(EE)Hoiatus Võib põhjustada allergilist nahareaktsiooni. Kanda kaitsekindaid/kaitserõivastust/kaitseprille/kaitsemaski. NAHALE SATTUMISE KORRAL: pesta rohke vee ja seebiga. Nahaärrituse või _obe korral: pöörduda arsti poole. Sisu/konteineri käitlus vastavuses kohalike/regionaalsete/rahvuslike/rahvusvaheliste nõuetega.

(EN)Warning May cause an allergic skin reaction. Wear protective gloves/protective clothing/eye protection/face protection. IF ON SKIN: Wash with plenty of soap and water. If skin irritation or rash occurs: Get medical advice/attention. Dispose of contents/container in accordance with local/regional/national/international regulations.

(ES)AtenciónPuede provocar una reacción alérgica en la piel. Llevar guantes/prendas/gafas/máscara de protección. EN CASO DE CONTACTO CON LA PIEL: Lavar con agua y jabón abundantes. En caso de irritación o erupción cutánea: Consultar a un médico. Eliminar el contenido o el recipiente conforme a la reglamentación local/regional/nacional/internacional.

(FI)VaroitusVoi aiheuttaa allergisen ihoreaktion. Käytä suojakäsineitä/suojavaatetusta/silmiensuojainta/kasvonsuojainta. JOS KEMIKAALIA JOUTUU IHOLLE: Pese runsaalla vedellä ja saippualla. Jos ilmenee ihoärsytystä tai ihottumaa: Hakeudu lääkäriin. Säilytä säiliö(t) noudattaen paikallisia/alueellisia/kansallisia/kansainvälisiä määräyksiä.

(FR)AttentionPeut provoquer une allergie cutanée. Porter des gants de protection/des vêtements de protection/un équipement de protection des yeux/du visage. EN CAS DE CONTACT AVEC LA PEAU: laver abondamment à l’eau et au savon. En cas d’irritation ou d’éruption cutanée: consulter un médecin. Éliminer le contenu/récipient conformément à la réglementation locale/régionale/nationale/internationale.

(GR)Προσοχή Μπορεί να προκαλέσει αλλεργική δερματική αντίδραση. Να φοράτε προστατευτικά γάντια/προστατευτικά ενδύματα/μέσα ατομικής προστασίας για ταμάτια/πρόσωπο. ΣΕ ΠΕΡΙΠΤΩΣΗ ΕΠΑΦΗΣ ΜΕ ΤΟ ΔΕΡΜΑ: Πλύνετε με άφθονο νερό και σαπούνι. Εάν παρατηρηθεί ερεθισμός του δέρματος ή εμφανιστεί εξάνθημα: Συμβουλευθείτε/Επισκεφθείτεγιατρό. Απορρίψτε τα περιεχόμενα/δοχείο σύμφωνα με τους τοπικούς/εθνικούς/διεθνείς κανονισμούς.

(HR)UpozorenjeMože izazvati alergijsku reakciju na koži. Nositi zaštitne rukavice/zaštitnu odijelo/zaštitu za oči/zaštitu za lice. U SLUČAJU DODIRA S KOŽOM: oprati velikom količinom sapuna i vode. U slučaju nadražaja ili osipa na koži: zatražiti savjet/pomoć liječnika. Odložite sadržaje /spremnike u skladu s lokalnim/regionalnim/nacionalni/međunarodnim odredbama.

(HU)Figyelem Allergiás bőrreakciót válthat ki. Védőkesztyű/védőruha/szemvédő/arcvédő használata kötelező. HA BŐRRE KERÜL: Lemosás bő szappanos vízzel. Bőrirritáció vagy kiütések megjelenése esetén: orvosi ellátást kell kérni. Az edény tartalmát / a tartályt a helyi/regionális/nemzeti/nemzetközi szabályozásoknak megfelelően kell hulladékként elhelyezni.

(IT)Attenzione Può provocare una reazione allergica cutanea. Indossare guanti/indumenti protettivi/Proteggere gli occhi/il viso. IN CASO DI CONTATTO CON LA PELLE: lavare abbondantemente con acqua e sapone. In caso di irritazione

o eruzione della pelle: consultare un medico. Smaltire il prodotto/recipiente in conformità con le disposizioni locali / regionali / nazionali / internazionali.

(LT)Atsargiai Gali sukelti alerginę odos reakciją. Mūvėti apsaugines pirštines/dėvėti apsauginius drabužius/naudoti akių (veido) apsaugos priemones. PATEKUS ANT ODOS: Nuplauti dideliu kiekiu muilo ir vandens. Jeigu sudirginama oda arba ją išberia: kreiptis į gydytoją. Turinį/talpą išpilti (išmesti) - šalinti pagal vietines / regionines / nacionalines / tarptautines taisykles.

(NL)Waarschuwing Kan een allergische huidreactie veroorzaken. Beschermende handschoenen/beschermende kleding/oogbescherming/gelaatsbescherming dragen. BIJ CONTACT MET DE HUID: met veel water en zeep wassen. Bij huidirritatie of uitslag: een arts raadplegen. De inhoud en de verpakking verwerken volgens de plaatselijke/regionale/nationale/internationale voorschriften.

(NO)AdvarselKan forårsake allergiske hudreaksjoner. Bruk vernehansker/verneklær/vernebriller/ansiktsskjerm. VED HUDKONTAKT: Vask med store mengder vann og såpe. Ved hudirritasjon eller -utslett: Kontakt / tilkall lege. Innholdet / emballasjen skal avhendes i henhold til de lokale / regionale / nasjonale / internasjonale forskrifter.

(PL)Uwaga Może powodować reakcję alergiczną skóry. Stosować rękawice ochronne/odzież ochronną/ochronę oczu/ochronę twarzy. W PRZYPADKU KONTAKTU ZE SKÓRĄ: Umyć dużą ilością wody z mydłem. W przypadku wystąpienia podrażnienia skóry lub wysypki: Zasięgnąć porady/zgłosić się pod opiekę lekarza. Zawartość / pojemnik usuwać zgodnie z przepisami miejscowymi / regionalnymi / narodowymi / międzynarodowymi.

(PT)Atenção Pode provocar uma reacção alérgica cutânea. Usar luvas de protecção/vestuário de protecção/protecção ocular/protecção facial. SE ENTRAR EM CONTACTO COM A PELE: lavar com sabonete e água abundantes. Em caso de irritação ou erupção cutânea: consulte um médico. Eliminar o conteúdo/recipiente de acordo com a legislação local/regional/nacional/internacional.

(RO)Atenţie Poate provoca o reacţie alergică a pielii. Purtaţi mănuşi de protecţie/îmbrăcăminte de protecţie/echipament de protecţie a ochilor/ chipament de protecţie a feţei. ÎN CAZ DE CONTACT CU PIELEA: spălaţi cu multă apă şi săpun. În caz de iritare a pielii sau de erupţie cutanată: consultaţi medicul. Aruncaţi conţinutul/containerul în acord cu regulamentele locale/regionale/naţionale/internaţionale.

(SE)Varning Kan orsaka allergisk hudreaktion. Använd skyddshandskar/skyddskläder/ögonskydd/ansiktsskydd. VID HUDKONTAKT: Tvätta med mycket tvål och vatten. Vid hudirritation eller utslag: Sök läkarhjälp. Innehållet / behållaren avfallshanteras enligt lokala / regionala / nationella / internationella föreskrifter.

(Sl)Pozor Lahko povzroči alergijski odziv kože. Nositi zaščitne rokavice/zaščitno obleko/zaščito za oči/zaščito za obraz. PRI STIKU S KOŽO: umiti z veliko mila in vode. Če nastopi draženje kože ali se pojavi izpuščaj: poiščite zdravniško pomoč/oskrbo. Vsebino/vsebnik odstranite v skladu z lokalnimi/regionalnimi/narodnimi/mednarodnimi predpisi.

(SK)Pozor Môže vyvolať alergickú kožnú reakciu. Noste ochranné rukavice/ochranný odev/ochranné okuliare/ochranu tváre. PRI KONTAKTE S POKOŽKOU: Umyte veľkým množstvom vody a mydla. Ak sa prejaví podráždenie pokožky alebo sa vytvoria vyrážky: vyhľadajte lekársku pomoc/starostlivosť. Zneškodnenie obsahu/obalu v súlade s miestnymi/oblastnými/národnými/medzinárodnými nariadeniami.

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