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Quick start guide
What’s in the box
1 alcohol
wipe
1 lancet
1 plaster
1 capillary
tube
1 buffer
1 cleaning
wipe
1 Bloom COVID-19
Test strip
C19-REF-1 (contains 1 test)
C19-REF-2 (contains 5 tests)
9
1x
10
11
14
15
1 instructions
for use
2020-07-20, 4-4-2-6-2 Bloom COVID-19 Test IFU ENGLISH, V1.0
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EN
IMPORTANT: Dear user, to avoid hazards and confusion, please read these instructions for use carefully before attempting to use the Bloom
COVID-19 Test. RETAIN INSTRUCTIONS FOR USE FOR FUTURE REFERENCE AND WARRANTY.
DE
WICHTIG: Sehr geehrter Nutzer, um
Gefahren zu vermeiden und Unklarheiten zu beseitigen, lesen Sie diese Bedienungsanleitung sorgfältig durch, bevor Sie versuchen, den Bloom
COVID-19-Test zu verwenden. BEWAHREN SIE DIE BEDIENUNGSANLEITUNG ZUM NACHLESEN UND FÜR DEN GARANTIEFALL AUF.
FR
IMPORTANT: Chère utilisatrice, cher utilisateur, pour éviter des dangers et une confusion, veuillez lire attentivement ce mode d’emploi avant d’es-
sayer d’utiliser le Test Bloom COVID-19.
IT
IMPORTANTE: gentile utilizzatore, per evitare pericoli e confusione si prega di leggere attentamente le
presenti istruzioni per l’uso prima di tentare di usare il Bloom COVID-19 Test. CONSERVARE LE ISTRUZIONI PER L’USO A SCOPO DI RIFERIMENTO
FUTURO E PER GARANZIA.
ES
Estimado/a usuario/a, para evitar peligros y confusión, lea detenidamente estas instrucciones antes de intentar
utilizar la prueba para COVID-19 de Bloom. CONSERVE LAS INSTRUCCIONES PARA FUTURA REFERENCIA Y A EFECTOS DE LA GARANTÍA.
Table of contents
1. General Information ...............................................3
1.1. Intended use EEA.... ............................................. 3
1.2. Intended use US .................................................. 3
1.3. Terms and definitions ........................................... 4
2. Bloom System .........................................................4
2.1. Overview of the Bloom System .............................. 4
2.2. Bloom COVID-19 Test ......................................... 4
2.2.1. Principle of the method ................................... 5
2.2.2. Test performance ........................................... 5
2.2.3. Components ................................................. 5
3. Safety Regulations ..................................................6
3.1. Disclaimer ........................................................... 6
3.2. General notes on safety ....................................... 6
3.3. Limitations of use ................................................. 6
3.4. Use-by-date ........................................................ 6
4. Operating steps ......................................................6
4.1. Preparation .................................................. 7
4.2. Blood sample collection .................................. 7
4.3. Process sampling and report collection ............ 10
4.4. Device cleaning .......................................... 10
5. Storage ...............................................................10
6. Bloom Lab LED indications .....................................10
6.1. Proper function .................................................. 10
6.2. Error case ......................................................... 11
7. Troubleshooting ....................................................12
7.1. Bloom Lab ........................................................ 12
7.2. Bloom App ........................................................ 13
8. Symbol information ..............................................14
9. Contact information ..............................................14
1. General information
Coronaviruses (CoV) are a large family of viruses that cause
illness ranging from the common cold to more severe diseas-
es. COVID-19 is caused by the coronavirus SARS-CoV-2. For
more information please visit www.bloomdiagnostics.com.
1.1. Intended use EEA
The Bloom COVID-19 Test is designed to detect IgG antibodies
against SARS-CoV-2 in individuals who suspect to have or have
had an infection. Not intended for persons who are under 18
years old or in an acute situation of emergency or distress.
1.2. Intended use US
The Bloom COVID-19 Test is a lateral flow immunoassay
intended for the qualitative detection of IgG antibodies to
SARS-CoV-2 in human blood. The Bloom COVID-19 Test
is intended for use as an aid in identifying individuals with
an adaptive immune response to SARS-CoV-2, indicating
recent or prior infection. At this time, it is unknown for
how long antibodies persist following infection and if the
presence of antibodies confers protective immunity. The
SARS-CoV-2 IgG assay should not be used to diagnose
acute SARS-CoV-2 infection.
Results are for the detection of SARS CoV-2 IgG antibodies.