4
EN
Warning
Do not use the Bloom System as a diagnostic device.
Using the information provided by the Bloom System
for diagnosis can lead to mistreatment and severe
consequences. Results should be reviewed by a medical
practitioner.
2.1. Overview of the Bloom System
Bloom Test packaging
Bloom App
Bloom Test strip
Sample
window
Read out
window
NFC tag
Bloom Lab
LED indication ring
Strip insertion flap
Bloom System�
The Bloom System is a medical testing system. It provides screen-
ing and monitoring of target markers and medical guidance. It
combines lateral fl ow assay-based bodily fl uid testing (Bloom Test
strips), an established diagnostics technology, with an electronic
reader for test strip analysis (Bloom Lab) and user-friendly
software for displaying and interpreting results (the Bloom App).
2.2. Bloom Ferritin Test
2.2.1. Principle of the method
The Bloom Ferritin Test strip is a rapid immunochromatographic
assay based on gold nanoparticles. When the blood is mixed with
the provided dilution buff er and applied onto the test strip, the
diluted blood fl ows along the test strip and binds to anti-Ferritin
antibodies, which detect the ferritin in the blood and will create a
color line detected by the Bloom Lab. The Bloom Ferritin Test strip
also includes a control line, which will be detected by the Bloom
Lab to verify whether the test has run correctly. Users will receive
their results in the form of a report via the Bloom App.
2.2.2. Test performance
Reference Test
Positive Negative
Total
Bloom
Ferritin
Test
Positive
65
2
67
Sensitivity
100�0 %
Negative
0
33
33
Specifi city
94�3%
Total
65
35
100
Accuracy
98.2%
The Bloom Ferritin Test has a quantifi able range between 10 - 500 μg/L.
2.2.3. Cross reactivity and Interferents
Unusually high titers of heterophile antibodies or rheumatoid
factor (RF) in the blood may aff ect the test results.
2.2.4. Components
The Bloom Ferritin Test includes one set of instructions for use and
enough material for either one or fi ve tests (indicated on the outer
package). Material for one test comprises of the following:
1
1 x Bloom Ferritin Test strip in aluminium pouch
2
1 x Alcohol wipe
for fi nger cleaning
Servoprax GmbH,
Wesel, Germany
3
1 x Sterile safety
lancet for fi nger
pricking
0197
Medipurpose Pte.
Ltd., Singapore,
Singapore
4
1 x Plaster for
incision patching
BSN Medical
GmbH, Hamburg,
Germany
5
1 x Capillary tube
(lithium heparin)
for blood collection
Sarstedt AG &
Co., Nümbrecht,
Germany
6
1 x Buff er
7
1x Disinfecting
cleaning wipe for
Bloom Lab
2797
PDI Ltd., Flint,
United Kingdom
3. Safety Regulations
3.1. General notes on safety
1� Do not use this Bloom Test if you are intoxicated or fi nd your-
self in an acute situation of emergency or distress. In case of
doubt, always consult with your medical practitioner.
2� The Bloom Report displays the result of the Bloom Test and,
together with the answers given in the questionnaire, off ers
additional information. It is not intended to diagnose or inform
about the treatment of medical conditions. Never avoid, put
off , change or start treatment based on the content of the
Bloom Report. In order to receive a diagnosis and treatment,
consult a medical practitioner. In case of health concerns, seek
medical attention immediately.
3� With the exception of the measured test value, all information
presented in the Bloom Report is the result of Bloom Diagnos-
tics’ research conducted with literature available at the time
of development. While the information in the Bloom Report
is provided with great care, all content provided is subject to
change depending on scientifi c discoveries and advances, and
might not apply globally�
