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catastrophic situation such as death or severe long-term
injury if not avoided.
• Caution: Points out a situation where a potentially hazard-
ous condition exists that could result in a serious situation
such as short-term injury or impairment requiring medical
intervention to correct if not avoided.
• Information: Points out a situation where a potentially
hazardous condition exists that could result in a not serious
situation, such as a slight inconvenience, if not avoided.
2. Bloom System
The Bloom Thyroid Test only works together with the Bloom App
and Bloom Lab. These form the “Bloom System”. To get started,
download and install the Bloom App on your smartphone.
Ensure you have access to a Bloom Lab.
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
screening and monitoring of target markers and medical
guidance. It combines lateral flow immunoassays (Bloom
Test strips), an established diagnostics technology, with an
electronic reader for test strip analysis (Bloom Lab) and an
app for displaying and interpreting results (Bloom App).
2.2. Bloom Thyroid Test
2.2.1. Principle of the method
The Bloom Thyroid Test strip is a lateral flow immunoassay
based on colloidal gold nanoparticles. It consists of a sample
window, a conjugate pad containing anti-TSH antibodies
bound to gold particles, a test line with anti-TSH antibodies
and a control line with anti-IgG antibodies. When blood and
buffer are applied, the mixture migrates by capillary force
along the test strip. The TSH present in the blood will bind to
the anti-TSH antibodies conjugated to gold particles. These
immune complexes are then captured by the anti-TSH anti-
bodies in the test line, creating a colored line detected by the
Bloom Lab. The control line is detected by the Bloom Lab to
verify whether the test has run correctly. Results are received
in the form of a Bloom Thyroid Report via the Bloom App.
2.2.2. Test performance
Limit of
Detection
Quantifiable
Range
Precision Sensitivity* Specificity*
1.5 mIU/L 2.6 - 30.0 mIU/L 15% 87.23% 90.57%
*determined based on a cut-off of 4.5 mIU/L.
2.2.3. Interferents
Ampicillin Na, hGH and Doxycycline Hyclate will interfere
with the test result. Unusually high levels of heterophile
antibodies or highly lipemic samples might interfere with the
test result. Cefoxitin Na, acetaminophen, citalopram and
fluoxetine HCl might slightly interfere with the test result. No
interference was observed from rheumatoid factors up to a
concentration of 510 IU/ml.
2.2.4. Components
The Bloom Thyroid Test includes one set of instructions for
use and enough material either one or five tests (indicated
on the outer package). Material for one test comprises of the
following:
1 1 x Bloom Thyroid Test strip in aluminium pouch
2
1 x Alcohol
wipe for finger
cleaning
Servoprax GmbH,
Wesel, Germany
3
1 x Sterile
safety lancet
for finger
pricking
0197
Medipurpose Pte.
Ltd., Plaza,
Singapore
4
1 x Plaster
for incision
patching
BSN Medical GmbH,
Hamburg, Germany