Bloom System; Overview Of The Bloom System; Bloom Amh Test; Principle Of The Method - Bloom Diagnostics AHM test Manual De Instrucciones

hazardous condition exists that could result in a critical or
catastrophic situation such as death or severe long-term
EN
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 AMH Test works only in conjunction with the Bloom
App and Bloom Lab, collectively known as the "Bloom System".
To get started, download and install the Bloom App on the
smartphone and 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

NFC tag
Bloom Test packaging Bloom Test strip
The Bloom System is a medical testing system. It provides
screening and monitoring of target markers and medical
guidance. It combines lateral flow assay-based bodily
fluid testing (Bloom Test strips), an established diagnostics
technology, with an electronic reader for test strip analyzation
(Bloom Lab) and user-friendly software for displaying and
interpreting results (the Bloom App).
Four main interactions are required (some of which might
include guided sub-steps):
1. Establishing Bluetooth connection between the Bloom
App and the Bloom Lab.
2. Applying a blood sample on the Bloom Test strip.
4
LED indication ring Strip insertion flap
Read out
window
Sample
window
Bloom Lab Bloom App
Bloom System.
3. Inserting the Bloom Test strip into the Bloom Lab.
4. Receiving test results (Bloom Report) and guidance on
the Bloom App.
The Bloom Lab is an electronic device intended to analyze
Bloom Test strips. The Bloom App is a smartphone app,
which connects to the Bloom Lab via Bluetooth and displays
and interprets its measurement results.

2.2. Bloom AMH Test

The Bloom AMH Test is a test kit containing test strip(s) and
single-use components for blood sampling.

2.2.1. Principle of the method

The Bloom AMH Test strip is a lateral flow immunoassay
based on colloidal gold nanoparticles. It consists of a sample
window, a conjugate pad containing anti-AMH antibodies
conjugated to colloidal gold and biotin, a test line with
streptavidin, and a control line with anti-IgG antibodies.
When blood and buffer are applied onto the test strip, the
mixture migrates by capillary force along the test strip. AMH
present in the sample will bind to the anti-AMH antibodies
present in the conjugate pad. These immune complexes are
then captured in the test line, creating a colored line detected
by the Bloom Lab. Control immune complexes are captured
by control antibodies in the control line. 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 AMH
Report via the Bloom App.

2.2.2. Test performance

Dynamic Range
0.3 - 15 ng/ml 0.7 ng/ml

2.2.3. Cross reactivity and interferents

Unusually high titers of heterophile antibodies or rheumatoid
factor (RF) in the blood may affect the test results. High biotin
levels have shown interference with the test results. Biotin
(also called vitamin B7) is present in biotin supplements
as well as supplements marketed for hair, skin, and nail
growth. Biotin supplements should be stopped 72 hours
prior to taking the test. If you have been prescribed biotin as
treatment for a medical condition, do not stop them without
consulting with your doctor. Bilirubin at a level of 0.66 mg/
mL and intralipid at 20mg/ml have shown interference with
the test results. The following drugs may also interfere with
LLoQ LLoD
0.3 ng/ml