CE Marked in vitro diagnostic (IVD) self Test (ferritin rapid test) – based on Silex ferritin self Test status in the EU/UK market
CE Marked in vitro diagnostic (IVD) self Test (ferritin rapid test) – based on Silex ferritin self Test status in the EU/UK market
At-Home Ferritin / Iron Deficiency Test
Description
The Iron Deficiency (Ferritin) Self Test Home Kit by Silex is a finger-prick blood test designed for early screening of iron deficiency anaemia (IDA) by measuring ferritin, the main iron-storage protein in the body. Using a small capillary blood sample taken from the fingertip, the test provides a rapid, qualitative indication of whether ferritin levels are below a defined threshold associated with low iron stores. It is intended as a convenient at-home screening tool and does not replace formal laboratory testing or medical diagnosis.
Bnefits
At-home screening test for iron deficiency anaemia (IDA) based on ferritin levels
Uses a simple finger-prick blood sample – no venous blood draw required
Provides a rapid indication of low iron stores (ferritin) without needing to visit a clinic or lab
Helps identify potential iron deficiency early, prompting further medical evaluation if needed
May be useful in individuals with symptoms such as tiredness, pallor, poor concentration, brittle hair and nails or shortness of breath
Compact kit suitable for home use with clearly marked components
Ideal as an initial self-check for iron deficiency as part of a broader health or aesthetic/wellness assessment
Indications
At-home self-testing for possible iron deficiency anaemia (IDA) by assessing ferritin levels in capillary blood
Screening in individuals experiencing symptoms potentially related to low iron, such as fatigue, pallor, reduced exercise tolerance, poor concentration, memory problems, brittle hair and nails, or slow wound healing
Supplementary self-check in individuals at increased risk of iron deficiency (e.g. heavy menstrual bleeding, limited dietary iron intake), prior to seeking professional medical advice
Composition
1 x ferritin rapid test cassette (immunochromatographic lateral-flow device) – exact cut-off (e.g. 20–30 µg/L) and chemistry not specified in the retailer listing
1 or more sterile lancets for finger-prick blood collection
Capillary pipette or dropper for blood sample transfer (if included by manufacturer)
Diluent / buffer solution vial (if part of the kit contents)
Alcohol swab(s) and/or cleansing wipe(s) (depending on manufacturer packaging)
Instructions for use leaflet
Formulation
Single-use, immunochromatographic lateral-flow test cassette for qualitative detection of ferritin in capillary whole blood
Packaging
Retail carton/pack containing the Iron Deficiency (Ferritin) Self Test Home Kit components (test cassette, lancet(s), buffer and accessories as provided by Silex)
Packed for consumer sale by Two Face Aesthetics with labelled outer packaging
Usage
Read the entire instruction leaflet supplied with the kit before starting.
Wash and dry hands thoroughly; choose a fingertip for sampling.
Clean the fingertip with the provided alcohol swab (or another suitable skin cleanser) and allow it to dry.
Use the sterile lancet to perform a finger prick and gently squeeze the finger to obtain a drop of blood.
Collect the required volume of capillary blood with the supplied pipette or by applying directly to the sample well of the test cassette, as instructed.
Add the specified drops of buffer/diluent into the appropriate well on the test cassette (if required by the kit design).
Place the test on a flat surface and start timing immediately.
Read the result at the time point indicated in the instructions (for example, after 10–15 minutes); do not interpret results after the maximum allowed reading time.
Compare the lines on the test cassette with the reference diagram in the instructions to determine whether the test is valid and whether ferritin is considered low or within/above range.
Dispose of the used lancet, cassette and other materials safely in household waste in accordance with local guidance; keep out of reach of children.
A positive/abnormal (suggesting low ferritin) or unclear result should be followed up with a healthcare professional and formal laboratory testing for confirmation and further evaluation.
Do not use the test as the sole basis for diagnosis or treatment decisions; always consult a doctor if symptoms persist or results are abnormal.
Contraindications
Not intended as a substitute for professional medical diagnosis or regular laboratory monitoring.
Should not be used by individuals unable to safely perform a finger-prick test or follow the instructions (e.g. small children without adult supervision).
People with bleeding disorders or those on anticoagulant therapy should seek medical advice before performing finger-prick blood tests.
Do not use the test after the expiry date or if the foil pouch/test cassette is damaged.
Do not reuse the test cassette or lancets; single-use only.
Adverse Effects
Mild, transient pain or discomfort at the finger-prick site.
Small risk of local bleeding, bruising or infection at the puncture site if the area is not kept clean.
Possible misinterpretation of results leading to unnecessary anxiety or delayed medical consultation if instructions are not followed correctly.
Storage Conditions
Store the kit in a cool, dry place, typically between 2°C and 30°C or as indicated on the packaging.
Protect from direct sunlight, heat and moisture.
Do not freeze the test kit.
Keep out of reach of children.
Use only within the expiry date printed on the packaging.
Duration
Single-use, one-time self-test; not a treatment product. Further testing or treatment decisions must be made by a healthcare professional.
Onset
Not applicable as a treatment; test results aretypically available within minutes as specified in the instructions (often around 10\u201315 minutes from sample application).
