Thyroid test - self-diagnostic kit for self-analysis

Product Description

Rapid test for the detection of underactive thyroid in whole blood.

Indications

The Thyroid Test by Sofarmapiù is a rapid immunodiagnostic test for the detection of increased TSH levels. It is therefore functional for screening for hypothyroidism through a fingerstick blood sample.

How to use

• Place the contents of the box on a clean, dry, flat surface and perform the test;
• Wash your hands thoroughly;
• Use warm water and soap;
• Dry your hands with a clean towel;
• Prepare the test device and pipette;
• Remove them from the protective pouch (tear at the notch) and place them within reach;
• Discard the desiccant sachet;
• Prepare the lancet;
• Hold the lancet without touching the activation button;
• Unlock the lancet cap by turning it 1/4 turn. turn until you feel it come off the lancet and then continue rotating it (2-3 rotations);
• Do not pull;
• Twist and discard the cap when finished;
• Clean the tip of your middle or ring finger with cotton moistened with alcohol;
• Rub the chosen finger towards the tip for 10-15 seconds to increase blood flow;
• Press the device firmly against the lateral side of the previously cleaned finger and press the trigger release button;
• The tip automatically retracts into the body of the device;
• Rub the tip of your finger to obtain a sufficient whole blood sample;
• Without squeezing the bulb, bring the plastic pipette into contact with the blood sample;
• The blood migrates into the pipette by capillary action up to the line indicated on the pipette;
• You can rub your finger again to obtain more blood if the line is not reached;
• As far as possible, avoid the formation of air bubbles;
• Put the blood collected with the pipette into the sample well of the device, pressing on the bulb of the pipette;
• Wait 30-40 seconds for the blood to be completely absorbed into the sample well;
• Unscrew the blue cap of the diluent dropper bottle (leave the white cap tightly screwed on) and add the diluent;
• Hold the dropper vertically and slowly add 4 drops to the sample well of the device with an interval of 2-3 seconds between each drop;
• Read the result after 10 minutes. Do not interpret the result after 15 minutes.

Reading the Results

Positive: Two colored lines appear, the test line (T) and the control line (C). The test line (T) may have the same color intensity as the control line (C) or a lower color intensity. In any case, the color intensity and color have no impact on the interpretation of the test results. This result means that the TSH level is higher than normal. This could be a sign of thyroid dysfunction; you should consult your doctor.

Negative: Only one colored line appears, the control line (C). The test line (T) does not appear. This result means that the TSH level is normal.

Invalid: Neither the test line (T) nor the control line (C) appear. the control line (C) or only the test line (T) appears. In this case, the test should be considered invalid. Repeat the test with a new test device and a new blood sample.

Warnings

Read the instructions carefully before performing the test. For in vitro diagnostic self-testing only. For external use only. Do not ingest. Strictly follow the indicated times and the quantities of blood and diluent indicated. The test is interpretable only if the instructions are followed correctly. Do not use if the pouch is opened or damaged. The test is for single use only: do not reuse. Keep out of reach of children.

Storage

Store between 4°C and 30°C. Do not freeze. Do not use after the expiration date. Shelf life with intact packaging: 24 months.

Format

The kit contains: test device; pipette; diluent; sterile lancet; package insert.