Self-diagnostic ths thyroid test

Product Description

Self-test for thyroid.

Indications

The Thyroid Thyroid Test from Munus Medical is a qualitative, membrane-based immunoassay for the detection of thyroid-stimulating hormone (TSH) in whole blood samples.

In this test procedure, anti-TSH antibody is immobilized in the test area and coated particles. After the sample is added to the sample well of the cassette, it reacts with the anti-TSH antibody-coated particles in the test. The mixture migrates chromatographically along the test and interacts with the immobilized anti-TSH antibody.

Positive samples react with the specific anti-TSH antibody-coated particles to form a colored line in the test area of ​​the membrane. The absence of the colored line suggests a negative result. For procedural control purposes, a colored line will always appear in the control region to indicate that an adequate volume of specimen has been added and capillary penetration into the membrane has occurred.

This test provides a preliminary diagnostic result and may be used for TSH screening.

Directions for use and Dosage

• Wash your hands with soap and rinse with warm water;
• Bring the pouch to room temperature before opening it;
• Open the foil pouch and remove the cassette.
• Carefully remove and discard the lancet cap;
• Use the alcohol swab provided to clean the tip of your middle or ring finger as the puncture site;
• Press the lancet, on the side from which the cap was removed, against the tip of your finger (the ring finger is recommended);
• The tip automatically and safely retracts after use;
• Keeping your hand pointing down, massage the pricked end to obtain a drop of blood;
• Put the capillary dropper bulb in contact with the blood, without squeezing the bulb;
• The blood will migrate into the capillary dropper up to the indicated line, if the line is not reached, you can massage your finger again to get more blood. blood;
• Avoid air bubbles;
• Pour the collected blood into the cassette sampling well by squeezing the dropper bulb;
• Wait until the blood is completely dispensed into the well;
• Unscrew the cap of the buffer bottle and add 2 drops of buffer to the cassette sampling well;
• Wait for the colored lines to appear;
• Read the result after 10 minutes;
• Do not interpret the result after 20 minutes.

Warnings

Read all information in this package insert before performing the test. For in vitro self-testing use only. Do not eat, drink, or smoke in the area where specimens or kits are handled. If the foil pouch is damaged or has been opened, do not use. This test kit should be used only as a preliminary test, and repeatedly abnormal results should be discussed with your doctor or clinical professional. Strictly adhere to the indicated timing. Use the test only once. Do not disassemble or touch the test window of the cassette. The kit should not be frozen or used after the expiration date printed on the package. Keep out of reach of children. The used test should be discarded according to local regulations. The test should only be used to detect TSH in whole blood samples. This qualitative test does not allow for the determination of either the quantitative value or the rate of increase in TSH concentration. The rapid test is intended only for screening for primary hypothyroidism in adults, not for newborns. As with all diagnostic tests, all results must be interpreted in conjunction with other clinical information available to the doctor. A positive test should be confirmed using a quantitative laboratory test for TSH. False positive results may occur due to heterophile (unusual) antibodies. In some clinical conditions, such as central hypothyroidism, TSH levels may be normal/low despite hypothyroidism. A medical consultation is recommended to evaluate such cases. For central/secondary hypothyroidism, TSH is not a reliable biomarker; this occurs in 1 in 1,000 cases of hypothyroidism.

Reading the Results

Positive: Two colored lines appear. Both the T (test) and C (control) lines appear. This result means that the TSH level is above normal (5 mcIU/mL) and that medical attention should be sought.

Negative: One colored line appears. Only the control (C) line appears. This result means that your TSH level is outside the range for hypothyroidism.

Invalid: The control line is not visible. The most likely reasons for the control line not appearing are insufficient sample volume or incorrect procedural techniques. Review the procedure and repeat the test with a new test. If the problem persists, discontinue use of the test kit immediately and contact your local distributor.

Storage

Store in a dry place at 2-30°C (36-86°F), avoiding areas of excessive humidity. Do not freeze. The test is stable until the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use. Do not use beyond the expiration date. Shelf life with intact packaging: 24 months.

Format

The kit contains: test cassette, capillary dropper, buffer, alcohol swab, lancet, package leaflet.