Thyroid Test Instructions

A rapid test for the qualitative detection of human Thyroid Stimulating Hormone (TSH) in human whole blood. For self-testing in vitro diagnostic use only.

INTENDED USE

The TSH Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of TSH in human whole blood at a cut-off concentration of 5μIU/mL. This assay provides a preliminary diagnostic test result and can be used to screening for TSH.

PRECAUTIONS

Please read all the information in this package insert before performing the test.

• For self-testing in vitro diagnostic use only.
• Do not eat, drink or smoke in the area where the specimens or kits are handled.
• Store in a dry place at 2-30°C (36-86°F), avoiding areas of excess moisture. If the foil packaging is damaged or has been opened, please do not use.
• This test kit is intended to be used as a preliminary test only and repeatedly abnormal results should be discussed with doctor or medical professional.
• Follow the indicated time strictly.
• Use the test only once. Do not dismantle and touch the test window of the test cassette.
• The kit must not be frozen or used after the expiration date printed on the package.
• Keep out of the reach of children.
• The used test should be discarded according to local regulations.

STORAGE AND STABILITY

Store as packaged in the sealed pouch at room temperature or refrigerated (2-30 °C). The test is stable through the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.

KIT CONTENTS

• Test Cassette
• Capillary Dropper
• Buffer
• Alcohol Pad
• Lancet
• Package Insert

MATERIALS REQUIRED BUT NOT PROVIDED

• Timer

PROCEDURE

1. Wash your hands with soap and rinse with clear warm water.
2. Bring the pouch to room temperature before opening it. Open the foil pouch and get out the cassette.
3. Carefully pull off and dispose the released cap of the lancet.
4. Use the provided alcohol pad to clean the fingertip of the middle or ring finger as the puncture site.
5. Press the lancet, on the side from where the cap was extracted; against the fingertip (Side of ring finger is advised). The tip retracts automatically and safely after use.
6. Keeping the hand down massage, the end that was pricked to obtain a blood drop.
7. Without squeezing the capillary dropper bulb, put it in contact with the blood. The blood migrates into the capillary dropper to the line indicated on the capillary dropper. You may massage again your finger to obtain more blood. Avoid air bubbles.
8. Put the blood collected into the sample well of the cassette, by squeezing on the dropper bulb.
9. Wait for the blood to be totally dispensed in the well. Unscrew the cap of the buffer bottle and add 2 drops of buffer into the sample well of the cassette.
10. Wait for the coloured line(s) to appear. Read results at 10 minutes. Do not interpret the result after 20 minutes.

READING THE RESULTS

POSITIVE: Two coloured lines appear. Both T (Test) and C (Control) line appear. This result means that the TSH level is higher than the normal (5 μIU/mL) and that you should consult a physician.

NEGATIVE: One coloured line appears. Only control line (C) appears. This result means that the TSH level is not in the range to consider Hypothyroidism.

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

CONTROL PROCEDURE

A procedural control is included in the test. A coloured line appearing in the control region (C) is the internal procedural control. It confirms sufficient specimen volume and correct procedural technique.

LIMITATIONS

1. The TSH Rapid Test Cassette (Whole Blood) is for in vitro diagnostic use only. The test should be used for the detection of TSH in whole blood specimens only. Neither the quantitative value nor the rate of increase in TSH concentration can be determined by this qualitative test.
2. The TSH Rapid Test Cassette (Whole Blood) is only for screening the primary hypothyroidism of adult population, not for neonates.
3. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.
4. A positive test must be confirmed using a quantitative laboratory TSH assay.
5. False positive results can occur due to heterophilic (unusual) antibodies. In certain clinical conditions such as central hypothyroidism, TSH levels may be normal/low, despite hypothyroidism. Medical consultation is recommended to exclude such cases.
6. For Central/Secondary Hypothyroidism, TSH is not a reliable biomarker, which occurs in 1 out of 1,000 Hypothyroidism cases.

PERFORMANCE CHARACTERISTICS

Accuracy

A clinical evaluation was conducted comparing the results obtained using the TSH Test to ELISA. The in-house clinical trial included 220 whole blood specimens. The results demonstrated 98.2% specificity and 98.2% sensitivity with an overall accuracy of 98.2%.