Thyroid test

	TSH test for underactive thyroid - Test instructions Manufacturers details The PreventID® TSH is a rapid assay test. The test sensitivity is 5 µ IU/ml. Explanation of the Test A thyroid stimulating hormone (TSH) test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone in whole blood. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. Symptoms of hypothyroidism: • Vague symptoms • Thyroid deficiency • Sluggishness • Cold sensitivity • Depression • Forgetfulness • Dry hair • Dry skin • Constipation • Increased menstrual flow • Weight gain Materials provided One PreventID® TSH test kit contains the following items to perform the test: 1. PreventID® TSH test device (with drying agent, not required for test) 2. 2 Blood sample droppers 3. Manual Materials required but not provided Alcohol pad, sterile lancet, clock. Reagent Storage The PreventID® TSH test kit should be stored at 4-30°C (40-86°F). Test Procedure 1. Remove the test disk from the foil pouch, and place it on a flat, dry surface. 2. Collect the blood sample as described in details below. 3. As the test begins to work, you will see purple color move across the Result Window in the center of the test disk. 4. Interpret test results at 10 minutes. Do not interpret the test after 15 minutes. Specimen Collection (capillary blood) 1. Prick fingertip with a sterile lancet. 2. Massage near the site to obtain blood fl ow. 3. Place the tip of the blood sample dropper into the blood sample and make sure the blood sample dropper is slightly lower than the blood sample so that the blood will automatically fl ow into the dropper. 4. Fill the dropper with blood sample until it reaches the black line ( Fig. A). A If insuffi cient blood sample, massage near the site again to obtain more blood flow and fill the blood sample dropper to the black line. 5. Holding the sample dropper above the test disk (Fig. B) and add one hanging drop into Fig. A: Filling the dropper with blood Fig. B: Expelling the blood sample into the sample well the sample well. After the drop is absorbed into the sample well, add another hanging drop; repeat the procedure until the pipette is empty. If specimen drops are added too quickly, especially for blood specimen, it may cause clogging of the sample well. 6. Repeat the steps 3 to 5 with the second pipette. 7. Interpret test results at 10 minutes. Do not interpret the test after 15 minutes. Limitations of the Test Although the PreventID® TSH Test is very accurate in detecting TSH, a low incidence of false results can occur. Some serum specimens with a high rheumatoid factor concentration may yield a nonspecific positive result. Other clinically available tests are required if questionable results are obtained. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated. Short instructions for the handling of the PreventID® TSH  Remove the test disk from the foil pouch, and place it on a flat, dry surface  Prick fingertip with a sterile lancet.  Let the blood flow into the two blood collection tubes  Squeeze blood samples into the sample well  Interpret test result at 10 minutes Interpretation of the Test A purple band will appear at the left section of the Result Window. This shows that the test is working properly. This band is the Control Band (C). The right section of the Result Window indicates the test results. If another color band appears at the right section of the Result Window, this band is the Test Band (T). Positive Result: The presence of two color bands (“T” band and “C” band) within the result window regardless of which band appears first indicates a positive result (Figure 2). Note: Generally, the higher the analyte level in the specimen, the stronger the “T” band color will be. When the specimen analyte level is close to but still within the sensitivity limit of the test, the color of the “T” band will be very faint. Negative Result: The presence of only one color band within the Result Window indicates a negative result (Figure 3). Invalid Result: If after performing the test no purple color band is visible within the Result Window, this result is considered invalid (Figure 4). Not following the procedures correctly or using a test kit that has deteriorated can cause invalid results. It is recommended that the specimen be retested. Note: A positive result will not change once it has been established at 10 minutes. However, in order to prevent any incorrect results, the test result should not be interpreted after 10 minutes. Sensitivity and Specificity The PreventID® TSH Test sensitivity is 5 µ IU/ml TSH. The ability of the test to specifically detect TSH was challenged through cross-reaction studies on specimens containing known quantities of structurally and physiologically related hormone. Serum specimens spiked with 500 mIU/ml LH (Human Leuteinizing Hormone), 1000 mIU/ml FSH (Follicle Stimulating Hormone), 200,000 mIU/ml hCG (human Chorionic Gonadotropin) show negative results.   PSA Laboratory Test Information A kit containing all you need for the blood samples to be taken together with needle, bottles etc and packaging to return sample will be sent to you with full instructions.   PSA Home Test Information Summary of the test The normal level of PSA in blood is between 0.1 ng/ml to 4 ng/ml. There is a grey area from 4 ng/ml to 10 ng/ml where the meaning of the result is uncertain. Above 10 ng/ml there is a strong indication of an underlying disease such as prostatic cancer or benign prostatic hyperplasia (BPH). The Acon PSA test gives a range for the value of PSA rather than a specific number ie undetected, abnormally high or in a grey area between these. Tests that give a number as a result have advantages over home tests but they are more expensive, less convenient and require a full blood sample not just a few drops of blood. If you would like the full blood test please ask your GP about it.  The home test requires only 2 drops of blood that can be obtained almost painlessly using a special finger pricking device. Any PSA in the drops of blood react with antibodies on the PSA plate and generate a coloured line on the plate. The intensity of the colour of the line relates to the amount of PSA in the blood ie if there is very little PSA (less than 4ng/ml) there will be no colour in the test line. If there is colour in the test line (T) that is weaker than the reference line (R) the result is in the grey area of 4 ng/ml to 10 ng/ml. The reference line (R) always gives a colour equivalent to 10 ng/ml. If there is colour in the test line (T) that is stronger than the reference line (R) the result is over 10 ng/ml (positive) and further action is required. For the PSA home test you will need: The PSA test plate (supplied) Sterile easy use finger pricking device to take blood sample (supplied) Buffer in a dropper bottle (supplied) PSA test instructions (supplied) Timer – (not supplied) result takes 5 minutes to develop after adding sample to the test well The procedure for collecting the blood sample for PSA testing is as described below. It is recommended that you use the hanging drop method. Hanging drop method for blood sample Wash the hand with soap and water and with the alcohol wipe and allow to dry. Massage the hand without touching the puncture site, rubbing the hand down towards the fingertip Puncture the skin with the finger pricker and wipe away the first sign of blood. Gently rub the hand from wrist to palm to finger to form a rounded drop of blood over the puncture site. Position the finger so that the drop of blood is ust above the specimen well (S) of the test device. Allow 2 hanging drops of blood to fall onto the specimen well (S) of the test device or just touch the well to release the drops. Do not touch the well directly with the finger. Add one drop of buffer and start the timer. If the sample has not migrated across the test device to the result plate after 30 seoconds add 1 or 2 more drops of buffer. Wait for the coloured line(s) to appear. Read the result after 5 minutes.  Reading the results Negative Coloured lines present in the Control (C) and Reference (R) lines but no colour in the Test (T) line Positive Colour in the test line (T) that is weaker than the reference line - the result is in the grey area of 4 ng/ml to 10 ng/ml Colour in the test line (T) that is equal or close to the reference line - the result is approximately 10 ng/ml Colour in the test line (T) that is stronger than the reference line - the result is positive, over 10 ng/ml Invalid Control line or reference line fails to appear. This line is often quite faint as it represents the grey area between a positive and a negative test. However it can be due to insufficient sample or incorrect procedure. Please request a replacement test if this happens. We strongly advise you to have your PSA plate interpreted by Oxford Screening. Please send a good quality digital photograph. We will be send the result back to you by email. What should you do if the PSA test is negative No further action is required but Oxford Screening will remind you in 12 months time that your annual PSA check is due. Regular screening is the best way to reduce your risk of prostate cancer. What should you do if the PSA test result is positive (more than 10ng/ml) You should make an appointment to see you doctor. It is likely that further investigations will be required. These would normally include digital rectal examination. Biopsies of the prostate may also be required to make a diagnosis. What should you do if the PSA test result is in the grey area (4 – 10 ng/ml) You should make an appointment to see you doctor. It would be advisable to have a formal blood test that you can arrange through your GP. If this test confirms an abnormal result then it may be necessary to undergo further investigation that may measurement of the free PSA level, PSA velocity (measuring the change in PSA level over time). Tests may also include digital rectal examination and biopsies of the prostate depending on the findings of the further tests.

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