Instructions 3. Collect your urine into a clean container (not provided) and dip the absorbent pad cyclotest® Early Pregnancy Test into the urine for at least 10 seconds. You can also point the absorbent tip downward and place it in urine stream for at least 10 seconds until it is thoroughly wet.
Ich bin mir sicher.
cyclotest® Early Pregnancy Test is a self-performing immunoassay designed for the qua- litative determination of humanchorionicgonadotropin (hCG) in urine for early detecti- on of pregnancy by visual.
cyclotest® Early Pregnancy Test is designed for both professional and lay users.
Safety instructions 4. Re-cap the device and wait for colored bands to appear. Read the result at 5 minutes.
In-vitro diagnostic aid for self-testing• Read directions for use carefully before performing this test. Pay attention to the po- 5. Depending on the concentration of hCG in the test specimen, positive results may be sition of the C and T line.
observed in as short as 40 seconds. However, to confirm negative results, the comple- • Do not use beyond the labeled expiration date.
te reaction time (5 minutes) is required. So read the result within 5 minutes.
• Do not reuse the test devices. Discard it in the dustbin after single use.
• Do not use if pouch is damaged or opened.
6. Discard the test device after single use in the dustbin.
• Do not touch the membrane on the strip.
Do not read results after 10 minutes.
• the pouch is opened, the test device should be used immediately. Prolonged exposure to ambient humidity will cause product deterioration.
• Treat urine samples and used devices as if they are potentially infectious. Avoid con- Interpretation of result tact with skin.
Positive: Two distinct color bands appear - one on the control and one on the test re-
• Make sure you have a urine sample cup before beginning (not included).
gion (see image). This indicates that pregnancy has been detected. The color intensity of the test bands may vary as the hormone concentration changes during pregnancy. Early precautions are important. Consult your doctor and your midwife immediately in Materials provided order to safeguard your health and that of your baby. Avoid potential risks to the embryo (e.g. X-rays).
Each box contains:• One foil pouch, contains one test stick and one desiccant (do not eat).
Negative: Only one color band appears on the control line and no band appears on the
• Instructions for Use test region. This means there is no pregnancy detected.
Other equipment or reagents needed but not provided Invalid: There are no visible bands at all, or if one red band appears only on the test
• A clean and dry container region. If this happens, repeat a new test. If the test still fails, please contact the distri- butor with the lot number.
When to begin testingThe test could be used already approx. 4 days before the day of your estimated menst- ruation. In most cases the test is accurate at this date. However, because of variation in hCG concentration among women, or potential miscalculation of the last period, if there is a negative result, and pregnancy is still suspected, you should retest after a few days.
Quality controlBuilt in Quality Control Features Performing the test In addition, a built procedural control is being used designated as control region (C) on the test device to indicate sufficient sample volume was added.
Specimen collection and handling 1. Urine specimen must be collected in a clean and dry container.
Summary and Explanation Human Chorionic gonadotropin (hCG) is a glycoprotein hormone secreted by the develo- 2. First morning urine specimen is preferred due to its high concentration of hCG. Ho- ping placenta shortly after fertilization. During normal pregnancy, hCG can be detected wever, urine specimens collected at any time of the day may be used. If specimens in urine as early as 7 days following conception, doubling every 1.3 to 2 days. At the cannot be assayed immediately, they can be stored at 2-8 °C for up 72 hours prior time of the last missed menstrual period, urine hCG levels are about 100 mIU/ml with peak levels of 100,000 to 200,000 mIU/ml seen at the end of the first trimester. The pre- sence of hCG soon after conception and its subsequent increase in concentration during 3. Urine specimens exhibiting visible precipitates should be settled to obtain a clear early gestational growth make it an ideal marker for the early detection of pregnancy.
specimen for testing.
Mode of operation 1. Bring the test pouch and urine to room temperature. To begin testing, open the sea- The cyclotest® Early Pregnancy Test is a rapid one-step test, based on an immunochro- led pouch by tearing along the notch. Remove the test from the pouch and use it as matographic technology. A membrane with an absorbent pad overlaps a strip of fiber soon as opened.
glass paper that is impregnated with lyophilized colloidal conjugate of gold particles and monoclonal solid phase antibodies to hCG. Another absorbent pad at the endof the 2. Hold the handle of the test with one hand. Use the other hand to remove the cap and assay absorbs excess sample fluid. The urine sample is introduced into the device, and expose the absorbent tip. Put the cap aside for re-cap later (See the picture).
proceeds through the absorbent pad, then laterally onto a chromatographic membrane. As it contacts the membrane, the sample dissolves the lyophilized conjugate. In a reac- tive sample, the hCG antigen will bind to the antibodies in the colloidal solution. As the Test line Check line conjugate moves forward on the membrane, anti-hCG monoclonal antibody affixed on the test zone („T") will bind the HCG-gold conjugate complex, forming a pink line („T"). All samples will cause a pink colored line in the control zone („C"). This lined is formed by the binding of the polyclonal antibodies (Anti-mouse lgG) affixed onto the cont- rol zone to the sample-colloidal gold conjugate. Presence of this line indicates sample amount is appropriate and the test has been carried out correctly. In less than 5 minutes, Sample well (absorbent tip) levels of hCG as low as 10mIU/ml can be detected.
4. Non-cross reacting compounds:
Test device comprised colloidal gold coated with anti ß-hCG monoclonal antibody; NC membrane coated with anti α-hCG monoclonal antibody and rabbit anti mouse lgG Information for professional use Testing of quality control material to verify the performance of the test is recommended Gentisic for each new lot of test. In addition, users should follow their state and local regulations Thiophene and guidelines regarding GLP requirements.
5. Repeatability and Reproducibility
Qualitiy control material. Commercial control material or fresh samples from known Three lots of cyclotest® Early Pregnancy Test were used and 10 strips of each lot tested pregnant and non-pregnant patients may be used with each lot as controls to verify the in HCG standard solution with different concentrations prepared at 0 mIU/ml, 5 mIU/ml, performance of the test. We recommend using control materials with hCG concentra- 10 mIU/ml, 25 mIU/ml and 100 mIU/ml.
tions known to be near (above and below) the clinical cutoff.
Interpretation of the symbols Consult instructions for use Temperature limitation Contains sufficient for <n> tests P: Positive N: Negative
In vitro diagnostic medical device All samples were positive at and beyond the cut-off level. No different results were observed.
Caution, see safety instructions Catalogue numberBatch code Limitation of the procedure Keep away from sunlight • Alcohol may interfere with test result. It is not recommended using the test after drin- Do not use if package is damaged • Occasionally specimens containing less than 10 mIU/ml for urine also yield positive This test complies with Council Directive 98/79/EC of 1998 on in-vitro diagno- stics and bears the CE 0123 mark (TÜV SÜD Product Service GmbH).
• A very early pregnancy containing an extremely low concentration of hCG can give a negative result. In this case, another specimen should be obtained at least 48 hours later and tested.
• HCG levels may remain detectable for several weeks after normal delivery, delivery by Chard T. Pregnancy tests: a review. Hum Reprod. 1992 May; 7 (5): 701-10. Review caesarean section, spontaneous abortion or therapeutic abortion.
American Pregnancy Association. Human Chorionic Gonadotropin (HCG): The Pregnancyc Hormone.
Womens health Research. Dept. of OB/GNY, University of New Mexico. HCG Reference Ser- • In cases where very high levels of hCG are present (>500,000 mIU/ml) a false negative result can occur due to a „Prozone" effect. If pregnancy is still suspected, simply dilute specimen 1:1 with deionized water and retest.
Chayen J, Daly JR, Loveridge N. The cytochemical bioassay of hormones. Recent Prog. Horm. Res. 1976; 32:33-72.
Henry JB. Clinical Diagnosis and Management by Laboratory Methods, 18th edition, 1991, WB Saunders and Co.
• If a urine sample is too dilute (i.e.: low specific gravity) it may not contain a represen- tative level of hCG. If pregnancy is still suspected, a first morning urine sample should Wide L, Gemzell CA. An immunological pregnancy test. Acta Endocrinology 1960; 35:261.
be obtained and retested 48 hours later.
Braustein, G. D. Am J. Obstet. Gynecol., 1976,126:678Cart, K.J. J. Clin. Endocrinol. Metab., 1975,40 :537Batzer, F.R. Fertility & Sterility, 1980, 34:1.
• As is true with any diagnostic procedure, the user should evaluate data obtained by Engvall, E. Method in Enzymology, 1980, 70:419.
the use of this kit in light of other clinical information and consult to the physicians for the final diagnosis of pregnancy before make any decision of medical relevance.
Storage and stability cyclotest® Early Pregnancy Test will display positive results with specimens containing The test kit can be stored at normal temperature (4 °C to 30 °C, or 39 °F to 86 °F) in the hCG at the level close to or greater than 10 mIU/ml.
sealed pouch to the date of expiration. The test kits should be kept away from direct sunlight, moisture and heat. Do not freeze.
2. Specificity
The following compounds exhibited no interference when dissolved in urine, which had
cyclotest® service hotline hCG levels of 0 and 10 mIU/ml.
Ensure you read our notes on using the cyclotest® Early Pregnancy Test carefully and Non-cross reacting homologous hormones
familiarised yourself with its features.
HFSH 1000 mIU/ml (WHO 1st IS) If you have any further questions, you can call our cyclotest® service hotline, which is HLH 500 mIU/ml (WHO 1st IRP) open from Mondays to Thursdays from 8.00 am to 5.00 pm and on Fridays until 4.30 pm.
HTSH 1000 µIU/ml (WHO 2nd IRP) Your team of cyclotest® advisers is looking forward to taking your call.
3. Accuracy
Comparison studies on the cyclotest® Early Pregnancy Test with a legally marketed de- cyclotest® service hotline
For customers from Germany: vice were performed in various clinical reference laboratory. Positive and negative re- +49 (0) 93 42 / 92 40 40
sultes were compared and the correlation was >99.9% cyclotest® service hotline
For customers from Switzerland: 052 / 224 41 47
Clinical Accuracy of the cyclotest® Early Pregnancy Test
Reference method Reference method Total
UEBE Medical GmbH cyclotest® and UEBE® are internationally Zum Ottersberg 9 protected trademarks of cyclotest® Early Pregnancy Test (positive) 97877 Wertheim, Germany cyclotest® Early Pregnancy Test (nega- E-Mail: [email protected] Internet: www.uebe.com Diagnostic Sensitivity (Positive agreement): a/(a+c) = 516/ 516 =100% Diagnostic Sensitivity (Negative Subject to technical modifications.
agreement): d/(b+d) = 326/326 = 100% Copyright 2013 UEBE Medical GmbH PZN 00041163
7 9055 708 AA 2014-01

Source: http://rdo-medical.nl/img/_instructions/ifu_en_cyclotest_pregnancy_test.pdf

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