PreventID® Ovulation Additional information • Manual Test Disk • Manual Test Strip PreventID® Ovulation Manual (for professional use) PreventID® Ovulation KST12112 (Test Disk) PreventID® Ovulation (Cat. No. KST 12112 Test Disk) is a one step test for the detection of luteinizing hormone (LH) in urine. An increase in LH triggers ovulation and therefore marks a woman‘s most fertile day of the month. Because the egg can be fertilized only 6 to 24 hours after ovulation, the PreventID® Ovulation is an important aid to pregnancy planning. Length of normal cycle (number of days) Start testing this many days after your last period began 21 5 22 5 23 6 Precautions 24 7 1. For in-vitro diagnostics only. 2. Do not use the test after the expiration date printed on the package. 3. Read the entire pamphlet carefully. Do not open the foil pouch until you are ready to perform the test. 4. During testing, do not eat, drink or smoke. 5. Wear protective gear such as disposable gloves, lab coat etc. and avoid spilling of sample material. If sample material has been spilled, clean the site thoroughly with disinfectant. 6. Samples and tests are considered potentially infectious and have to be treated and disposed accordingly. 7. If the foil pouch has been damaged, do not use the test disk. 25 8 26 9 27 10 28 11 29 12 30 13 31 14 32 15 33 16 34 17 35 18 36 19 37 20 38 21 39 22 40 23 Storage Store at room temperature or at 4 – 30 °C (40 – 86 °F). If test kit is refrigerated, it should be brought to room temperature before use. Do not freeze. When to begin testing? Table 1: Test begin in relation to cycle length • You may do this test at any time of the day, but you should test at approxi- • • • • mately the same time each day. Reduce your liquid intake for 2 hours before testing. To decide when to begin testing, determine the length of your normal menstrual cycle. The length of your cycle is from the beginning of one period to the beginning of the next (count the first day of bleeding or spotting as day 1). If your cycle length is irregular, that is, if it varies by more than a few days each month, take the average number of days for the last 3 months. Use the chart to work out the day you should begin testing. The day you begin testing is listed opposite the number of days in your normal cycle (Table 1). For example, if your period normally begins every 28 days, you should begin testing 11 days after the first day of your last period. Note: If the 2nd day of the month is the first day of menstrual bleeding (day 1), then the 12th day of the month is day 11 of your cycle. This is the day to begin testing (Table 2). Test equipment Sun Mon Tue Wed Thu Fri Sat 1 2 1. Day of period 3 4 5 6 7 8 9 10 11 12 11. Day of cycle 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Table 2: Example of how to calculate test begin 1. Test disk 2. Sample dropper 3. Manual In addition, you will need a sample container (not included in delivery). PreventID® Ovulation Manual (for professional use) Test procedure 1. 2. 3. 4. 5. Collect urine in a sample container. Remove the test disk from the foil pouch, and place it on a flat, dry surface. Holding the sample dropper above the test disk, squeeze 2 drops of urine into the sample well (Fig. 1). As the test begins to work, you will see a purple colored band move across the result window located in the center of the test disk. Interpret test results after 5 minutes. Function of the control band The control band is used as a reference. If the test band is similar in color or darker than the control band, the test result is positive. If the test band is lighter in color than the control band, the test result is negative. The control band is also used for procedural control to determine if the test reagent is working properly. Test limits 1. Although the PreventID® Ovulation Test is highly accurate in detecting ovulation, a low incidence of false results (positive when no ovulation exists or negative when ovulation is present) can occur. 2. The PreventID® Ovulation Test should not be used for contraception. Fig. 1: Apply urine into sample well Test interpretation 1. As the test kit begins to work, a purple colored band will appear at the left section of the result window to show that the test is working properly. This band is the control band (C). 2. The right section of the result window indicates the test results. If another purple colored band appears at the right section of the result window, this band is the test band (T). Positive result 1. The presence of two purple bands of similar color and darkness within the result window, no matter which one appears first, means that an increase in LH is detected. 2. The test band may be darker than the control band (Fig. 2). Short instructions PreventID® Ovulation 1. Remove test disk and sample dropper from the foil pouch. Place test with the sample well to the right on a flat and dry surface. 2. Using the sample dropper, squeeze 2 drops of urine into the sample well. 3. Interpret test result after 5 minutes. Status: 21.08.2012* Fig. 2: Two purple bands mark a positive test result Negative result 1. The presence of a purple control band and a lighter purple test band means that an increase in LH is not detected. 2. The presence of only one purple colored band (control band) within the result window indicates that no LH increase has been detected (Fig. 3). Fig. 3: Negative test results Invalid result The test result is considered invalid if no purple colored band is visible within the result window. Not following the directions correctly or using a test after the expiration date can cause invalid results. Repeat the test using a new PreventID® Ovulation test disk. US: all products: Research Use Only. Not for use in diagnostic procedures. Used symbols: Distributed by: Preventis GmbH Wiesenstr. 4 64625 Bensheim, Germany www.preventis-online.de Phone: +49 (0) 6251-70 711-0 Fax: +49 (0) 6251-70 711-25 E-Mail: [email protected] Storage temperature Manufacturer In vitro diagnostic device Lot number Catalogue number Expiry date Read instructions before use Single use only Content sufficient for <n> tests MPC INTERNATIONAL S.A. 26, Boulevard Royal 2449 Luxembourg, Luxembourg PreventID® Ovulation Manual (for professional use) PreventID® Ovulation KST12110 (Test Strip) The PreventID® Ovulation (Art.-Nr. KST 12110 Test Strip) is a one step test for the detection of luteinizing hormone (LH) in urine. An increase in LH triggers ovulation and therefore marks a woman‘s most fertile day of the month. Because the egg can be fertilized only 6 to 24 hours after ovulation, the PreventID® Ovulation is an important aid to pregnancy planning. Length of normal cycle (number of days) Start testing this many days after your last period began 21 5 22 5 23 6 Precautions 24 7 1. For in-vitro diagnostics only. 2. Do not use the test after the expiration date printed on the package. 3. Read the entire pamphlet carefully. Do not open the foil pouch until you are ready to perform the test. 4. During testing, do not eat, drink or smoke. 5. Wear protective gear such as disposable gloves, lab coat etc. and avoid spilling of sample material. If sample material has been spilled, clean the site thoroughly with disinfectant. 6. Samples and tests are considered potentially infectious and have to be treated and disposed accordingly. 7. If the foil pouch has been damaged, do not use the test strip. 25 8 26 9 27 10 28 11 29 12 30 13 31 14 32 15 33 16 34 17 35 18 Storage 36 19 Store at room temperature or at 4 – 30 °C (40 – 86 °F). If test kit is refrigerated, it should be brought to room temperature before use. Do not freeze. 37 20 38 21 39 22 40 23 When to begin testing? • You may do this test at any time of the day, but you should test at approxi- • • • • mately the same time each day. Reduce your liquid intake for 2 hours before testing. To decide when to begin testing, determine the length of your normal menstrual cycle. The length of your cycle is from the beginning of one period to the beginning of the next (count the first day of bleeding or spotting as day 1). If your cycle length is irregular, that is, if it varies by more than a few days each month, take the average number of days for the last 3 months. Use the chart to work out the day you should begin testing. The day you begin testing is listed opposite the number of days in your normal cycle (Table 1). For example, if your period normally begins every 28 days, you should begin testing 11 days after the first day of your last period. Note: If the 2nd day of the month is the first day of menstrual bleeding (day 1), then the 12th day of the month is day 11 of your cycle. This is the day to begin testing (Table 2). Test equipment 1. Test strip 2. Manual In addition, you will need a sample container (not included in delivery). Table 1: Test begin in relation to cycle length Sun Mon Tue Wed Thu Fri Sat 1 2 1. Day of period 3 4 5 6 7 8 9 10 11 12 11. Day of cycle 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Table 2: Example of how to calculate test begin PreventID® Ovulation Manual (for professional use) Test procedure LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH Result area Dip strip up to this line into the urine sample Test limits 1. Although the PreventID® Ovulation Test is highly accurate in detecting ovulation, a low incidence of false results (positive when no ovulation exists or negative when ovulation is present) can occur. 2. The PreventID® Ovulation Test should not be used for contraception. MAX MAX MAX 1. Collect urine in a sample container. 2. Shake test strip from the foil pouch. Hold test strip at the upper end. Discard pouch in general waste. 3. Dip the test strip up to the MaximumLine into the urine sample (Fig. 1). 4. Remove the strip from the urine sample as soon as the purple color band travels through the result area (after a few seconds). 5. Place strip on a dry surface. 6. Interpret test result after 5 min. Function of the control band The control band is used as a reference. If the test band is similar in color or darker than the control band, the test result is positive. If the test band is lighter in color than the control band, the test result is negative. The control band is also used for procedural control to determine if the test reagent is working properly. Fig. 1: PreventID® OvulationTest Strip Test interpretation • For test interpretation place the test strip as shown in Fig. 2 (sample area at the bottom). A colored band appears in the upper part of the result area to indicate that the test is working properly (C= control band). • The test result appears in the lower part of the result area. If a colored band appears here, it is the test band (T). • Depending on the colored bands, the following results are possible: Positive: If two bands with similar color intensity appear in the result area, independent of which one appears first, an elevated LH-level has been detected (Fig. 2). In this case, the test band may appear more pronounced than the control band. Short instructions PreventID® Ovulation (Test Strip) 1. Remove test strip from the foil pouch. 2. Dip test strip up to the maximum-line into the urine sample. Remove test strip from the sample as soon as a colored band appears in the result window. 3. Interpret test exactly after 5 minutes. Negative: If a pronounced control band and a weak test band appears, an elevated LH-level has not been detected. If only the control band is visible in the result area, an elevated LH-level has also not been detected (Fig. 2). Invalid: The test is considered invalid if no band or only the test band appears in the result area. For example, the control band does not appear if the strip membrane has not soaked enough sample fluid. The test should be repeated using a new test strip. Negative MAX MAX MAX Fig. 2: LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH MAX MAX MAX MAX MAX MAX T LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH T MAX MAX MAX C T MAX MAX MAX C MAX MAX MAX C US: all products: Research Use Only. Not for use in diagnostic procedures. Used symbols: Invalid LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH LH Positive Status: 21.08.2012* Interpretation of the PreventID® Ovulation-Test Strip Distributed by: Preventis GmbH Wiesenstr. 4 64625 Bensheim, Germany www.preventis-online.de Tel.: +49 (0) 6251-70 711-0 Fax: +49 (0) 6251-70 711-25 E-Mail: [email protected] Storage temperature Manufacturer In vitro diagnostic device Lot number Catalogue number Expiry date Read instructions before use Single use only Content sufficient for <n> tests MPC INTERNATIONAL S.A. 26, Boulevard Royal 2449 Luxembourg, Luxembourg
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