Additional information Ovulation Prevent

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