LXMD 0SST-ST10-000 Midstream Pregnancy Test Instruction Manual
- June 15, 2024
- LXMD
Table of Contents
0SST-ST10-000 Midstream
Pregnancy Test
One Step Pregnancy Test (Urine)
For self-testing and In Vitro diagnostic only
Please read these instructions carefully before performing the test.
BEFORE YOU BEGIN
- The unopened test can be stored at room temperature (up to 30°C / 86°F). Do not freeze.
- Do not open the foil pouch until the urine specimen is collected and ready to be tested.
- Do not use if the foil pouch is torn or not well sealed.
- Do not use this test past the indicated expiry date on the label.
CONTENTS OF THE TEST KIT
One foil pouch contains a midstream pregnancy test and a desiccant.
Note: The desiccant is for storage purpose only and is not used in the
test procedures.
WHAT ELSE DO YOU NEED
- Timer (watch or clock).
- A clean, dry container for the urine sample collection (optional).
SPECIMEN COLLECTION AND PREPARATION
WHEN TO COLLECT URINE FOR THE TEST? (refer to question 2)
If testing from the day your period is due onward, you can test at any time of
the day. If testing earlier, use the first morning urine of the day.
HOW TO COLLECT THE URINE?
Fresh urine does not require any special pretreatment. If you want to test
later, you can collect your urine sample in a clean, dry plastic or glass
container and store it at room temperature before test.
Note: Do not mix urine samples collected at different times of the day.
HOW TO DO THE TEST
If the test and the urine sample are stored refrigerated, allow them to reach room temperature before testing (about 20 minutes).
-
Remove the midstream test from the sealed pouch and remove the cap.
Note: Do not touch the membrane located within the result windows and the absorbent tip. -
Hold the test by the thumb grip with the exposed absorbent tip pointing downward. Urinate on the absorbent tip only until it is thoroughly wet (about 2 – 3 seconds).
If you prefer, you can urinate into a clean and dry container, then dip only the absorbent tip of the midstream test into the urine for at least 10 seconds. -
After removing the midstream test from your urine, immediately replace the cap over the absorbent tip. Lay the midstream test down on a flat surface with the result window facing upwards.
-
You can read your result as early as five (5) minutes after adding the specimen, but do not read your result after fifteen (15) minutes. (refer to question 9)
If urine migration is not seen in the result window within one to two minutes, you need to expose the absorbent tip to additional urine.
HOW TO READ THE RESULT
Pay attention to the position of the Control region (C) and Test region (T).
- POSITIVE RESULT: Two colored lines appear. One in the Test region (T) and another in the Control region (C). (refer to question 3, 4)
- EGATIVE RESULT: Only one colored line appears in the Control region (C). No colored line appears in the Test region (T). (refer to question 5, 6)
- INVALID RESULT: Absence of a colored line in the Control region represents an invalid result. You should repeat the test with a new test device. (refer to question 8, 9)
PRECAUTIONS
- For in vitro diagnostic use (not for internal use).
- This test is intended for single use only. DO NOT REUSE.
- Discard with normal household waste.
- The test should be stored between 4°C – 30°C / 39°F – 86°F.
- Keep out of the reach of children.
- This test is for home use.
LIMITATIONS
As with all diagnostic tests, a confirmed pregnancy diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.
QUESTIONS AND ANSWERS
-
How does the LuxmedIQ One Step Pregnancy Test work?
When you are pregnant, your body produces a pregnancy hormone called hCG (human Chorionic Gonadotropin). This hormone appears in the urine shortly after fertilization takes place. This test can detect small amounts of this hormone in your urine and thus indicate a pregnancy. -
When can I test with the LuxmedIQ One Step Pregnancy Test?
LuxmedIQ One Step Pregnancy Test is designed to detect hCG as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period.
The amount of pregnancy hormone increases as pregnancy progresses. If you test before your period is due and get a “Not Pregnant” result, there is still a chance that you may be pregnant. See the chart below for results from clinical testing of the uxmedIQ One Step Pregnancy Test:
Number of Days before the expected Period| Percent of Samples from Pregnant
Women giving a “Pregnant” Result
---|---
-1 Day| >99%
-2 Days| >99%
-3 Days| >99%
-4 Days| 96%
-5 Days| 78%
3. To determine when your period is expected, calculate your usual cycle length by counting the number of days from the first day of your period until the day before your next period starts. The day of the expected period is based on the average number of menstrual cycle days counted for the previous 3 cycles.
4. What shall I do if the result is positive (TWO LINES)? This means that you are probably pregnant. You must see your doctor to confirm that you are pregnant and to discuss the steps you should take. If you test positive, but you think you may not be pregnant, you should check with your doctor. If the Test line (T) is very faint and you are not sure, you should test again at least 48 hours after initial testing. The test line will darken as a greater concentration of the hCG hormone is produced by your body over time after impregnation.If I see two distinct and clear lines appear, but one band is darker than the other, am I pregnant? Yes. This result should be interpreted as a positive result.
5. What should I do if the result is negative (ONE LINE)? It means that you are probably not pregnant, or the level of pregnancy hormone may not be high enough yet to be detected, or you may have miscalculated the day your period was expected.
If pregnancy is still suspected, the test should be repeated with a fresh
urine specimen at least 48 hours after initial testing.
If the second test is still negative, and you still have not menstruated, you
should see your doctor for further advice.
-
I see a very faint line, or what looks like a line in the test area. Is this a positive result?
Many women seeking pregnancy wish to see a line in the test area. Blotches, shadows, or evaporation marks are not a positive result. If you are pregnant, the test line will be distinct and clearly visible. If the line is very faint and you are not sure, you should test again in 48 hours as the test line will darken as the concentrations of hCG increases over time after impregnation. -
Can I get a false or misleading result?
Negative results are expected in healthy non-pregnant women. If you do get an unexpected result, you should discuss them with your doctor.
(a) Fertility drugs containing hCG give misleading results (these fertility drugs are usually given by injection and testing too soon after administration may give a false “pregnant” result).
(b) The test should not be affected by other fertility therapies (such as clomiphene citrate)，pain killers, antibiotics,or the hormonal contraceptives (e.g. contraceptive pill).
(c) If you have recently stopped using hormonal contraception or are using fertility therapies like clomiphene citrate, your period may be irregular and lead you to test too soon.
(d) If you haverecentlybeen pregnant (forexample, delivery,spontaneous abortion, or termination), you may get a false “pregnant”result. -
How do I know the test was performed correctly?
The appearance of a colored line in the control region (C) indicates that you have followed the test procedure correctly and the proper amount of urine was absorbed. -
Can the result change after waiting for a certain length of time?
Strong positive results may be observed after as soon as 10-30 seconds. Weak positive results may take longer time, up to 5 minutes. However, to confirm negative results, the complete reaction time of 5 minutes is required.
A positive result will not change after the test is completed after 5 minutes. However, to prevent any incorrect results, the test results should not be interpreted after 15 minutes. -
Does alcohol affect the test?
It is not recommended to use the test after drinking. -
How accurate is LuxmedIQ One Step Pregnancy Test? Clinical evaluations have shown that the test is over 99% accurate from the day of your expected period.
The amount of hCG will vary greatly with gestational age and between individuals.
INDEX OF SYMBOLS
| Do not re-use| | Temperature Limit
---|---|---|---
| Catalogue Number| | Consult instructions
| In Vitro Diagnostics| | European Representative
| Use-by-date| | Batch/Lot Code
| Keep dry| | Quantity
| Keep away from sunlight| | CE Symbol
| Manufacturer| |
EQUINOX BIOTECH CO., LTD.
R116, 1/F, Transportation Bureau Building, No. 95, Yingbin Avenue, Huacheng
Subdistrict, Huadu District, Guangzhou 510806, Guangdong, China
MedNet EC-REP GmbH
Borkstrasse 10 48163 Minster, Germany
Distribution by:
LuxmediQ Deutschland UG
Altonaer Strasse 27
10555 Berlin, Germany
DOCUMENT NUMMER: RH-TD-HCG10-6-B02
VERSION NUMBER: HCG10-B01-1905A
Eff.Datum: 2019-05-18
https://www.luxmediq.de
CUSTOMER SERVICE
E-mail: service@luxmediq.de
Tel: +49 6401 9699 390
WhatsApp: +49 6401 9699 390
Web: www.luxmediq.de
Read User Manual Online (PDF format)
Read User Manual Online (PDF format) >>