Pregnancy Midstream Test

• Type: Ivd Test
• Trademark: DAVID or OEM
• Origin: China
• Model NO.: Midstream
• HS Code: 3002150090
• Production Capacity: 100 Million Per Yearly

Product Description

DAVID One Step home use Pregnancy Test(Midstream)

(CATALOG:RH-HCG10-B)

Please read instructions carefully before performing the test.
BEFORE YOU BEGIN
1.The unopened test can be stored at room temperature(up to30ºC/ 86ºF) . Do not freeze.
2.Do not open foil pouch until specimen is collected and ready to be tested.
3.Do not use If the foil pouch is torn or not well sealed.
4.Do not use this test past the indicated expiry date on the label.
CONTENTS OF THE TEST KIT
One pouch containing a test midstream and a desiccant.
Note: The desiccant is for storage purpose only, and is not used in the test procedures.
WHAT ELSE DO YOU NEED
1.Timer(watch or clock).
2.a clean, dry container for a 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, you can test any time of day.
If testing early, use the first-morning urine of the day.
HOW TO COLLECT URINE
You can collect your urine sample in a clean, dry plastic or glass container. Fresh urine does not require any special pretreatment.
Note: Do not mix urine samples collected at different times.
HOW TO DO THE TEST
If the test and urine sample are stored refrigerated, allow to reach room temperature(about 20 minutes).
1.Remove the test midstream from the sealed pouch and take the cap off.
Note: Do not touch the membrane located within the "Show Windows" and "Absorbent Tip".
2.Hold the stick by the thumb grip with the exposed Absorbent Tip pointing downward. Urinate on the Absorbent Tip only until it is thoroughly wet {about 2-3seconds}.
If you prefer, you can urinate into a clean and dry container, then dip only the Absorbent Tip of the test midstream into the urine for at least 10 seconds.
3.After remove the test midstream from your urine, immediately replace with the Cap over the Absorbent Tip, Lay the test midstream down on a flat surface with the "Show Windows"facing upwards.
4.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 Line(C) and Test Line (T).
1.POSITIVE RESULT: Two colored lines appear both one at the test line(T) and another at the control line(C).
 (refer to question 3,4)
2.NEGATIVE RESULT: Only one colored line appears in the Control line(C).No colored line in the Test line(T). (refer to question 5,6)
3.INVALID RESULT: Absence of a colored line in the control region is an invalid result. You should repeat the test with a new test device.
 (refer to question 8,9)
PRECAUTIONS
1.For in vitro diagnostic use (not for internal use).
2.This test is intended for single use only. DO NOT REUSE.
3.Discard with normal household waste.
4.The test should be stored between 2ºC-30ºC/36ºF-86ºF.
5.Keep out of the reach of children.
6.The 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 to be evaluated.
QUESTIONS AND ANSWER
1.How does the DAVID 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. The Test can detect tiny amounts of this hormone in your urine.
2.When can I test with DAVID One Step Pregnancy Test?
DAVID 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 David One Step Pregnancy Test:

NUMBER OF DAYS BEFORE THE EXPECTED PERIOD	% of samples from pregnant women giving a"Pregnant"result
-1days	>99%
-2days	99%
-3days	99%
-4days	96%
-5days	78%

To work out 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 was based on the average number of menstrual cycle days reported for the previous 3 cycles.
3.If the result is positive(TWO LINES), what shall I do?
It 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 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. Because the test line will darken as greater concentration of hCG hormone are produced by the body after impregnation.
4.If I see two distinct and clear bands appear, but one band is darker than the other, am I pregnant?
Yes. This should be interpreted as a positive result.
5.If the result is negative(ONE LINE),what should I do?
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.

6.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 want very much 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 obvious. If the line is very faint and you are not sure, you should test again in 48 hours as the line will darken as greater concentrations of hCG hormone are produced by the body after impregnation.
7.Can I get a false or misleading result?
Negative results are expected in healthy non-pregnant women.I f you do get 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 periods may be irregular,leading you to test too soon.
(d)If you have recently been pregnant(for example,delivery, spontaneous abortion or termination ) ,you may get a false "Pregnant"result.
8. How do I know the test was run properly?
The appearance of a coloured line in the control region (C) tells you that you followed the test procedure correctly and the proper amount of urine was absorbed.
9. Can the result change after standing for a certain length of time?
Strong positive results may be observed 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 at 5 minutes. However, in order to prevent any incorrect results, the test results should not be interpreted after 15 minutes.
10. Does alcohol affect the test?
It is not recommended using the test after drinking.
11. How accurate is David One Step Pregnancy Test?
Clinical evaluations have shown that the test device is more than 99% accurate from the day of your expected period.
The amount of hCG will vary greatly with gestational age and between individuals.

MANUFACTURER
RUNBIO BIOTECH CO., LTD.             
Rongsheng Technological Zone, Univ. Rd.
Shantou, Guangdong, P.R.China 515063


EUROPEAN REPRESENTATIVE
MedNet GmbH
Borkstrasse 10, 48163 Münster,Germany       



DOCUMENT NUMBER:RH-TD-HCG10-6-B02
VERSION NUMBER: HCG10-B01-1905A
Eff.Date:2019-05-18