easy Home EZW1-M Early Pregnancy Test Installation Guide

easy Home EZW1-M Early Pregnancy Test Installation Guide

INTENDED USE

Easy@Home pregnancy test (midstream) is an immunochromatographic assay designed for the rapid determination of human chronic nontropical (nCG)in urine. The testis used to obtain a visual qualitative result. For n vitro infesting use only.

PRINCIPLE

Human chronic nontropical (hCG) is a hormone, produced by the developing placenta shortly after the conception and secreted into the urine. The pregnancy test contains antibodies which specifically react with this hormone. When the test is inserted to a urine specimen, capillary action carries the specimen to migrate along the membrane. When hCG in the sample reaches the Test Zone region of the membrane, it will form a colored line. Absence of this colored line suggests a negative result. To serve as a procedure control, a colored line will appear at the control zone region if the test has been performed properly

MATERIALS SUPPLIED

1. One pouch contains a test midstream and a desiccant. The desiccant is for storage purposes only and should not be used in the test procedures.
2. One instruction for use.

MATERIAL REQUIRED BUT NOT PROVIDED

1. Clock or Timer
2. Specimen collection containers.

PRECAUTIONS

1. This kit s for external use only. Do Not swallow.
2. Discard after first use. The test midstream cannot be used more than once.
3. Do not use the test kit beyond expiry date.
4. Do not use the kit if the pouch is punctured or is not well sealed.
5. Keep out of the reach of children.
6. Urine specimens may be infectious; Ensure proper handing and disposal of ll used reaction devices as per the local statute.

STORAGE AND STABILITY

1. Store at 2°C to 30°C i the sealed pouch up to the expiration date.
2. DO NOT FREEZE.
3. The test should be used immediately after opening.

SPECIMEN COLLECTION

Any urine specimen is appropriate for pregnancy testing but the first morning urine specimen is optimal because of its highest concentration of hCG,

TEST PROCEDURE

1. Remove the midstream test from the foil pouch.

2. Remove the Cap and hold the midstream test by the Handle with the exposed Absorbent Tip pointing downward directly into your urine strearm for at least 10 seconds untilt s thoroughly wet. See the iiustration below.
   Note: Do not urinate on the Resut Window. 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.

3. After removing the midstream test from your urine, immediately replace the Cap over the Absorbent Tip, lay the midstream test on a flat surface with the result window facing upwards, and then begin timing

4. As the test begins to work, you may notice a light red flow moving across the Result Window. Read the result in 5 minutes. Do Not read the result after 5 minutes.

**OR

**

INTERPRETATION OF RESULTS

Positive
The presence of two red lines in both the test window (T) and control window (C) means you are probably pregnant. One line may be lighter than the other. They do not have to match.

Negative
‘The presence of one red line i the control window (C) means you are probably not pregnant.

Invalid
The result s invalid if o red line appears in the control window (C), even ifa line appears in the test window (T). You should repeat the test with a new midstream test.

NOTE: if the test line is weak, it is recommended that the test be repeated in 48 hours

LIMITATIONS

1. As it is with any diagnostic procedure, a confirmed pregnancy diagnosis should only be made by a physician after evaluating all clinical and laboratory findings

2. If a urine sample is too dilute (ie, low specific gravity) it may not contain a representative level of hCG. If pregnancy still suspected, another urine specimen should be collected 48 hours later and tested.

3. Low concentration of NCG i a very early pregnancy can give a negative result. In this case, another specimen should
   be obtained at least 48 hours later and tested.

4. Elevated levels of hCG can be caused by a few conditions other than pregnancy. Therefore, the presence of iCG in urine specimen should not be used to diagnose pregnancy unless these conditions have been ruled out

5. Anormal pregnancy can not be distinguished from an ectopic pregnancy based on hCG levels alone. Also, spontaneous miscarriage may cause confusion in interpreting test results.

6. Sterility treatments, based on hCG, may cause false results. Consult your physician.

PERFORMANCE CHARACTERISTICS

A layer users evaluation was conducted comparing the results obtained using the HCG Pregnancy Rapid Test (Urine) to professional users. The study included 60 urine specimens, and layer users and professional users identified 30 negative and 30 positive results. The results demonstrated an identical agreement between layer users and professional users.

Layer users vs professional users

Tests (tester)| Total Evaluated Samples| Correct Positive Results| Correct Negative Results
---|---|---|---
hCG Test by Layer users| 60| 30| 30
Positive Agreement| /| 30/30=100%| /
Negative Agreement| /| /| 30/30=100%
Total Agreement| (30+30)/60=100%| /| /
hCG Test by Professional users| 60| 30| 30
Positive Agreement| /| 30/30=100%| /
Negative Agreement| /| /| 30/30=100%
Total Agreement| (30+30)/60=100%| /| /

Sensitivity:

The HCG Pregnancy Rapid Test detects hCG in the urine at a concentration of 10 miU/m or greater.

Specificity:

The test has been stand faradized to the W.H.O. International Standard. The addition of LH (300 miU/mi), FSH (1000 miUfmi) and TSH (1000 ulU/ml) to negative (0 miUfml hCG) and positive (10 mIU/ml hCG) specimens showed no cross-reactivity.

QUESTIONS AND ANSWERS

1..: How soon after | suspect that | am pregnant can | take the test?

A: You can test your urine as early as the first day you miss your period. You can perform the test anytime of the day; however, if you are pregnant, fist morning urine contains the most pregnancy hormone.

2.Q: Do | have to test with first morning urine?

A: Although you can test any time of the day, your first moring urine specimen is usually the most concentrated of the day and would have the most hCG in i

3.Q: How accurate is the test?

A: A clinical evaluation was conducted comparing the results obtained using the pregnancy test to another commercially available urine membrane hCG test. The consumer clinical trial included 216 urine specimens: both assays identified 76 positive and 140 negative results. The results demonstrated >99% overall accuracy of the pregnancy test when compared o the other urine membrane hCG test.

a. Which factors may affect the test result?

A: Drugs which contain hCG (such as Pregnancy, Profanity, Personal, APL) can give a false positive result. Alcohol, oral contraceptives, painkillers, antibiotics or hormone therapies that do not contain hCG should not affect the test resit,

5.Q: What should | do if the result shows that | am pregnant?

A: It means that your urine contains hCG and you are probably pregnant. See your doctor to confirm that you are pregnant and to discuss the steps you should take.

6..Q: Does the result mean anything other than normal pregnancy if it shows

that | am pregnant?

A: A number of medical conditions other than pregnancy, including, ovarian cyst or ectopic pregnancy (pregnancy outside the uterus) can cause elevated levels of CG.

7.Q: How do | know that the test was run properly?

A: The appearance of a red line in the control window (C) tells you that you followed the test procedure properly and the proper amount of urine was absorbed.

8. Q: What should | do if the result shows that | am not pregnant?

A: It means that no hCG has been detected in your urine and probably you are not pregnant. If you do not start your period wihin a week of s due dale, repeat the test wilh a new tesi. If you receive the same result after repeating the test and you still do not get your period, you should see your doctor.

Please take the following steps to increase your chances for a healthy pregnancy and your baby.

1. Use the pregnancy test o detect pregnancy when your period i late. You can begin better prenatal care as soon as you learn of your pregnancy.
2. If you get a positive result it is advisable to visit your doctor immediately
3. Maintain a well-balanced diet, stop smoking, and reduce your intake of alcohol

INDEX OF SYMBOLS

| Consult instructions for use| | For in vitro diagnostic use only| | Used by
---|---|---|---|---|---
| Store between 2~30°C| | Tests per kit| | Catalog#
| Lot number| | Authorized representative| | Do not reuse
| e marking of conformity| | Manufacturer| |

QARAD BV Cipalstraat 3, 2440 Geel, BELGIUM

Zhejiang Orient Gene Biotech Co. Ltd 3787#, East Yangguang Avenue, Dipu Street Anji, 313300 Huzhou, Zhejiang CHINA

If you have any questions, please contact us via email support@premom.com
Distributed by Easy Healthcare Corporation
360 Shore Dr., Burr Ridge, IL USA 60527
To learn more, please visit us at www.premom.com

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