GoldN GN013ST Rapid Ovulation Test

Product Specifications

• Product Name: GoldNTM Rapid Ovulation Test For Self-Testing
• Model: GN013ST
• Type: Lateral flow immunoassay test kit
• Detection: Human Luteinizing Hormone (LH) in urine
• Usage: Predict time of ovulation

Product Usage Instructions

1. Step 1 – Preparation
   Wash your hands thoroughly and ensure they are dry before starting the test. Check the components for any damage.

2. Step 2 – Reading Instructions
   Read the instructions for use carefully before proceeding with the test.

3. Step 3 – Bringing to Room Temperature
   Allow the test stick to reach room temperature by bringing the pouch to room temperature.

4. Step 4 – Strip Removal
   Carefully remove the Test Stick from the sealed pouch and use it within 5 minutes.

5. Step 5 – Performing the Test
   Insert the Sample Tip into your urine stream for 15 seconds.

6. Step 6 – Waiting for Result
   Set a timer and wait for 5 minutes before interpreting the results.

7. Step 7 – Reading Results
   Interpret the results after 5 minutes. Refer to the Interpretation of Results section for guidance.

8. Step 8 – Disposal
   Dispose of all parts of the test kit in household waste or rubbish bin following local regulations.

Interpretation of Results

• Positive Result: If two lines are present, with the test line (T) equal to or darker than the control line (C), ovulation is likely in the next 24-48 hours.
• Negative Result: If no test line is present or it is lighter than the control line, it is not peak ovulation.
• Invalid Result: No line in the control region (C) indicates an invalid result. Repeat the test with a new stick.

FAQ – GoldNTM Rapid Ovulation Test Kit

1. How does the test work? The test detects an increase in Luteinizing Hormone (LH) levels to predict ovulation.
2. When to take the tests? To determine when to begin testing, calculate the length of your cycle.

GoldNTM Rapid Ovulation Test For Self-Testing
GN013ST
GoldNTM Rapid Ovulation Test Kit is a lateral flow immunoassay for the qualitative detection of human Luteinizing Hormone (LH) in urine to predict time of ovulation.

Read instructions carefully prior to taking the test.

IMPORTANT
For more information email us at: info@novo-dx.com

Scan the QR code to watch “How to Use Video” and for more information on how to use the test.

MATERIALS PROVIDED WITH KIT

(25 Sticks

/ pouch x 25 pouches)

Packing insert| 1 Instructions for use| 1 Instructions for use

HOW TO PERFORM THE TEST

1. STEP 1 – Wash your hands prior to test
   Wash your hands and make sure they are dry prior to starting the test.
   After washing your hands, open the box, and check the components for damage prior to use.

2. STEP 2 – Read Instructions for use
   Read instructions for use thoroughly prior to using the test.

3. STEP 3 – Bring the pouch to room temperature
   Allow pouch to come to room temperature (15-30°C) before opening it.

4. STEP 4 – Take out the strip
   Carefully remove the Test Stick from the sealed pouch and use it within 5 minutes. IMPORTANT
   The test must be performed 5 minutes after opening.

5. STEP 5 – Performing the test
   Insert the Sample Tip into your urine stream for 15 seconds. IMPORTANT
   Do not urinate on the plastic portion of the Test Stick.

6. STEP 6 – Wait for result
   Set timer and wait 5 minutes. Interpret results after 5 minutes.

7. STEP 7 – Read your results
   See the Interpretation of Results section below.

8. STEP 8 – Disposal after use
   Please dispose of all parts of the test kits and place them in the household waste or rubbish bin if there are local regulations please follow them.

INTERPRETATION OF RESULTS

+Positive Result
If two lines are present, and the test line (T) is equal to or darker than the control line (C), you will probably ovulate in the next 24-48 hours. If you are attempting to get pregnant, the best time to get lucky is after 24 but before 48 hours. – Negative Result
If no test line is present or the test line is lighter than the control line. (Not in peak ovulation).

Invalid
The result is invalid if no line appears in the control line region (C), even if a line appears in the test line region (T). Repeat the test with a new test stick.

GoldNTM RAPID OVULATION (LH) TEST KIT QUESTIONS & ANSWERS

1. How the test works

   • The GoldN™ Rapid Ovulation Test works by detecting an increase (spike) in production of a hormone called Luteinizing Hormone (LH) in your urine. LH in your urine will increase approximately 24-36 hours before an egg is released from the ovaries, this indicates ovulation is occurring. You are at your most fertile the day your LH increase is detected. The GoldN™ Rapid Ovulation Test can detect your 2 most fertile days, which begin from the time that the ovulation test detects your LH surge. Make love at any time in the next 48 hours to maximize your chance of becoming pregnant. Note: Sperm can survive for several days and your LH spike may occur inside of the window between insemination and LH spike. Therefore, the GoldNTM Rapid Ovulation Test should not be used as a contraceptive.

2. When to take the tests

   • To find out when to begin testing, determine the length of your normal 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 below to figure out the day you should begin testing. The day you begin testing is listed opposite the number of days in your cycle.

3. How accurate is the test result?

   • A clinical evaluation was conducted comparing the results obtained using the GoldNTM Rapid Ovulation Test to another commercially available urine LH test. The in-house clinical trial included 298 urine specimens. The results demonstrated 100% specificity and >99%sensitivity with an overall accuracy of >99%.

4. I have tested for several days and I did not see a surge.
   What do I do?

   • Since every woman does not always ovulate at mid-cycle, you may not detect the LH surge in the first seven days of testing. This could mean you have not ovulated yet and you should continue testing with an additional LH Test.

5. I have used the ovulation test for 3 months and have not become pregnant yet, is something wrong?

   • First, it is important to remember that it can take normal, healthy couples many months to become pregnant. There are many factors that can affect your ability to become pregnant even if you have been able to have intercourse during your most fertile days. If after several months you have no success, consult with your physician or health care provider.

6. What could interfere with my test result?
   If you are already pregnant, have recently been pregnant, or have reached menopause you may get a misleading result. Some prescription drugs, such as menotropins for injection and Danazol may affect the results you see. Please consult your physician if you have any questions about prescription drug interactions.

7. Will oral contraceptives affect the result?
   After using the pill your cycle may be irregular and may take some time to stabilize again. You may wish to wait until you have had two normal periods before starting to use the Test.

8. How sensitive is the GoldNTM Rapid Ovulation Test?

   • The GoldNTM Rapid Ovulation Test detects LH at a concentration of 25mIU/ml or greater. The test has been standardized to the W.H.O. International Standard. The addition of FSH (1,000 mIU/mL), hCG (10,000 mIU/mL), and TSH (40mIU/mL hLH) specimens showed no cross-reactivity.

9. Do alcohol or common medications affect the test?

   • No, but you should consult your physician if you are taking any hormonal medication. Also, recent oral contraceptive use, breastfeeding, or pregnancy could affect the test results.

INTENDED USE
The GoldNTM Rapid Ovulation Test is a rapid chromatographic immunoassay for the qualitative detection of Luteinizing Hormone (LH) in urine to predict the time of ovulation. The test is intended for women who want to conceive.

SUMMARY AND EXPLANATION

Luteinizing hormone (LH) in elevated quantities causes ovulation (the release of the egg from the ovarian follicle). Throughout the menstrual cycle a small amount of LH is produced, but during the middle of the cycle LH briefly and dramatically increases. This increase is called the “LH surge” and precedes ovulation. Ovulation is most likely to occur within 24 to 48 hours following the LH surge. The GoldNTM Rapid Ovulation Test Kit is specifically designed to detect your LH surge – the time when you are likely to ovulate. If you receive a positive on an LH test, you are in your most fertile phase of your menstrual cycle.

PRINCIPLE OF THE TEST
The test reagent is exposed to urine, allowing urine to migrate through the absorbent test strip. The labelled antibody-dye conjugate binds to the LH in the specimen forming an antibody-antigen complex. This complex binds to the anti-LH antibody in the test region (T) and produces a colour line. In the absence of LH, there is no colour line in the test region (T). The reaction mixture continues flowing through the absorbent device past the test region (T) and control region (C). Unbound conjugate binds to the reagents in the control region (C), producing a colour line, demonstrating that the test strip is functioning correctly.

STORAGE AND STABILITY

1. Store as packaged in the sealed pouch at temperature 2 – 30°C and relative humidity between 40 – 60%. The kit is stable within the expiration date printed on the labelling.
2. The test strips must be used within 15 minutes after removal from the foil pouch.
3. The kit must not be used after the expiry date. The expiry date is stated on the label/packaging.

PRECAUTIONS
Please read all the information in this package insert before performing the test.

1. For self-testing in vitro diagnostic use only. Do not use after the expiration date.
2. The test should remain in the sealed pouch until ready to use.
3. All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent.
4. The used test should be discarded according to local regulations.

LIMITATIONS

1. For self-testing in-vitro diagnostic use.
2. The GoldNTM Rapid Ovulation Test cannot be used as a form of birth control.
3. Medication containing LH may affect the test and should not be taken while using any of these Rapid Tests. In addition, the test will not work properly for subjects who are pregnant, in menopause, or taking birth control pills.
4. The GoldNTM Rapid Ovulation Test Kit is a preliminary qualitative test, therefore, neither the quantitative value nor the rate of increase in LH can be determined by this test.
5. The test works only if the instructions are followed precisely. Although the GoldNTM Rapid Ovulation Test is highly accurate and sensitive in detecting ovulation, an extremely low incidence of false results (positive when no ovulation exists or negative when ovulation exists) can occur.
6. This test may produce false negative results. These may occur when the levels of LH are below the sensitivity level of the test.
7. This test provides a presumptive diagnosis. A confirmed diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.

REF: GN013ST
Corresponds to Catalog #:
GN013ST10 (10 Pack); GN013ST25 (25 Pack). IFU: IFU-GN013ST-US-EN
Version : 1 Revision date : 2024-04-10
177 N US Highway 1

309 Tequesta, FL 33469, USA

email: info@novo-dx.com
web: www.iamgoldn.com
Manufactured for NOVODX Corporation by Vitrosens Biyoteknoloji Anonim Sirketi Add: Serifali Mh., Sehit Sk. No.17/1 Ümraniye/Istanbul/Türkiye

References

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