Ovulation Predictor Kit Female Lh Test Strip Fertility Monitor Combo Kit at Home

• Type: IVD Reagent
• Product Name: Product Name:
• Certification: CE
• Format: Strip
• Assay Type: Urine Sample
• Reading Time: 3~5 Min
• Accuracy: Over 99.6%
• OEM: Acceptable
• Storage Temperature: 2-30ºC
• Shelf Life: 24 Months
• Trademark: Testsealabs
• Origin: China
• Production Capacity: 1000000 Pieces/Year

Product Description

Ovulation Predictor Kit Female LH Test Strip Fertility Monitor Combo Kit at Home IVD Tests Cassette With High Accuracy &CE Approval

[INTRODUCTION]
Testsealabs HCG Pregnancy Test Strip is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy.
As with all diagnostic tests, a final clinical diagnosis should not be based on the results of a single test, but should only be made by a physician after all clinical and lab findings have been evaluated.
 
 

Product name:	Testsealabs LH Test Strip
Assay type:	Urine sample
Reading time:	3~5 min
Accuracy	Over 99.6%
OEM	Acceptable
Storage temperature:	2-30ºC
Shelf life:	24 months
Certification:	CE

[PRODUCT FEATURE]
Easy to Use
Fast Result
High Accuracy
Good Quality

[Principle]
Ovulation is the release of an egg from the ovary. The egg then passes into the fallopian tube where it is ready to be fertilized. In order for pregnancy to occur, the egg must be fertilized by sperm within 24 hours after its release. Immediately prior to ovulation, the body produces a large amount of luteinizing hormone (LH) which triggers the release of a ripened egg from the ovary. This "LH surge" usually takes place in the middle of the menstrual cycle.1
The LH One Step Ovulation Test Strip (Urine) is a complete system to help predict the time of ovulation, and peak fertility. It is during this fertile time that pregnancy is most likely to occur.
The LH One Step Ovulation Test Strip (Urine) detects the LH surge in urine, signaling that ovulation is likely to occur in the next 24-36 hours. The test utilizes a combination of antibodies including a monoclonal LH antibody to selectively detect elevated levels of LH.Important: The LH surge and ovulation may not occur in all cycles.

[MAIN COMPONENTS]
The test contains anti-LH particles and anti-LH antibody coated on the membrane.
 
[Storage Conditions And Shelf Life]
1.Store as packaged in the sealed pouch at room temperature or refrigerated (4-30ºC or 40-86ºF). The test device is stable through the expiration date printed on the sealed pouch.
2.The test must remain in the sealed pouch until use.

[Materials Provided]
Ÿ Test  devices                                                                  
Ÿ Disposable specimen droppers
Ÿ Buffer                                                    
ŸPackage insert

Materials Required But Not Provided:
Ÿ Timer                                   
ŸCentrifuge                         
ŸSpecimen collection containers


[Sample Requirements]
ŸDo not eat, drink or smoke in the area where the specimens or kits are handled.
ŸHandle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout the procedure and follow the standard procedures for proper disposal of specimens.

[ When To Start Testing]
First, determine the subject's Menstrual Cycle Length. The Menstrual Cycle Length is the number of days from the first day of the subject's period (menstrual bleeding) to the last day before the next period starts.
Next, determine the Days to Count Ahead after the period to start testing. Find the subject's menstrual cycle length on the first row of the chart below, and read the corresponding Days to Count Ahead in the second row. This is the number of days after the subject's period to begin testing.

21	22	23	24	25	26	27	28	29	30
6	6	7	7	8	9	10	11	12	13
31	32	33	34	35	36	37	38
14	15	16	17	18	19	20	21

Menstrual Cycle Length

Note: If uncertain about the length of the subject's menstrual cycle, use the shortest menstrual cycle length (21 days) when reading the chart. In this case, it may be necessary to test for more than 5 days.
Example: The subject's usual menstrual cycle length is 28 days. The chart indicates to count ahead 11 days from the subject's last period. The subject's last period started on the 3^rd. Starting from and including the 3^rd, count ahead 11 days to arrive at the 13^th. Urine collection and testing should start on the 13^th and proceed through the 17^th. (See the Example Specimen Calendar below).

Example Specimen Calendar

Sun.	Mon.	Tue.	Wed.	Thu.	Fri.	Sat.
	1	2	(3)	4	5	6
7	8	9	10	11	12	<13>
14	15	16	17	18	19	20
21	22	23	24	25	26	27
28	29	30	31

(   )  -- First day of the last period
<  > -- Begin testing with the LH One Step Ultra Ovulation Test Device (Urine)

[Testing Method]
Allow the test device, urine specimen and/or controls to reach room temperature (15-30°C) prior to testing.
1.Determine the day to begin testing. (See the above section: "WHEN TO START TESTING").
2.Bring the pouch to room temperature before opening it. Remove the test device from the sealed pouch and use it as soon as possible.
3.Place the test device on a clean and level surface. Hold the dropper vertically and transfer 3 full drops of urine (approximately 100 mL) to the specimen well (S) of the test device, and then start the timer. Avoid trapping air bubbles in the specimen well (S). See illustration below.
4.Wait for the colored line(s) to appear. Read results at 5 minutes. Do not read results after 10 minutes.


[Results interpretation]



(Please refer to the illustration above)
POSITIVE: Two lines are visi
ble, and the line in test line region (T) is the same as or darker than the one in the control line region (C). This indicates probable ovulation in 24-36 hours.
NEGATIVE: Two lines are visible, but the line in the test line region (T) is lighter than the one in the control line region (C), or if there is no line in the test line region (T). This indicates that no LH surge has been detected.
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

[Quality control] 

1. A procedural control is included in the test. A colored line appearing in the control line region (C) is an internal procedural control. It confirms sufficient specimen volume, adequate membrane wicking and correct procedural technique.
2. A positive result indicates that the urine specimen contains the level of LH that would indicate the beginning of ovulation. Ovulation should

begin in 24-36 hours.

1. A negative result indicates that no LH surge has been detected and daily testing should continue.
2. Not every woman ovulates mid-cycle, therefore, a positive result may not appear during the selected days of testing. If you see no positive result, continue testing with the LH One Step Ultra Ovulation Test Device (Urine) for several more days. If negative results persist, test again during the next menstrual cycle.