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Accu-Tell® LH Ovulation Rapid Test Cassette/Midstream/Strip (Urine)

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Accu-Tell® LH Ovulation Rapid Test Cassette/Midstream/Strip is a self-testing immunoassay for the qualitative detection of human Luteinizing hormone (LH) to predict the time of ovulation.
Product Description

CATALOG

Product NameSpecimenCatalog No.Quantity per boxCertificate
LH StripUrineABT-FT-A35TCE 0197
LH CassetteUrineABT-FT-B35TCE 0197
LH MidstreamUrineABT-FT-C35TCE 0197


KEY POINTS

Detection for: human Luteinizing hormone (LH)

Reading time: 10 minutes

Sensitivity: 35 mIU/mL LH.

Diagnostic Specificity: 100%

Accuracy: 99%

 

INTRODUCTION

Ovulation is the release of an egg from the ovary. The egg passed 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), This is known as the “LH surge” and usually takes place in the middle of the menstrual cycle .LH triggers the release of an egg from the ovary. Accu-Tell® LH Ovulation Rapid Test is a complete system to help you predict the time of ovulation and peak fertility. It is during this fertile time that pregnancy is most likely to occur. Detection of the LH surge can aid in predicting the time of ovation. The onset of the LH surge precedes ovulation by approximately 30 hours.

Important: The LH surge and ovulation may not occur in all cycles.

 

INTENDED USE

Accu-Tell® LH Ovulation Rapid Test Cassette/Midstream/Strip is a self-testing immunoassay for the qualitative detection of human Luteinizing hormone (LH) to predict the time of ovulation.

 

TEST PROCEDURE

For Cassette:

LH Cassette Procedure.jpg

For Midstream:

LH Cassette Procedure.jpg

For Strip:

LH Cassette Procedure.jpg

Allow the test kit, urine specimen and/or controls to equilibrate to room temperature (15-30℃) prior to testing

For Cassette:

1.     Open the foil pouch and remove the test cassette.

2.     Draw 0.2ml (about 4 drops) sample into the pipette, and dispense it into the sample well on the cassette.

3.     Wait 5 minutes and read results. Do not read results after 30 minutes

 

For Midstream:

1.     Bring the pouch to room temperature before opening it. Remove the test device form the sealed pouch and use it as soon as possible. Remove the cap to expose the sample absorbent.

2.     Hold the handle with the exposed sample absorbent pointing downward. Urinate on the sample absorbent.

3.     Lay the test midstream down on flat surface with the windows on top and wait for the red line(s) to appear. Read result within 10 minutes but no longer than 15 minutes.

 

For Strip:

1.     Open the foil pouch and remove the test strip.

2.     Dip the test strip with arrow downside into the urine for about 5 minutes and lay the strip flat on a clean, dry, non-absorbent surface. Do not exceed the marker line.

3.     Wait for colored bands to appear. Depending on the concentration of LH in the test specimen, positive results may be observed in as short as 40 seconds. However, to confirm negative results, the complete reaction time (10 minutes) is required. Do not read results after 30 minutes.

 

PERFORMANCE CHARACTERISTICS

Sensitivity and Specificity

Accu-Tell®  LH Ovulation Rapid Test at a concentration of 35mIU/mL or greater. 300 know negative urine samples were equally divided into 6 groups. Each group of samples(50) were spiked with LH to the concentration of 0mlU/ml, 10 mlU/ml, 20 mlU/ml, 35 mlU/ml, 50 mlU/ml and 5 IU/ml separately, calibration against WHO 3rd international standard. Each group of sample of samples were tested with Accu-Tell® LH Ovulation Rapid Test. The results from this study gave 100% agreement with the expected results.

 Result 0mlU/ml 10mlU/ml 20mlU/ml 35mlU/ml 50mlU/ml 5lU/ml Total
Positive000505050150
Negative505050000150
Total505050505050300

Diagnostic sensitivity=100%(150/150)
Diagnostic specificy=100%(150/150)

INTERFERENCE TESTING

Accu-Tell® LH Ovulation Rapid Test  has been tested with commonly known drugs and hormones including FSH(200mlU/ml),and TSH (200µIU/ML),At the levels tested, none of these substances interfered with the expected test results.

For example:

Acetaminophen                   20mg/dl

Acetylsalicylic Acid              20mg/dl

Ascorbic Acid                      20mg/dl 

Atropine                               20mg/dl

Caffeine                               20mg/dl  

Gentesic Acid                      20mg/dl  

Glucose                               2g/dl    

Hemoglobin                         1mg/dl

 

LIMITATIONS

1.     Reagents used in the test kit are cross-reactive with HCG. The kit is intended only for the analysis of LH in HCG-free samples.

2.     Women suffering form polycystic ovary syndrome may have elevated LH concentration.

3.     The test kit will not work properly if you are pregnant, menopausal, or taking birth control pills.

4.     The test kit results should not be affected by pain relievers. Antibiotics containing HCG or LH may affect the test and should not be taken while using the Accu-Tell® LH Ovulation Rapid Test.

5.     The test provides a presumptive diagnosis for the time of ovulation. The user should not take any decision of medical relevance without first consulting his or her medical practitioner.

 

Note: The above information is for reference use only. Please refer to the product insert provided with the products before use.