Home > Products > Fertility Tests > HCG Rapid Test

Accu-Tell® HCG Pregnancy Rapid Test Cassette/Midstream/Strip (Urine)

Share
Accu-Tell® hCG Pregnancy Rapid Test Cassette/Midstream/Strip is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid for the early detection of pregnancy.
Product Description

CATALOG

Product NameSpecimenCatalog No.Quantity per boxCertificate
HCG Strip UrineABT-FT-A1200T; 100TCE 0197
HCG   CassetteUrineABT-FT-B150T;   25TCE 0197
HCG MidstreamUrineABT-FT-C125T; 1TCE 0197


KEY POINTS

Detection for: Human chorionic gonadotropin (hCG) in urine

Reading time: 5 minutes

Sensitivity: 25mlU/mL

Diagnostic Specificity: 100%

 

INTRODUCTION

The pregnancy hormone human Chorionic Gonadoteophin (hCG) starts to be produced the developing placenta shortly after fertilization. The role of HCG is to simulate production of the hormones progesterone and oestrogen. These in turn maintain the uterine lining and prevent menstruation, so allowing the pregnancy to continue. The appearance of hCG in both urine and serum soon after conception, and its subsequent rapid rise in concentration during early gestational growth, make it an excellent marker for the early detection of pregnancy. The level of hCG increases rapidly during early pregnancy. The level of HCG increases rapidly during early pregnancy, doubling every 1.3-2 days, soon reaching  a level that can be detected in blood or in urine. While the level of HCG can vary between pregnant women, published literature has shown that the level of HCG reaches at least 50 mIU/ml on the day the period is due. Accu-Tell® One Step hCG Pregnancy Test is sensitive enough to detect HCG at this level.

 

INTENDED USE

Accu-Tell® hCG Pregnancy Rapid Test Cassette/Midstream/Strip is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid for the early detection of pregnancy.

 

TEST PROCEDURE

For Cassette:

HCG Cassette Procedure.jpg

For Midstream:

HCG Cassette Procedure.jpg

For Strip:

HCG Cassette Procedure.jpg


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

For Cassette:

1.     Bring all materials and specimens to room temperature.

2.     Remove test card from the sealed foil pouch.

3.     Place the test card on a flat dry surface.

4.     Using the provided plastic dropper, dispense 100ul of urine sample (3 drops) to the sample well of the test cassette.  Start timing.

5.     Read result between 3 to 10 minutes after adding the sample.

 

For Midstream:

When you are ready to test, remove the test and take off the cap. With the test pointing downwards, hold the absorbent sampler in your urine stream for 1–2 seconds. Do not stream pass the arrow end and taking care not to splash the window. Hold the test for a few seconds or lay the test flat. When you see the urine pass the show window and purple line appear, the test is complete and has worked correctly. Read the result in 5 minutes.

 

For Strip:

1.     Remove the test device form the sealed pouch and use it as soon as possible.

2.     With arrows pointing toward the urine specimen, immerse the Strip test vertically in the urine specimen, for at least 5 seconds. Do not pass the maximum line (max) on the Strip test when immersing the strip.

3.     Lay the strip flatly on a non-absorbent clean surface. Start the timer and wait for the red line (s) to appear. Read result within 5 minutes but no longer than 15 minutes.

 

PERFORMANCE CHARACTERISTICS

Sensitivity and Specificity

Accu-Tell® hCG Pregnancy Rapid Test detects hCG at a concentration of 25mlU/mL or greater. 300 know negative urine samples were equally divided into 6 groups.Each group of samples(50) were spiked with HCG to the concentration of 0mlU/ml, 10 mlU/ml, 15 mlU/ml, 25 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® hCG Pregnancy Test. The results from this study gave 100% agreement with the expected results.

 Result 0mlU/ml 10mlU/ml 15mlU/ml 25mlU/ml 50mlU/ml 5lU/ml Total
Positive000505050150
Negative505050000150
Total505050505050300

Diagnostic sensitivity=100%(150/150)

Diagnostic specificy=100%(150/150)

Interference Testing

Accu-Tell® hCG Pregnancy Rapid Test has been tested with commonly known drugs and hormones including LH(500mlU/ml),FSH(1,000mlU/ml),and TSH(1,000µlU/mL).At the levels tested, none of these substances interfered with the expected test results. For example: Acetaminophen 20mg/dl,Ace-tylsalicylic Acid 20mg/dl, Ascorbic Acid 20mg/dl,Atropine 20mg/dl,Caffeine 20mg/dl,Gentesic Acid 20mg/dl,Glucose2g/dl,Hemoglobin 20mg/dl, Ampicillin     20mg/dl,Tetracycline 20mg/dl.

 

LIMITATIONS

1.     The content of this kit are for use in the qualitative detection of hCG in urine only.

2.     A specimen with a low level of hCG may show color development over time. If a negative result is obtained but pregnancy is suspected, another specimen should be collected after 48-72 hours and tested.

3.     Alcohol may interfere the test result. It is not recommended using the test after drinking.

4.     Although it is not necessary to test with an early morning urine sample, excessive fluid intake should be avoided before testing. A ‘Not Pregnant’ result may be obtained if the urine sample is too dilute.

5.     Fertility drugs containing hCG can give misleading results (these fertility drugs are usually given by injection and testing too soon after administration may give a false ‘Pregnant’ result.)

6.     Other fertility therapies (such as clomiphene citrate) painkillers and hormonal contraceptives (e.g contraceptive pill) should not affect the result.

7.     hCG may remain detectable for a few days to several weeks after delivery, spontaneous abortion, or hCG injections.

8.     Ectopic pregnancy, ovarian cysts, menopause, and some very rare medical conditions can give misleading results.

9.     While pregnancy is the most likely reason for the presence of hCG in serum and urine, elevated hCG concentrations unrelated to pregnancy have been reported in some patients, for example, trophoblastic disease and certain nontrophoblastic neoplasms.

10.   This test provides a presumptive diagnosis for pregnancy. A confirmed pregnancy diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.

 

 

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