hCG Pregnancy Rapid Test Midstream

• Product Name:

  hCG Pregnancy Rapid Test Midstream

• Category: Others
• Package: Storage Requirements :The kit should be stored at
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• Product Detials:

  hCG pregnancy rapid test cassette 

  ESWT 1-0001

  INTENDED USE

  hCG pregnancy rapid test cassette is an in vitro diagnostic (IVD) qualitative test for rapid detection of hCG in urine. This test is designed for self-testing use only.

  PRECAUTION

  1. For in vitro diagnostic use only.

  2. Do not use after expiration date.

  3. Test strip should remain sealed until ready for use. Do not use if pouch is damaged or opened.

  4. Read this instruction carefully before performing the test.

  5. Do not re-use the test strip.

  6. Do not touch the membrane.

  7. Do not eat the desiccant in the pouch.

  SUMMARY AND EXPLANATION OF THE TEST

  Human chorionic gonadotropin (hCG) is produced by trophoblastic tissue and it appears around the 8-9th day after ovulation where fertilization has occurred, or around the 4th day after conception. In a 28 day cycle with ovulation occurring at day 14 hCG can be detected in urine or serum in minute quantities around day 23, or 5 days before the expected menstruation. Its function includes facilitation of implantation as well as maintenance and development of the corpus luteum. The hormone concentration doubles approximately every 2 days and peaks between 7-12 weeks after the first day of the last menstrual period with a mean concentration of 50,000 mIU/mL. Concentrations as high as 100,000 mIU/mL have been reported in normal pregnancies during the first trimester. In normal subjects, hCG in urine provides an early indication of pregnancy. Since elevated hCG levels are also associated with trophoblastic disease and certain nontrophoblastic neoplasms, the possibility of having these diseases must be eliminated before a diagnosis of pregnancy can be made.(1)(2)

  PRINCIPLE

  hCG pregnancy rapid test cassette is two-side sandwich immunoassay for the qualitative determination of human chorionic gonadotropin (hCG) in urine. The membrane was precoated with anti alpha hCG capture antibodies on the test band region and goat anti mouse on the control band region. During the test, the urine specimen is allowed to react with anti beta hCG monoclonal antibody-colloid gold conjugate, which was predried on the test cassette. The mixture then moves forward on the membrane by the capillary action. For a positive specimen, the conjugate binds to the hCG forming an antibody-antigen complex. This complex is captured by anti alpha hCG antibody on the test region to produces a visual pink color band when hCG concentration in specimen is equal to or greater than 25 mIU/ml. Regardless of the presence of hCG, as the mixture continues to move across the membrane to the control band region, the complex is captured by immobilized goat anti mouse antibodies to form a distinct pink colored control band. The presence of the control band indicated: 1) a normal flow is obtained, 2) antibody precoated on control line and colloidal gold conjugate are functional.

  MATERIALS SUPPLIED

  1.        25 or 50 individually wrapped test. Each wrap contains a hCG pregnancy rapid test cassette, plastic dropper pipette and a desiccant.

  2.        One instruction insert.

   MATERIALS NOT PROVIDED BUT REQUIRED

  1.        Urine specimen collection container, either plastic or class.

  2.        Timer.

  SPECIMENS COLLECTION AND STORAGE

  1.        The urine specimens must be collected in a clean dry container either plastic or glass without preservatives. No centrifugation or filtration of urine is required. Specimens collected at any time may be used.

  2.        The urine specimens can be stored at, if not tested immediately, 2-8 °C for up to 3 days after collection.

   QUALITY CONTROL

  An internal procedural control is included in the test. A red-purple line will appears in the control region (C), which confirms sufficient specimen volume and correct operation for the test.

  ASSAY PROCEDURE

  1.        Remove the test device from pouch by tearing and label the device with specimen identification.

  2.        Draw specimen with dropper pipette provided for each device. Carefully dispense 2-3 drops (70-100 ml) into the sample well

  1.        Wait for 5 minutes to read result, even though some positive results may be observed within a minute.  Do not try to interpret results after 10 minutes.

  INTERPRETATION OF RESULTS

  Pregnant: In addition to the control band, a pink colored band also appears in the test region.

  Not Pregnant: Only one pink colored band appears on the control region. No pink colored band in the test region.

  Invalid: If no bands appear, or a test band appears without a control band, the test should be repeated using a new cassette.

  EXPECTED VALUES

  Health men and health non-pregnant women do not have detectable hCG by hCG pregnancy rapid test cassette. HCG levels of 100 mIU/ml can be reached on the day of the first missed manstrual period. HCG levels peak about 7-12 weeks after the last menstrual period and then decline to lower values for the remainder of the pregnancy. Following delivery, hCG levels rapidly decrease and usually return to normal within days after parturition.

  CALIBRATION

  hCG pregnancy rapid test cassette has been calibrated against World Health Organization the Third International Standard (3^rd IS).

  PERFORMANCE CHARACTERISTICSSESITIVITY

  The test will detect hCG in urine at concentration of 25 mIU/ml and higher. This sensitivity level has been confirmed with hCG standards (25, 50, 250, 2500, and 500,000 mIU/ml) in urine calibrated against the WHO Third I.S.. Occasionally, specimens containing less than 25 mIU/ml hCG can give positive results.

  SPECIFICITYMenopausal urine samples

  A study was performed using urine specimens from 20 postmenopausal women. Urine of postmenopausal women can interfere with pregnancy testing due to elevated concentrations of gonadotropic hormone structurally similar to hCG. All 20 samples tested negative with the y.b.t. hCG  Card.

  Potentially interfering substances

  The following substances did not interfere with hCG testing using y.b.t. Pregnancy Test Card when added to urine samples containing 0 mIU/ml and 25 mIU/ml hCG:

  Acetaminophen 20mg/dl, Ascorbic acid 20mg/dl, Acetylsalicylic acid 20 mg/dl, Ampicilline 20 mg/dl, Atropine 20 mg/dl, Caffeine 20 mg/ml, Cortisol 200 ng/ml, Albumin 2,000mg/dl, DHEAS 500 ng/ml, Estradiol (E-2) 25 ng/ml, Estriol (E-3) 25 ng/ml, Gentisic acid 20 mg/dl, Glucose 2,000 mg/dl, Tetracycline 20 mg/dl, Uric acid 10 mg/dl

  Cross reactive glycoprotein hormones

  The following hormones structurally related to hCG did not interfere with hCG testing using the y.b.t. Pregnancy Test Card when added to urine specimens at the concentrations indicated below:

  Luteinizing hormone 50-500 mIU/ml,

  Follicle stimulating hormone 100-1,000 mIU/ml

  Tyroid stimulating hormone 100-1,000 mIU/ml

  Diagnostic Sensitivity and Specificity

   60 positive and 60 negative patient urine specimens confirmed with routine diagnostic method were tested against  hCG pregnancy rapid test cassette at two certified hospital. The results showed 100% consistence., pregnant women should not drink alcohol because of the risk of birth defects.