E-Mail: sales@accubiotech.com

Products

HCG Test
Current location - Home - Products - Rapid Fertility Tests - HCG Test
HCG Urine Strip

Catalog No.      Product Name            

ABT- FT-A1      HCG Pregnancy Test Strip     

 

INTENDED USE

ACCU-TELL® One Step HCG Pregnancy Test Strip(urine) is a One Step, self-performing, qualitative immunoassay for the determination of human chorionic gonadotropin (hCG) in urine specimen at 25mIU/ml or above. This kit is intended for using as an aid in the early detection of pregnancy.

PERFORMANCE CHARACTERISTICS

Accuracy

In both laboratory and consumer clinical studies, ACCU-TELL® One Step HCG Pregnancy Test Strip(urine) has been proven to be greater than 99% accurate.

Sensitivity

The analytical sensitivity of ACCU-TELL® One Step HCG Pregnancy Test Strip(urine) is 25mIU/mL (based on the 4th IRP of HCG). ACCU-TELL® One Step HCG Pregnancy Test Strip(urine) does not show a “high dose Hook” or “Prozone Effect” up to the maximal observed physiological

Specificity

The specificity of ACCU-TELL® One Step HCG Pregnancy Test Strip(urine) was determined from cross-reactivity studies with known amounts of Luteinizing Hormone (hLH), Follicle Stimulating Hormone (hFSH), and Thyroid Stimulating Hormone (hTSH). Negative results were obtained from all tests conducted with 300 mIU/ml hLH, 1000 mIU/ml hFSH and 1000 mIU/ml hTSH.

Interference Testing

The following substances were added to hCG free urine and urine samples spiked with 25mIU/mL hCG. None of the substances interfered with the assay at the listed concentrations.

Acetaminophen                                  20 mg/dL              

Acetylsalicylic Acid                             20 mg/dL

Ascorbic Acid                                      20 mg/dL              

Atropine                                              20 mg/dL

Caffeine                                              20 mg/dL     

Gentisic Acid                                      20 mg/dL

Glucose                                                   2 g/dL     

Hemoglobin                                          1 mg/dL

Reproducibility

Urine specimens with 25, 100 and 250 mIU/mL hCG were run in replicates of 10 strips. Test results were consistent on the ten strips of each specimen

LIMITATIONS

  1. ACCU-TELL® One Step HCG Pregnancy Test Strip(urine) is for self diagnostictest use, and should only be used for the qualitative detection of human chorionic gonadotropin.

  2. Very dilute urine specimens, exhibiting low specific gravity, may not contain representative levels of hCG. If pregnancy is still suspected after a negative result, a first morning urine sample should be obtained 48-72 hours later and tested.

  3. Very low levels of hCG (less than 50 mIU/mL) are present in urine or serum shortly after implantation. However, because a significant number of first trimester pregnancies terminate for natural reasons, a test result that is weakly positive should be interpreted in conjunction with other clinical and laboratory data.

  4. A number of conditions other than pregnancy, including trophoblastic disease and certain non-trophoblastic neoplasms including testicular tumors, prostate cancer, breast cancer, and lung cancer, cause elevated levels of hCG (>10 mIU/mL). Therefore, the presence of hCG in urine as determined by using ACCU-TELL® One Step HCG Pregnancy Test Strip (urine)  should not be used to diagnose pregnancy unless these conditions have been ruled out.

  5. When hCG levels are below the minimum detection level of the test, a false negative result may be obtained. If pregnancy is suspected after a negative result, a first morning urine specimen should be collected 48-72 hours later and tested. If pregnancy is suspected and the test continues to produce negative results, see a physician for further diagnosis.

  6. As with all diagnostic tests, a confirmed pregnancy diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.