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HCG Urine/Serum Cassette

Catalog No.          Product Name

ABT-FT-B2             HCG Pregnancy Serum/Urine  Test Cassette 


INTENDED USE

ACCU-TELL® One Step HCG Pregnancy Test Cassette (Serum/Plasma/Urine) is a One Step chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin in urine or serum or plasma to aid in the early detection of pregnancy.


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PERFORMANCE CHARACTERISTICS

Accuracy

A multi-center clinical evaluation was conducted comparing the results obtained using ACCU-TELL® One Step HCG Pregnancy Test Cassette(Serum/Plasma/Urine) to another commercially available urine and serum or plasma HCG One Step test. The urine study included 413 specimens, and both assays identified 296 negative and 117 positive results. The serum study included 200 specimens, and both assays identified 141 negative and 59 positive results. The plasma study included 200 specimens, and both assays identified 141 negative and 59 positive results. The results demonstrated a >99% overall accuracy of ACCU-TELL® One Step HCG Pregnancy Test Cassette(Serum/Plasma/Urine) when compared to the other urine and serum or plasma HCG One Step test.

HCG Reference Method (Urine)

Method

Other HCG One Step Test

Total Results

ACCU-TELL® One Step HCG Pregnancy Test Cassette(Serum/Plasma/Urine)

Results

Positive

Negative

Positive

117

0

117

Negative

0

296

296

Total Results

117

296

413


 

Sensitivity: 99.9% (97.5%~100%)*

Specificity:99.9%(99.0%~100%)*

Accuracy:  99.9 %( 99.3%~100%) *

              * 95% Confidence Intervals



HCG Reference Method(Serum )

Method

Other HCG One Step Test

Total Results

ACCU-TELL® One Step HCG Pregnancy Test Cassette(Serum/Plasma/Urine)

Results

Positive

Negative

Positive

59

0

59

Negative

0

141

141

Total Results

59

141

200

Sensitivity: 99.9% (95.0%~100%)*

Specificity:99.9%(97.9%~100%)*

Accuracy: 99.9%(98.5%~100%) *

* 95% Confidence Intervals

HCG Reference Method (Plasma )

Method

Other hCG One Step Test

Total Results

ACCU-TELL® One Step HCG Pregnancy Test Cassette

(Serum/Plasma/

Urine)

Results

Positive

Negative

Positive

59

0

59

Negative

0

141

141

Total Results

59

141

200

Sensitivity: 99.9% (95.0%~100%)*

Specificity:99.9%(97.9%~100%)*

Accuracy: 99.9%(98.5%~100%) *

* 95% Confidence Intervals

Sensitivity and Cross-Reactivity

ACCU-TELL® One Step HCG Pregnancy Test Cassette (Serum/Plasma/Urine) detects HCG at a concentration of 25mIU/mL or greater. The test has been standardized to the W.H.O. International Standard. The addition of LH (300mIU/mL), FSH (1,000mIU/mL), and TSH (1,000μIU/mL) to negative (0mIU/mL HCG) and positive (25mIU/mL HCG) specimens showed no cross-reactivity.

Precision

Intra-Assay

Within-run precision has been determined by using 10 replicates of three specimens containing 25mIU/ml, 100mIU/ml, 250mIU/ml and 0mIU/ml of HCG. The negative and positive values were correctly identified 100% of the time.

Inter-Assay

Between-run precision has been determined by using the same three specimens of 25mIU/ml, 100mIU/ml, 250mIu/ml and 0mIU/ml of HCG in 10 independent assays. Three different lots of ACCU-TELL® One Step HCG Pregnancy Test Cassette (Serum/Plasma/Urine) have been tested. The specimens were correctly identified 100% of the time.

Interfering Substance

The following potentially interfering substances were added to HCG negative and positive specimens.

Acetaminophen        20 mg/Dl                     Caffeine         20 mg/dL

Acetylsalicylic Acid  20 mg/dL               Gentisic Acid        20 mg/dL

Ascorbic Acid           20 mg/dL                      Glucose             2 g/dL

Atropine                 20 mg/dL                   Hemoglobin         1 mg/dL

Bilirubin(urine)          2 mg/dL

Bilirubin(serum or plasma )                           40 mg/dL  

Triglycerides (serum or plasma)               1,200 mg/dL

None of the substances at the concentration tested interfered in the assay.

LIMITATIONS

  1. ACCU-TELL® One Step HCG Pregnancy Test Cassette (Serum/Plasma/Urine) is a preliminary qualitative test, therefore, neither the quantitative value nor the rate of increase in HCG can be determined by this test.

  2. Very dilute urine specimens, as indicated by a low specific gravity, may not contain representative levels of HCG. If pregnancy is still suspected, a first morning urine specimen should be collected 48 hours later and tested.

  3. Very low levels of HCG (less than 50 mIU/mL) are present in urine and serum or plasma specimen shortly after implantation. However, because a significant number of first trimester pregnancies terminate for natural reasons,5 a test result that is weakly positive should be confirmed by retesting with a first morning urine or serum or plasma  specimen collected 48 hours later.

  4. This test may produce false positive results. 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.6,7 Therefore, the presence of HCG in urine or serum or plasma  specimens should not be used to diagnose pregnancy unless these conditions have been ruled out.

  5. This test may produce false negative results.  False negative results may occur when the levels of HCG are below the sensitivity level of the test. When pregnancy is still suspected, a first morning urine specimen should be collected 48 hours later and tested.  In case pregnancy is suspected and the test continues to produce negative results, see a physician for further diagnosis.

  6. As with any assay employing mouse antibodies, the possibility exists for interference by human anti-mouse antibodies (HAMA) in the specimen. Specimens from patients who have received preparations of monoclonal antibodies for diagnosis or therapy may contain HAMA. Such specimens may cause false positive or false negative results.

  7. 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.