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HCG Test
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HCG Urine/Serum Strip

Catalog No.             Product Name                     

ABT-IDT-B7             HCG Urine/Serum Strip


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


Precision


Intra-Assay


Within-run precision has been determined by using 10 replicates of three specimens containing 25 mIU/ml, 100 mIU/ml, 250 mIU/ml and 0 mIU/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 25 mIU/ml, 100 mIU/ml, 250 mIU/ml and 0 mIU/ml of HCG in 10 independent assays. Three different lots of ACCU-TELL® One Step HCG Pregnancy Test Strip (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

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 Strip (Serum/Plasma/Urine)  is a preliminary qualitative test, herefore, 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 50mIU/mL) are present in urine specimens 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 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 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.