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

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

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Accu-Tell® HCG Pregnancy Rapid Test Cassette/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.

Product Description

Product Description

CATALOG

Product NameSpecimenCatalog No.Quantity per boxCertificate
HCG StripSerum/Plasma/UrineABT-FT-A2100TCE
HCG CassetteSerum/Plasma/UrineABT-FT-B225TCE


KEY POINTS

Detection for: Human chorionic gonadotropin (HCG) in plasma, Serum, and urine

Reading time: at 3 minutes when testing a urine specimen, or at 5 minutes when testing a serum or plasma specimen

Sensitivity: 25 mIU/mL

Relative Specificity: >99.9%

Accuracy: >99.9 %

 

INTRODUCTION

Human chorionic gonadotropin(HCG) is a glycoprotein hormone produced by the developing placenta shortly after fertilization. In normal pregnancy, HCG can be detected in both urine and serum or plasma  as early as 7 to 10 days after conception. HCG levels continue to rise very rapidly,frequently exceeding 100 mIU/mL by the first missed menstrual period, and peaking in the 100,000-200,000 mIU/mL range about 10-12 weeks into pregnancy. The appearance of HCG in both urine and serum or plasma soon after conception, and its subsequent One Step rise in concentration during early gestational growth, make it an excellent marker for the early detection of pregnancy.

 

INTENDED USE

ACCU-TELL® HCG Pregnancy Rapid Test Cassette/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.

 

TEST PROCEDURE

For Cassette:

HCG Urine Serum Test 1.jpg

For Strip:

HCG Urine Serum Test 1.jpg


For Cassette:

1. Bring the pouch to room temperature (15-30℃) before opening it. Remove the cassette from the sealed pouch and use it as soon as possible.

2. Place the cassette on a clean and level surface. Hold the dropper vertically and transfer 3 full drops of urine or serum or plasma (approximately 120ul) to the specimen well of the cassette, and then start the timer. Avoid trapping air bubbles in the specimen well. See illustration below.

3. Wait for the colored line(s) to appear. Read the result at 3 minutes when testing a urine specimen, or at 5 minutes when testing a serum or plasma specimen.

NOTE: A low HCG concentration might result in a weak line appearing in the test line region (T) after an extended period of time; therefore, do not interpret the result after 10 minutes.

 

For Strip:

1. Bring the pouch or canister to room temperature before opening it. Remove the test strip from the sealed pouch or closed canister and use it as soon as possible.

2. With arrows pointing toward the urine or serum or plasma specimen, immerse the test strip vertically in the urine or serum or plasma specimen for at least 15 seconds. Do not pass the maximum line (MAX) on the test strip when immersing the strip. See illustration below.

3. Place the test strip on a non-absorbent flat surface, start the timer and wait for the colored line(s) to appear. Read the result at 3 minutes when testing a urine specimen, or at 5 minutes when testing a serum or plasma specimen.

NOTE: A low HCG concentration might result in a weak line appearing in the test line region (T) after an extended period of time. Do not interpret the result after 10 minutes.

 

PERFORMANCE CHARACTERISTICS

Accuracy

A multi-center clinical evaluation was conducted comparing the results obtained using ACCU-TELL® HCG Pregnancy Rapid Test Cassette/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® HCG Pregnancy Rapid Test Cassette/Strip (Serum/Plasma/Urine) when compared to the other urine and serum or plasma HCG One Step test.

Sensitivity and Cross-Reactivity

ACCU-TELL® HCG Pregnancy Rapid Test Cassette/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® HCG Pregnancy Rapid Test Cassette/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.

Acetaminophen20 mg/dLCaffeine20 mg/dL
Acetylsalicylic Acid20 mg/dLGentisic   Acid20 mg/dL
Ascorbic Acid20 mg/dLGlucose2 g/dL
Atropine20 mg/dLHemoglobin1 mg/dL
Bilirubin2 mg/dLBilirubin (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® HCG Pregnancy Rapid Test Cassette/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. 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.

 

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

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