One Step HCG Pregnancy Test (Strip)

Short Description:

One Step hCG Pregnancy Test is a rapid chromatrographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine at a concentration level from 20mIU/ml or greater to aid in the early detection of pregnancy. The test is designed for over-the–counter use.

hCG is a glycoprotein hormone produced by the developing placenta shortly after fertilization. In normal pregnancy, hCG can be detected in urine as early as 7 to 10 days after conception. hCG levels continues to rise very rapidly, frequently exceeding 100mIU/mL by the first missed menstrual period, and peaking in the 100,000-200,000mIU/mL range about 10-12 weeks into pregnancy. 7,8,9,10The appearance of hCG in urine soon after conception, and its subsequent rapid rise in concentration during early gestational growth, make it an excellent marker for the early detection of pregnancy.


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PRINCIPLE OF TEST

One Step hCG Pregnancy Test is a rapid chromatrographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The test utilizes a combination of antibodies including a monoclonal hCG antibody to selectively detect elevated levels of hCG. The assay is conducted by immersing the test in a urine specimen and observing the formation of pink colored lines. The specimen migrates via capillary action along the membrane to react with the colored conjugate.

Positive specimens react with the specific antibody-hCG-colored conjugate and form a pink colored line at the test line region of the membrane. Absence of this pink colored line suggests a negative result. To serve as a procedural control, a pink colored line will always appear at the control line region if the test has been performed properly.

TESTING STEPS

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Allow the test and the specimen to equilibrate to room temperature (15-30°C) prior to testing.

1.To begin testing, open the sealed pouch by tearing along the notch. Remove the test kit from the pouch and use it as soon as possible.

2.Immerse the strip vertically into the urine sample with the arrow end pointing towards the urine. Do not immerse past the “Mark” Line.  Take the strip out after 3 seconds and lay the strip flat on a clean, dry, non-absorbent surface.

3.Wait for pink colored bands to appear. Depending on the concentration of hCG in the test specimen. For all results, wait 5 to 10 minutes to confirm the observation. Do not interpret the result after 30 minutes. It is important that the background is clear before the result is read.

Note: A low hCG concentration might result in a weak line appearing in the test region (T) after an extended period of time; therefore, do not interpret the result after 30 minutes.

The following substances were added in hCG free and 20 mIU/mL spiked samples.

luteinizing hormone (LH)

500mIU/ml

follicle stimulating hormone (FSH)

1000mIU/ml

thyroid stimulating hormone(TSH)

1000µIU/ml

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

INTERFERING SUBSTANCES

The following substances were added in hCG free and 20 mIU/mL spiked samples.

Hemoglobin 10 mg/mL
bilirubin 0.06 mg/mL
albumin 100 mg/mL

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

COMPARISON STUDY

Other commercially available qualitative test kits were used to compare with One Step hCG Pregnancy Test for relative sensitivity and specificity in 201 urine samples. None of samples was discordant, the agreement is 100%.

Test

Predicate Device

Subtotal

+

-

AIBO

+

116

0

116

-

0

85

85

Subtotal

116

85

201

Sensitivity: 100%;  Specificity: 100%


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