Product Information

• Product Code: HCG-1M1
• Quantity: 1 Test/Kit
• Sample: Urine
• Format: Midstream
• Sensitivity: 20 mIU/mL
• Specificity: Human Chorionic Gonadotropin
• Time-to-Result: 3 minutes
• Storage Condition: 36-86°F/2-30°C
• Test Principle: Lateral Flow Immunoassay

Contents

1 Midstream Test
Product Insert

The Rapid Response™ Pregnancy Test is a rapid, qualitative test for detecting human chorionic gonadotropin (hCG) in human urine specimens, to aid in the early detection of pregnancy. For in vitro diagnostic use.

Pregnancy Testing

The Rapid Response™ Pregnancy Test is a rapid visual read test for the detection of hCG in urine specimen at 20 mIU/mL or higher. This test has a high sensitivity, selectively detecting hCG in urine and shows no cross-reactivity interference from related glycoprotein hormones hFSH, hLH and hTSH at physiological levels. Test results do not show a "high-dose Hook" or "Prozone Effect".

What is hCG

Human chorionic gonadotropin (hCG), a glycoprotein hormone secreted by viable placental tissue during pregnancy, is excreted in urine approximately 20 days after the last menstrual period. hCG levels rise rapidly, reaching peak levels after 60-80 days. The appearance of hCG in urine soon after conception and its rapid rise in concentration makes it an ideal marker for the early detection and confirmation of pregnancy. However, elevated hCG levels are frequently associated with trophoblastic and non-trophoblastic neoplasms and hence these conditions should be considered before a diagnosis of pregnancy can be made.

Sensitivity

Urine hCG concentration in pregnant women rises very rapidly after implantation, reaching a peak concentration in excess of 200 mIU/mL about 2-3 months after the last menstrual period. The Rapid Response™ Pregnancy Test has a sensitivity of 20 mIU/mL. Reportedly, a level of 20 mIU/mL or more, is present 7-10 days after conception or 4-5 days prior to the first missed menses.

Accuracy

>99.9% Overall agreement.*

*Clinical study value from product insert.

Result interpretation

Interpret the results as follows: 2 lines is pregnant, 1 line is not pregnant, no lines or no line in the control region (C) is invalid.

References

1. Batzer FR. Fertility and Sterility 1980; 34:1.
2. Catt KJ, Dufan ML, Vaitukaitis JL. J. Clin. Endocrinol. Metab. 1975; 40:537.
3. Baunstein GD, Rasor J, Adler D, Danzer H, Wade ME. Am. J. Obstet. Gynecol. 1976;
   126:678.
4. Lenton EA, Neal LM, Sulaiman R. Fertility and Sterility 1982; 37:773.
5. Engvall E. Methods in Enzymology 1980; 70:419.
6. Uotila M, Ruoslahti E, Engvall EJ.E. J. Immunol. Methods 1981; 42:11.
7. Steier JA, Bergsjo P, Myking OL.Am. J. Obstet. Gynecol. 1984; 64:391.
8. Dawood MY, Saxena BB, Landesman R. Am. J. Obstet. Gynecol. 1977; 50:172.
9. Braunstein GD, Vaitukaitis JL, Carbone PP. Ann. Inter. Med. 1973; 78:39.

Disclaimers

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• Our products are intended for use as specified in the product documentation. It is important to carefully read and follow all instructions provided with the product.