Quick and Clear II Test Information

The Quick & Clear II Pregnancy test can detect pregnancy as early as 1 day after a missed menses. Since levels of 20 mIU/ml of hCG have been observed as early as 3 to 4 days after implantation, hCG may be detected before a first missed menses.⁸ The amount will vary greatly with gestational age and between patients. First morning urine specimens approximate serum hCG levels which reach 5 to 50 mIU/ml within 1 week of gestational age.²

Summary and Explanation

Human Chorionic Gonadotropin (hCG) is a glycoprotein hormone which is secreted by the developing placenta after fertilization.¹ The appearance and increased levels of hCG provide an excellent indicator of pregnancy. The hCG hormone doubles approximately every 2.2 days during the first trimester.² Detectable levels start at 5 mIU/ml during the first week of gestation and rise to 100,000 mIU/ml at 2 to 3 months. High risk terminations may be associated with a slow rise in hCG levels.³ During the 2nd and 3rd trimester, hCG levels decline 10% to 15% from peak concentrations.¹

Intended Use

Quick & Clear II Pregnancy test is for the rapid qualitative determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. This test is for professional use.

Performance Characteristics: Sensitivity and Specificity

Quick & Clear II Pregnancy test detects hCG concentrations of 20 mIU/ml and greater. Specimens containing less than 20 mIU/ml of hCG may also test positive. Suspected low hCG levels should be evaluated considering all possible clinical conditions associated with low hCG levels. The test has been standardized to the World Health Organization 3rd International Standard. The addition of LH (300 mIU/ml), FSH (1000 mIU/ml) and TSH (1000 IU/ml) to negative and positive urine specimens showed no cross-reactivity.

Performance Characteristics: Accuracy

A multi-center clinical evaluation was conducted comparing the results obtained using Quick & Clear II Pregnancy tests and another commercially available membrane test. The study included 148 urine specimens and both assays identified 84 negative and 64 positive results. The results demonstrated a 100% overall agreement between Quick & Clear II Pregnancy test and the other commercially available test.

Test Name: Heritage Quick & Clear II Pregnancy Test
Test Type: hCG (human chorionic gonadotropin) Detection in Urine
Tests Per Box: 25
Test Sensitivity: 20 mIU/ml
Read Time: 3 minutes (positives may show much sooner)
Best Time for Sample: Early morning.
Contents of Each Packet: One pouch containing a reaction cassette, a dropper and a desiccant. The desiccant is for storage purposes only, and is not used in the test procedures.

• 1. Easy to Use
  Designed for simple, easy use with fast results.
• 2. High Quality with Accurate Results
  The testing strips in our new Quick & Clear II tests are able to detect as little as 20 mIU/ml of hCG giving accurate and quick results. These tests have the same quality, sensitivity, and speed as similar tests that cost $10-20 at the store.
• 3. Manufactured in the USA
  The Quick and Clear II test strip is manufactured and assembled in the USA!

 
 

REFERENCES

1. Braunstein GD, Rasor J, Adler D, Danzer H, Wade ME: Serum human chorionic gonadotropin levels through normal pregnancy. Am J Obstet Gynecol, 126: 678-681, 1976.
2. Schwartz S, Berger P, and Wick G: Epitope-selective monoclonal antibody based immunoradiometric assay of predictable specificity for differential measurement of choriogonadotropin and its subunits, Clin Chem 31:1322- 1328, 1985.
3. Kaplin LA, Pesce AJ. Clinical Chemistry Theory, Analysis, & Correlation, 2nd Edition, Missouri, 1989, C.V. Mosby Co., p. 944.
4. Jacobs DS, et al: Laboratory Test Handbook, 2nd Edition, Ohio, Lexi-Comp Inc., pp. 224, 305-307, 1990.
5. Steier JA, Bergso p, Myking OL: Human chorionic gonadotropin in maternal plasma after induced abort., spontaneous abortion, and removed ectopic pregnancy. Obstet Gynecol 64: 391-394, 1984.
6. Thorneycroft IH: When you suspect ectopic pregnancy. Diagnosis January: 67-82, 1976.
7. Wilcox EG, Weinberg CR, O'Connor JF, et al: Incidence of early loss of pregnancy. N Eng J Med 319: 189-194, 1988.
8. Chard T, Pregnancy Tests: A Review. Human Reproduction, 7:701-710, 1992.