Pregnancy Tests (2-Count)

Our test’s accuracy was evaluated in a clinical study of over 1000+ urine samples. It found that our test is over 99% accurate* in predicting pregnancy at three days before your expected period. At four days before your expected period, the test result is 97% accurate and at five days before your expected period, the test is 77% accurate. These accuracy cut-offs are regulated by the FDA and our test is equivalent to, or better than, other early-result pregnancy tests on the market.

You can use our test up to five days before your expected period. At five days before your expected period, the test is 77% accurate, at four days before your expected period, the test is 97% accurate, and at three days before your expected period until the day of your missed period, the test result is over 99% accurate.* Early on, a pregnant woman may not be producing enough hCG for the test to detect. This is why the test is less accurate the earlier you take it. hCG can only be detected in urine after the embryo implants itself in the uterine wall, which occurs between the 7th and 10th day post-fertilization. At five days before an expected period, an embryo may have just implanted and hCG hormone production may not have yet increased enough to meet the test’s detection threshold. Early on in pregnancy hCG levels rise rapidly, doubling every two days. The closer you are to your missed period, the more reliable your early pregnancy test results will be. At Natalist, we understand that urge to test as early as possible—we’ve been there ourselves. You get two early pregnancy tests in each box so that you can test at five days before, three days before, and on the day of your expected period, or whenever you choose.

The sale of home pregnancy tests is regulated by the Food and Drug Administration (FDA) in the United States. Pregnancy tests are classified as Class II medical devices, and the FDA sets regulatory standards for their manufacture, clinical accuracy, sale, and distribution. When a Class II medical device meets these standards, it’s dubbed “cleared” after the 510k Premarket “Clearance” that it receives once it is approved for sale. Our early-result pregnancy test is FDA compliant and 510k Cleared.

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Eichner, Samantha F., and Erin M. Timpe. 02/2004. “Urinary-Based Ovulation and Pregnancy: Point-of-Care Testing.” The Annals of Pharmacotherapy 38 (2): 325–31.

Gnoth, C., and S. Johnson. 2014. “Strips of Hope: Accuracy of Home Pregnancy Tests and New Developments.” Geburtshilfe Und Frauenheilkunde 74 (7): 661–69.

Johnson, Sarah R., Sonya Godbert, Paul Perry, Pauline Parsons, Louise Roberts, Philip Buchanan, John Larsen, Todd A. Alonzo, and Michael Zinaman. 2013. “Accuracy of a Home-Based Device for Giving an Early Estimate of Pregnancy Duration Compared with Reference Methods.” Fertility and Sterility 100 (6): 1635–41.e1.

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Robinson, Joan H. 2016. “Bringing the Pregnancy Test Home from the Hospital.” Social Studies of Science 46 (5): 649–74.

Wilcox, A. J., D. D. Baird, D. Dunson, R. McChesney, and C. R. Weinberg. 2001. “Natural Limits of Pregnancy Testing in Relation to the Expected Menstrual Period.” JAMA: The Journal of the American Medical Association 286 (14): 1759–61.