New Choice Plus Pregnancy Test accuracy chart

Early use of the New Choice Plus One Step Pregnancy Test can result in inaccurate results. This is because the test is 99% accurate on the day of your missed period. So, what should you do if you want to take the test early?

For starters, if you take any pregnancy test early, you must retest later to confirm your results. After all, before your missed period, you may not have enough of the HCG pregnancy hormone in your urine to trigger a positive result. In other words, testing early increases your chance of a pregnancy test false negative.

Visit the National Center for Biotechnology Information to learn more about the accuracy of pregnancy tests.

New Choice Plus Pregnancy Test Accuracy Chart

FDA Identification

SCI International, the distributor of New Choice Pregnancy Tests has registered their products under FDA document number K03443. Although the main title of this document specifies the “cassette” version of the test, the Decision Summary applies to this product as test strips, cassettes, and midstream test sticks.

New Choice Sensitivity

New Choice Pregnancy Tests work by using a test strip that reacts to urine and human chorionic gonadotropin (HCG). The test has two sections: (1) a “Control” section that reacts only to urine. This helps to assure you of a valid test result, and (2) a “Test” section that reacts to HCG and displays a pink line when a sufficient HCG concentration exists in your urine.

New Choice Pregnancy Tests have a cut off value of 25 mIU/mL urine. This means that, more than 50% of pregnant women will have a positive test result when they have 25 mIU of HCG in 1 milliliter of their urine.

To further clarify:

All results (100%) below 18.75 mIU/mL tested negative. Fourteen (14) out of 15 samples (98.8%) at 25 mIU/mL tested positive. All samples (100%) above 50 mIU/mL tested positive. The sponsor claims a cutoff for positive of 25 mIU/mL.

https://www.accessdata.fda.gov/cdrh_docs/reviews/K043443.pdf

New Choice Plus Pregnancy Test accuracy chart

The following pregnancy test accuracy chart reflects laboratory tests of 60 urine samples with varying levels of HCG:

ConcentrationPositiveNegativeAccuracy
0 mIU/mL05100%
12.5 mIU/mL05100%
18.75 mIU/mL05100%
25 mIU/mL29197%
50 mIU/mL100100%
100 mIU/mL50100%
New Choice Pregnancy Test accuracy at various HCG levels.

New Choice Pregnancy Tests are over 99% accurate on the day of your expected period.

More about New Choice Pregnancy Tests

Use the following links hosted by CPG-Health.com to learn more about New Choice.