Women depend on the New Choice One Step Pregnancy Test to find out now. Because of this, potential mothers often ask, “What is New Choice Pregnancy Test accuracy?
Before we answer your question, you need to know that two versions exist of the New Choice Pregnancy Test.
First, the New Choice One Step Pregnancy Test is a cassette-based test. To use it, you collect a urine sample in a clean cup or glass. You use the enclosed dropper to apply several drops of urine to the test’s collection zone.
The other product, the New Choice Plus One Step Pregnancy Test is a test stick. To use it, you insert the test’s absorbent tip into your urine stream for a few seconds. (Please read and follow the directions that come with your pregnancy test unit.
What is New Choice Pregnancy Test accuracy?
Both New Choice tests have an accuracy rating of over 99 percent from the first day of your missed period.
What do you mean by pregnancy test accuracy?
The U.S. FDA requires pregnancy test manufacturers and distributors to specify the accuracy of their products.
To determine accuracy, laboratories study a select group of women who may or may not be pregnant.
As time passes, it becomes obvious who is pregnant and who isn’t. Researchers compare this information to test results to determine how many women received accurate positive or negative result.
Similarly, scientists can determine the percentage of false positive and negative results supplied by their product.
FDA data
To find out about your pregnancy test, you can visit the FDA’s online OTC database. Use the following URL:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfIVD/search.cfm
The FDA published the following statistics in document K043443, the decision summary for the New Choice Pregnancy Test cassette.
- “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.
Using this data, you can see that the test has a 99% accuracy at and HCG concentration of 25 mIU/mL of urine.
Can I use the New Choice Pregnancy Test to test early?
No. The test does not produce reliable results unless you have 25 mIU/mL HCG in your urine. That level of HCG doesn’t normally occur until the day of your missed period.
The test should detect hCG levels one day after the woman’s missed menstrual cycle.
https://www.accessdata.fda.gov/cdrh_docs/reviews/K043443.pdf
What were the clinical results of the New Choice Pregnancy Test study?
According to documents filed with the FDA:
Urine samples from 100 patients who were clinically confirmed to be pregnant and 166 randomly chosen, non-pregnant female patients were tested with the strip form of the device. All 100 samples from pregnant women tested positive with the device, and all 166 non-pregnant women tested negative
https://www.accessdata.fda.gov/cdrh_docs/reviews/K043443.pdf
Now that you understand the accuracy rating of the New Choice Pregnancy Test, use our Amazon affiliate link to buy the product. You’ll get a fantastic price and check out directly with Amazon.
Learn more at CPG Health
Don’t leave before checking out our other published articles about the New Choice Pregnancy Test.
- What is New Choice Plus Pregnancy Test sensitivity?
- Where can I buy the New Choice Plus One Step Pregnancy Test?
- How much does the New Choice Plus One Step Pregnancy Test cost?
- Can I buy the New Choice Plus One Step Pregnancy Test from Amazon?
- Why is my New Choice Plus Pregnancy Test positive after time limit?
- New Choice Pregnancy Test Review
- What is New Choice Plus One Step Pregnancy test faint line?
