FDA and ACOG pregnancy testing standards
Over-the-counter home pregnancy tests cleared by the U.S. Food and Drug Administration (FDA) typically advertise 99% accuracy when used on or after the first day of an expected missed period.
ACOG warns that testing 4 or 5 days before a missed period carries a false negative rate of roughly 10% to 25% because implantation may have occurred later in the 6–12 DPO window.
For definitive quantitative confirmation, an OB-GYN can order a quantitative serum beta-hCG blood test, which can detect levels as low as 1 to 2 mIU/mL.
Worked example: FDA OTC testing
An expected period date of October 28th corresponds to approximately 14 DPO.
An FDA-cleared early test used on October 24th detects 10 mIU/mL hCG. A negative result warrants re-testing on October 28th.
US test inputs
Test Type
Choose early detection or standard OTC test.
CALCULATOR QUESTIONS
FDA & ACOG pregnancy test accuracy calculator questions
What is a faint line on a pregnancy test?
Any visible test line, no matter how faint, indicates the presence of hCG and is considered a positive test result, provided it appeared within the test’s specified read time.
What is an evaporation line?
An evaporation line is a faint, colorless streak that appears after urine dries on the test stick past the recommended reading window (usually 10 minutes). It is not a positive result.