The Mira Pregnancy Test is an over-the-counter urine hCG test intended for early detection of pregnancy. The test is indicated for use four days before the expected period. Throughout this study, volunteers with non-medical backgrounds were recruited to test hCG with urine samples using the Mira Pregnancy Test during the not pregnancy cycle or pregnancy cycle. To perform the study, a total number of more than 200 volunteers will be recruited to participate in the study.
The studies include two parts, which are a lay user study and a urine samples test during the trying to conceive cycle. Part 1: Lay user study Part 2: Detection of hCG in Early Pregnancy Clinical Samples
Study Type
OBSERVATIONAL
Enrollment
200
Women perform the hCG test and share the test results
Quanovate Tech Inc.
San Ramon, California, United States
RECRUITINGCognitive evaluation via survey and calculating the consistency
The consistency between the lay-user test results and the actual test results
Time frame: From July 2022 to August 2022
The accuracy of data was expressed as per the Pregnancy Detection Rate
The number of positive results on different days obtained by the user of the Mira pregnancy test is divided by the total number of women who confirmed pregnancy.
Time frame: From July 2022 to August 2022
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