Consumer Genetics: Retail DNA TestingConsumer Genetics: Retail DNA Testing

Monday, January 18, 2021    

  Consumer Genetics: Examining Pink or Blue: Is it a Boy or a Girl?
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About Consumer Genetics Pink or Blue® product uses the latest innovations around early gender testing. The DNA test is based on analysis of fetal DNA found in the mother's blood.


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The Science is Proven...

  • PCR detection of cell-free circulating fetal DNA in maternal plasma and serum (Lo et al. Lancet 1997; 350:485-7)
  • Earliest detection of fetal DNA: 5 weeks of gestation (Prenatal Diagnosis, 2003; 23: 1042)
  • Source of fetal DNA? Passive diffusion across placental barrier (van Wijk et al. Clinical Chemistry, 2000; 46:729-731)

In a natural process, fetal cells die and pass into the mother’s bloodstream. As these cells break down, fetal DNA is released into the mother’s own circulatory system. Pink or Blue® can detect the baby’s DNA as early as 7 weeks into a pregnancy which is approximately How the DNA gender testing works. 10 weeks from your last menstrual period. Pink or Blue® have developed a process to determine the baby’s sex based on analysis of the fetal DNA in the mother's bloodstream.

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The human Y-chromosome is only found in males. Pink or Blue® looks for Y-chromosomal DNA in the mother’s blood using a technique called Real-Time Polymerase Chain Reaction (RT-PCR) that can amplify small amounts of DNA to easily detectable levels. Pink or Blue®'s patented technology is more sensitive than previous techniques and thus we can provide an accurate answer from three drops of your blood (average amount/drops to fill one circle) on our DNA collection card. Although, we can run a sample from one circle, we request that the expectant mother fill all three circles. The DNA sample is tested twice in parallel for quality assurance purposes. Y-DNA will only be present in the sample if the baby is a boy, since the mother does not carry the Y-chromosomal DNA herself. If no Y-DNA is detected by Pink or Blue®, the mother is expecting a baby girl.

The DNA samples are analyzed in our lab using RT-PCR. The classic study validating the PCR method for detecting fetal sex was published in the Journal of Human Genetics in 2005. Scientists in Italy (Galbiati et al) obtained blood from pregnant women at different stages of pregnancy and isolated fetal DNA as early as 5 weeks of pregnancy. The isolated fetal DNA is amplified and analyzed using PCR. They studied 1,837 pregnant women. This included women with previous pregnancies, miscarriages and live births. The test results were confirmed after the baby's birth and their study had a 99% accuracy rate. Please note that the 99% accuracy rate does not reflect Pink or Blue®'s accuracy rate. Pink or Blue® is 95% accurate based on an internal survey.

Pink or Blue® is highly accurate in determining the presence of male DNA in the mother’s blood. However, there are a few instances, such as a recent blood transfusion or a bone marrow transplant. These situations, amongst others, can cause Y-specific chromosomal DNA detection causing false results.

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Consumer Genetics, Inc. - The Pink or Blue® Company
1055 E. Brokaw Rd. #30, PMB #400, San Jose, CA 95131, USA
Phone: 1-(408)789-6864

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