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
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.
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 usingRT-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.
More Information About the Consumer Genetics
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