 The
Consumer Genetics laboratory uses state-of-the-art equipment
and proven techniques. The methods employed by the laboratory
undergo rigorous quality assessments, and modifications to
these methods are implemented only after extensive quality
assurance and research. All reagents used, whether they are
purchased from a commercial supplier or manufactured in-house,
undergo regular quality control inspection. Consumers can
be rest assured that the laboratory is performing at a high
standard of quality.
The DNA laboratory is capable of high-throughput
processing and currently perform 1000s of tests per month
with the capacity of tripling production without interruption.
The DNA laboratory performs all CaffeineGEN™,
AsthmaGEN™, WineGEN™, and Pink or Blue® DNA
testing applications.
Furthermore, Consumer Genetics recognizes the
importance of maintaining strict privacy with respect to its
customers personal and financial information, as well as the
genetic results. Results of DNA testing are never deposited
into any public genetic database, or shared with anyone outside
the company.
Pink or Blue Laboratory Testing:
The home office,
located in Sunnyvale, California, laboratory processes all
of the Pink or Blue® DNA tests. Because the process is
extremely delicate, time and labor intensive, and requires
skill and experience, other laboratories are never contracted
to process samples.
Several standards and quality control procedures are in place
to guarantee that our results exceed your expectations:
- Only female scientists work in the laboratory to reduce
the possibility of contamination
- Every new reagent is thoroughly tested
- We keep track of our boy:girl ratio to ensure it is within
an acceptable range from published birth rates
- Any case of an incorrect result is thoroughly investigated
to understand the error and make necessary improvements
to the Pink or Blue® test
- Results are only released if they pass strict standards.
In fact, not every customer gets a result on the first test.
In the Laboratory
Each sample goes through a 3 step process of;
- DNA Extraction
- DNA Purification
- Amplification with Pink or Blue® unique biomarkers
DNA Extraction and Purification
After the dried blood sample arrives in the laboratory, the
blood-soaked filter paper is cut into small pieces. The DNA
is extracted from the filter paper and then washed to remove
impurities such as protein and cellular debris.
 Depending
on how much blood fills the circles on the filter paper we
can process samples 2-6 times. Each sample is purified a minimum
of two times to validate results. If there is not enough blood
for at least two purifications then a retest is required.
Controls:
With each set of samples purified, a blood sample from a
female who is not pregnant is processed as a negative control.
If male DNA is detected in the female processing control then
male DNA may have been introduced into the processing procedure
and all data from this set of samples is discarded.
Amplification:
The purified DNA is put in an amplification reaction (PCR).
In this reaction, DNA is multiplied 240 times. PCR requires
knowledge of the DNA sequence of interest. Based on published
knowledge of Y chromosomal DNA, we can target amplification
of a specific portion of the Y chromosomal DNA. If no Y chromosomal
DNA is present in a sample, no amplification occurs.
Each result is validated by redundant tests:
- For each portion of a sample processed, we detect three
different areas of Y chromosomal DNA in order to assure
accuracy.
- In addition, amplification of each of the 3 areas is run
in triplicate before the results are analyzed.
Controls:
For each amplification reaction:
- We detect total purified DNA to insure that enough DNA
is purified.
- We test whether the reaction is efficient or not (inhibition).
- We have a positive and a negative control to make sure
the amplification reagents are working correctly.
The Pink or Blue® test is Highly Sensitive:
Our amplification reagents are very sensitive and specific.
The blue curve is a dilution of male genomic DNA. As the diagram
indicates, very low levels of male DNA are detectable with
the Pink or Blue test - even less than 1 genome equivalent
(that’s about one cell!). The pink curve is a dilution
of female genomic DNA. Even very concentrated amounts of female
DNA result in low levels of background.
Analysis:
Samples are analyzed only if all quality control measures
pass inspection. The ability to detect Y-chromosomal DNA amplification
may sound simple but in reality, there is an inconclusive
range where we are not able to determine a result. Reasons
for inconclusive results are:
- Samples with no Y-chromosomal DNA still have background
levels of amplification.
- Some women may have very low levels of fetal DNA due to
rapid clearance of the cell-free DNA from their blood.
If these background levels of amplification are higher than
expected or if levels of male DNA are low then the sample
is inconclusive.
We will not release results of samples with an inconclusive
result unless the sample is purified at least two additional
times with a clear result.
More Information About the Consumer Genetics
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