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 San Jose, 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:
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;
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.
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.
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.
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.
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.