The Double Marker Test is a popular test during pregnancy for the screening of individual risk of chromosomal abnormalities in the fetus. The test is important as it gives an early indication of risks for down syndrome also known as Trisomy 21 and other common genetic abnormalities.
The double market test is done in the first trimester between 10 to 14 weeks of gestation age. It is a biochemical screening test which includes testing for Free B-hCG and PAPPA levels. These readings are combined with the NT and CRL values obtained through an ultrasound scan. All the values are entered in analysis software to generate the risk score.
While there are a number of platforms available for biochemical screening and risk assessments, the BRAHMS Kryptor platform from Thermo Scientific is considered the best in class. Here are five reasons why the double marker test report from BRAHMS Kryptor is considered the most reliable first-trimester screening test.
1. Noble Prize Winning Technology: The BRAHMS Kryptor platform is based on the Time‐Resolved Amplified Cryptate Emission (TRACE) technology. TRACE is based on the work of the French chemist Jean-Marie Lehn, a French scientist who was awarded the Nobel Prize in Chemistry in 1987 for this technique. This technology enables a very precise measurement of the analytes.
2. Fully Automated with Auto Dilution: BRAHMS Kryptor is a fully automated immunoanalyzer requiring minimum human intervention. This means that there is no scope for errors or manipulation in the processing of the analytes. Additionally, the system has the capability to initiate automatic dilution and rerun of samples in case the results are out of the linear range. In case of any issues related to controls and calibrations, the machine gives an alarm and stops the processing until the issue is resolved. These capabilities ensure that the system will give only the right results every time.
3. Lowest Coefficient of Variation (CV): The relative variability of any data set is measured through the Coefficient of Variation or the CV value. This is an indication of the reliability of the data. Every process has a certain variability wherein the results vary slightly every time the process is run. The lower the variability, the higher is the reliability of the data. As the image below depicts, higher CV can mean that specific data may be out of range and hence make completely miss the target of the study leading to wrong results/conclusion.
Amongst all the biochemical processing systems available, BRAHMS Kryptor boasts of the lowest CV values of 3-3.2% thereby providing excellent reproducibility and quality. This means that the Free B-hCG and PAPP-A values are measured through this system are most reliable.
4. Biotin Interference: Biotin (also known as vitamin B7), is a water-soluble vitamin often found in multi-vitamins and dietary supplements marketed for hair, skin, and nail growth.
There is growing evidence that if a patient is taking high levels of biotin in their dietary supplements, the biotin in their blood or other samples can cause clinically significant incorrect test results.
The TRACE™ (Time Resolved Amplified Cryptate Emission) technology used in B·R·A·H·M·S KRYPTOR assays is
independent of a biotin-streptavidin binding. Hence the B·R·A·H·M·S KRYPTOR prenatal screening assays are not affected by biotin interference
5. FMF Approved: The Fetal Medicine Foundation (FMF) is a UK headquartered organization which is promoting research and training in the area of fetal medicine across the world. FMF programs are aimed at improving maternal screening protocols through training and awareness campaigns. The FMF evaluates the data of various platforms and approves certain platforms which fulfill its evaluation criteria. BRAHMS Kryptor was the first platform to receive FMF approval and has been a platform of choice of fetal medicine specialists for almost two decades.
6. UK NEQAS Performance: United Kingdom National External Quality Assessment Service, popularly known as UK NEQAS is one of the oldest quality assessment services started in 1969. They provide a comparison opportunity for evaluation of laboratory quality data. BRAHMS Kryptor platform has outperformed the competition on various data sets.
7. Extensive Database: Being one of the oldest approved platforms, BRHAMS Kryptor boasts of one of the highest installations as well as evaluation databases. The risk analysis software of BRAHMS Karyptor is based on the data of more than 220,000 pregnancies. Plus it takes into account demographic data, pregnancy-specific data, obesity data, smoking status and several other parameters to fine tune the risk scores.
This gives the gynecologists and the expecting couple a greater assurance about the risks for downs syndrome and other chromosomal abnormalities.
So here are the seven important reasons why BRAHMS Kryptor is considered the gold standard for first trimester biochemical screening.