Discover the power of prenatal screening on KRYPTOR for your laboratory
Our Thermo Scientific B·R·A·H·M·S Biomarkers offer a wide range of options to cover screening strategies throughout pregnancy. With our solution, you have the flexibility to choose the most suitable biomarkers for your specific screening needs. By utilizing just one instrument, you can streamline your workflow and optimize efficiency in your laboratory.
Explore our full portfolio of assays and large range of intended uses for first and second trimester trisomy and neural tube defect screening.
Aneuploidy and neural tube defect screening products do not have FDA clearance for sale in the US.
All the intended uses covered by our assays have been clinically validated ensuring the highest clinical performance and are fully compliant with the IVDR.
First trimester trisomy screening:
| Intended use | ||||
| Risk assessment for | Trisomy 21 | Trisomy 18 | Trisomy 13 | Pre-eclampsia |
| PAPP-A |  |
|
|
|
| Free βhCG | |
|
|
|
| PIGF | |
|
||
| AFP | |
|||
Second trimester trisomy and neural tube defect screening:
| Intended use | ||||
| Risk assessment | Diagnosis | |||
| Trisomy 21 | Trisomy 18 | NTD* in serum and plasma (heparin) | NTD* in amniotic fluid | |
| AFP |  |
|
|
|
| hCG+β | |
|
||
| Free βhCG | |
|
||
| uE3 | |
|||
| Inhibin A | |
|||
* Neural Tube Defect
Aneuploidy and neural tube defect screening products do not have FDA clearance for sale in the US.
Optimize your laboratory routine with prenatal screening on KRYPTOR
With Nobel Prize winning TRACE technology, Thermo Scientific B·R·A·H·M·S KRYPTOR Analyzers and biotin-free assays provide results with low interference and high precision. These user-friendly bench-top instruments are easily integrated into any laboratory. Enhance prenatal screening in your lab with:
- A full portfolio on Thermo Scientific B·R·A·H·M·S KRYPTOR GOLD Analyzer to consolidate your prenatal screening on one instrument only
- An easy and straightforward laboratory routine requiring less operator intervention
- With the self-determining dilution factor, eliminate cumbersome re-run of out-of-range samples and improve turnaround time for your patients allowing the use of KRYPTOR in your OSCAR* clinic
- Cost reduction due to efficient sample processing
- Low level of liquid and plastic waste for an environment friendly solution
* One Stop Clinical Assessement of Risk
B·R·A·H·M·S KRYPTOR GOLD is not available for sale in the US.
Ensure a reliable risk calculation with Fast Screen pre I plus software
CE marked Thermo Scientific B·R·A·H·M·S Fast Screen pre I plus Software provides reliable and effective risk calculation, with high quality algorithms based on FMF data and a database with over 220,000 pregnancies.1,2
References
1. Wright D et al. Ultrasound Obstet Gynecol 2010 ;36(4) :404-411
2. Pandya P et al. Fetal Diagn Ther 2012; 31(2):87-93
Trust the precision of our solution to support your clinical practice
As a trusted laboratory manager, you understand the importance of accurate and reliable results in prenatal screening. Our B·R·A·H·M·S KRYPTOR Instruments are known for their exceptional performance, delivering reliable results with minimal interference.
For more than 20 years, UK NEQAS data are showing that PAPP-A and Free βhCG measured on B·R·A·H·M·S KRYPTOR Instruments provide consistently the lowest mean coefficient of variation (CV) and therefore the highest precision compared to competitors.1
UK NEQAS Quality Data comparing CV data for PAPP-A KRYPTOR vs competitor.1
UK NEQAS Quality Data comparing CV data for Free βhCG KRYPTOR vs competitor1
Your benefits with the exceptional precision of the Prenatal Screening solution on KRYPTOR:
- Save time and cost with a short and seamless validation of new lot
- Stable medians limiting the need for update in your risk assessment software
- Full traceability for your audits with stable and accurate results
- Reliable results for improved clinical decisions
With our solution, you can minimize the risk of false positives or negatives, providing peace of mind for both you and your patients.2
In a recent publication (Jones et al, 2023), false positive results resulting from interferences were reported with PAPP-A assays from different manufacturers. Unusually low PAPP-A values (<0.15 MoM) were detected with competitor assays and samples were referred to a KRYPTOR laboratory for confirmatory analysis. In all samples, PAPP-A MoMs were higher than 0.15 MoM with B·R·A·H·M·S KRYPTOR PAPP-A assay, confirming the assay interference. Authors recommend that if unusually low PAPP-A MoM values (<0.15 MoM) are obtained from competitor PAPP-A immunoassays, results may need to be checked by another method, such as KRYPTOR, to exclude assay interference2. Choose PAPP-A on KRYPTOR for the best quality.
Learn from our customers: B∙R∙A∙H∙M∙S KRYPTOR GOLD for prenatal screening
Additional resources
References
1. Monthly UK NEQAS reports, February 2003 - December 2023
2. Jones et al. Ultrasound Obstet Gynecol 2023; 61(6) :776-777
Thermo Fisher Scientific products are distributed globally and their uses, applications, indications, claims and availability of products in each country depend on local regulatory marketing authorization status, please consult the Instructions For Use (IFU) available in your country.
© 2024 Thermo Fisher Scientific Inc. All rights reserved. All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified. B·R·A·H·M·S is a registered trademark of B·R·A·H·M·S GmbH.
KRYPTOR and TRACE are trademarks of Cisbio Bioassays, licensed for use by B·R·A·H·M·S GmbH, a part of Thermo Fisher Scientific. Nobel Prize is a registered trademark of the Nobel Foundation.