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.
| First trimester | Second/third trimester |
| B·R·A·H·M·S PAPP-A KRYPTOR | B·R·A·H·M·S PlGF plus KRYPTOR |
| B·R·A·H·M·S PlGF plus KRYPTOR | B·R·A·H·M·S sFlt-1 KRYPTOR |
All the intended uses covered by our assays have been clinically validated ensuring the highest clinical performance and are fully compliant with the IVDR.
| T1 | T2 (from week 20) | T3 | Cut-off | |
| Screening | PIGF PAPP-A |
PIGF sFlt-1 |
PIGF sFlt-1 |
It is the responsibility of the user to choose the cut-off which will apply for further procedures |
| Aid for diagnosis | sFlt-1/PIGF | sFlt-1/PIGF | 85 | |
| Short-term prediction | sFlt-1/PIGF | sFlt-1/PIGF | 66 |
Optimize your laboratory routine with prenatal screening on KRYPTOR for pre-eclampsia management
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
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
Demonstrated quality: Long-term precision data
As a trusted laboratory manager, you understand the importance of accurate and reliable results in prenatal screening. Our KRYPTOR instruments are known for their exceptional performance, delivering reliable results with minimal interference.
For more than 20 years, UK NEQAS data have shown that PAPP-A measured on KRYPTOR instruments consistently provides the lowest mean coefficient of variation (CV) and therefore the highest precision compared to competitors.2
UK NEQAS Quality Data comparing CV data for PAPP-A KRYPTOR vs competitor.2
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 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.3
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 immunoassay, results may need to be checked by another method, such as KRYPTOR, to exclude assay interference3. Choose PAPP-A on KRYPTOR for the best quality.
Easy interpretation with the universal cut-off for sFlt-1/PlGF ratio
With the sFlt-1/PlGF ratio on KRYPTOR, you can offer an improved pre-eclampisa diagnosis, prognosis and short-term prediction to your clinicians.
With the universal cut-off of 66, clinical use of the sFlt-1/PlGF on KRYPTOR for short-term prediction and diagnosis of pre-eclampsia is easy and safe. The sFlt-1/PlGF ratio at cut-off 66 on KRYPTOR has a clinical sensitivity of 82% and a clinical specificity of 91%, as described below.4
.jpg "Image illustrating cut-off 66 for the sFl1-1/PlGF ratio. Evidence shows optimal predictive performance with a KRYPTOR-specific cut-off at 66 for the sFlt-1/PlGF ratio. With a ratio of less than 66, there is a low risk of developing pre-clampsia and at a ratio greater than or equal to 66, there is a high risk of developing pre-eclampsia.")
The first FDA cleared assays to stratify pregnant women with pre-eclampsia with severe features
Thermo Scientific B·R·A·H·M·S sFlt-1/PlGF KRYPTOR Test System is the first FDA approved test to be used on the Thermo Scientific B·R·A·H·M·S KRYPTOR compact PLUS Analyzer.
Benefit from this fully-automated, random-access, benchtop immunoassay analyzer delivering highly accurate and precise results. Get your sFlt-1/PlGF ratio result in 30 minutes and leverage the optimized workflow offered by the instrument.
The FDA approved clinical indication:
*As defined by the American College of Obstetricians and Gynecologists (ACOG) guidelines.
**Preeclampsia, chronic hypertension with or without superimposed preeclampsia, or gestational hypertension.
The evidence from PRAECIS study:
The PRAECIS (Pre-eclampsia Risk Assessment: Evaluation of cut-offs to Improve Stratification) study is the largest prospective US study to date and included 30% Black and 16% Hispanic women. The PRAECIS study clearly demonstrated that in women hospitalized with a hypertensive disorder of pregnancy presenting between 23 and 35 weeks of gestation, measurement of serum sFlt-1/PlGF provided stratification of the risk of progressing to severe PE within the coming fortnight as well as a strong association with adverse outcomes.5
Key results
At a cut-off of 40, the clinical performance of the sFlt-1/PlGF ratio is:
- 65% PPV (95% CI, 59 to 71)
- 96% NPV (95% CI, 93 to 98)
- 94% Sensitivity (95% CI, 89 to 96)
- 75% Specificity (95% CI, 70 to 79)
The measurement of sFlt-1/PIGF can be used to determine if patients require stepped up care or to follow expectant management per ACOG guidelines.6
Interpreting results:
| sFlt-1/PlGF < 40 (low risk)* | sFlt-1/PlGF ≥ 40 (high risk)* |
| If the result of the ratio is lower than 40, the pregnant woman is at low risk for progression to pre-eclampsia with severe features within 2 weeks. | If the result of the ratio is higher or equal to 40, the pregnant woman is at high risk for progression to pre-eclampsia with severe features within 2 weeks. |
Quantitative results for PlGF, sFlt-1, and sFlt-1/PlGF ratio are individually reported by the instrument. These results for PlGF and sFlt-1 should only be used by laboratories to assess assay performance as part of a quality control program and are not intended for interpretation of results. It is recommended to only provide the sFlt-1/PlGF ratio on the laboratory report for healthcare practitioners.
*Interpretations may differ in regions outside of the US.
Learn from our customers: B∙R∙A∙H∙M∙S KRYPTOR GOLD for pre-eclampsia screening
Additional resources
References
- Wright D et al. Ultrasound Obstet Gynecol 2010; 36: 404-411
- Monthly UK NEQAS reports, February 2003 - April 2017
- Jones et al. Ultrasound Obstet Gynecol 2023; 61(6) :776-777
- Andersen LLT et al. J Am Heart Assoc. 2021;10(17):e021376
- Thadhani et al. (2022). NEJM 2022 :1(12)
- ACOG practice bulletin 222 (2020).
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