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During a clinical trial the ISR pass rate (n=70) for Sufentanil bioanalysis was higher than 95 %, for Ketamine/Norketamine higher than 98 %.
pharm-analyt has completed the validations according to the EMA guideline for 2 assays just before Christmas 2021. Sufentanil with a calibration range of 0.250 to 250 pg/mL and Ketamine and its metabolite Norketamine with a calibration range of 0.100 to 100 ng/mL can be determined in human plasma. For sufentanil only 100 µL plasma and for Ketamine/Norketamine only 50 µL plasma need to be used due to the sensitivity of the LC-MS/MS assays. The assays are non-exclusive with the sponsor and can be used for other purposes as well by pharm-analyt, due to the low sample volumes especially trials with children are possible. If you need the determination of controlled substances, pharm-analyt could be of your service.
The described biomarker (BM1) is a nucleic acid derivative, more precisely an adenosine derivative. In plasma of septic patients this substance is clearly enhanced compared to healthy subjects. Another important aspect is that BM1 has very stable concentrations in healthy species/animals compared with healthy humans.
It seems like a general principle that also septic animals have similar enhanced concentrations like humans. In comparison to the gold standard PCT (Procalcitonin) for sepsis in humans the sensitivity of BM1 is comparable and the specificity is clearly better compared with the gold standard PCT.
Up to now more than 2500 plasma samples of humans or animals were analysed for BM1. But BM1 is also enhanced in urine of septic persons and also in synovia to differentiate between septic and non-septic. Especially for diagnosing trauma or after large surgeries BM1 has low levels if no sepsis is involved. This is different from PCT. Therefore, PCT is most likely not used in this area to differentiate between septic and non-septic patients.
Further investigations are planned for newborn sepsis (first limited impressions are very positive). Also in the veterinary area a first investigation showed very similar levels for healthy animals compared with humans (e.g. rat, dog, rabbit, baboon, goat, cattle, pig, lama) but clearly enhanced concentrations in septic animals. Also trauma in pigs could be differentiated, no enhancement was shown.
Through a careful screening for similar substances in septic samples we found two structurally similar substances to BM1. Both show concentrations which are in the range of 5 – 20 % of BM1 in human plasma. Both have a good discrimination power for septic and non-septic. One substance is the same as BM1, only plus CH2, and the other is the same as BM1 plus CH2 plus 32 amu.
The picture is the front page of this patent publication.