Based on our advanced toxicity assessment platforms and powerful technology, Creative Biolabs provides a complete range portfolio of assays for toxicity assessment including quantification of total bilirubin. As an end-to-end company offering high-quality analytical development and qualification services, we have the best advantages in assisting our worldwide customers.

Introduction of Total Bilirubin

Bilirubin is a daily generated endogenous compound as the ultimate breakdown product of hemoglobin. The main metabolic and transport pathways of bilirubin, along with pharmaceuticals are shown in Fig.1. Within the normal physiologic range bilirubin as a powerful antioxidant has positive effects to protect against cardiovascular diseases and cancers. But extremely elevated levels of bilirubin will result in severe health conditions, such as hyperbilirubinemia, jaundice, neurotoxicity, and hepatotoxicity, which may be life-threatening.

Because bilirubin is related to several drug metabolism processes, total bilirubin is a widely known diagnostic and prognostic biomarker for drug-induced injuries, like hepatocellular or cholestatic damage. The total bilirubin test, combined with alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase, is routinely required to interpret liver safety by the FDA guidance of clinical trials.

Fig.1 The fate of bilirubin interfering with selected drugs in liver cells. (Tátrai & Krajcsi, 2020)

Total Bilirubin Services at Creative Biolabs

Measurement of total bilirubin levels in the initial stages or before treatment is a fundamental requirement to identify the potential risks of the progression to chronic liver disease. By comparing the concentration changes of total bilirubin between the experimental group and control group, we could timely monitor possible toxic effects caused by the metabolism of candidate drugs or vaccines. At the same time, total bilirubin monitoring is necessary for dose optimization to manage bilirubin abnormalities and prevent the occurrence of toxicities.

Considering its importance in the evaluation of the toxic effects, total bilirubin measurement has been researched well by scientists of Creative Biolabs. The physiological fluid samples to determine total bilirubin mainly include serum and urine, which could be collected by invasive or noninvasive methods. Total bilirubin mainly includes the unconjugated and conjugated fraction forms of bilirubin. Measurement of total bilirubin could be achieved by various methods, such as the diazo method, direct spectroscopy, chemiluminescence spectroscopy, enzymatic method (some combined with the diazo method), high-performance liquid chromatography (HPLC), electrophoresis method, electrochemical method, and transcutaneous method.

Among these methods, the diazo method and spectroscopy methods are widely used to quantify total bilirubin. The advantages of the diazo method are that it is not affected by pH changes and maintains optical sensitivity even at a low bilirubin concentration. Spectroscopic assays quantify bilirubin directly, precisely, fast, and require samples in a small volume. Creative Biolabs provides total bilirubin measurements suitable for our customers.

With decades of in-depth study of the toxicity assessment area, Creative Biolabs is one most potent professional technical developers. We will bridge the gap between your sample materials and a well-rounded assessment result of your specific treatment strategies. With dedicated laboratory equipment and specially trained technicians, the detection procedures could be performed on semi-automatic or fully automated analyzers, making it a routine service at Creative Biolabs.

Normally, Total Bilirubin is always quantified along with other enzymes and compounds described detailedly in our Toxicity Assessment Service, like total protein, alanine aminotransferases (ALT), alkaline phosphatase (ALP) and aspartate aminotransferase (AST). No matter which panel of biomarkers you need to test, our experienced experts at Creative Biolabs will do their best to complete your project. If you are interested in this, please feel free to contact us directly.

References

1. Tátrai, P.; Krajcsi, P. Prediction of drug-induced hyperbilirubinemia by in vitro testing. Pharmaceutics. 2020, 12(8): 755.
2. Ngashangva, L.; et al. Development of new methods for determination of bilirubin. Journal of pharmaceutical and biomedical analysis. 2019, 162: 272-285.

For Research Use Only | Not For Clinical Use