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By Dajana Domik
Neopterin is a valuable diagnostic biomarker which can be applied in research and in clinical settings. As an inflammation marker, it is a global “catch all” biomarker that serves as an early warning system for many different diseases without the need to perform a battery of tests. But how do you decide which neopterin test is right for your lab? The answer depends on exactly what you need from your diagnostic assay.
Is the neopterin assay right for you?
Why neopterin?
As discussed in previous articles, neopterin is an excellent universal biomarker for the activation of the cellular immune response associated with many different diseases. The Tecan Neopterin ELISA1 can be applied to detect any infection, which is advantageous when a specific test is unavailable or not sensitive enough. However, even when specific tests are available, it is possible that they will not detect the disease until a relatively late stage. Neopterin levels can be detected very early, before the onset of symptoms. Specific tests, on the other hand, are normally applied only in the acute stages of disease, when there is less time for effective action.
It has also recently been demonstrated that neopterin can aid in monitoring progression of COVID-19.2 Neopterin levels correlate with severity of the disease and are elevated before the onset of any overt clinical symptoms or antibody response.
Methods for detecting neopterin
There are three main methods for detecting neopterin: ELISA, HPLC and radioimmunoassay (RIA).
- Perhaps the most reliable option is neopterin ELISA. This is a sensitive and robust immunoassay technology that provides accurate quantification of neopterin, even in complex samples like serum, plasma and urine.
- HPLC is also very sensitive and robust, although it can be difficult to detect neopterin in serum due to the presence of many other proteins. Concentrations are a lot lower in serum which also adds to the complexity.
- RIA is another suitable method for detecting neopterin although the use of radioisotopes in research and diagnostics is being limited where possible.
Automated ELISA kits support scale-up
ELISAs are relatively easy to scale up simply by deploying more people to carry out the assays. However, at some point, as was the case during the COVID-19 pandemic, scaling the workforce becomes unmanageable and automation becomes essential.
During the pandemic, automation became a necessity for many labs—not only to manage the sheer volume of tests that needed to be done, but also to align working practices with more stringent safety requirements at this time. Some labs postponed the decision to automate, thinking that it would involve a large overhaul of infrastructure and incur higher running costs. In reality, this doesn’t have to be the case because there are automation and scale-up options to fit almost every situation and budget.
In fact, the key to cost-efficient scale-up is to consider automation options as early as possible – well before they are needed — so that you have time to identify the best solution for your needs and plan accordingly.
Clinical validation
It’s important to know that the methods we apply in the lab and diagnostic settings have been properly validated. Even for research purposes, if you’re looking to have an impact on clinical practice, it is best practice to benchmark research experiments against methods that are really being used in the clinical lab. For example, a major Austrian blood bank has been using Tecan Neopterin ELISA for many years for routine screening of all blood transfusions prior to banking.
It’s not just a matter of knowing that a particular method works, however; diagnostic tests must be cleared and approved by the relevant regulating bodies. Today’s regulatory requirements for diagnostic tests are more stringent than ever before, due to the introduction of the new European In Vitro Diagnostic Regulation (IVDR). Tecan is among the leaders in the industry when it comes to the IVDR transition, working to ensure that its Neopterin ELISA will be fully IVDR-compliant. This means that the switch should be a smooth transition as the regulation is in place since May 26th 2022.
Neopterin makes disease monitoring safer
Ultimately, applying neopterin as a biomarker increases patient safety. Neopterin is a broad-range inflammation marker that can be measured in the blood of patients, and indicates a multitude of diseases – from acute viral infections to autoimmune conditions. The main drawback of neopterin being non-specific is also its biggest strength, when the information is used in the right context. Evidence of elevated neopterin provides an early indication of severe infection, and therefore serves as a first alarm that a patient will need close observation.
That said, if more information about the patient is available, neopterin can provide very detailed insights into disease progression. A perfect example is the application of neopterin testing in COVID-19 cases. Monitoring neopterin levels in infected patients can give medical professionals a good idea of how the disease is progressing and how severe it might become. This in turn can lead to more effective triage and better patient care.2
The Tecan Neopterin ELISA (ref: RE59321) can be applied to different matrices like serum, plasma or urine and gives results within 2 hours. The ELISA is correlated to HPLC (urine: R=0.99, serum: r=0.92) and validated for serum, plasma (EDTA) and urine. The assay can be performed manually or on any open-format ELISA processor. * To learn more about the Tecan Neopterin ELISA, download our brochure here.
*Disclaimer: “For the use of products on automated instruments it is absolutely necessary to perform and maintain a validation according to legal requirements. A successful validation of the process is a prerequisite for diagnostic use. The responsibility for the implementation and documentation of validation in accordance with the country-specific requirements is assumed by the organization or institution.”
References:
1. Hamerlinck F. F. (1999). Neopterin: a review. Experimental dermatology, 8(3), 167–176. https://doi.org/10.1111/j.1600-0625.1999.tb00367.x
2. Chauvin, M., Larsen, M., Quirant, B., Quentric, P., Dorgham, K., Royer, L., Vallet, H., Guihot, A., Combadière, B., Combadière, C., Barallat, J., Mayaux, J., Luyt, C. E., Mathian, A., Amoura, Z., Boddaert, J., Armestar, F., Gorochov, G., Martinez-Caceres, E., & Sauce, D. (2021). Elevated Neopterin Levels Predict Fatal Outcome in SARS-CoV-2-Infected Patients. Frontiers in cellular and infection microbiology, 11, 709893. https://doi.org/10.3389/fcimb.2021.709893
About the author
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Dajana Domik
Dr. Dajana Domik joined Tecan in 2020 as a product manager responsible for the saliva portfolio as well as diverse other products, e.g. Immunology. Dajana has a scientific background and spent time in the USA as a postdoc and is now supporting the Global Reagent Marketing & Support Department with immunoassay solutions at Tecan.