An ultra-sensitive homologous chemiluminescence immunoassay to tackle penicillin allergy

[EN] Penicillin is one of the most widely used antibiotics to treat bacterial infections in clinical practice. The antibiotic undergoes degradation under physiological conditions to produce reactive compounds that in vivo bind self- proteins. These conjugates might elicit an immune response and trigger allergic reactions challenging to di- agnose due to the complex immunogenicity. Penicillin allergy delabeling initiatives are now part of antibiotic stewardship programs and include the use of invasive and risky in vivo tests. Instead, the in vitro quantification of specific IgE is highly useful to confirm immediate allergy to penicillins. However, discrepant results associated with the low sensitivity and accuracy of penicillin allergy in vitro tests have limited their routine diagnostic use for delabeling purposes. We aimed to develop a homologous chemiluminescence-based immunochemical method for the reliable determination of specific IgE to penicillin G, using unprecedented synthetic human-like Analytica Chimica Acta 1214 (2022) 339940 2standards. The synthetic standard targets the major antigenic determinant of penicillin G and the paratope of Omalizumab, acting as human-like specific IgE. It is a potent calibrator, highly stable, easy, and inexpensive to produce, overcoming the limitations of the pooled human serum preparations. The developed method achieved a good agreement and strong positive relationship, reaching a detection limit below 0.1 IU mLP.Q-C acknowledges financial support from Generalitat Valenciana through the research staff-training program (GVA ACIF/2018/173). P.C. awards grants Ramon y Cajal and PID2019-110630 GB-I00 funded by MCIN/AEI/10.13039/501100011033 and by ERDF A way of making Europe¿. S.M awards grants PID2019-110713RB-I00 funded by MCIN/ AEI/10.13039/501100011033 and by ERDF A way of making Europe. PROMETEO/2020/094 funded by Generalitat Valenciana, and program UPV-La FE 2019 (P105 VALBIOAL), FMV-ANII 148245, FMV-ANIII 156321 funded by Agencia Nacional de Investigacion and CSIC 2007- 348 UdelaR, Uruguay, are also acknowledged.Quintero-Campos, P.; Segovia-De Los Santos, P.; Ibáñez-Echevarría, E.; Hernández-Fernández De Rojas, D.; Casino, P.; Lassabe, G.; Gonzalez-Sapienza, G.... (2022). An ultra-sensitive homologous chemiluminescence immunoassay to tackle penicillin allergy. Analytica Chimica Acta. 1214:1-8. https://doi.org/10.1016/j.aca.2022.33994018121