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P342 Correlation of the first lateral flow-based Point of Care test to quantify infliximab and anti-infliximab antibodies in a finger prick sample with the reference ELISA technique

Ruiz-Argüello, M.B.(1);Pascual, J.(1);Del Río, L.(1);Urigoitia, A.(1);Balo Farto, C.(2);Fernández, C.(3);Mera, A.(2);De Toro, J.(3);Nagore, D.(1);Ametzazurra, A.(1);

(1)Progenika Biopharma - Grifols, Department of R&D, Derio, Spain;(2)Hospital Clínico Universitario de Santiago, Servicio Reumatología, Santiago de Compostela, Spain;(3)Complexo Hospitalario Universitario A Coruña, Servicio Reumatología, A Coruña, Spain

Background

The goal of this study was to validate the use of capillary blood in a real point-of-care (POC) setting for patients under infliximab treatment by using Promonitor Quick lateral flow (LF) tests. Results were compared to the Promonitor ELISA reference technique in serum samples used by centralised laboratories.

Methods

A prospective, observational study was designed to evaluate the performance of a rapid LF test (Promonitor Quick IFX, Progenika, Spain). 160 infliximab treated rheumatology consecutive patients (400 samples) were recruited in two hospitals in Galicia, Spain. Prior to the infusion, a finger prick sample was obtained and analysed. Anti-infliximab antibodies were also determined with Promonitor Quick ANTI-IFX1-4. Results were read with the automated portable PQreader instrument. Additionally, a serum sample was collected for subsequent comparative analysis with either LF or ELISA tests.

Qualitative (positive (PPA) and negative (NPA) agreements) and quantitative (Pearson correlation and bias) performance of the LF test was compared to ELISA, as well as between different specimens following CLSI EP09-A3.

Results

Overall agreement between Promonitor Quick IFX finger prick and ELISA test was 91% (88% PPA; 100% NPA). The quantitative comparison showed a good correlation (Pearson correlation coefficient: 0.85 and observed bias: 25%) (Table 1).

Similar results were also observed when serum was used with either the LF or the ELISA tests (98% overall agreement, 0.91 correlation coefficient; 6% bias) (Table 1).

Overall agreements for visual and automated (PQreader) interpretations with Promonitor Quick ANTI-IFX were 99% and 100% for finger prick and serum specimens, respectively (Table 2).

Conclusion

Promonitor Quick can be used to reliably quantify infliximab in capillary blood samples and results are comparable to those obtained with the reference ELISA technique. The use of the rapid POC test with finger prick will allow clinicians to monitor their patients in a fully decentralized mode to aid in the decision making process. PQreader is a sensitive portable equipment to report drug as well as antibody levels in the patient samples.


References
(1) Atreya, R. et al.  J Crohns Colitis. 2019;13:S391
(2) Ametzazurra, A. et al.  J Crohns Colitis. 2017;11:S335-S336
(3) Fiorino, G. et al.  J Crohns Colitis. 2017;11:S388
(4) Facchin, A. et al. J Crohns Colitis. 2019;13:S349- S350

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