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Accuracy of the new rapid test for monitoring adalimumab levels.

ABSTRACT: Background:The loss of response to adalimumab (ADL) has been related to low serum concentrations at trough. Currently, most methods commercially available for the quantification of ADL are enzyme-linked immunosorbent assay (ELISA) based, with a turnaround time of approximately 8?h, delaying the target dosage adjustment to the subsequent infusion. In this study, we aimed to evaluate the performance of the newly available rapid-test ADL quantification assay by comparing it with three established ELISA methods, using spiked samples and a set of clinical samples. Methods:Spiked samples from control donors and 120 serum samples from inflammatory bowel disease (IBD) patients undergoing ADL therapy were quantified using lateral flow Quantum Blue® Adalimumab and, the ELISA formats from Immundiagnostik, R-Biopharm and an in-house assay. Results:The rapid-test assay had intraclass correlation coefficients of 0.590, 0.864 and 0.761 when comparing with the Immundiagnostik, R-Biopharm and in-house assays, respectively. For the five therapeutic windows, the accuracy was high: ADL rapid test compared with the Immundiagnostik (58-88%); R-Biopharm, 68-89%; and in house, 60-88%; and kappa statistics revealed 0.492-0.602, 0.531-0.659 and 0.545-0.682, respectively. Conclusions:The Quantum Blue® Adalimumab assay can replace the commonly used ELISA-based ADL quantification kits and it is a reliable alternative to these methods. This rapid-test assay enables the quantitative determination of ADL serum trough level in only 15?min. The developed assay allows measurement of ADL over a wide range. Hence, it represents a valuable tool for the clinician to assess the ADL trough level.

SUBMITTER: Rocha C

PROVIDER: S-EPMC6393825 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Accuracy of the new rapid test for monitoring adalimumab levels.

Rocha Cátia C Afonso Joana J Lago Paula P Arroja Bruno B Vieira Ana I AI Dias Claudia C CC Magro Fernando F

Therapeutic advances in gastroenterology 20190227

<h4>Background</h4>The loss of response to adalimumab (ADL) has been related to low serum concentrations at trough. Currently, most methods commercially available for the quantification of ADL are enzyme-linked immunosorbent assay (ELISA) based, with a turnaround time of approximately 8 h, delaying the target dosage adjustment to the subsequent infusion. In this study, we aimed to evaluate the performance of the newly available rapid-test ADL quantification assay by comparing it with three estab ...[more]

PMID: 30833984

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Project description:OBJECTIVE:To assess the accuracy of the AbC-19 Rapid Test lateral flow immunoassay for the detection of previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. DESIGN:Test accuracy study. SETTING:Laboratory based evaluation. PARTICIPANTS:2847 key workers (healthcare staff, fire and rescue officers, and police officers) in England in June 2020 (268 with a previous polymerase chain reaction (PCR) positive result (median 63 days previously), 2579 with unknown previous infection status); and 1995 pre-pandemic blood donors. MAIN OUTCOME MEASURES:AbC-19 sensitivity and specificity, estimated using known negative (pre-pandemic) and known positive (PCR confirmed) samples as reference standards and secondly using the Roche Elecsys anti-nucleoprotein assay, a highly sensitive laboratory immunoassay, as a reference standard in samples from key workers. RESULTS:Test result bands were often weak, with positive/negative discordance by three trained laboratory staff for 3.9% of devices. Using consensus readings, for known positive and negative samples sensitivity was 92.5% (95% confidence interval 88.8% to 95.1%) and specificity was 97.9% (97.2% to 98.4%). Using an immunoassay reference standard, sensitivity was 94.2% (90.7% to 96.5%) among PCR confirmed cases but 84.7% (80.6% to 88.1%) among other people with antibodies. This is consistent with AbC-19 being more sensitive when antibody concentrations are higher, as people with PCR confirmation tended to have more severe disease whereas only 62% (218/354) of seropositive participants had had symptoms. If 1 million key workers were tested with AbC-19 and 10% had actually been previously infected, 84?700 true positive and 18?900 false positive results would be projected. The probability that a positive result was correct would be 81.7% (76.8% to 85.8%). CONCLUSIONS:AbC-19 sensitivity was lower among unselected populations than among PCR confirmed cases of SARS-CoV-2, highlighting the scope for overestimation of assay performance in studies involving only PCR confirmed cases, owing to "spectrum bias." Assuming that 10% of the tested population have had SARS-CoV-2 infection, around one in five key workers testing positive with AbC-19 would be false positives. STUDY REGISTRATION:ISRCTN 56609224.

Dataset Information

Accuracy of the new rapid test for monitoring adalimumab levels.

Publications

Accuracy of the new rapid test for monitoring adalimumab levels.

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