Tools
Tools
Piec, Isabelle Danielle 
ORCID: https://orcid.org/0000-0002-0648-1330, Tompkins, Beatrice and Fraser, William Duncan
(2020)
Interference of Asfotase alfa in immunoassays employing alkaline phosphatase technology.
Journal of Applied Laboratory Medicine, 5 (2).
pp. 290-299.
ISSN 2576-9456
Preview |
PDF (Accepted_Manuscript)
- Accepted Version
Download (219kB) | Preview |
Abstract
BACKGROUND: Asfotase alfa (STRENSIQ®, Alexion Pharmaceuticals, Inc.) is the only approved treatment for patients with pediatric-onset hypophosphatasia, a disease caused by a mutation in the tissue-nonspecific alkaline phosphatase (TNSALP) gene. ALP is often used as signaling system in routine immunoassays. Because asfotase alfa contains the active site of the full ALP enzyme, it can catalyze the substrate as the antibody-conjugated ALP would within an assay. Therefore, its presence in a treated patient's sample may generate false positive or false negative results. We investigated whether the presence of asfotase alfa within a sample induced interference in immunoassays that utilize ALP or alternative detection systems. METHODS: Asfotase alfa was added to samples at concentrations from 0.08-5 µg/mL and analysed on various immunoassays following manufacturer's instructions. RESULTS: Asfotase alfa was detected in all ALP assays but ALKP1 (RayBiotech). We observed no changes in normetanephrine and noradrenaline (IBL) at any asfotase alfa concentration. However, asfotase alfa notably interfered in an oxytocin (ENZO) assay in nonextracted samples. Extraction using a C18 column eliminated the interference. No interference was observed on automated analyzers using alternative detection system (COBAS fT4 and TSH; Advia Centaur FSH, fT4; Architect LH; FSH). Immulite 2000 fT4, TSH, testosterone and hCG (ALP-based) showed no interference. However, the presence of asfotase alfa resulted in a dose-dependent increase of Troponin I signal. CONCLUSION: The presence of asfotase alfa must be taken into consideration when analyzing blood samples in treated patients to avoid any risk of misinterpretation of false positive/negative results. It is essential that assays be tested for this possible interference.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | alkaline phosphatase,asfotase alfa,immunoassay,interference,medicine(all) ,/dk/atira/pure/subjectarea/asjc/2700 |
| Faculty \ School: | Faculty of Medicine and Health Sciences > Norwich Medical School |
| UEA Research Groups: | Faculty of Medicine and Health Sciences > Research Groups > Musculoskeletal Medicine Faculty of Medicine and Health Sciences > Research Centres > Metabolic Health |
| Related URLs: | |
| Depositing User: | LivePure Connector |
| Date Deposited: | 26 Jun 2020 00:03 |
| Last Modified: | 19 Oct 2023 02:42 |
| URI: | https://ueaeprints.uea.ac.uk/id/eprint/75779 |
| DOI: | 10.1093/jalm/jfz007 |
Downloads
Downloads per month over past year
Actions (login required)
 |
View Item |