Multi-center evaluation of a user-friendly lateral flow assay to determine IP-10 and CCL4 levels in blood of TB and non-TB cases in Africa

Corstjens, P. L.A.M. et al. (2016) Multi-center evaluation of a user-friendly lateral flow assay to determine IP-10 and CCL4 levels in blood of TB and non-TB cases in Africa. Clinical Biochemistry, 49(1-2), pp. 22-31. (doi: 10.1016/j.clinbiochem.2015.08.013) (PMID:26285074)

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Abstract

Objective: Multi-center evaluation of a user-friendly lateral flow test for detection of IP-10 and CCL4 levels in Mycobacterium tuberculosis (Mtb) antigen-stimulated whole blood samples from tuberculosis (TB) suspects. Design and methods: A quantitative lateral flow (LF)-based assay platform was applied to detect chemokines IP-10 and CCL4. Chemokine quantitation was achieved using interference-free, fluorescent up-converting phosphor (UCP) labels. The new assays allowed worldwide shipping and storage without requiring a cold chain and were tested at seven institutes (including Ethiopia, Malawi, The Gambia, South Africa, Uganda and Namibia) employing portable lightweight readers for detection of the UCP label. At each site, clinical samples, confirmed TB and non-TB (i.e. other respiratory diseases (ORD)) cases, were collected and analyzed simultaneously with quality control (QC) human IP-10 or CCL4 standards. Results: Performance of the UCP-LF assay in Africa using QC standards indicated high robustness allowing quantitative detection between 100 and 100,000 pg/mL. The optimized assays allowed successful determination of chemokine levels using 1 μL whole blood sample from the locally recruited subjects with TB or ORD. Conclusion: This African multi-center trial further demonstrated the applicability of the low-tech and robust UCP-LF platform as a convenient quantitative assay for chemokine detection in whole blood. Ambient shipping and storage of all assay reagents and the availability of lightweight standalone readers were acknowledged as essential requirement for test implementation in particular in remote and resource-limited settings.

Item Type:Articles
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Crampin, Professor Mia
Authors: Corstjens, P. L.A.M., Tjon Kon Fat, E. M., de Dood, C. J., van der Ploeg-van Schip, J. J., Franken, K. L.M.C., Chegou, N. N., Sutherland, J. S., Howe, R., Mihret, A., Kassa, D., van der Vyver, M., Sheehama, J., Simukonda, F., Mayanja-Kizza, H., Ottenhoff, T. H.M., Walzl, G., Geluk, A., and AE-TBC Consortium,
College/School:College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Public Health
Journal Name:Clinical Biochemistry
Publisher:Elsevier
ISSN:0009-9120
ISSN (Online):1873-2933
Published Online:15 August 2015

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