Background
Methods
Protein antigens
Donation of plasma samples
Lyophilization of anti-malaria defibrinated plasma pool (10/198)
Reference controls
Collaborative study design
Participants
ELISA protocol for collaborative study
Sample number | Product code | Product name |
---|---|---|
Control | Pool 4 | Positive control (XC) |
1 | 10/198 | Reference Reagent (S1) |
2 | 10/198 | Reference Reagent (S2) |
3 | Pool 2 | Control 2 (C2) |
4 | 10/198 | Reference Reagent (S1) |
5 | 12/192 | Control 3 (C3) |
6 | 10/198 | Reference Reagent (S2) |
7 | Pool 1 | Control 1 (C1) |
8 | 10/198 | Reference Reagent (S1) |
9 | 10/198 | Reference Reagent (S2) |
Stability studies
Statistical analysis
Cross reactivity with other antigens
Results and discussion
Data returned from study participants
Relative potencies of S1 and S2
Analysis of potency relative to 10/198 reduces inter laboratory variation
Antigen | Sample | |||
---|---|---|---|---|
XC | C1 | C2 | C3 | |
A. Potency relative to S1: Between-laboratory geometric mean and geometric coefficient of variation (%) after exclusion of laboratories 2, 3, 4 and 13
| ||||
AMA-1 | 0.809 (9.6%) | 3.549 (8.2%) | 0.870 (5.7%) | 0.014 (12.5%) |
MSP-142
| 0.493 (8.3%) | 2.447 (8.4%) | 0.871 (6.6%) | 0.033 (11.5%) |
MSP-3 | 0.548 (7.9%) | 3.026 (6.2%) | 0.812 (5.4%) | 0.041 (13.9%) |
B. EC
50
estimates: Between-laboratory geometric mean and geometric coefficient of variation (%) after exclusion of laboratories 2, 3, 4 and 13
| ||||
AMA-1 | 0.071 (79.7%) | 0.016 (62.4%) | 0.069 (69.5%) | 3.849 (82.7%) |
MSP-142
| 0.309 (52.8%) | 0.061 (48.1%) | 0.167 (56.0%) | 4.406 (46.6%) |
MSP-3 | 0.620 (60.6%) | 0.108 (63.9%) | 0.441 (53.6%) | 7.892 (62.0%) |
Reference reagent 10/198 is stable at elevated temperature and after reconstitution
Unitage proposal
Reference reagent 10/198 recognizes CSP of Plasmodium falciparum
Reference plasma 10/198 binds to PmMSP119 and PoMSP119 but not PvMSP119
Conclusions
Authors’ contributions
Acknowledgements
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Evelina Angov. USMMVP-WRAIR, 503 Robert Grant Avenue, Silver Spring, MD 20910, USA
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Ed Remarque. Department of Parasitology Biomedical Primate Research centre, Post Box 3306, 2280 GH Rijswijk. The Netherlands
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Daniel Dodoo. Department of Immunology, Noguchi Memorial Institute of Medical Research, Accra, P.O. Box Lg 581, University of Ghana, Ghana
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Chris Drakeley. Division of Immunology, Faculty of Infectious and tropical Diseases, The London School of Hygiene and Medicine, Keppel St, London WC1E 7HT, UK
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James Beeson, Linda Reiling, and Gaoqian Feng. Burnet Institute, 85 Commercial Road, Melbourne, Victoria 3004, Australia
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A. Manjurano. National Institute for Medical Research (NIMR) P.O.BOX 1462 Mwanza, Tanzania
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Simon Kariuki. KEMRI/CDC, Off Busia Road, P. O. Box 1578, Kisumu-40100, Kenya
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Francis Ndungu and Dr Faith Osier. Kenya Medical Research Institute, PO Box 230, 80108, Kilifi, Kenya
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Denise L. Doolan. Molecular Vaccinology Laboratory The Queensland Institute of Medical Research Courier address: 300 Herston Road, Herston, QLD 4006, Australia Mailing address: QIMR Locked Bag 2000, Brisbane, QLD 4029, Australia
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Carlota Dobano. University of Barcelona Centre for International Health Research, Hospital Centre For International health Research, Carrer Roselló 153, 1ª Planta E-08036 Barcelona, Spain, Barcelona
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Benjamin Mordmueller. Medical Research Unit, Albert Schweitzer Hospital BP118 Lambarere, Gabon
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Ogobara Doumbo and Bourèma Kouriba. Malaria Research and Training Centre (MRTC), department of Epidemiology of Parasitic Diseases University of Sciences, Techniques and Technologies of Bamako, BP 1805, Point G, Bamako, Republic of Mali.
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Paushali Mukherjee. Malaria Research Group, International Centre for Genetic Engineering and Biotechnology, Aruna Asaf Ali Marg, New Delhi-110067, India
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Carole Long. NIAID/NIH. Malaria Immunology Section, Laboratory of Malaria and Vector Research. Twinbrook III, Room 3W13, 12735Twinbrook Parkway MSC 8132. Rockville, MD 20892-8132 USA
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Nilupa Silva, Donna Bryan, Mei Mei Ho. Bacteriology Division, MHRA-NIBSC, Blanche lane, South Mimms, Potters Bar, Hertfordshire EN6 3QG, UK
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David Cavanagh. University of Edinburgh, Institute of Immunology and Infection Research, Ashworth Laboratories, King’s Buildings, Edinburgh EH9 3JT, UK