The online version of this article (doi:10.1186/1475-2875-11-326) contains supplementary material, which is available to authorized users.
The authors declare that they have no competing interests.
BB, PG and JJ designed the study protocol, PG, GB and KF organized sample collection. BB, PG and GB carried out the RDT test evaluations, BB, PG and JJ analyzed and interpreted the results. BB, PG and JJ drafted the manuscript. “All authors critically reviewed the manuscript and approved the final manuscript.”
Malaria rapid diagnostic tests (RDTs) are protected from humidity-caused degradation by a desiccant added to the device packaging. The present study assessed malaria RDT products for the availability, type and design of desiccants and their information supplied in the instructions for use (IFU).
Criteria were based on recommendations of the World Health Organization (WHO), the European Community (CE) and own observations. Silica gel sachets were defined as self-indicating (all beads coated with a humidity indicator that changes colour upon saturation), partial-indicating (part of beads coated) and non-indicating (none of the beads coated). Indicating silica gel sachets were individually assessed for humidity saturation and (in case of partial-indicating silica gels) for the presence of indicating beads.
Fifty malaria RDT products from 25 manufacturers were assessed, 14 (28%) products were listed by the “Global Fund Quality Assurance Policy” and 31 (62%) were CE-marked. All but one product contained a desiccant, mostly (47/50, 94%) silica gel. Twenty (40%) RDT products (one with no desiccant and 19 with non-indicating desiccant) did not meet the WHO guidelines recommending indicating desiccant. All RDT products with self- or partial-indicating silica gel (n = 22 and 8 respectively) contained the toxic cobalt dichloride as humidity indicator. Colour change indicating humidity saturation was observed for 8/16 RDT products, at a median incidence of 0.8% (range 0.05%-4.6%) of sachets inspected. In all RDTs with partial-indicating silica gel, sachets with no colour indicating beads were found (median proportion 13.5% (0.6% - 17.8%) per product) and additional light was needed to assess the humidity colour. Less than half (14/30, 47%) IFUs of RDT products with indicating desiccants mentioned to check the humidity saturation before using the test. Information on properties, safety hazards and disposal of the desiccant was not included in any of the IFUs. There were no differences between Global Fund-listed and CE marked RDT products compared to those which were not. Similar findings were noted for a panel of 11 HIV RDTs that was assessed with the same checklist as the malaria RDTs.
RDTs showed shortcomings in desiccant type and information supplied in the IFU.
Additional file 1: List of malaria RDT products that were assessed. (XLSX 13 KB)12936_2012_2471_MOESM1_ESM.xlsx
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World Health Organization: Good practices for selecting and procuring rapid diagnostic tests for malaria. 2011, http://whqlibdoc.who.int/publications/2011/9789241501125_eng.pdf,
World Health Organization: Guidelines for the treatment of malaria, second edition. 2010, http://whqlibdoc.who.int/publications/2010/9789241547925_eng.pdf,
World Health Organization: Universal access to malaria diagnostic testing. An operational manual. 2011, http://whqlibdoc.who.int/publications/2011/9789241502092_eng.pdf,
World Health Organization: World Malaria Report 2011. 2011, http://www.who.int/malaria/world_malaria_report_2011/9789241564403_eng.pdf,
McMorrow ML, Masanja MI, Kahigwa E, Abdulla SM, Kachur SP: Quality assurance of rapid diagnostic tests for malaria in routine patient care in rural Tanzania. AmJTrop Med Hyg. 2010, 82: 151-155. CrossRef
Chiodini PL, Bowers K, Jorgensen P, Barnwell JW, Grady KK, Luchavez J, Moody AH, Cenizal A, Bell D: The heat stability of Plasmodium lactate dehydrogenase-based and histidine-rich protein 2-based malaria rapid diagnostic tests. Trans R Soc Trop Med Hyg. 2007, 101: 331-337. 10.1016/j.trstmh.2006.09.007. CrossRefPubMed
Crucitti T, Fransen K, Maharaj R, Tenywa T, Massinga LM, Murugavel KG, Mendonca K, Abdellati S, Beelaert G, Van DL: Obtaining valid laboratory data in clinical trials conducted in resource diverse settings: lessons learned from a microbicide phase III clinical trial. PLoS One. 2010, 5: e13592-10.1371/journal.pone.0013592. PubMedCentralCrossRefPubMed
Gillet P, Scheirlinck A, Stokx J, De Weggheleire A, Chauque HS, Canhanga OD, Tadeu BT, Mosse CD, Tiago A, Mabunda S, Bruggeman C, Bottieau E, Jacobs J: Prozone in malaria rapid diagnostics tests: how many cases are missed?. Malar J. 2011, 10: 166-10.1186/1475-2875-10-166. PubMedCentralCrossRefPubMed
The Global Fund: List of RDT kits for malaria classified according to the Global Fund Quality Assurance Policy, version 3. 2012, www.theglobalfund.org/Documents/psm/PSM_QADiagnostics_Malaria_list,
Rennie W, Harvey SA: Field report. Developing and testing a generic job aid for malaria rapid diagnostic tests (RDTs). 2004, http://www2.wpro.who.int/internet/resources.ashx/RDT/docs/pdf_version/Developing_and_testing_an_RDT_Job_Aid.pdf,
World Health Organization: How to use a Rapid Diagnostic Test (RDT): A guide for training at a village and clinic level. 2008, http://www.wpro.who.int/sites/rdt/using_rdts/training/rdt_training_falciparum.htm,
World Health Organization: Methods manual for laboratory quality control testing of malaria rapid diagnostic tests. Version 6. 2010, http://www2.wpro.who.int/internet/resources.ashx/RDT/docs/pdf_version/rdt_laboratory_qc_testing_meth_man_v6.pdf,
World Health Organization: Regional Office for the Western Pacific 2003. Malaria Rapid Diagnosis: Making it Work. Meeting report 20–23 January 2003. Manila, the Philippines. 2003, http://www.searo.who.int/LinkFiles/Malaria_MalariaRDT.pdf,
World Health Organization: Malaria Rapid Diagnostic Test Performance; Results of WHO product testing of malaria RDTs: Round 3 (2011). 2011, http://www.finddiagnostics.org/export/sites/default/resource-centre/reports_brochures/docs/RDTMalariaRd3_web.pdf,
European Chemicals Agency: Background document for cobalt dichloride. 2011, http://echa.europa.eu/documents/10162/13640/backgroundoc_cobalt_dichloride_en.pdf,
European Chemicals Agency: Support document for identification of cobalt dichloride as a substance of very high concern because of its CMR properties. 2011, http://echa.europa.eu/documents/10162/80921ae6-5109-4057-9640-b066ed58a766,
European Commission: Commission Regulation (EC) No 790/2009 of 10 August 2009 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) no 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of subtances and mixtures. 2009, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:235:0001:0439:en:PDF,
European Commission: Regulation (EC) No 1272/2008 of the European parliament and of the council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006. 2008, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:353:0001:1355:en:PDF,
Millipore Corporation: Rapid lateral flow test strips. Considerations for product development. 2008, http://www.millipore.com/publications.nsf/a73664f9f981af8c852569b9005b4eee/348ee7096d93729b85256bf40066a40d/$FILE/tb500en00.pdf,
National Institute for Occupational Safety and Health: International Chemical Safety Card 0783 - Cobalt (II) Chloride. 2004, http://www.cdc.gov/niosh/ipcsneng/neng0783.html,
Schier JG, Hoffman RS, Nelson LS: Desiccant-induced gastrointestinal burns in a child. Vet Hum Toxicol. 2002, 44: 343-344. PubMed
Bronstein AC, Spyker DA, Cantilena LR, Green JL, Rumack BH, Dart RC: 2010 Annual Report of the American Association of Poison Control Centers' National Poison Data System (NPDS): 28th Annual Report. Clin Toxicol (Phila). 2011, 49: 910-941. 10.3109/15563650.2011.635149. CrossRef
Science Lab: Material Safety Data Sheet Silicon Dioxide, Amorphous. 2012, http://www.sciencelab.com/msds.php?msdsId=9924924,
Brownell Limited: Material Safety Data Sheet Envirogel Indicating (orange-to-green) silica gel. 2008, http://www.envirogel.co.uk/material_safety_datasheet_env.htm,
World Health Organization: How to do the rapid test for malaria. Modified for training in the use of the generic Pf test for falciparum malaria. 2010, http://www2.wpro.who.int/NR/rdonlyres/D76666F7-5BF8-453F-9DA8-3EB4A9056CD6/0/GenericPfJobAid_Final_lowRES.pdf,
World Health Organization: Transporting, Storing, and Handling Malaria Rapid Diagnostic Tests in Health Clinics. 2009, http://deliver.jsi.com/dlvr_content/resources/allpubs/guidelines/TranStorRDT_Clinic.pdf,
World Health Organization: Methods and techniques for clinical trials on antimalarial drug efficacy: genotyping to identify parasite populations. Informal consultation organized by the Medicines for Malaria Venture and cosponsored by the World Health Organization. 2008, http://whqlibdoc.who.int/publications/2008/9789241596305_eng.pdf,
Clinical and Laboratory Standards Institute (CLSI): Blood collection on filter paper for newborn screening programs; Approved standard - Fifth edition. LA4-A5, Vol. 27, No. 20. 2007
World Health Organization: Maintenance manual for laboratory equipment, 2nd edition. 2008, http://whqlibdoc.who.int/publications/2008/9789241596350_chapters1-9_eng.pdf,
World Health Organization: The microscope: A practical guide. 1999, http://www.tbcindia.nic.in/pdfs/Microsc1.pdf,
GeeJay Chemicals Ltd: UK supplier of desiccants. 2012, http://www.geejaychemicals.co.uk/default.htm,
SorbentSystems: 2012, http://www.sorbentsystems.com/.
Conservation by Design Limited: MSDS Self-indicating green-orange silica gel. 2012, http://ge-iic.com/files/fichas%20productos/gel_silice_color.pdf,
Wisepack Desiccants: 2012, http://www.wisepac.com,
- Assessment of desiccants and their instructions for use in rapid diagnostic tests
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