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Assessment of desiccants and their instructions for use in rapid diagnostic tests

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dc.contributor.author Barbé, B.
dc.contributor.author Gillet, P.
dc.contributor.author Beelaert, G.
dc.contributor.author Fransen, K.
dc.contributor.author Jacobs, J.
dc.date.accessioned 2012-12-12T13:27:56Z
dc.date.available 2012-12-12T13:27:56Z
dc.date.issued 2012
dc.identifier.issn 1475-2875
dc.identifier.doi http://dx.doi.org/10.1186/1475-2875-11-326
dc.identifier.other ITG-C1B
dc.identifier.other ITG-C2B
dc.identifier.other ITG-C3B
dc.identifier.other ITG-C4A
dc.identifier.other ITG-CLA
dc.identifier.other DCS
dc.identifier.other U-TLM
dc.identifier.other U-ARLAB
dc.identifier.other JIF
dc.identifier.other DOI
dc.identifier.other FTA
dc.identifier.other E-only
dc.identifier.other URL
dc.identifier.other Abstract
dc.identifier.other UPD53
dc.identifier.uri http://hdl.handle.net/10390/7243
dc.description.abstract BACKGROUND: 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). METHODS: Criteria were based on recommendations of the World Health Organization (WHO), the European Community (CE) and own observations. Silica gel sachets were defined as selfindicating (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. RESULTS: 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 partialindicating 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. CONCLUSION: RDTs showed shortcomings in desiccant type and information supplied in the IFU. en
dc.language English en
dc.subject Protozoal diseases en
dc.subject Malaria en
dc.subject Plasmodium falciparum en
dc.subject Vectors en
dc.subject Mosquitoes en
dc.subject Anopheles en
dc.subject Diagnosis en
dc.subject Rapid diagnostic tests en
dc.subject Quality control en
dc.subject Humidity en
dc.subject Desiccants en
dc.subject Packaging en
dc.subject Use en
dc.subject Availability en
dc.subject Types en
dc.subject Design en
dc.subject WHO en
dc.subject Guidelines en
dc.title Assessment of desiccants and their instructions for use in rapid diagnostic tests en
dc.type Article-E en
dc.citation.issue 326 en
dc.citation.jtitle Malaria Journal en
dc.citation.volume 11 en
dc.citation.pages 1-10 en
dc.identifier.pmid http://www.ncbi.nlm.nih.gov/pubmed/22974115
dc.identifier.url http://www.malariajournal.com/content/11/1/326
dc.citation.jabbreviation Malar J en


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