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Malaria rapid diagnostic kits: quality of packaging, design and labelling of boxes and components and readability and accuracy of information inserts

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dc.contributor.author Gillet, P.
dc.contributor.author Maltha, J.
dc.contributor.author Hermans, V.
dc.contributor.author Ravinetto, R.
dc.contributor.author Bruggeman, C.
dc.contributor.author Jacobs, J.
dc.date.accessioned 2011-02-22T14:34:11Z
dc.date.available 2011-02-22T14:34:11Z
dc.date.issued 2011
dc.identifier.issn 1475-2875
dc.identifier.doi http://dx.doi.org/10.1186/1475-2875-10-39
dc.identifier.other ITG-C1A
dc.identifier.other ITG-C3B
dc.identifier.other ITG-I4A
dc.identifier.other ITG-CLA
dc.identifier.other CLINIC
dc.identifier.other U-CLIBIO
dc.identifier.other INTER
dc.identifier.other U-CTU
dc.identifier.other JIF
dc.identifier.other DOI
dc.identifier.other URL
dc.identifier.other Electronic
dc.identifier.other Abstract
dc.identifier.other UPD31
dc.identifier.other FTA
dc.identifier.uri http://hdl.handle.net/10390/6477
dc.description.abstract BACKGROUND: The present study assessed malaria RDT kits for adequate and correct packaging, design and labelling of boxes and components. Information inserts were studied for readability and accuracy of information. METHODS: Criteria for packaging, design, labelling and information were compiled from Directive 98/79 of the European Community (EC), relevant World Health Organization (WHO) documents and studies on end-users' performance of RDTs. Typography and readability level (Flesch-Kincaid grade level) were assessed. RESULTS: Forty-two RDT kits from 22 manufacturers were assessed, 35 of which had evidence of good manufacturing practice according to available information (i.e. CE-label affixed or inclusion in the WHO list of ISO13485:2003 certified manufacturers). Shortcomings in devices were (i) insufficient place for writing sample identification (n = 40) and (ii) ambiguous labelling of the reading window (n = 6). Buffer vial labels were lacking essential information (n = 24) or were of poor quality (n = 16). Information inserts had elevated readability levels (median Flesch Kincaid grade 8.9, range 7.1 - 12.9) and user-unfriendly typography (median font size 8, range 5 - 10). Inadequacies included (i) no referral to biosafety (n = 18), (ii) critical differences between depicted and real devices (n = 8), (iii) figures with unrealistic colours (n = 4), (iv) incomplete information about RDT line interpretations (n = 31) and no data on test characteristics (n = 8). Other problems included (i) kit names that referred to Plasmodium vivax although targeting a pan-species Plasmodium antigen (n = 4), (ii) not stating the identity of the pan-species antigen (n = 2) and (iii) slight but numerous differences in names displayed on boxes, device packages and information inserts. Three CE labelled RDT kits produced outside the EC had no authorized representative affixed and the shape and relative dimensions of the CE symbol affixed did not comply with the Directive 98/79/EC. Overall, RDTs with evidence of GMP scored better compared to those without but inadequacies were observed in both groups. CONCLUSION: Overall, malaria RDTs showed shortcomings in quality of construction, design and labelling of boxes, device packages, devices and buffers. Information inserts were difficult to read and lacked relevant information. 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 Rapid diagnostic tests en
dc.subject Design en
dc.subject Information en
dc.subject Quality control en
dc.subject Laboratory equipment en
dc.title Malaria rapid diagnostic kits: quality of packaging, design and labelling of boxes and components and readability and accuracy of information inserts en
dc.type Article-E en
dc.citation.issue 39 en
dc.citation.jtitle Malaria Journal en
dc.citation.volume 10 en
dc.identifier.pmid http://www.ncbi.nlm.nih.gov/pubmed/21314992
dc.identifier.url http://www.malariajournal.com/content/10/1/39
dc.citation.jabbreviation Malar J en


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