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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.

Gillet P, Maltha J, Hermans V, Ravinetto R, Bruggeman C, Jacobs J - Malar. J. (2011)

Bottom Line: 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).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.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Clinical Sciences, Institute of Tropical Medicine (ITM), Unit of Tropical Laboratory Medicine, Nationalestraat 155, B 2000 Antwerp, Belgium. pgillet@itg.be

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.

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Related in: MedlinePlus

Example of typography used in RDT information inserts: the package insert on the top is user-unfriendly (font size 6, line spacing 0,5, close letter type, average number of words per line 21, Flesch-Kincaid grade 9,5). The package insert on the background, from the same company but for another RDT uses a better typography (font size 8, line spacing 2, open letter type, average number of words per line 14), but the readability is still elevated (Flesch-Kincaid grade 9,8).
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Figure 7: Example of typography used in RDT information inserts: the package insert on the top is user-unfriendly (font size 6, line spacing 0,5, close letter type, average number of words per line 21, Flesch-Kincaid grade 9,5). The package insert on the background, from the same company but for another RDT uses a better typography (font size 8, line spacing 2, open letter type, average number of words per line 14), but the readability is still elevated (Flesch-Kincaid grade 9,8).

Mentions: Figure 6 displays the font size and line spacing of the information inserts. Median font size was 8 ± 1.3, none of them exceeded 10. User-unfriendly typographic features included combinations of font sizes of eight or smaller with a closed letter type (n = 10) or with line spacing lower than two and more than 12 words per line (n = 14) (Figure 7). Median readability level was grade 8.9 (range 7.1 - 12.9) and 18 and four of the inserts' readability levels were above grade 9 and 10 respectively (Figure 8). Readability levels of the job aids were also high (median 8.5, range 5.1 - 9.4), and six out of seven exceeded the readability level of the most recent WHO job aids. Five inserts showed prints of very poor quality hindering reading of the text (Figure 9).


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

Gillet P, Maltha J, Hermans V, Ravinetto R, Bruggeman C, Jacobs J - Malar. J. (2011)

Example of typography used in RDT information inserts: the package insert on the top is user-unfriendly (font size 6, line spacing 0,5, close letter type, average number of words per line 21, Flesch-Kincaid grade 9,5). The package insert on the background, from the same company but for another RDT uses a better typography (font size 8, line spacing 2, open letter type, average number of words per line 14), but the readability is still elevated (Flesch-Kincaid grade 9,8).
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3045995&req=5

Figure 7: Example of typography used in RDT information inserts: the package insert on the top is user-unfriendly (font size 6, line spacing 0,5, close letter type, average number of words per line 21, Flesch-Kincaid grade 9,5). The package insert on the background, from the same company but for another RDT uses a better typography (font size 8, line spacing 2, open letter type, average number of words per line 14), but the readability is still elevated (Flesch-Kincaid grade 9,8).
Mentions: Figure 6 displays the font size and line spacing of the information inserts. Median font size was 8 ± 1.3, none of them exceeded 10. User-unfriendly typographic features included combinations of font sizes of eight or smaller with a closed letter type (n = 10) or with line spacing lower than two and more than 12 words per line (n = 14) (Figure 7). Median readability level was grade 8.9 (range 7.1 - 12.9) and 18 and four of the inserts' readability levels were above grade 9 and 10 respectively (Figure 8). Readability levels of the job aids were also high (median 8.5, range 5.1 - 9.4), and six out of seven exceeded the readability level of the most recent WHO job aids. Five inserts showed prints of very poor quality hindering reading of the text (Figure 9).

Bottom Line: 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).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.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Clinical Sciences, Institute of Tropical Medicine (ITM), Unit of Tropical Laboratory Medicine, Nationalestraat 155, B 2000 Antwerp, Belgium. pgillet@itg.be

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.

Show MeSH
Related in: MedlinePlus