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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 the lateral side of a RDT box: all essential information is printed on a single side of the box, contributing to clear storage.
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Figure 12: Example of the lateral side of a RDT box: all essential information is printed on a single side of the box, contributing to clear storage.

Mentions: With regard to user-friendliness and adequacy of RDT presentation and instructions, interesting features not listed on the compiled criteria were noted. For instance, some device packages carried short instructions for use based upon the generic WHO job aids [16], witch may increase the test performance [9,10,19,31]. The availability of job aids for the different brands on the company websites in an adaptable text format may help Malaria National Programs to translate it in the end-user language and to adapt it on the local context. In addition, some RDT kits provided a glossary with explanation of the affixed symbols, which may help in their comprehension and acquisition and another five had all essential information printed on a single (lateral) side of the box, contributing to easy storage (Figure 12). Another asset was the presence of more than one buffer vial per RDT box, as shortage and replacement of buffer vials is a common problem in resource limited settings [5]. Likewise, the above described observations and corrective measures could be extended to other IVDs, such as human immunodeficiency virus RDTs.


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 the lateral side of a RDT box: all essential information is printed on a single side of the box, contributing to clear storage.
© Copyright Policy - open-access
Related In: Results  -  Collection

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

Figure 12: Example of the lateral side of a RDT box: all essential information is printed on a single side of the box, contributing to clear storage.
Mentions: With regard to user-friendliness and adequacy of RDT presentation and instructions, interesting features not listed on the compiled criteria were noted. For instance, some device packages carried short instructions for use based upon the generic WHO job aids [16], witch may increase the test performance [9,10,19,31]. The availability of job aids for the different brands on the company websites in an adaptable text format may help Malaria National Programs to translate it in the end-user language and to adapt it on the local context. In addition, some RDT kits provided a glossary with explanation of the affixed symbols, which may help in their comprehension and acquisition and another five had all essential information printed on a single (lateral) side of the box, contributing to easy storage (Figure 12). Another asset was the presence of more than one buffer vial per RDT box, as shortage and replacement of buffer vials is a common problem in resource limited settings [5]. Likewise, the above described observations and corrective measures could be extended to other IVDs, such as human immunodeficiency virus RDTs.

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