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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

Information insert of a three-band RDT, procedure section. There is a discrepancy between the reading time mentioned in the text compared to that showed on the illustration.
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Figure 5: Information insert of a three-band RDT, procedure section. There is a discrepancy between the reading time mentioned in the text compared to that showed on the illustration.

Mentions: All inserts used figures to illustrate the interpretation section. Other figures depicted blood sampling (n = 17), application of sample and buffer (n = 21) and a clock indicating the correct reading delay (n = 10). Fourteen inserts used red colour to indicate control and test lines but in four, they were pictured green or blue. Most inserts (n = 35) showed differences between depicted and real devices of which some were major, such as discrepancies between characters used for sample and buffer well identification (n = 4) and differences in labelling of the reading window (n = 5) (Figures 3 and 4). One insert mentioned a reading delay of 15 minutes, but the illustration mentioned a reading delay of 20 minutes (Figure 5).


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)

Information insert of a three-band RDT, procedure section. There is a discrepancy between the reading time mentioned in the text compared to that showed on the illustration.
© Copyright Policy - open-access
Related In: Results  -  Collection

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

Figure 5: Information insert of a three-band RDT, procedure section. There is a discrepancy between the reading time mentioned in the text compared to that showed on the illustration.
Mentions: All inserts used figures to illustrate the interpretation section. Other figures depicted blood sampling (n = 17), application of sample and buffer (n = 21) and a clock indicating the correct reading delay (n = 10). Fourteen inserts used red colour to indicate control and test lines but in four, they were pictured green or blue. Most inserts (n = 35) showed differences between depicted and real devices of which some were major, such as discrepancies between characters used for sample and buffer well identification (n = 4) and differences in labelling of the reading window (n = 5) (Figures 3 and 4). One insert mentioned a reading delay of 15 minutes, but the illustration mentioned a reading delay of 20 minutes (Figure 5).

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