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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- 作者：Philippe Gillet (1)
Jessica Maltha (2)
Veerle Hermans (1)
Raffaella Ravinetto (3)
Cathrien Bruggeman (4)
Jan Jacobs (1) (2) - 刊名：Malaria Journal
- 出版年：2011
- 出版时间：December 2011
- 年：2011
- 卷：10
- 期：1
- 全文大小：2812KB
- 参考文献：1. World Health Organization: [http://whqlibdoc.who.int/publications/2010/9789241547925_eng.pdf] / Guidelines for the treatment of malaria. second edition. 2010.
2. Bell D, Perkins MD: Making malaria testing relevant: beyond test purchase. / Trans R Soc Trop Med Hyg 2008, 102:1064鈥?066. CrossRef
3. Chiodini PL, Bowers K, Jorgensen P, Barnwell JW, Grady KK, Luchavez J, Moody AH, Cenizal A, Bell D: The heat stability of Plasmodium lactate dehydrogenase-based and histidine-rich protein 2-based malaria rapid diagnostic tests. / Trans R Soc Trop Med Hyg 2007, 101:331鈥?37. CrossRef
4. Gillet P, Mori M, Van Esbroeck M, Van Den Ende J, Jacobs J: Assessment of the prozone effect in malaria rapid diagnostic tests. / Malar J 2009, 8:271. CrossRef
5. Gillet P, Mori M, Van Den Ende J, Jacobs J: Buffer substitution in malaria rapid diagnostic tests causes false-positive results. / Malar J 2010, 9:215. CrossRef
6. Jorgensen P, Chanthap L, Rebueno A, Tsuyuoka R, Bell D: Malaria rapid diagnostic tests in tropical climates: the need for a cool chain. / Am J Trop Med Hyg 2006, 74:750鈥?54.
7. McMorrow ML, Masanja MI, Abdulla SM, Kahigwa E, Kachur SP: Challenges in routine implementation and quality control of rapid diagnostic tests for malaria--Rufiji District, Tanzania. / Am J Trop Med Hyg 2008, 79:385鈥?90.
8. World Health Organization: [http://www.wpro.who.int/sites/rdt/using_rdts/qa/lot_testing.htm] / Lot-testing: Using quality control parasite dilutions to test the sensitivity of malaria RDTs. 2010.
9. Rennie W: [http://www.wpro.who.int/internet/resources.ashx/RDT/docs/pdf_version/Developing_and_testing_an_RDT_Job_Aid.pdf] / Developing and testing a generic job aid for malaria rapid diagnostic tests (RDTs). 2004.
10. Rennie W, Phetsouvanh R, Lupisan S, Vanisaveth V, Hongvanthong B, Phompida S, Alday P, Fulache M, Lumagui R, Jorgensen P, Bell D, Harvey S: Minimising human error in malaria rapid diagnosis: clarity of written instructions and health worker performance. / Trans R Soc Trop Med Hyg 2007, 101:9鈥?8. CrossRef
11. World Health Organization: [http://www.wpro.who.int/sites/rdt/using_rdts/training/rdt_training_falciparum.htm] / How to use a Rapid Diagnostic Test (RDT): A guide for training at a village and clinic level. 2008.
12. World Health Organization: [http://www.wpro.who.int/internet/resources.ashx/RDT/docs/MD_table34+(1)_totallistofISO131485criteria.pdf] / List of known commercially-available antigen-detecting malaria RDTs with adequate evidence of good manufacturing practice. 2009.
13. Maltha J, Gillet P, Cnops L, Van Den Ende J, Van Esbroeck M, Jacobs J: Malaria rapid diagnostic tests: Plasmodium falciparum infections with high parasite densities may generate false positive Plasmodium vivax pLDH lines. / Malar J 2010, 9:198. CrossRef
14. World Health Organization: [http://whqlibdoc.who.int/publications/2004/9241592206.pdf] / Hepatitis B Assays: Operational Characteristics Report 1 & 2. 2004.
15. World Health Organization: [http://www.wpro.who.int/NR/rdonlyres/A30D47E1鈥?612鈥?674鈥?DF8-FCA031CDB9BA/0/Reduced_web2_MalariaRDT_20062ndedition.pdf] / The Use of Rapid Malaria Diagnostic Tests, Second Edition. 2006.
16. World Health Organization: [http://www.wpro.who.int/NR/rdonlyres/06B185E0鈥?E63鈥?991-B8F5-B3D62D6C8373/0/SHORTNOTESONJOBAIDfinal.pdf] / Notes on job aids for malaria rapid diagnostic tests (RDTs). 2006.
17. World Health Organization: [http://www.who.int/entity/diagnostics_laboratory/publications/Report16_final.pdf] / HIV Rapid Assays: Operational Characteristics Report 16. 2009.
18. Gillet P, Mukadi P, Vernelen K, Van Esbroeck M, Muyembe J-J, Bruggeman C, Jacobs J: External quality assessment on the use of malaria rapid diagnostic tests in a non-endemic setting. / Malar J 2010, 9:359. CrossRef
19. Harvey SA, Jennings L, Chinyama M, Masaninga F, Mulholland K, Bell DR: Improving community health worker use of malaria rapid diagnostic tests in Zambia: package instructions, job aid and job aid-plus-training. / Malar J 2008, 7:160. CrossRef
20. Knebel E: [http://www.qaproject.org/pubs/PDFs/ISSUESJA.PDF] / The Use of Manual Job Aids by Health Care Providers: What Do We Know?. 2000.
21. Moonasar D, Goga AE, Kruger PS, La Cock C, Maharaj R, Frean J, Chandramohan D: Field evaluation of a malaria rapid diagnostic test (ICT Pf). / S Afr Med J 2009, 99:810鈥?13.
22. Murray CK, Bell D, Gasser RA, Wongsrichanalai C: Rapid diagnostic testing for malaria. / Trop Med Int Health 2003, 8:876鈥?83. CrossRef
23. Seidahmed OM, Mohamedein MM, Elsir AA, Ali FT, Malik eF, Ahmed ES: End-user errors in applying two malaria rapid diagnostic tests in a remote area of Sudan. / Trop Med Int Health 2008, 13:406鈥?09. CrossRef
24. Tavrow P, Shabahang J, Makama S: Vendor-to-vendor education to improve malaria treatment by private drug outlets in Bungoma District, Kenya. / Malar J 2003, 2:10. CrossRef
25. Wallace LS, Keenum AJ, Roskos SE, Blake GH, Colwell ST, Weiss BD: Suitability and readability of consumer medical information accompanying prescription medication samples. / Patient Educ Couns 2008, 70:420鈥?25. CrossRef
26. Wallace LS, Zite NB, Homewood VJ: Making sense of home pregnancy test instructions. / J Womens Health (Larchmt ) 2009, 18:363鈥?68. CrossRef
27. Wallace LS, Keenum AJ, Roskos SE, Koopman RJ, Young KG: Blood glucose monitor quick reference guides: are they suitable for patients? / Diabetes Technol Ther 2008, 10:11鈥?5. CrossRef
28. Tests Document Readability [http://www.online-utility.org/english/readability_test_and_improve.jsp]
29. Flesch R: [http://www.mang.canterbury.ac.nz/writing_guide/writing/flesch.shtml] / How to Write Plain English. 2004.
30. Wallace LS, Roskos SE, Weiss BD: Readability characteristics of consumer medication information for asthma inhalation devices. / J Asthma 2006, 43:375鈥?78. CrossRef
31. Mayxay M, Newton PN, Yeung S, Pongvongsa T, Phompida S, Phetsouvanh R, White NJ: Short communication: An assessment of the use of malaria rapid tests by village health volunteers in rural Laos. / Trop Med Int Health 2004, 9:325鈥?29. CrossRef
32. Arnold CL, Davis TC, Frempong JO, Humiston SG, Bocchini A, Kennen EM, Lloyd-Puryear M: Assessment of newborn screening parent education materials. / Pediatrics 2006, 117:S320-S325. CrossRef
33. White LJ, Jones JS, Felton CW, Pool LC: Informed consent for medical research: common discrepancies and readability. / Acad Emerg Med 1996, 3:745鈥?50. CrossRef
34. Wallace LS, Keenum AJ: Using a home blood pressure monitor: do accompanying instructional materials meet low literacy guidelines? / Blood Press Monit 2008, 13:219鈥?23. CrossRef
35. Wallace LS, Keenum AJ, DeVoe JE: Evaluation of consumer medical information and oral liquid measuring devices accompanying pediatric prescriptions. / Acad Pediatr 2010, 10:224鈥?27. CrossRef
36. Hashizume M, Kondo H, Murakami T, Kodama M, Nakahara S, Lucas ME, Wakai S: Use of rapid diagnostic tests for malaria in an emergency situation after the flood disaster in Mozambique. / Public Health 2006, 120:444鈥?47. CrossRef
37. Hawkes M, Katsuva JP, Masumbuko CK: Use and limitations of malaria rapid diagnostic testing by community health workers in war-torn Democratic Republic of Congo. / Malar J 2009, 8:308. CrossRef
38. Doak LG, Doak CC, Meade CD: Strategies to improve cancer education materials. / Oncol Nurs Forum 1996, 23:1305鈥?312.
39. Kaphingst KA, DeJong W: The educational potential of direct-to-consumer prescription drug advertising. / Health Aff (Millwood ) 2004, 23:143鈥?50. CrossRef
40. Grobusch MP, Hanscheid T, Zoller T, Jelinek T, Burchard GD: Rapid immunochromatographic malarial antigen detection unreliable for detecting Plasmodium malariae and Plasmodium ovale . / Eur J Clin Microbiol Infect Dis 2002, 21:818鈥?20. CrossRef
41. Maltha J, Gillet P, Bottieau E, Cnops L, Van Esbroeck M, Jacobs J: Evaluation of a rapid diagnostic test (CareStart Malaria HRP-2/pLDH (Pf/pan) Combo Test) for the diagnosis of malaria in a reference setting. / Malar J 2010, 9:171. CrossRef
42. Van der Palen M, Gillet P, Bottieau E, Cnops L, Van Esbroeck M, Jacobs J: Test characteristics of two rapid antigen detection tests (SD FK50 and SD FK60) for the diagnosis of malaria in returned travellers. / Malar J 2009, 8:90. CrossRef
43. van Dijk DP, Gillet P, Vlieghe E, Cnops L, Van Esbroeck M, Jacobs J: Evaluation of the Palutop+4 malaria rapid diagnostic test in a non-endemic setting. / Malar J 2009, 8:293. CrossRef
44. van Dijk DP, Gillet P, Vlieghe E, Cnops L, Van Esbroeck M, Jacobs J: Evaluation of the Immunoquick+4 malaria rapid diagnostic test in a non-endemic setting. / Eur J Clin Microbiol Infect Dis 2010, 29:577鈥?83. CrossRef
45. World Health Organization: [http://www.who.int/entity/diagnostics_laboratory/evaluations/pqdx_007_pq_overview_document_v3.pdf] / Overview of the prequalification of diagnostics assessment process. 2010.
46. World Health Organization: [http://www.finddiagnostics.org/resource-centre/reports_brochures/malaria-diagnostics-report-2009.html] / Malaria Rapid Diagnostic Test Performance; Results of WHO product testing of malaria RDTs: Round 1 (2008). 2009.
47. World Health Organization: [http://www.finddiagnostics.org/resource-centre/reports_brochures/malaria-diagnostic-test-report-round2.html] / Malaria Rapid Diagnostic Test Performance; Results of WHO product testing of malaria RDTs: Round 2 (2009). 2010.
48. European Commission: [http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:1998:331:0001:0037:EN:PDF] / European standards in vitro diagnostic medical devices. 1998.
49. Taylor HA: Barriers to informed consent. / Semin Oncol Nurs 1999, 15:89鈥?5. CrossRef - 作者单位：Philippe Gillet (1)
Jessica Maltha (2)
Veerle Hermans (1)
Raffaella Ravinetto (3)
Cathrien Bruggeman (4)
Jan Jacobs (1) (2)
1. Department of Clinical Sciences, Institute of Tropical Medicine (ITM), Unit of Tropical Laboratory Medicine, Nationalestraat 155, B 2000, Antwerp, Belgium
2. Faculty of Health, Medicine and Life Sciences (FHML), Maastricht, The Netherlands
3. Clinical Trials Unit, Institute of Tropical Medicine (ITM), Antwerp, Belgium
4. Department of Medical Microbiology, School for Public Health and Primary Care: CAPHRI, Maastricht University Medical Center, Maastricht, The Netherlands
文摘
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.