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

Abstract

BackgroundThe 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.MethodsCriteria 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.ResultsForty-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.ConclusionOverall, 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.

The Comparison of Microscopic Method and Rapid Diagnostic Test in Detecting Plasmodium species

“…Due to the quality of the kit manufacturers, the difference could be seen because the used kit in this study was made in china; therefore, more attention should be paid to the selection of high quality kit. Bell et al study on the stability level of RDTs revealed that PLDH and aldolase were less stable in comparison to PfHRP-2 in terms of temperature rise and they lost their sensitivity rapidly in the uncontrollable conditions (7)(8)(9). Since the present study was performed in tropical areas, the results might be different in sensitivity of considered tests with similar studies conducted on the mentioned subject.…”

“…The RDTs are based on immune chromatography, P. falciparum-specific histidine rich protein 2 (pfHRP-2), and solubility in water and can identify the type of P. falciparum. In addition, Plasmodium lactate dehydrogenase (PLDH) is produced in sexual and nonsexual stages in all Plasmodium species (4)(5)(6)(7)(8)(9). RDTs have some limitations such as low sensitivity in people who have no clinical symptoms, positive tests in a large number of people due to incomplete treatment, no distinction between non-falciparum species in mixed infections, and absence of various stages of parasite identification in blood, which limit the use of RDTs in research work.…”

Laboratory Diagnosis of Malaria: Conventional and Rapid Diagnostic Methods

“…3,4 Even today, in many countries regulatory oversight of manufacturing continues to be inadequate or lacking altogether, and there remain serious concerns about the quality of many of these products. 5 Nonetheless, a wide variety of test methods are available commercially: WHO estimates that there are at least 60 brands offering more than 200 commercial MRDTs worldwide. 6 …”

Rapid Diagnostic Tests for Neglected Infectious Diseases: Case Study Highlights Need for Customer Awareness and Postmarket Surveillance

“…For example, in a study of 42 different malaria RDTs, shortcomings were found at the level of devices, buffers, packaging, labelling, and IFU [12]. For malaria and other frequent infections such as HIV and hepatitis B and C, WHO has taken a leading role in quality assurance of IVDs through prequalification and guidance on postmarket surveillance [6, 7, 11].…”