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. 2016 Nov 3;10(11):e0004655.
doi: 10.1371/journal.pntd.0004655. eCollection 2016 Nov.

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

Barbara Barbé  1 , Kristien Verdonck  1 , Sayda El-Safi  2 , Basudha Khanal  3 , Syna Teav  4 , Jean-Roger Lilo Kalo  5 , Raffaella Ravinetto  1   6 , François Chappuis  7 , Marleen Boelaert  1 , Jan Jacobs  1   8
Affiliations

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

Barbara Barbé et al. PLoS Negl Trop Dis. .
No abstract available

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Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1
Fig 1. Cassettes and buffer bottles from different products but indistinguishable from each other.
Fig 2
Fig 2
Above: Rapid diagnostic test with correct lateral flow and timely migration of sample/buffer mixture. Below: Rapid diagnostic test with blocked lateral flow and no or delayed migration. The sample/buffer mixture is not flowing through the test strip but is staying behind in the sample well. This is considered as an invalid result.
Fig 3
Fig 3. Two successive versions of the instructions for use of a rapid diagnostic test (most recent version on the right).
The change in reading time (indicated with a red arrow on the picture) was not communicated to the user in writing, by an alert on the box, or through a new version number, “track changes,” or a revision history of the instructions for use. Only the date of issue of the instructions for use had changed.
See this image and copyright information in PMC

References

    1. Chappuis F, Alirol E, d'Acremont V, Bottieau E, Yansouni CP. Rapid diagnostic tests for non-malarial febrile illness in the tropics. Clin Microbiol Infect. 2013. May;19(5):422–31. 10.1111/1469-0691.12154 - DOI - PubMed
    1. Yansouni CP, Bottieau E, Lutumba P, Winkler AS, Lynen L, Büscher P, et al. Rapid diagnostic tests for neurological infections in central Africa. Lancet Infect Dis. 2013. June;13(6):546–58. 10.1016/S1473-3099(13)70004-5 - DOI - PubMed
    1. World Health Organization. Medical device regulations. Global overview and guiding principles WHO Press, World Health Organization, Geneva, Switzerland, 2003.
    1. Technical Committee ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems, International Organization for Standardization. Medical laboratories—Requirements for quality and competence. ISO 15189:2012.
    1. Technical Committee ISO/TC 210, Quality management and corresponding general aspects for medical devices, International Organization for Standardization. Medical devices—Quality management systems—Requirements for regulatory purposes. ISO 13485:2003.

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