Skip to main content
main-content

01.12.2012 | Research | Ausgabe 1/2012 Open Access

Malaria Journal 1/2012

Assessment of desiccants and their instructions for use in rapid diagnostic tests

Zeitschrift:
Malaria Journal > Ausgabe 1/2012
Autoren:
Barbara Barbé, Philippe Gillet, Greet Beelaert, Katrien Fransen, Jan Jacobs
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​1475-2875-11-326) contains supplementary material, which is available to authorized users.

Competing interests

The authors declare that they have no competing interests.

Author’s contributions

BB, PG and JJ designed the study protocol, PG, GB and KF organized sample collection. BB, PG and GB carried out the RDT test evaluations, BB, PG and JJ analyzed and interpreted the results. BB, PG and JJ drafted the manuscript. “All authors critically reviewed the manuscript and approved the final manuscript.”

Abstract

Background

Malaria rapid diagnostic tests (RDTs) are protected from humidity-caused degradation by a desiccant added to the device packaging. The present study assessed malaria RDT products for the availability, type and design of desiccants and their information supplied in the instructions for use (IFU).

Methods

Criteria were based on recommendations of the World Health Organization (WHO), the European Community (CE) and own observations. Silica gel sachets were defined as self-indicating (all beads coated with a humidity indicator that changes colour upon saturation), partial-indicating (part of beads coated) and non-indicating (none of the beads coated). Indicating silica gel sachets were individually assessed for humidity saturation and (in case of partial-indicating silica gels) for the presence of indicating beads.

Results

Fifty malaria RDT products from 25 manufacturers were assessed, 14 (28%) products were listed by the “Global Fund Quality Assurance Policy” and 31 (62%) were CE-marked. All but one product contained a desiccant, mostly (47/50, 94%) silica gel. Twenty (40%) RDT products (one with no desiccant and 19 with non-indicating desiccant) did not meet the WHO guidelines recommending indicating desiccant. All RDT products with self- or partial-indicating silica gel (n = 22 and 8 respectively) contained the toxic cobalt dichloride as humidity indicator. Colour change indicating humidity saturation was observed for 8/16 RDT products, at a median incidence of 0.8% (range 0.05%-4.6%) of sachets inspected. In all RDTs with partial-indicating silica gel, sachets with no colour indicating beads were found (median proportion 13.5% (0.6% - 17.8%) per product) and additional light was needed to assess the humidity colour. Less than half (14/30, 47%) IFUs of RDT products with indicating desiccants mentioned to check the humidity saturation before using the test. Information on properties, safety hazards and disposal of the desiccant was not included in any of the IFUs. There were no differences between Global Fund-listed and CE marked RDT products compared to those which were not. Similar findings were noted for a panel of 11 HIV RDTs that was assessed with the same checklist as the malaria RDTs.

Conclusion

RDTs showed shortcomings in desiccant type and information supplied in the IFU.
Zusatzmaterial
Additional file 1: List of malaria RDT products that were assessed. (XLSX 13 KB)
12936_2012_2471_MOESM1_ESM.xlsx
Authors’ original file for figure 1
12936_2012_2471_MOESM2_ESM.pdf
Authors’ original file for figure 2
12936_2012_2471_MOESM3_ESM.jpeg
Authors’ original file for figure 3
12936_2012_2471_MOESM4_ESM.jpeg
Authors’ original file for figure 4
12936_2012_2471_MOESM5_ESM.pdf
Literatur
Über diesen Artikel

Weitere Artikel der Ausgabe 1/2012

Malaria Journal 1/2012 Zur Ausgabe

Neu im Fachgebiet Innere Medizin

Meistgelesene Bücher aus der Inneren Medizin

2017 | Buch

Rheumatologie aus der Praxis

Entzündliche Gelenkerkrankungen – mit Fallbeispielen

Dieses Fachbuch macht mit den wichtigsten chronisch entzündlichen Gelenk- und Wirbelsäulenerkrankungen vertraut. Anhand von über 40 instruktiven Fallbeispielen werden anschaulich diagnostisches Vorgehen, therapeutisches Ansprechen und der Verlauf …

Herausgeber:
Rudolf Puchner

2016 | Buch

Ambulant erworbene Pneumonie

Was, wann, warum – Dieses Buch bietet differenzierte Diagnostik und Therapie der ambulant erworbenen Pneumonie zur sofortigen sicheren Anwendung. Entsprechend der neuesten Studien und Leitlinien aller wichtigen Fachgesellschaften.

Herausgeber:
Santiago Ewig

Mail Icon II Newsletter

Bestellen Sie unseren kostenlosen Newsletter Update Innere Medizin und bleiben Sie gut informiert – ganz bequem per eMail.

© Springer Medizin 

Bildnachweise