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Rapid Antigen Detection Tests and Possible Implications For Self-Diagnostic Use 2003 s1477-8939 (03) 00037-1
Rapid Antigen Detection Tests and Possible Implications For Self-Diagnostic Use 2003 s1477-8939 (03) 00037-1
www.elsevierhealth.com/journals/tmid
a
Department of Infectious Diseases, Charité, Humboldt University, Berlin, Germany
b
Department of Parasitology, Institute of Tropical Medicine, Eberhard Karls University, Wilhelmsstr.
27, D-72074 Tuebingen, Germany
c
Lab. Microbiologia, Instituto de Medicina Molecular, Faculdade de Medicina de Lisboa, Portugal
Received 11 February 2003; received in revised form 21 March 2003; accepted 24 March 2003
KEYWORDS Summary In a prospective study amongst febrile travellers returning from malaria-
Malaria; Diagnosis; Self- endemic areas to Berlin, Germany, two rapid malarial antigen detection tests were
diagnosis; Rapid antigen compared for the diagnosis of vivax malaria with routine microscopy. With ICT Malaria
detection; P. vivax P.f./P.v.w, 664 samples of 492 patients were examined. 17 patients had vivax malaria,
out of which 11 infections were missed (35.3% sensitivity). With OptiMalw, 659 samples
of 539 patients were examined. 22 patients had vivax malaria, and all infections were
identified correctly (100% sensitivity). Specificity was 100% with both tests. The ICT
Malaria P.f./P.v.w is advertised for layman use during travel, and the literature was
reviewed with respect to the question of suitability of these devices for self-testing. It
is concluded that with the ICT Malaria P.f./P.v.w, the detection of non-falciparum (i.e.
predominantly vivax) malaria is unreliable, and test interpretation for medically
untrained individuals particularly in distress might be too complicated even after
proper instruction.
Q 2003 Elsevier Ltd. All rights reserved.
1477-8939/03/$ - see front matter Q 2003 Elsevier Ltd. All rights reserved.
doi:10.1016/S1477-8939(03)00037-1
120 M.P. Grobusch et al.
Test ntotal of n ptsa n micr.b n micr. non-vivax P. vivax Correct RDTc sens.d
samples tested neg. pos. Pl. spp. for P. vivax (%)
combined written and oral instructions.6 With better adapted to laboratory use. However, that
only 70.6% correct results, the interpretation of might change with the cassette format intro-
pre-prepared tests was regarded as unsatisfying. duced recently, for which published sensitivity
An accomplishing comparative study between data and handling experience is, to our knowl-
ParaSight-Fw and MalaQuickw (identical with ICT edge, not yet at hand.
Malaria P.f.w) 164 participants in total yielded no Apart from technical problems directly inherent
significant difference regarding self-testing with to these tests and those related to their handling as
both systems.7 Regarding test interpretation of described above in detail, the most profound
pre-prepared tests, both test systems were problem with layman use of a test for malaria is
associated with unacceptably high levels of probably that it seeks to diagnose only one of many
false-negative interpretations. In an investigation possible causes of fever, and it would need a very
of 98 European tourists with febrile disease in intelligent and well informed traveller to put the
Kenya under field conditions, only 68% of patients information obtained from the test result in a useful
were able to complete the MalaQuickw correctly. context.
Most important, 10 of 11 patients with micro- In conclusion, rapid malarial antigen detection
scopically confirmed falciparum malaria were tests are a useful adjuvant diagnostic tool provided
unable to self-diagnose their condition by rapid that their drawbacks are understood, and that
testing. The authors concluded that a consider- variations in their antigen detection capacity are
able proportion of patients might be too sick to taken into account. With the ICT Malaria P.f./P.v.w,
obtain a correct diagnosis and subsequently, to the detection of non-falciparum (which is predomi-
start standby-emergency malaria treatment by nantly vivax) malaria is unreliable. Although simple
themselves.8 In contrast, in a prospective UK to carry out, test interpretation for medically
study with 153 febrile returning travellers, only untrained individuals particularly if in distress
14 (9%) failed to carry out a valid MalaQuickw might be too complicated even after comprehensive
test on presentation, using an improved test and thoughtful instruction.
instruction leaflet based on feedback from earlier
test persons. Most importantly, all 22 patients
with microscopically confirmed falciparum
malaria successfully completed self-testing.9 The Acknowledgements
authors argued that differences in the various
studies were possibly due to poor quality of the We thank S. Schwenke and C. Acar, Department of
instructions provided. They concluded that a Infectious Diseases, Charité, Berlin, Germany, for
more user-friendly kit could possibly be technical assistance.
implemented correctly by travellers
without additional instruction and training. The
importance of a correct diagnosis of falciparum
malaria is under most circumstances of greater References
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