Research article summary (published 13 Sep 2009):

Diagnostic performance of rapid diagnostic tests versus blood smears for malaria in US clinical practice.

Full Abstract

BACKGROUND: Approximately 4 million US travelers to developing countries are ill enough to seek health care, with 1500 malaria cases reported in the United States annually. The diagnosis of malaria is frequently delayed because of the time required to prepare malaria blood films and lack of technical expertise. An easy, reliable rapid diagnostic test (RDT) with high sensitivity and negative predictive value (NPV), particularly for Plasmodium falciparum, would be clinically useful. The objective of this study was to determine the diagnostic performance of a RDT approved by the US Food and Drug Administration compared with traditional thick and thin blood smears for malaria diagnosis. METHODS: This prospective study tested 852 consecutive blood samples that underwent thick and thin smears and blinded malaria RDTs at 3 hospital laboratories during 2003-2006. Polymerase chain reaction verified positive test results and discordant results. RESULTS: Malaria was noted in 95 (11%) of the 852 samples. The RDT had superior performance than the standard Giemsa thick blood smear (p = .003). The RDT's sensitivity for all malaria was 97% (92 of 95 samples), compared with 85% (81 of 95) for the blood smear, and the RDT had a superior NPV of 99.6%, compared with 98.2% for the blood smear (p = .001). The P. falciparum performance was excellent, with 100% rapid test sensitivity, compared with only 88% (65 of 74) by blood smear (p = .003). CONCLUSIONS: This operational study demonstrates that the US Food and Drug Administration-approved RDT for malaria is superior to a single set of blood smears performed under routine US clinical laboratory conditions. The most valuable clinical role of the RDT is in the rapid diagnosis or the exclusion of P. falciparum malaria, which is particularly useful in outpatient settings when evaluating febrile travelers.

Author information

Author/s: Stauffer, William M (WM); Cartwright, Charles P (CP); Olson, Douglas A (DA); Juni, Billie Anne (BA); Taylor, Charlotte M (CM); Bowers, Susan H (SH); Hanson, Kevan L (KL); Rosenblatt, Jon E (JE); Boulware, David R (DR);

Affiliation: Department of Medicine, Division of Infectious Diseases and International Medicine, University of Minnesota, Minneapolis, Minnesota 55455, USA. stauf005(-atsign-)umn.edu

Grants: K12RR023247 (Agency:NCRR NIH HHS) ; L30 AI066779-03 (Agency:NIAID NIH HHS) ; L30AI066779 (Agency:NIAID NIH HHS) ; T32-AI055433 (Agency:NIAID NIH HHS)

Journal and publication information

Publication Type: Comparative Study; Journal Article; Research Support, N.I.H., Extramural

Journal: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America (Clin Infect Dis), published in United States. (Language: eng)

Reference: 2009-Sep; vol 49 (issue 6) : pp 908-13

Dates: Created 2009/08/21; Completed 2009/11/05;

PMID: 19686072, status: MEDLINE (last retrieval date: 11/5/2009, IMS Date: )

Sourced from the National Library of Medicine. Abstract text and other information may be subject to copyright.

External Links for this article
(including full text providers, if available):

Click Electronic Full-text Provider Links to see options for finding the electronic full text links to this article. Note there may be a subscription or fee required for access to the full text. See our FAQ for information on finding FREE full text articles.

This article may also be located in paper journal collections available in many libraries. Use the Journal and Publication Information above to find the full article.

MeSH headings (categories)

This article was linked to the MESH Headings shown below.

Adolescent Adult Aged Animals Antibodies, Monoclonal Antigens, Protozoan - blood Child Child, Preschool Female Fructose-Bisphosphate Aldolase - blood; metabolism Hematologic Tests Humans Infant Malaria - blood; diagnosis Malaria, Falciparum - blood; diagnosis

Malaria, Falciparum - blood; diagnosis Male Middle Aged Parasitemia - diagnosis Plasmodium - enzymology; isolation & purification Polymerase Chain Reaction Predictive Value of Tests Prospective Studies Protozoan Proteins - blood Reagent Kits, Diagnostic Sensitivity and Specificity Travel United States United States Food and Drug Administration Young Adult

Associated Chemicals: Antibodies, Monoclonal (0) ; Antigens, Protozoan (0) ; Protozoan Proteins (0) ; Reagent Kits, Diagnostic (0) ; Fructose-Bisphosphate Aldolase (EC 4.1.2.13)

Related articles

These are the highest related articles currently in the database:

• Accuracy and reliability of malaria diagnostic techniques for guiding febrile outpatient treatment in malaria-endemic countries. 30 Jan 2008
• Evaluation of OptiMAL Assay test to detect imported malaria in Italy. 29 Sep 2000
• A comparison of two rapid field immunochromatographic tests to expert microscopy in the diagnosis of malaria. 30 Mar 2002
• Evaluation of a new Plasmodium lactate dehydrogenase assay (OptiMAL-IT) for the detection of malaria. 30 Oct 2003
• Development of a single tube hemi-nested PCR for genus-specific detection of Plasmodium in oligoparasitemic patients. 29 Sep 2004
• The usefulness of a new rapid diagnostic test, the First Response Malaria Combo (pLDH/HRP2) card test, for malaria diagnosis in the forested belt of central India. 9 Jul 2008
• Rapid diagnostic tests for malaria parasites. 30 Dec 2001
• Diagnosis of malaria using thick bloodsmears: definition and evaluation of a faster protocol with improved readability. 27 Feb 2002
• Evaluation of the ICT malaria P.f/P.v and the OptiMal rapid diagnostic tests for malaria in febrile returned travellers. 30 Oct 2002
• [Serum HRP-2 antigens and imported Plasmodium falciparum malaria: comparison of ParaSight-F and ICT malaria P.f.] 30 Dec 1996

See 100+ related articles.

Related Article Map

Legend: - FREE Full text Article. - Abstract only. - Title only. More help.

See a large map of 100+ related articles.