Malaria Diagnostic

For the diagnosis of malaria infection

Diagnostic
Diagnostic
  • PREVENTION
  • DIAGNOSTIC
  • TREATMENT
  • OVERVIEW
  • TECHNOLOGY Characteristics
  • Malaria Diagnostic
    Representative Product

    GLOBAL ANNUAL DEATHS ASSOCIATED WITH MALARIA

    PERCENT (%)
    NUMBER

    Maternal

    *
    *

    Neonatal

    1%
    30,000

    Stillbirth

    *
    *

     

    Condition:

    Globally, there are over 200 million annual cases of malaria causing an estimated 660,000 deaths. Malaria accounts for about one quarter of non-neonatal childhood mortality and is the greatest disease burden in Africa in disability adjusted life years.


    Mechanism of Action:
    Malaria is detected through two broad strategies: microscopy and antigen tests.

    Microscopy can diagnose malaria through skilled examination of either thin or thick film samples of blood. A small sample, ~1ml, of blood is taken from the patient and examined under a microscope. This test can diagnose malaria parasites down to concentrations of 20 parts per microliter. Furthermore, the test can cost less than $0.50 in some facilities in the right conditions with high throughputs.

     

    Rapid Diagnostic Tests (RDTs), on the other hand, are point-of-care tests. Costing $0.60-$2.50, an RDT can be used in clinics and by community health workers. RDTs react to antigens found in the blood of a person infected with malaria. A particular RDT will respond only to certain strains of malaria infection and so must be chosen for the region.


    Current use in High-Resource Settings:
    The standard diagnostic in high-resource settings is a microscopy based test done in a laboratory setting. RDT's are seldom used, as malaria is uncommon in these settings.


    Current Use in Low-Resource Settings:

    Both microscopy and RDTs are common in low income contexts. Microscopy has been the standard of care, though issues with microscope reliability, technical skill, and laboratory turnaround time are problematic in many locations.

     

    Rapid diagnostic tests are increasingly common. The tests are inexpensive and do not require specialized training. However, the proliferation of different tests requires diligence to ensure that the selected test is appropriate, accurate, and stored in a way in which its effectiveness will be maintained. The WHO has carried out interventions using RDTs and found many of them appropriate and effective.

    REPRESENTATIVE RAPID DIAGNOSTIC TEST

    MAKE
    MODEL
    PRICE
    STATUS

    Carestart

    Malaria pLDH (PAN) G0111
    $0.60-$2.50
    Marketed

    Advantage

    Malaria Card IR013025
    $0.60-$2.50
    Marketed

    SD

    BIOLINE Malaria Ag P.f/PAN
    $0.70
    Marketed

    BIONOTE

    MALARIA P.f. & P.v. Ag Rapid Test Kit RG19-12
    $0.60-$2.50
    Marketed

    * Prices are approximated. Actual pricing can, and will vary by marketplace and market conditions.

  • CHARACTERISTICS OF REPRESENTATIVE PRODUCT

    TECHNOLOGY CHARACTERISTICS

    OPERATIONAL PARAMETERS

    POTENTIAL OPPORTUNITIES FOR IMPROVEMENT

    SKILLS

    REQUIRED

    Intended end user
    Training required
    Time required per use
    Community health worker
    <1 hour
    <10 minutes

    ENVIRONMENT/ INFRASTRUCTURE

    Power required
    Waste collection
    Complementary technologies required
    Temperature and storage
    Maintenance
    None
    <10 g biological waste
    Needle prick: sterile needle, antiseptic.
    Varies by test
    None

    The thermal stability of the tests is one of the most promising areas for improvement. Besides accuracy, this is the primary aspect of the diagnostic which the WHO examines when assessing a rapid malaria diagnostic.

    COST

    Device cost (approximate)
    Cost/course (approximate)
    $0.60-$2.50
    $0.60-$2.50

    OTHER

    Portability
    Regulatory
    Efficacy
    <50g
    Some RDTs approved by the FDA
    Some RDTs have specificity and sensitivity over 90%

    For this test to be part of a successful intervention, it must be paired with effective and appropriate treatment methods.

Sources: The Role of Laboratory Diagnosis to Support Malaria Disease Management, WHLO http://www.who.int/malaria/publications/atoz/reportlabdiagnosis-web.pdf http://www.finddiagnostics.org/export/sites/default/resource-centre/reports_brochures/docs/RDTMalariaRd3_web.pdf http://whqlibdoc.who.int/publications/2008/9789241563697_eng.pdf Abba K, Deeks JJ, Olliaro PL, Naing CM, Jackson SM, Takwoingi Y, Donegan S, Garner P. Rapid diagnostic tests for diagnosing uncomplicated P. falciparum malaria in endemic countries. Cochrane Database of Systematic Reviews 2011, Issue 7. Art. No.: CD008122. DOI: 10.1002/14651858.CD008122.pub2.