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Chapter 42 : Rapid Point-of-Care Diagnosis of Malaria and Dengue Infection

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Abstract:

Malaria and dengue are both mosquito-borne diseases and are endemic in many subtropical and (sub)tropical regions (1, 2). They have a major impact on public health, and prompt diagnosis is important in endemic settings as well as in travel medicine. Early diagnosis, timely treatment, and case management prevent severe disease and complications (3, 4). Point-of-care (POC) (or bedside) testing offers timely diagnosis in the acute phase of infection for both diseases (5–7), and the POC diagnostics used are mostly referred to as “rapid diagnostic tests” (RDTs). Over 20 definitions are given for POC (8), but most essentially, RDTs should comply with certain diagnostic and performance criteria and—because they are deployed in endemic and low-resource settings—meet the ASSURED criteria (affordable, sensitive, specific, user-friendly, rapid and robust, equipment-free, and delivered) (9).

Citation: Cnops L, Van Esbroeck M, Jacobs J. 2016. Rapid Point-of-Care Diagnosis of Malaria and Dengue Infection, p 589-609. In Persing D, Tenover F, Hayden R, Ieven M, Miller M, Nolte F, Tang Y, van Belkum A (ed), Molecular Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555819071.ch42
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Image of FIGURE 1
FIGURE 1

Areas at risk of dengue infection (14). Reprinted from the ( ) with permission of the publisher.

Citation: Cnops L, Van Esbroeck M, Jacobs J. 2016. Rapid Point-of-Care Diagnosis of Malaria and Dengue Infection, p 589-609. In Persing D, Tenover F, Hayden R, Ieven M, Miller M, Nolte F, Tang Y, van Belkum A (ed), Molecular Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555819071.ch42
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Image of FIGURE 2
FIGURE 2

Timing of diagnostic tests in a primary dengue infection. Reprinted from reference with permission of the publisher.

Citation: Cnops L, Van Esbroeck M, Jacobs J. 2016. Rapid Point-of-Care Diagnosis of Malaria and Dengue Infection, p 589-609. In Persing D, Tenover F, Hayden R, Ieven M, Miller M, Nolte F, Tang Y, van Belkum A (ed), Molecular Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555819071.ch42
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Image of FIGURE 3
FIGURE 3

Different RDT formats (malaria rapid diagnostic tests). From left to right: cassette; dipstick; auto-transfer cassette (in which the nitrocellulose strip is uncovered at the indentation and can be applied directly to the blood); hybrid format.

Citation: Cnops L, Van Esbroeck M, Jacobs J. 2016. Rapid Point-of-Care Diagnosis of Malaria and Dengue Infection, p 589-609. In Persing D, Tenover F, Hayden R, Ieven M, Miller M, Nolte F, Tang Y, van Belkum A (ed), Molecular Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555819071.ch42
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Image of FIGURE 4
FIGURE 4

Inside view of a malaria RDT cassette showing the nitrocellulose strip with the specimen/buffer pad (left), conjugate pad (red because of the colloidal gold), and absorption pad (right). Note that the cassette has a single specimen (sample)/buffer well.

Citation: Cnops L, Van Esbroeck M, Jacobs J. 2016. Rapid Point-of-Care Diagnosis of Malaria and Dengue Infection, p 589-609. In Persing D, Tenover F, Hayden R, Ieven M, Miller M, Nolte F, Tang Y, van Belkum A (ed), Molecular Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555819071.ch42
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Image of FIGURE 5
FIGURE 5

Schematic representation of the two-band malaria RDT targeting HRP2 antigen. Only the nitrocellulose membrane is displayed. This membrane is glued to a plastic backing. The sequence of events is as follows: (i) whole blood is applied to the specimen (sample) well and is absorbed by the specimen (sample) pad. (ii) Buffer is applied to the buffer well and is absorbed by the buffer pad. (iii) Migration of the blood/buffer mixture starts toward the opposite end of the membrane (attracted by the absorption pad). (iv) The blood-buffer mixture passes the conjugate pad, which contains detection antibodies directed to the target. These detection antibodies are conjugated to colloidal gold. If present in the specimen, the target antigen binds to this detection antibody-conjugate. (v) The antigen-antibody-conjugate complex migrates farther and binds to the capture antibodies present on the test line. These capture antibodies bind to another site (epitope) of the target antigen. (vi) The capture antibodies are applied on a narrow section of the test strip: as a result, the antibody-conjugate with the colloidal gold will be concentrated and become visible as a red line. (vii) The excess of the detection antibody-conjugate that was not bound by the target antigen and the capture antibodies moves farther until it binds to a goat antimouse control antibody. There, the colloidal gold will create a colored control line.

Citation: Cnops L, Van Esbroeck M, Jacobs J. 2016. Rapid Point-of-Care Diagnosis of Malaria and Dengue Infection, p 589-609. In Persing D, Tenover F, Hayden R, Ieven M, Miller M, Nolte F, Tang Y, van Belkum A (ed), Molecular Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555819071.ch42
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Image of FIGURE 6
FIGURE 6

Specimen (blood) transfer devices. Most malaria RDTs require only 5 or 10 µl of whole blood. The depicted devices include pipettes, straws and capillaries (some of which are very tiny), a loop (at 8 o'clock) and an inverted cup (at 11 o'clock). Some devices have no volume mark.

Citation: Cnops L, Van Esbroeck M, Jacobs J. 2016. Rapid Point-of-Care Diagnosis of Malaria and Dengue Infection, p 589-609. In Persing D, Tenover F, Hayden R, Ieven M, Miller M, Nolte F, Tang Y, van Belkum A (ed), Molecular Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555819071.ch42
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Image of FIGURE 7
FIGURE 7

Lancets for capillary blood samples. Plain metal lancets (below, in paper packaging), “safety-seal” lancets (upper right, blue; the plastic cap has to be unscrewed to free the lancet's point), auto-retractable lancets (upper left).

Citation: Cnops L, Van Esbroeck M, Jacobs J. 2016. Rapid Point-of-Care Diagnosis of Malaria and Dengue Infection, p 589-609. In Persing D, Tenover F, Hayden R, Ieven M, Miller M, Nolte F, Tang Y, van Belkum A (ed), Molecular Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555819071.ch42
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Image of FIGURE 8
FIGURE 8

A dengue duo cassette for combined antigen-antibody detection. (Left) An acute-phase serum sample positive for NS1 and dengue IgM. (Right) Serum that is positive for dengue IgM only.

Citation: Cnops L, Van Esbroeck M, Jacobs J. 2016. Rapid Point-of-Care Diagnosis of Malaria and Dengue Infection, p 589-609. In Persing D, Tenover F, Hayden R, Ieven M, Miller M, Nolte F, Tang Y, van Belkum A (ed), Molecular Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555819071.ch42
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Image of FIGURE 9
FIGURE 9

Two- and three-band malaria RDT (above and below, respectively) run with whole blood from a patient infected with . Control and test lines are visible as cherry-red lines. The three-band test shows a visible test line for the “P.f” () target antigen as well as for the “Pan” antigen (in this case pan- lactate dehydrogenase, reacting with all four common species).

Citation: Cnops L, Van Esbroeck M, Jacobs J. 2016. Rapid Point-of-Care Diagnosis of Malaria and Dengue Infection, p 589-609. In Persing D, Tenover F, Hayden R, Ieven M, Miller M, Nolte F, Tang Y, van Belkum A (ed), Molecular Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555819071.ch42
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Image of FIGURE 10
FIGURE 10

Shortcomings of quality in design, construction, and labeling of RDT components and accessories. (A) Non-humidity-proof label poorly glued to the RDT box. (B) Incorrectly packed lancet: point is directed to the end opposite to what is indicated on the package). (C) Poor-quality cardboard RDT box; temperature symbols are not internationally recognized; symbol below is over-written by hand. (D) Terminology: simultaneous use of different terms: “clearing buffer” and “blood buffer.”

Citation: Cnops L, Van Esbroeck M, Jacobs J. 2016. Rapid Point-of-Care Diagnosis of Malaria and Dengue Infection, p 589-609. In Persing D, Tenover F, Hayden R, Ieven M, Miller M, Nolte F, Tang Y, van Belkum A (ed), Molecular Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555819071.ch42
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Image of FIGURE 11
FIGURE 11

Examples of design and labeling of malaria RDT cassettes: different shapes and surface structure (with embossments in the plastic housing impeding writing the patient's name), reading legends as printed symbols displaying the species targeted versus embossed universal characters (T and C). Some cassettes have double reading scales. The second cassette from the left has a large evaporation hole (labeled “lysis”) which may be mistaken for the specimen well.

Citation: Cnops L, Van Esbroeck M, Jacobs J. 2016. Rapid Point-of-Care Diagnosis of Malaria and Dengue Infection, p 589-609. In Persing D, Tenover F, Hayden R, Ieven M, Miller M, Nolte F, Tang Y, van Belkum A (ed), Molecular Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555819071.ch42
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Image of FIGURE 12
FIGURE 12

Shortcomings in instructions for use of malaria RDTs that detract from user-friendliness. (Top left) Shows sampling without gloves. (Top right) Left-handed application of the sample. (Bottom) Depicted cassette is different from the actual cassette (photograph below): evaporation holes are missing and labeling at the distal end is not displayed on the cassette; the reading legend at the reading window is shown on the opposite side. On the photo, note the double reading legend (printed characters as well as “C” and “T” characters embossed in the plastic housing.

Citation: Cnops L, Van Esbroeck M, Jacobs J. 2016. Rapid Point-of-Care Diagnosis of Malaria and Dengue Infection, p 589-609. In Persing D, Tenover F, Hayden R, Ieven M, Miller M, Nolte F, Tang Y, van Belkum A (ed), Molecular Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555819071.ch42
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