Gl o ba l M a laria Programme

Malaria rapid
diagnostic test
products
Suggested use of terms,
requirements and preferences for
labelling and instructions for use
© World Health Organization 2017

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WHO/HTM/GMP/2017.16
Table of contents

Introduction 1

Suggested use of terms 2

WHO requirements and preferences for the labelling of malaria

RDT kit components: box, cassette packaging, cassette,
buffer bottle and accessories 8
Labelling of the RDT box 9
Labelling of kit contents 12
Labelling of the cassette 14
Labelling of the buffer bottle 16
Labelling of accessories 17

WHO suggested generic template for

Instructions for Use (IFU) 19

Annexes 32
2
Introduction

Rapid diagnostic tests (RDTs) largely account for the scale-up of malaria diagnosis
in endemic settings. However, diversity in terminology, labelling and the instructions
for use (IFU) limits their interchangeability and userfriendliness. Uniform, easy to
follow and consistent terminology and labelling, aligned with international standards
and appropriate for the level of the end user’s education and training, is crucial. This
document is intended as a reference for malaria RDT manufacturers and follows on
from the consensus building efforts of a 2014 Roll Back Malaria Partnership stakeholder
consultation and special taskforce to harmonize terms and abbreviations as well
as specifications for labelling of box, device packaging, cassettes, buffer bottle and
accessories.1 Specifically, this reference indicates if WHO considers these specifications
are requirements based on international standards or preferences based on the
outcome of consultations with country programme implementers, experts in RDT
implementation, IVD regulatory experts and manufacturers. These requirements
and preferences are aligned with those of the WHO Prequalification (PQ) of IVDs
programme and compliance will be monitored through the dossier and laboratory
evaluation components of the WHO PQ process.2

suggested use of terms, requirements and preferences for labelling and instructions for use
Malaria rapid diagnostic test products

1 Jacobs et al. Malaria Journal 2014, 13:505.

2 http://www.who.int/malaria/publications/atoz/978924151268/en/

1
 Suggested use of terms

2
 Synonym
Preferred term Abbrev. Description Comments Category
(not suggested term)

Accessories Articles intended and validated by the RDT manufacturer Ancillary items The accessories provided might be replaced by
to be used with the RDT in order to achieve its intended other items without compromising safe, accurate
purpose (i.e. specimen transfer device, lancet, alcohol performance of the test, e.g. different lancets
swab)
This possibility of substitution differentiates “accessories”
from “components” (see ‘Component’).
Alcohol swab A pad saturated with alcohol that is used to clean and/or Alcohol pad, alcohol There was consensus that “alcohol swab” is the term in
disinfect skin wipe, alcohol pre-pad broadest use, both in spoken language and in labelling.
Buffer A buffered solution to enable specimen flow and Many synonyms are
conditioning of specimens, to optimize sensitivity and in use, e.g. “blood lysis
minimize non-specific reactions. buffer”, “clearing buffer”,
“assay diluent”, “sample
diluent”, “reagent”
Buffer bottle Plastic bottle, often with cap and nozzle, containing the
buffer, intended to be used in multiple tests
Buffer vial Small vial containing a sufficient volume of buffer to “Buffer ampulla”
perform a single RDT test. See “primary packaging”
Buffer well Physical place in the test device in which the buffer is Some RDTs have a
applied. single well for both
buffer and specimen.
Cassette This is the test format in which the nitrocellulose strip is Commonly referred to
encased in a plastic housing, presenting openings for the as the “device”
result window, for the specimen and buffer well(s) and in
some cases for evaporation.
Combination rapid Test for detecting multiple malaria species and which Commonly referred to
diagnostic test distinguishes P. falciparum from other malaria species as a “combo test”
Component Dedicated parts of a finished, packaged, labelled RDT Note: There can be no substitution for a kit component,
kit that are specific to and necessary for performing the whereas accessories such as a lancet or alcohol swab
RDT. These include the test device, buffer bottle/vial and may be replaced by items that perform the same
instructions for use. function or are purchased separately.
Control line Visible line on the nitrocellulose strip that generally only,
indicates satisfactory migration of buffer a
Desiccant Drying agent used to protect the test device from Silica gel is the most
humidity. These may change colour (self-indicating) to commonly used
indicate humidity saturation. The beads are contained in desiccant for RDT
a transparent, partially transparent or non-transparent products.
fiber pouch.

Malaria rapid diagnostic test products

3
suggested use of terms, requirements and preferences for labelling and instructions for use
4
Synonym
Preferred term Abbrev. Description Comments Category
(not suggested term)

In vitro diagnostic A device, used alone or in combination, intended by http://www.imdrf.org/ Required

medical device the manufacturer for in vitro examination of specimens docs/ghtf/archived/
derived from the human body, solely or principally sg1/technical-docs/
to provide information for diagnosis, monitoring or ghtf-sg1-n045r12-
compatibility. They include reagents, calibrators, control in-vitro-diagnostic-
materials, specimen receptacles, software, related classification-070209.
instruments or apparatus or other articles (International pdf
Medical Devices Regulators forum)
Instructions for use IFU Information provided by the manufacturer to the user “Package insert”, Required
about the intended purpose and proper use of in vitro “instructions leaflet”
diagnostics and any precautions to be taken (GHTF/SG1/
n70:2011)
Job aid(s) Document describing the essential materials to perform “Quick guide”, Refer to the “WHO generic job aids” for an example.
an RDT (i.e. procedure or interpretation) provided apart “pictogram testing
from the IFU, either as a separate leaflet and/or printed procedure”
on the device packaging or in/on the RDT box
Kit Set of components and accessories packed together Required
and intended for using a specific RDT (test device, buffer
bottle, specimen transfer device, lancet, alcohol swab,
instructions for use) (definition adapted from ISO 18113-
1:2009)
Lancet Sharp, needle-like, sterile medical device used to
puncture skin to obtain blood (CLSI H04-A6)
They include:
• plain metal lancets (packed in a single packages for
sterility)
• safety-seal lancets (in plastic housing with a plastic cap)
• auto-lancing lancets (mounted in plastic housing that is
ejected automatically when the plunger is pressed)
• auto-retractable lancets (mounted in plastic housing
that is retracted automatically after puncture)
Lot Defined amount of material with uniform properties that “Batch” Required
has been produced in one process or series of processes
so that it can be expected to be homogeneous (ISO 18113-
1:2009)
 Synonym
Preferred term Abbrev. Description Comments Category
(not suggested term)

Lot number Distinctive set of numbers and/or letters for a kit or “Batch number”, “batch Required
component that specifically identifies a lot and permits code”
tracing of its manufacture, packaging, labelling and
distribution history (ISO 18113-1:2009)
Malaria rapid RDT A collection of reagents and other associated materials for This test is commonly used in the laboratory or in point-
diagnostic test in vitro diagnostics, intended to be used for the qualitative of-care analyses.
and/or quantitative detection of antigens from one or
more species of Plasmodium in a clinical specimen within
a short period, relative to standard laboratory testing
procedures, typically by an immunochromatographic test
method
Manufacturer Any natural or legal person with responsibility for design
and/or manufacture of a medical device with the intention
of making the medical device available for use, under
his or her name, whether the medical device is designed
and/or manufactured by that person him- or herself or on
his or her behalf by another person(s) (GHTF/SG1/N055:
2009 Definitions of the terms “manufacturer”, “authorized
representative”, “distributor” and “importer”)
Plasmodium Antigen b produced by malaria parasites and detected Target, marker, analyte
antigen with RDTs
Plasmodium P “P” is to be used only as the abbreviation of the genus
and in combination with the species name (e.g. P.
ovale) or as part of the abbreviations “Pm, Po, Pv, Pf
and Pvom”; it should not be used alone.
pan- A group of human Plasmodium species: Pf, Pv, Po and Pm
Plasmodium Pf Plasmodium falciparum
falciparum
Plasmodium (or pLDH Plasmodium (or parasite) lactate dehydrogenase In papers and documents, both “parasite” and
parasite) lactate “Plasmodium” lactate dehydrogenase are used. In the
dehydrogenase present context and documents (such as IFU). it would
be better to maintain “Plasmodium”
Plasmodium Pm Plasmodium malariae
malariae
Plasmodium ovale Po Plasmodium ovale
Plasmodium vivax Pv Plasmodium vivax

Malaria rapid diagnostic test products

5
suggested use of terms, requirements and preferences for labelling and instructions for use
6
Synonym
Preferred term Abbrev. Description Comments Category
(not suggested term)

Plasmodium vivax, Pvom Plasmodium vivax, ovale, malariae

ovale, malariae
Point-of-care POCT Testing used at or near the site of patient care, leading to
testing a possible change in the care of the patient (ISO 22870
2006)
Primary packaging Layer of packaging in immediate contact with the item Alcohol swab, lancet, Use “primary packaging” in technical comments
of alcohol swabs, desiccant or cassette for manufacturers (for instance when describing
lancets, desiccant packaging requirements for labelling), and use “packaging
and cassettes of the alcohol swab” or “alcohol swab packaging”
Packaging of alcohol
when addressing users during training and in IFU (for
swab, lancet, desiccant
instance: “open the cassette packaging”).
or cassette
Pouch, sachet
Product RDT as currently marketed and identified, with assigned
name, product code and regulatory version
Product code Unique code identifying one product (or product variant) Catalogue number,
with an assigned name and a regulatory version product number,
reference number
RDT box or Box Physical box, usually made of cardboard, in which the kit Secondary packaging,
contents (components and accessories) are packed kit box
Reading legend Acronyms or characters in the result window, referring Reading scale
to the control and test lines. The characters may be
embossed in the plastic housing or printed on it. The
reading legend can be on either side of the result window.
(Minimum and Interval during which valid results can be obtained
maximum) reading
time
Result window Opening in the test cassette showing the area of the strip Reading window
containing the control and test line(s)
Revision history A table in which amendments are recorded each time a
new version of the IFU is issued
Single pack Kit individually packed with all the content required for the Single test pack,
performance of one test single test, individually
packaged test
Species spp. Species
 Synonym
Preferred term Abbrev. Description Comments Category
(not suggested term)

Specimen well Physical place in the test cassette or dipstick to which the Some malaria RDTs
specimen is applied have a single well for
both specimen and
buffer.
Specimen transfer Device used to transfer blood (or plasma or serum) to Sampling device The term “specimen transfer device” may be shortened
device the test device. This includes: inverted cup, loop, (glass) to “transfer device”.
capillary tube, (plastic) straw, pipette.
Symbol key List of symbols with written explanation (“legend”) Key to symbols
Test line Line on the nitrocellulose strip that is intended to display The term “band” can
the reaction with a specific target antigen (HRP2, pLDH, be used depending on
aldolase) the RDT design (two-,
three- and four-band
RDT products)
Test strip The physical medium, e.g. nitrocellulose, in which the “Test membrane”
migration and reaction take place
Two-, three- and RDTs with two, three or four lines, including the migration
four-band RDTs control line, and one, two or three test lines
User A trained or skilled person, who is competent and who Operator, end-user
uses the RDT
Version number Number given to any labelling, including labels,
instructions for use (or job aids) or any other materials
distributed with the product, to allow tracking of changes.

a. In the case of malaria RDTs, the control line becomes visible if sufficient dye-labelled antibody (carried in the buffer) accumulates on the test strip line containing sufficient, intact bound
capture antibody.
b. Antigens are not recombinant.

Malaria rapid diagnostic test products

7
suggested use of terms, requirements and preferences for labelling and instructions for use
 WHO requirements
and preferences for the
labelling of malaria RDT
kit components
box, cassette packaging, cassette, buffer bottle
and accessories

General note on labelling legibility

There are no international guidelines on font sizes for labels of in-vitro

diagnostics.

• According to the Guideline on the readability of the labelling and

package leaflet of medicinal products for human use, revision 1,
12 January 2009, characters of at least 7 points (or of a size in which the
lower case “x” is at least 1.4 mm in height) with a space between the lines
of at least 3 mm are recommended.*

• The US Food and Drug Administration document Guidance on medical

device patient labelling; final guidance for industry and FDA reviewers
(2001), for patients and lay caregivers, recommends use of at least
12-point type whenever possible and a serif font for text.

*  ttp://ec.europa.eu/health/files/eudralex/vol2/c/2009_01_12_readability_guideline_final_
h
en.pdf

8
Labelling of the RDT box

Orientation

Figure 1.
Convention of terms for the front view of a malaria RDT box

Back

Top

Left Right
(lateral) (lateral)

Front

Bottom

Labelling of the RDT box

• Left (lateral) • Front

• Top • Right (lateral)
• Back • Bottom

suggested use of terms, requirements and preferences for labelling and instructions for use
General requirements and preferred options for labelling
Category
malaria RDT boxes

1. Labels should be printed on the cardboard as permanent printing or Preferred

applied as water-resistant labels (applied with water-resistant glue).
Printing should be indelible and should last the life span of the RDT product.

2. Use only internationally recognized symbols (ISO 15223–2012 or, if Required

applicable, the Globally harmonized system of classification and labelling of
chemicals.1

3. Labelling must be legible, for instance in open letter type and font size Required
equivalent to Miriad bold 10.

4. The official language(s) in which the intended use is displayed should be Preferred
relevant to the region in which the RDT product will be used. In Figure 2,
Malaria rapid diagnostic test products

English, French, Spanish and Portuguese are displayed.

5. Display the essential information on the top (see Figure 2), front and at Preferred
least one lateral side of the RDT box (left or right) (see Figure 3). The
label contains all the relevant information required for stock management
(e.g. product identity, storage conditions and material provided). An
exception can be made for custom or variable prints, such as lot number
and expiration date, and, in case of use, also production date. These can be
printed on only one side of the box.

1. http://www.hse.gov.uk/chemical-classification/labelling-packaging/hazard-symbols-hazard-
pictograms.htm

9
 What should be displayed: Category

1. Product name with sufficient detail for the user to uniquely identify the Required
device and its intended use, e.g.
• commercial name of the RDT product
• “malaria”
• targeted species and antigen(s)
• “antigen” or “Ag”

2. Product code (and symbol) Required

3. Intended use (to be included if the product name does not include Required
sufficiently specific information). If there is insufficient space on the label,
this statement can be included on the IFU: diagnosis of malaria, in vitro
diagnostic, professional use.

4. Number of tests provided in the kit box Required

5. In vitro diagnostic (symbol) Required

6. Name and physical address of the legal manufacturer Required

Telephone and/or fax number and/or website

7. Lot number (and symbol) Required

8. Expiration date (and symbol) Required

Preferred format: YYYY-MM

9. Materials (content) and quantities

9a. • Materials provided, and quantities of each Required
9b. • Items required but not provided, i.e. those items required for safe, Preferred
accurate use of the test, such as a lancet (with symbol)

10. Storage conditions (symbols) Required

11. Warnings or precautions (symbols) Required

For instance: - do not use if package is damaged (symbol)
• read instructions before use (symbol)
• biohazard (symbol), if applicable i.e. desiccant containing cobalt
chloride; buffer with sodium azide concentration (≥0.1%)

12. Additional easily visible warning in case the procedure or IFU has changed Preferred
substantially
Information about the change and effective date should be included as a
separate note in the box or in the IFU

10
Figure 2.
Example label on the top of the RDT box. Blue indicates specific RDT product items

30°C

4°C

Commercial name, Malaria Antigen Pf/Pan (HRP2/ pLDH) RDT

Σ
xxxxxxxxxx xx

Rapid test for the antigen detection of malaria (Plasmodium x)

Test rapide de détection d’antigène du paludisme (Plasmodium x)

Prueba rápida para detección de antígeno de malaria (Plasmodium x)

Teste rápido para detecção de antígeno da malária (Plasmodium x)

Professional use only xxxxxxx

YYYY-MM

Name, physical address

of legal manufacturer,
website, telephone and/or
fax number

Figure 3.
Example labelling of one lateral side and the front of an RDT box. Blue indicates
specific RDT product items

Commercial name, Malaria Antigen Pf/Pan (HRP2/pLDH) RDT

suggested use of terms, requirements and preferences for labelling and instructions for use
xxxxxxxxxxx

Content: XX indicates quantities. Could state xx

number of pouches and what each
pouch contains Σ
• Cassettes (XX) xxxxxxx
• Specimen
• Transfer devices (XX)
• Alcohol swabs (XX)
• Lancets (XX)
Indicate symbol
• Buffer bottle (XX) for method of
• Instructions for use (X) sterilization

Required but • Gloves YYYY-MM

not provided
Malaria rapid diagnostic test products

• Biosafety sharps container

• Biohazard waste container
• Timer
• Pencil/pen

30°C

4°C

11
 Labelling of kit contents

General note

According to ISO 18113-2:2009, in the case of a kit, each component shall be

identified by name, letter, number, symbol, colour or graphics in the same
manner on all labels and in the instructions for use.

Labelling of cassette primary packaging

Category
What should be displayed:

1. Product name with sufficient detail for the user to uniquely identify the Required
product and its intended use, e.g.
• commercial name of the RDT product
• “malaria”
• targeted species and antigen(s)
• “antigen” or “Ag”
Example: Commercial name, Malaria Pf/Pv (HRP2/pLDH) Antigen (RDT)

2. For product code (or symbol) Preferred

3. Intended use (to be included if the product name does not include Required
sufficiently specific information): If there is insufficient space on the label,
this statement can be included on the IFU: diagnosis of malaria, in vitro
diagnostic, professional use only, point-of-care.

4. In vitro diagnostic (symbol) Required

5. Name (or logo) of the legal manufacturer Required

6a. Lot number (and symbol) Required

6b. The lot number is preferably identical to the one on the RDT box. Preferred

7a. Expiration date (and symbol) Required

7b. Preferred format: YYYY-MM
The expiration date is preferably identical to that on the RDT box. The Preferred
expiration date must not be earlier than the expiration date on the RDT box.

8. Quantity of tests per packaging (if more than one test) Preferred

9. Unless there is no space, list contents of packaging and quantities, Preferred

including desiccant

10. Storage conditions (symbols) Required

11. Warnings or precautions (symbols) Required

For instance:
• do not use if package is damaged (symbol)
• read instructions before use (symbol)
• single use (symbol)

12
Where labels should be put:

Display all standard generic information on one side of the packaging and the custom
or variable information (expiration date, lot number) on the opposite side. Preferred

Figure 4.
Example labelling of cassette primary packaging. Blue indicates specific RDT
product items

30°C

4°C

Commercial name, Malaria Antigen Pf/Pan (HRP2/ pLDH) RDT

For product code: XXXXXXX

Σ xx

• 1 cassette
Content: • 1 desiccant
• 1 specimen transfer device

Manufacturer name or logo

xxxxxxx

YYYY-MM

suggested use of terms, requirements and preferences for labelling and instructions for use
Malaria rapid diagnostic test products

13
 Labelling of the cassette

Convention of terms used to describe the orientation of the cassette

Figure 5 shows the most common RDT, a three-band RDT targeting two antigens
(P. falciparum and pan-Plasmodium antigens) in a two-step procedure (add
specimen, next add buffer), with a cassette containing individual specimen and buffer
wells. The following convention of terms is used: proximal (closest to the specimen and
buffer wells) and distal (at the end of the migration [absorption] pad). A vertical view
of the cassette (with the direction of the specimen and buffer flow “upwards”) shows a
right- and a left-hand side.

Figure 5.
Conventions for terms to describe the cassette

Distal
Long axis

Left Right

Proximal

Short axis

14
 Labelling: Category

1. Printing in indelible ink is recommended instead of characters embossed Preferred

in the cassette housing. The test and control line legends and the actual test
lines should be well aligned.

2. All printing should be along the short axis. Preferred

3. A single, unequivocal reading legend should be present on the right-hand Preferred

side of the results window.

4. All abbreviations comply with those listed in document “Abbreviations”. In Preferred

addition, “1” for the sample well, “2” for the buffer well (chronological order)

5. Labelling must be legible: for instance, open letter type, clear print Required

Note: The cassette surface should be of a material (and profile) on which it is

possible to write (with a standard ink pen or pencil). Space should be left for
writing patient identification. Preferred

What should be displayed: Category

1. Product name (with indication of “Malaria”, antigen-based “Ag”, the Required

Plasmodium species and the antigens detected) or logical abbreviation
(referenced in the IFU)

2. Labelled specimen and buffer wells (see above) e.g. “1” for the sample well, Required
“2” for the buffer well (chronological order) – Preferred

3. Reading legend with Plasmodium species detected (see abbreviations: Pf, Preferred
pan, Pv)

suggested use of terms, requirements and preferences for labelling and instructions for use
Malaria rapid diagnostic test products

15
 Labelling of the buffer bottle

General requirements and outlines for labelling RDT buffer bottles: Category

1. Labels: Well-fixed water-resistant label (applied with water-resistant glue) Preferred

or permanent printing, indelible ink lasting the life span of the RDT product.

2. Use only internationally recognized symbols (ISO 15223–2012). Required

3. The official language(s) displayed should be relevant to the region in which Preferred
the RDT product will be used.

What should be displayed: Category

1. Product name, with sufficient detail for the user to uniquely identify the Preferred
product and its intended use, e.g.
• commercial name of the RDT product
• “malaria”
• targeted species and antigen(s)
• “antigen” or “Ag”
Example: Commercial name, Malaria Pf/Pv (HRP2/pLDH) Antigen(RDT)
(preferred option)
or with sufficient detail for the user to identify the type of product with which
to use the buffer, e.g. Malaria RDT
(acceptable option)

2. Contents: Buffer Required

3a. For product code (symbol) Preferred

(preferred option)
3b. or a reference code that is also written on the RDT packaging and/or in the Required
instructions for use
(acceptable option)

4. In vitro diagnostic (symbol) Required

5. Name (or logo) of the legal manufacturer Required

6. Lot number (and symbol) Required

7. Volume of contents or number of examinations that can be performed Required

8. Expiration date (and symbol) Required

Preferred format: YYYY-MM
The expiration date must not be earlier than the expiration date on the RDT Required
box and test packaging.

9. Storage conditions (symbols) Required

10. Warnings or precautions (symbols) Required

At least :do not use if package is damaged (symbol); hazard symbol, if
sodium azide concentration is ≥ 0.1% (symbol); read instructions before use
(symbol)

16
Figure 6.
Proposal for printing relevant information on the buffer bottle

30°C

4°C

Commercial name, Malaria Antigen Pf/Pan (HRP2/ pLDH) RDT

For product code: XXXXXX

Contents : Buffer

xxxxxxx

YYYY-MM

Manufacturer name (or logo)

xx ml or number of examinations

Labelling of accessories

Definitions

Accessories of in vitro diagnostics are articles specifically and explicitly intended by the
manufacturer to be used with a device to enable that device to be used in accordance
with the intended purpose (ISO 18113-1, CE Directive 98/79). Specimen transfer devices,
lancets, alcohol swabs and desiccant are included.

suggested use of terms, requirements and preferences for labelling and instructions for use
General requirements and outlines: Category

1. Labels should be printed on the device or packaging as permanent printing Required

or applied as water-resistant labels (with water-resistant glue). The ink
should be indelible and should last the life span of the product. If it is not
practicable to display the information on the device itself (e.g. lancets,
specimen transfer devices), some or all of the information may appear on
the packaging of multiple items (if used) (GHTF/SG1/N70/2011:5.0 and
Annex 1.8.8.1 of EU Directive 98/79).

2. Use of symbols, when adequate, is encouraged instead of text. Only Required

Internationally recognized symbols (ISO 15223-2012) should be used.

3. The language(s) used should be relevant to the region in which the RDT Preferred
Malaria rapid diagnostic test products

product will be used.

4. The table below lists the information to be displayed on different

accessories or on their packaging.

17
 Label information Transfer Lancet Alcohol Desiccant Category
device swab

Name of accessory X X X X Required

Intended use if name of X X X X Required

accessory does not indicate it
(sufficient to identify the device
and its intended use: e.g. transfer
device, antiseptic, desiccant)

Name of the legal manufacturer X X X X Preferred

of the accessory (preferred to
RDT manufacturer)

For alcohol swab: antiseptic, X Required

product and concentration (e.g.
isopropyl alcohol70%)

Product code of the accessory X X Preferred

For a transfer device other X Preferred

than inverted cup and loop:
permanent volume mark

Lot number X X X Required

X Preferred

Indicate “in vitro diagnostic” use X

Expiration date (preferred X Preferred

format: YYYY-MM)
X X Required

Quantity of items, indicated X X X Required

on the outer packaging (if
applicable) (symbol)

Specimen volume transferred X Preferred

Single use (symbol) X X X Required

Sterile (and by what method), if X Required

applicable
X Preferred

Do not use if package is X X Required

damaged (symbol)

Warning: “Do not swallow or eat” X Preferred

and “harmful” (text or symbols) in
relevant language(s) X Required

Interpretation of colour change, if X Required,

applicable if
applicable

18
WHO suggested generic
template for Instructions
for Use (IFU)

The present document is a template for generic IFU of malaria rapid diagnostic tests.

It must be adapted to the specific product.

Words or terms that are definitely product-related and variable are in blue. This
template can be adapted according to present or future characteristics of the concrete
product. Instructions for the designer are printed in italics and put into text boxes.

The present document uses the safety-seal lancet and inverted cup as an example.
Other combinations are possible.

General suggestions

• Provide IFU version number including indication of language and date.

• Highlight changes (shaded in grey) with regard to the previous version.

• Text: ensure that the IFU is easily readable (e.g. Flesch-Kincaid grade < 6)
• use type size of at least 9 points, as measured in font ‘Times New Roman’, not
narrowed, with a space between lines of at least 3 mm and an open letter

suggested use of terms, requirements and preferences for labelling and instructions for use
type;
• use short sentences and terms that are easy to understand;
• use consistent terms and words throughout the IFU (see the section on
Suggested use of terms);
• use active verb (imperative) rather than passive voice/”should”;
• stress important information (capitals, italics, underline);
• turn any list into a bulleted or numbered list;
• put “when” and “if” before “what” (“If the color indicator is red, discard the
test”);
• put the warning before the action step in the procedure;
• make sure warnings are clearly indicated;
Malaria rapid diagnostic test products

• use one line per action.

References on readability and a readability calculator are included in Annex 1.

• Figures:
• use figures that are large enough so that they are easily visible;
• drawings may be more informative than photographs;

19
 • Generic job aids for malaria RDTs published by WHO-FIND provide clear
drawings (see http://www.who.int/malaria/areas/diagnosis/rapid-
diagnostic-tests/job-aids/en/);
• put figures on the left side, text on the right side;
• refer to each figure in the text;
• check that the figures match the real-life situation (device, transfer device,
gloves, right-handed operator).

20
Table of contents

Product
• Product name
• Product code
• Number of tests provided in the kit

Intended use
• Test principle
• Intended user
• Required specimen

Warnings and precautions

Materials
• Materials provided
• Materials required but not provided

Storage and stability

Procedure
• Before testing
• Sample preparation
• Test procedure
• Capillary whole blood from finger prick
• Venous whole blood from venipuncture

suggested use of terms, requirements and preferences for labelling and instructions for use
• Interpretation of the test result

Limitations of the test, causes of false-negative and false-positive results

• Limitations of Malaria RDTs
• False negative results
• False positive results
• Invalid tests and problems of background clearing

Performance specifications

Bibliography

Manufacturer contact information

Malaria rapid diagnostic test products

IFU version number and date of issue of the instructions for use

Symbol key

Product specific and other variables printed in blue

21
 Product

• Commercial name, Malaria Antigen Pf/Pan (HRP2/ pLDH) Rapid Diagnostic Test
(RDT)

• Product code xxxxxx and presentation (number of tests per kit)

Intended use

This XXX test kit is an in-vitro diagnostic immunochromatographic assay for the
qualitative detection of infection with Plasmodium parasites causing malaria in human
whole blood specimens. It does not assess parasite densities.

It assists trained competent users and is not intended for lay users:

• in detecting Plasmodium infections

• to differentiate infection by Plasmodium falciparum from the non-P. falciparum

species (Plasmodium vivax, Plasmodium malariae, Plasmodium ovale).

Note: Malaria RDTs can give positive results after successful anti-malarial treatment.
Therefore, the XXX test kit is not recommended for monitoring response to anti-malarial
treatment.

Test principle

The following Plasmodium antigens are detected in this test:

• Histidine rich protein 2 specific for P. falciparum (Pf-HRP2)

• Plasmodium lactate dehydrogenase specific for P. falciparum (Pf-pLDH)

• Plasmodium lactate dehydrogenase specific for P. vivax (Pv-pLDH)

• Plasmodium lactate dehydrogenase common to all human Plasmodium species

(pan-pLDH)

• Aldolase common to all human Plasmodium species

The cassette contains a test strip pre-coated with capture antibodies.

The sequence of events is as follows:

1. Whole blood is applied to the specimen well (labelled well 1).

2. Next, buffer is applied to the buffer well (labelled well 2).

22
 3. Migration of the specimen/buffer mixture starts, towards the other end of the
cassette.

4. The specimen-buffer mixture passes the conjugate pad, which contains

detection antibodies targeting Pf-HRP2, Pf-pLDH, Pv-pLDH, pan-pLDH and/or
aldolase antigens. These detection antibodies are conjugated to colloidal gold.
If present in the specimen, Plasmodium target antigens bind to this detection
antibody-conjugate.

5. The antigen-antibody-conjugate complex migrates further and binds to the

capture Plasmodium-specific antibodies present on the test line. These capture
antibodies bind to another site (epitope) of the Plasmodium target antigens.

6. 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 colored line.

7. The excess of the detection antibody-conjugate that was not bound by the
Plasmodium target antigens and the capture antibodies moves further until it
binds to a goat anti-mouse control antibody. There, the colloidal gold will create
a red colored control line. The visualization of the control line indicates that the
migration was successful. It does not confirm the presence of specimen.

The main components of the test are:

• Test strip:

• Detection antibodies conjugated to colloidal gold (in the conjugate pad):

– Mouse monoclonal antibodies (IgG) specific to Pf-HRP2-gold colloid

– Mouse monoclonal antibodies (IgG) specific to pan-pLDH-gold colloid

– (any other combination)

suggested use of terms, requirements and preferences for labelling and instructions for use
• Capture antibodies (on the nitrocellulose membrane):

– Plasmodium falciparum line: Mouse monoclonal antibodies (IgG)

specific to Pf-HRP2

– Plasmodium species (pan) line: Mouse monoclonal antibodies (IgG)

specific to pan-pLDH

• Control line (on the nitrocellulose membrane) : Goat anti-mouse polyclonal

antibodies (IgG)

• Buffer vial:
Malaria rapid diagnostic test products

• Bovine serum albumin, Triton X-100, Sodium azide (0.095 %)

Intended user

• The test is intended to be performed by a trained user.

23
 Specimen required

• Capillary whole blood or venous whole blood with the following anticoagulant:
EDTA, heparin, oxalate or citrate.

• Time between specimen collection and specimen testing:

• Capillary: immediately
• Venous: immediately. If immediate Do not use any
testing is not possible, store the other specimen than
whole blood specimen at X-X °C whole blood
for maximum XX hours.

Warnings and precautions

• For in vitro diagnostic use only.

• Read the instructions carefully before performing the test.

• Apply standard biosafety precautions for handling and disposal of potentially

infective material.

• Handle all specimens as potentially infectious.

• Wear gloves while handling specimens and performing the test.

• Avoid splashing and aerosol formation.

• Clean up spills thoroughly using an appropriate disinfectant.

• The buffer contains 0.095% sodium azide as a preservative which may be toxic if
ingested. When disposed of through a sink, flush with large quantities of water.

• Do not use any other buffer than the buffer supplied within this kit.

• Do not use the kit beyond the expiration date.

• Do not use if the packaging is damaged.

• Do not use any other specimen than whole blood.

• Do not use if the product has been exposed to excessive heat or humidity.

• Perform the test immediately after opening of the cassette packaging.

• Do not re-use the test.

Materials

Materials provided

• XX cassette package, each containing:

• 1 test device
• 1 packet of desiccant

• X buffer bottle(s) – XX ml

24
 • XX specimen transfer devices (inverted cup) – x µl

• XX single-use safety-seal lancets

• XX alcohol swabs

• 1 instructions for use

Materials required but not provided

• New pair of disposable gloves

• Pen/pencil

• Timer

• Extra lancets and alcohol swabs, if needed (lancet misfires, lancet does not
produce sufficient blood volume, alcohol swab is dried out, etc.)

• Biosafety sharps container

• Biohazard waste container (for potentially infectious waste)

• If whole blood is collected by venipuncture, venipuncture blood collection

materials and precision pipette, plus tips

Test kit storage and stability

• Store the kit between X–XX °C.

• Do not store the kit in the freezer.

suggested use of terms, requirements and preferences for labelling and instructions for use
• Protect the kit from humidity.

• The kit has a shelf life of XX months from the date of manufacture. The kit is
stable until the expiration date marked on the RDT box and/or the packaging of
individual components when stored as specified.

• The buffer is stable for XX months (or until the expiry date) even after opening.

Procedure

Before testing

1. Prepare all necessary materials :

Malaria rapid diagnostic test products

• When stored in the refrigerator, bring the kit to room temperature

(XX-XX°C) minimum xx minutes before use.
• Prepare the materials (refer to the section on Materials).

2. Check the expiration date of the kit (including buffer).

If expired, do not use but take another unexpired kit.

25
 3. Check that the cassette packaging is not damaged.

If damaged, discard the test and use another test.

4. Open the cassette packaging and check the desiccant (if provided).

If there is a humidity indicator and it shows

saturation (color changed from orange to Perform the test
green), throw away the cassette and take immediately after
another cassette packaging. opening of the
If the color of the desiccant does not show cassette packaging.
a change, you can use the test. Do not re-use the
Throw away the desiccant in the non- test.
sharps (non-infectious) disposal container.

5. Take the cassette and place it on a flat surface, horizontally.

You see:

• a result window (marked with C, pan, Pf )

• a circle well marked “1” (for specimen)
• a square well “2” (for buffer)

6. Write the patient name or identifier on the cassette.

7. Put on gloves. Use new gloves for each patient.

8. Add if needed additional instructions on how to open the buffer bottle correctly
– for instance, how to pierce the nozzle.

Test procedure (see reference Generic RDT training manual in Annex 2)

Capillary whole blood from finger prick

1. Wear gloves.

2. Choose a finger for the finger prick:

• Do not choose a finger that is swollen, bruised or scarred.

• Preferably choose the 3rd or 4th finger of the hand the patient does not use
to write. Alternatively choose the heel or the earlobe for neonates.

3. Open the packaging of the alcohol swab. Take out the alcohol swab. Do not
throw away the empty packaging (wrapper) but keep it aside.

4. Wipe the complete fingertip with the alcohol swab.

Wait until the finger has completely dried (minimum 30 seconds).

5. Place the alcohol swab in the wrapper and set it aside (you will use it again to
stop the bleeding after you collected the patient’s blood).

6. Take the safety-seal lancet.

7. Detach the cap of the lancet.

26
 Puncture the side of the pulp (ball) of the
finger with the lancet, perpendicular to the Avoid the tip or
lines of the fingerprint. center of the finger.
Dispose the lancet immediately into the
sharps box.

8. Make sure a well-formed drop of blood is present.

9. If there is no well-formed drop of blood, repeat the finger prick using a new
lancet and choose a different puncture site.

10. Take the inverted cup and collect 5 µl of blood by dipping the circular end of the
inverted cup into the whole blood drop.

11. Place the circular end of the inverted cup in the circle well (marked “1”) so that it
touches the strip (pad at the bottom of the well).

Press down lightly to transfer all the blood to the strip.

Put the used inverted cup into the non-sharps disposal container for potentially
infectious waste.

12. Take the alcohol swab you put aside (step 5).

Ask the patient to press it to the finger prick to stop the bleeding.

After use, put the alcohol swab into the non-sharps disposal container for
potentially infectious waste.

13. Take the buffer bottle.

Hold the open buffer bottle vertically above

Do not use water
the square well (marked “2”).
or any other buffer
In a vertical position, squeeze the buffer than the buffer

suggested use of terms, requirements and preferences for labelling and instructions for use
bottle gently and apply exactly X drops into supplied within this
the square well (marked “2”). kit.

Hold the buffer

14. Remove your gloves and discard them
bottle vertically –
into the non-sharps disposal container for
this ensures that
potentially infectious waste.
the drops contain
the correct volume
15. Write the time on the cassette or set a
of buffer.
countdown timer to the required reading
time.

16. Read test results after a minimum of xx

minutes but no later than xx minutes. Use a Do not read results
good light source when reading the test after xx minutes
results.
Malaria rapid diagnostic test products

Venous whole blood from venipuncture

1. Wear gloves.

2. Collect blood by standard venipuncture procedure into a tube containing the

correct anticoagulant (EDTA, heparin, oxalate or citrate).

3. Mix the tube gently.

27
 4. Transfer 5 µl of whole blood in the circle well (marked “1”) of the cassette using a
precision pipette.

5. Perform steps 12–16 of the previous section (“Capillary whole blood from finger
prick”).

Interpretation of the test result

1. After xx but no later than xx minutes: compare the test lines with the presentation
in the table below.

2. Where possible, have the results confirmed by a second reader within this time
frame.

3. Line intensities may vary from faint to strong intensity.

Consider also a faint test line as a positive result.

4. Record the test results as noted in the table below.

5. Consult the national guidelines for malaria case management to complement

the table below.

Lines that you see Picture/Drawing Record the following result

Take the following action

NO line at ‘C’ Put figures of all possible line Invalid

(= control) combinations
Take a new cassette packaging and
repeat the test

Line at ‘C’ and Put figures of all possible line Negative

NO other line combinations

Line at ‘C’ AND at Put figures of all possible line Positive for Plasmodium falciparum
‘Pf’ combinations

Line at ‘C’, at ‘Pf’ Put figures of all possible line Positive for Plasmodium falciparum
AND at ‘pan’ combinations (or rarely, a mixed infection with
P. vivax, P. ovale and/or P. malariae)

Line at ‘C’ AND at Put figures of all possible line Positive for non-falciparum malaria:
‘pan’ combinations P. vivax, P. ovale or P. malariae (or,
rarely, a mixed infection with these
species)

Other line Put figures of all possible line Write down the result
combinations combinations

Note: the XXX test kit does not differentiate between P. vivax, P. ovale and P. malariae

28
Limitations of the product, causes of false-negative and false-
positive results

All malaria RDTs have limitations in common

They may occur despite correct storage and test procedure and are related to:

• the general design of the RDT (detection limit, prozone, no quantification)

• the antigen (HRP-2 deletions, HRP-2 persistence after treatment)

• the operator (overlooking faint test lines)

• the species (in general: sensitivity for P. falciparum > P. vivax > P. ovale/
malariae).

Other limitations related to the end-user and the conditions during transport
and storage. Some limitations are listed below – unless they do not apply for
the RDT product under consideration, they should be mentioned.

See also reference “Universal access to malaria diagnostic testing: an operational manual. World
Health Organization 2011

Malaria RDT have limitations

They may be the cause of:

• false-negative results (no test lines but the patient has malaria)

• false-positive results (test lines visible but the patient does not have malaria)

• invalid test result (no control line and/or incomplete clearing of background)

suggested use of terms, requirements and preferences for labelling and instructions for use
Sensitivity for detecting malaria is lower in the case of P. ovale and P. malariae.

False-negative results can occur in the following conditions:

• very low antigen concentrations/parasite densities, for instance < 100 parasites/
µl. Note that most clinical cases have higher parasite densities.

• very high parasite densities (very exceptional, prozone or high-hook effect) for
the HRP-2 antigen

• deletions in the HRP-2 gene resulting in no production of the HRP-2 antigen (of
relevance only for mRDTs that detect this antigen, and only significantly present
in the Peruvian Amazon)
Malaria rapid diagnostic test products

• high fraction of insterstitial fluid due to “milking” of fingertip

False-positive results can occur – amongst others – in the following conditions:

• rheumatoid factors, antinuclear antibodies, human anti-mouse antibodies

• viral infection (such as hepatitis B or hepatitis C, dengue)

• parasitic infection (such as schistosomiasis and trypanosomiasis)

29
 Invalid tests and problems of background clearing may occur:

• In lipaemic and icteric specimens

Note: The presence of the control line only means that migration of added liquid
occurred. It does not guarantee that:

• the correct specimen has been used

• the specimen has been applied correctly

• the specimen and test have been correctly stored

• the test procedure was followed correctly

Performance specifications

Recommendations for diagnostic performance specifications

• State at least the following specifications and information:

1. Analytical sensitivity (detection limit)

2. Analytical specificity (rheumatoid factor, antinuclear antibody, other

infections and influence of lipemic/icteric/hemolyzed specimens)

3. Diagnostic sensitivity

4. Diagnostic specificity

5. Repeatability (test-related, laboratory conditions)

6. Reproducibility (operator-related, field conditions)

• Give enough detail and oversight:

• the numbers of specimens used (and if applicable, confidence

intervals)

• the different specifications for P. falciparum, P. vivax, P. ovale and

P.  malariae

• type of study and setting, geographic place, study period and

population
(e.g. laboratory study on stored specimens, clinical study, field study)

• parasite densities and reference methods when appropriate

• present results in a clear way (e.g. table)
• refer to type of study (in-house study, external study, study report or
published in scientific literature)/include a bibliography/reference
list

30
Bibliogaphy

Recommendations for bibliography

• Select relevant publications in a practical and product-oriented way.

• In Annex 3, some references for relevant topics are provided.

Product-related publications

• Test kit evaluations (product related studies)

General publications

• Biosafety and sampling

• WHO reference documents

• Description of problems on RDT implementation, end-user errors

Contact of manufacturer

Name of the legal manufacturer

Full physical address of the manufacturing site (street, city, zip code,
country)

suggested use of terms, requirements and preferences for labelling and instructions for use
Contact for technical assistance ( telephone/fax number, email address)

Version number of IFU and date of issue

XXXXX – Language (En, Esp, Fr, etc.) – YYYY/MM/DD

Symbol key

Recommendations for Symbol key

Malaria rapid diagnostic test products

• Only use internationally recognized symbols.

• In Annex 4, an example of a symbol key is provided.

31
 Annexes

Annex 1: References for readability

The following websites explain how to assess and calculate readability – the tool is
primarily developed for English texts.

• http://www.online-utility.org/english/readability_test_and_improve.jsp

• http://www.mang.canterbury.ac.nz/writing_guide/writing/flesch.shtml

Readility can also be assessed in a Microscoft Word document:

1. Click the File tab, and then click Options

2. Click Proofing

3. Under “When correcting spelling and grammar in Word”, make sure the “Check
grammar with spelling check” box is selected

4. Select “Show readability statistics” and click on “OK”

After you enable this feature, open a file that you want to check, and check the
spelling. When Outlook or Word finishes checking the spelling and grammar, it displays
information about the reading level of the document.

Annex 2: resources

Generic and product specific job aids for Pf –only and combination RDT
Refer to the following websites:

• Generic: http://who.int/malaria/areas/diagnosis/rapid-diagnostic-tests/job-
aids/

• Product specific: https://www.finddx.org/implementation-resources/

Generic RDT training manual

How to use a rapid diagnostic test (RDT): a guide for training at a village and clinic level
2009.

Universal access to malaria diagnostic testing: an operational manual. World Health

Organization 2011
• http://www.who.int/malaria/publications/atoz/9789241502092/en/

32
Annex 3: Example of bibliogaphy

Product-related publications

• Test evaluations (product related study)

General publications

• Biosafety and sampling

1. Clinical and Laboratory Standards Institute. Procedures and devices for the
collection of diagnostic capillary blood specimens; approved standard, fifth
edition. CLSI H04-A6, Vol. 28, No. 25, 2008.

2. Clinical and Laboratory Standards Institute. Procedures for the collection of

diagnostic blood specimens by venipuncture; approved standard, sixth edition.
CLSI H03-A6, Vol. 27, No. 26, 2007

3. World Health Organization: Laboratory biosafety manual, third edition. Geneva:

WHO; 2004. http://www.who.int/csr/resources/publications/biosafety/
Biosafety7.pdf

• WHO reference documents

1. World Health Organization: Good practices for selecting and procuring rapid
diagnostic tests for malaria. Geneva: WHO; 2011. http://www.who.int/malaria/
publications/atoz/9789241501125/en/

2. World Health Organization: Guidelines for the treatment of malaria. Third

edition. Geneva: WHO; 2015. http://www.who.int/malaria/publications/
atoz/9789241549127/en/

3. World Health Organization: Malaria Rapid Diagnostic Test Performance; Results

suggested use of terms, requirements and preferences for labelling and instructions for use
of WHO product testing of malaria RDTs: Rounds 1–7 (2008–2016). Geneva:
WHO; 2017. http://apps.who.int/iris/bitstream/10665/258597/1/9789241512916-
eng.pdf

4. World Health Organization: Malaria RDT job-aids and training manuals. http://
www.who.int/malaria/areas/diagnosis/rapid-diagnostic-tests/job-aids/en/

5. World Health Organization: Management of severe malaria – A practical

handbook. Third edition. Geneva: WHO; 2013. http://www.who.int/malaria/
publications/atoz/9789241548526/en/

6. World Health Organization: Transporting, storing and handling malaria rapid

diagnostic tests at central and peripheral storage facilities. Geneva: WHO; 2009.
http://www.who.int/malaria/publications/atoz/malaria_rdt_central_2009.pdf
Malaria rapid diagnostic test products

7. World Health Organization: Universal access to malaria diagnostic testing.

An operational manual. Geneva: WHO; 2011. http://www.who.int/malaria/
publications/atoz/9789241502092/en/

33
 • Description of problems on RDT implementation, end-user errors (included
prozone, buffer substitution, false positive,…)

1. Gamboa D, Ho M, Bendezu J, Torres K, Chiodini P, Barnwell J, Incardona S,

Perkins M, Bell D, McCarthy J, Cheng Q: A large proportion of P. falciparum
isolates in the Amazon region of Peru lack pfhrp2 and pfhrp3: implications for
malaria rapid diagnostic tests. PLoS One 2010, 5:e8091. http://www.plosone.
org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0008091

2. Gillet P, Scheirlinck A, Stokx J, De Weggeleire A, Chauque H, Canhanga O, Tadeu

B, Mosse C, Tiago A, Mabunda S, Bruggeman C, Bottieau E, Jacobs J: Prozone
in malaria rapid diagnostics tests: how many cases are missed? Malar J 2011,
10:166. http://www.malariajournal.com/content/10/1/166

3. Gillet P, Mori M, Van Den Ende J, Jacobs J: Buffer substitution in malaria rapid
diagnostic tests causes false-positive results. Malar J 2010, 9:215 http://www.
malariajournal.com/content/9/1/215

4. Maltha J, Gillet P, Cnops L, Van Den Ende J, Van Esbroeck M, Jacobs J: Malaria
rapid diagnostic tests: Plasmodium falciparum infections with high parasite
densities may generate false positive Plasmodium vivax pLDH lines. Malar J
2010, 9:198. http://www.malariajournal.com/content/9/1/198

5. Maltha J., Gillet P., Jacobs J. Review: Malaria rapid diagnostic tests in endemic
settings. Clin Microbiol Infect 2013; 19: 399–407. http://onlinelibrary.wiley.com/
doi/10.1111/1469-0691.12151/pdf

6. Maltha J., Gillet P., Jacobs J. Review: Malaria rapid diagnostic tests in travel
medicine. Clin Microbiol Infect 2013; 19: 408–415. http://onlinelibrary.wiley.com/
doi/10.1111/1469-0691.12152/pdf

34
Annex 4: Example of symbol legend

Symbol Explanation Symbol Explanation

In vitro diagnostic
Product code
medical device

Σ Content sufficient for Consult instructions for

< n > tests use

Lot number Use by YYYY-MM-(DD)

Date of manufacture
Manufacturer
YYYY-MM-(DD)

Do not use if packaging

Do not reuse
is damaged

Lower limit of
Temperature limitation
temperature

Upper limit of
Sterile
temperature

suggested use of terms, requirements and preferences for labelling and instructions for use
Irritant Biological risk

Keep away from sunlight Keep dry

Malaria rapid diagnostic test products

35