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Malaria RDTs Use and Interpretation

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Malaria RDTs: use and

interpretation

Module L11:
Refresher Training in
Good Diagnostic Practices
for Laboratory Staff

Rapid Diagnostic Tests (RDTs)


Principles of RDTs
Use of RDTs
Recording & reporting results
Interpretation of RDT results
Limitations of RDT use
Comparison of RDTs and microscopy
Quality assurance of RDT examination
Practical demonstration of RDT use
Exercises on use of malaria RDTs for group
discussion and presentation
Common errors doing RDTs
IMaD LM- 10

Rapid Diagnostic Tests


RDTs are tests based on the qualitative

detection of parasite antigen


Parasite antigens used are:
Histidine-rich Protein 2
p-LDH
Tests detect Pf or Pm/Pv/Po / (Pk ) combined
Detection is by use of immunochromatography
Sensitivity and specificity is above 90%
(compared with microscopy)
IMaD LM- 10

Test principle
Test cassette/dipstick contains a strip with

antibodies against the malaria parasite


antigen
When blood is added it flows along the strip
If malaria parasite antigens are present two
bands are formed: a control band and a
positive band
In the absence of malaria parasite antigens,
only the control band is formed
IMaD LM- 10

Kit format

Dipsticks or cassettes
Buffer
Capillary
Lancet
Alcohol swabs
Instruction leaflet
Gloves
Store in a cool place in the facility
IMaD LM- 10

Test procedure
Swab and prick the finger
Wipe off the first drop of blood
Draw blood from pricked area using a capillary

tube
Transfer blood into the sample well (S) on the
cassette
Add buffer solution (contents of buffer) into the
assay well (A)
Read results within 15 - 20 minutes (depending
IMaD instructions)
LM- 10
on manufacturers

Interpretation/Reporting
Pf test
One band (control)
negative
Two bands
positive
No line or more
than two lines
invalid test
IMaD LM- 10

Combo test
One band (control)
negative
Two bands positive
for Pf
Three bands
positive (Pf or mixed)
No control line
invalid test

Lateral Flow schematic


presentation

Ag (POS)
or
No Ag (NEG)

rabbit
conjugate colored reagent

Solution

Anti-rabbit
immunoglobulins
Malaria Ab
Ag/Ab complex
No reaction

IMaD LM- 10

472U100

CONTROL

PATIENT

Parasite -F

Client #

7A

472U100

Sample pad

Parasite - F

CONTROL

PATIENT

Client #

7A

Advantages of
RDTs

Simple and fast


Can be performed anywhere
Portable
Kit components easily packed
Robust: storage from 2 - 40C
Need not be a trained microscopist to
carry out test
IMaD LM- 10

Disadvantages of
RDTs
Cannot be used for patient follow up
Cannot determine parasite density
Cannot be used in antimalarial drug

efficacy studies
Cannot be stored for reference has to be
read within 15 20 min
Cannot be sure of performance
IMaD LM- 10

What is the result of this


test?
a. Invalid test
b. Plasmodium falciparum
c. Pf OR non-falciparum Plasmodium
d. Non-falciparum Plasmodium
e. Mixed (Pf AND non-falciparum)
parasitemia
f. Negative test
g. Pf OR mixed infection

What is the result of this


test?
a. Invalid test
b. Plasmodium falciparum
c. Pf OR non-falciparum Plasmodium
d. Non-falciparum Plasmodium
e. Mixed (Pf AND non-falciparum)
parasitemia
f. Negative test
g. Pf OR mixed infection

What is the result of this


test?
a. Invalid test
b. Plasmodium falciparum
c. Pf OR non-falciparum Plasmodium
d. Non-falciparum Plasmodium
e. Mixed (Pf AND non-falciparum)
parasitemia
f. Negative test
g. Pf OR mixed infection

What is the result of this test?


a. Invalid test
b. Plasmodium falciparum
c. Pf OR non-falciparum Plasmodium
d. Non-falciparum Plasmodium
e. Mixed (Pf AND non-falciparum)
parasitemia
f. Negative test
g. Pf OR mixed infection

What is the result of this


test?
a. Invalid test
b. Plasmodium falciparum
c. Pf OR non-falciparum Plasmodium
d. Non-falciparum Plasmodium
e. Mixed (Pf AND non-falciparum)
parasitemia
f. Negative test
g. Pf OR mixed infection

Common errors by end users


doing RDTs
Not checking expiration date
Not maintaining RDTs within the
recomended temperature range
Finger other than 4th on left hand is
selected
If doing several RDTs at once, patient ID
is written on RDT
Contamination: ie touching finger after
disinfection
Putting the lancet on a non-sterile
surface
Not using gloves

Common errors by end users


doing
RDTs
Not discarding lancet
in sharps
collector
immediately
Loop, capillary, gloves and/or swab thrown in the
garbage can
Used RDTs are not kept in a plastic bag
Time: Not measuring time for performing test
Time of blood collection not recorded
Not waiting 15-20 min before reading results
Not registering the result immediately,
Negative results are ignored, case treated anyway

Common errors by end users


doing RDTs
Loop, capillary, gloves and/or swab
thrown in the garbage can
Used RDTs not kept in a plastic bag
Time of blood collection not recorded
Time: Not measuring time for performing
test
Not waiting 15-20 min before reading
results
Not registering the result immediately
Negative results are ignored, case
treated anyway

THANKS FOR
LISTENING
PRESENTER:
MRS COMFORT NYAMEBA OPOKU
CHIEF BIOMEDICAL SCIENTIST &
REGIONAL BIOMEDICAL
SCIENTIST
GAR
0277844496

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