Tri-line Malaria pf/pv antigen Home Testing kits, personal use, 4mm
cassette full kit, remote area use
Product Name: Malaria P.f & P.v Home Testing kits
INTENDED USE: The One Step Malaria (p.f/p.v) Cassette Test is a two site
sandwich immunoassay utilizing whole blood for the detection of P.
falciparum specific histidine rich protein-2 (Pf. HRP-2) and P.
vivax specific pLDH. The test can also be used for specific
detection and differentiation of P. falciparum and P. vivax
Malaria is a mosquito-borne, hemolytic, febrile illness that
infects over 200 million people and kills more than 1 million
people per year. It is caused by four species of Plasmodium: P.
falciparum, P. vivax, P. ovale, and P. malariae. These plasmodia
all infect and destroy human erythrocytes, producing chills, fever,
anemia, and splenomegaly. P. falciparum causes more sever disease
than the other plasmodial species and accounts for most malaria
deaths. P. falciparum and P. vivax are the most common pathogens,
however, there is considerable geographic variation in species
Traditionally, malaria is diagnosed by the demonstration of the
organisms on Giemsa stained smears of peripheral blood, and the
different species of plasmodium are distinguished by their
appearance in infected erythrocytes1. The technique is capable of
accurate and reliable diagnosis, but only when performed by skilled
microscopists using defined protocols2, which presents major
obstacles for the remote and poor areas of the world.
A capture monoclonal antibody is immobilized on the membrane within
the cassette. The red blood cells are lysed releasing Pf. HRP11 and
P. vivax specific pLDH which binds selectively to this antibody as
the blood flows along the strip inside the cassette. The signal
reagent is coated with specific antibodies, which bind with the
antibody-antigen complex, producing a black line. The presence of
an upper black line (the control line) demonstrates the test has
been performed correctly.
1. Bring the pouched test device to room temperature(15-30℃) prior
to testing. Do not open pouch until ready to perform the assay.
2. Remove the test device from the sealed pouch. Lay it on a flat,
clean and dry surface.
3.Dispense 1 drop (10µl) of whole blood to the “S” well of the test
cassette using the plastic pipette provided, according to the
4. Add three drops of Sample Diluent to the “D” well after the
specimen is added and absorbed.
5. Interpret test results within 10-15 minutes. Do not interpret
after 20 minutes.
Caution: The above interpreting time is based on room temperature
range of 15 - 30°C. If your room temperature is significantly lower
than15 °C, then the interpreting time should be properly increased
to 30 minutes.
INTERPRETATION OF RESULTS
Malaria P.f Positive
The control line and Malaria P.f line (T1) are visible in the
result window. The test is positive for Malaria P.f.
Malaria P.v Positive
The control line and Malaria P.v line (T2) are visible in the
result window. The test is positive for Malaria P.v.
Malaria P.f and Malaria P.v Positive
The control line, Malaria P.f (T1) and Malaria P.v (T2) lines are
visible in the result window. The test is positive for Malaria P.f
and Malaria P.v.
The control line is the only line visible in the result window. No
Malaria P.f or Malaria P.v has been detected.
If the control line does not appear in the result window, the test
results are INVALID regardless of the presence or absence of the
line in the test region.
The following data was generated from previously frozen whole blood
samples and was determined by correlation to standard thick and
thin smear microscopic examination with discrepancies evaluated via
PCR. Retrospective study results are summarized below:
|Site||Pos||Neg||Test Pos||Test Neg|
|India||66||86||64 (97%)||86 (100%)|
|Senegal||8||10||8 (100%)||10 (100%)|
|Varied Origin||48||53||46 (95.8%)||53 (100%)|
|South Africa||102||150||99 (97%)||149 (99.3%)|
|TOTAL||224||299||217 (96.9%)||298 (99.7%)|