Malaria Pf/Pv Whole Blood Rapid Test Cassette,specification,price,image-Bio-Equip in China

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INTENDED USE

The Malaria Gold Rapid Test is a lateral flow chromatographic
immunoassay for the simultaneous detection and differentiation of
antibodies including IgG, IgM and IgA to Plasmodium falciparum (Pf)
and vivax, ovale, and malariea (Pv.o.m) in whole blood. This device is
intended to be used as a screening test and as an aid in the diagnosis of
infection with Plasmodium. Any reactive specimen with the Malaria
Gold Rapid Test must be confirmed with alternative testing method(s)
and clinical findings.

SUMMARY AND EXPLANATION OF THE TEST

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 distribution1.
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.
The Malaria Gold Rapid Test is developed for solving these above
obstacles. It detects the antibodies generated in serum or plasma in
response to the infection of plasmodium. Utilizing the Pf. specific
antigen (HRP-II) and pan-malaria antigen (aldolase),the test enables
simultaneous detection and differentiation of the infection of
P.falciparum and or P. vivax, ovale,and malariae3-5, by untrained or
minimally skilled personnel, without laboratory equipment.

TEST PRINCIPLE

The Malaria Gold Rapid Test is a lateral flow chromatographic
immunoassay. The test cassette consists of: 1) a burgundy colored
conjugate pad containing recombinant HRP-II and aldolase conjugated
with colloid gold (Pf conjugates and Pan-malariaconjugates) and
rabbit IgG-gold conjugates, 2) a nitrocellulose membrane strip
containing two test bands (T1 and T2 bands) and a control band (C
band). The T1 band is pre-coated with recombinant HRP-II antigen for
the detection of antibodies to Pf only, T2 band is pre-coated with
aldolase for the detection of antibodies to Pan-malaria protozoa, and
the C band is precoated with goat anti rabbit IgG.
When an adequate volume of test specimen is dispensed into the
sample well of the test cassette, the specimen migrates by capillary
action across the cassette. Antibodies including IgG, IgM and IgA
against HRP-II antigen, only found in P. falciparum infection, if
present in the specimen will bind to the Pf conjugates. The
immunocomplex is then captured on the membrane by the pre-coated
HRP-II antigen, forming a burgundy colored T1 band, indicating a
Pf positive test result.
Alternatively, antibodies including IgG, IgM and IgA against aldolase,
generated following the infection by the either form of malaria
protozoa if present in the specimen will bind to the Panmalaria
conjugates. The immunocomplex is then captured by the pre-coated
aldolase antigen on the membrane, forming a burgundy colored T2
band, indicating a plasmodium antibody positive result.
Absence of any T bands (T1 and T2) suggests a negative result. The
test contains an internal control (C band) which should exhibit a
burgundy colored band of the immunocomplex of goat anti-rabbit
IgG/rabbit IgG-gold conjugate regardless of the color development on
any of the T bands. Otherwise, the test result is invalid and the
specimen must be retested with another device.

REAGENTS AND MATERIALS PROVIDED

1. Each kit contains 25 test devices, each sealed in a foil pouch with
three items inside:
a. One cassette device.
b. One plastic dropper.
c. One desiccant.
2. Sample diluent (1 vial, 5 ml)
3. One package insert (instruction for use).
MATERIALS REQUIRED BUT NOT PROVIDED
1. Clock or Timer
2. Lancing device for whole blood test

WARNINGS AND PRECAUTIONS

For in Vitro Diagnostic Use
1. This package insert must be read completely before performing the
test. Failure to follow the insert gives inaccurate test results.
2. Do not open the sealed pouch, unless ready to conduct the assay.
3. Do not use expired devices.
4. Bring all reagents to room temperature (15-30 °Ċ) before use.
5. Do not use the components in any other type of test kit as a
substitute for the components in this kit.
6. Do not use hemolized blood for the testing.
7. Wear protective clothing and disposable gloves while handling the
kit reagents and clinical specimens. Wash hands thoroughly after
performing the test.
8. Users of this test should follow the US CDC Universal Precautions
for prevention of transmission of HIV, HBV and other
blood-borne pathogens.
9. Do not smoke, drink, or eat in areas where specimens or kit
reagents are being handled.
10. Dispose of all specimens and materials used to perform the test as
biohazardous waste.
11. Handle the Negative and Positive Control in the same manner as
patient specimens.
12. The testing results should be read within 15 minutes after a
specimen is applied to the sample well or sample pad of the device.
Read result after 15 minutes may give erroneous results.
13. Do not perform the test in a room with strong air flow, ie. an
electric fan or strong airconditioning.