Malaria P.f/P.v Rapid Test Kit Diagnostic Whole Blood Plasma Serum
Quantitative Screen Test
【INTENDED USE】
This Malaria P.f/P.v Rapid Test Kit is a rapid test for the
qualitative detection of Malaria Antigen P.f or/and P.v in
human venous and capillary whole blood.
【INTRODUCTION】
This Malaria Antigen P.f/P.v Rapid Test Kit is a lateral flow
immunochromatographic assays for qualitatively detection of Malaria
Antigen P.f or/and P.v in human venous and capillary whole blood of individuals with
signs and symptoms of malarial infection. The test targets the
histidine-rich protein II (HRPII) antigen specific to Plasmodium falciparum (P.f.) and a p.v-malarial antigen, common to P. vivax (P.v.).It is intended to aid in the rapid diagnosis of human
malaria infections and to aid in the differential diagnosis of Plasmodium falciparum (P.f.) infections from P. vivax (P.v.) infections.
【PRINCIPLE】
This Malaria Antigen P.f/P.v Test is based on the principle of
sandwich immunoassay for detection of Malaria Antigen P.f and P.v
Monoclonal antibodies are employed to identify Malaria Antigen
specifically. The histidine-rich protein II (HRPII) monoclonal
antibody (T1 Line), P.v specific pLDH monoclonal antibody (T2 Line)
and IgG polyclonal antibody (Control Line)
are used as the solid of the assay. The monoclonal antibody can
bind with the Malaria Antigen P.f or/and P.v in the whole blood
specimen. During the test procedures, the Malaria Antigen P.f in
the whole blood specimen will bind with the colloidal gold- HRPII
monoclonal antibody specifically, or/and the Malaria Antigen P.v
will bind with the colloidal gold- pLDH monoclonal antibody
specifically. Because of capillary and chromatographic effects of
the Nitrocellulose membrane, the complexes migrate along the
membrane to the antibody line (T1,T2), form Abα-Ag-Abβ-Au complexes
and remain captured in the T line. As a result a red colored band
develops in T1 or/and/T2 and the result is positive. If there is no
Malaria Antigen in the whole blood specimen, there is no red band
in the Test zone, indicating negative result. No matter if there’s
Malaria Antigen P.f/P.v in the whole blood specimen, when the
complexes migrate along the Control zone, a red band must be
developed in the C zone To serve as a procedure control, a colored
line will appear at the Control Region (C), of each strip, if the
test has been performed properly.
【STORAGE AND STABILITY】
The kit should be stored at 2-30°C until the expiry date printed on
the sealed pouch.
The test must remain in the sealed pouch until use.
Keep away from direct sunlight, moisture and heat.
Do not freeze.
Do not use if there is evidence of microbial contamination or
precipitation. Biological contamination of dispensing equipment,
containers or reagents can lead to false results.
【INTERPRETATION OF RESULTS】
Positive (+)
Malaria P.f Positive: Both T1 test region (G) and control region appear color line.
Malaria P.v Positive: Both T2 test region (M) and control region appear color line.
Malaria P.f and P.v Positive: Both test region (T1 and T2) and control region appear color line.
Negative (-)
Only one colored band appears, in the control region (C). No colored band appears in the test region (T).
Invalid Control band fails to appear. Results from any test which has not produced
a control band at the specified read time must be discarded. Please
review the
procedure and repeat with a new test. If the problem persists,
discontinue
using the kit immediately and contact your local distributor.
