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.
