Malaria

Introduction

Malaria, a protozoan infection transmitted to humans by Anopheles mosquito is a serious disease endemic to many parts of the world. Four species of Plasmodium, i.e., P.falciparum, P.vivax, P.malariae and P.ovale are known to cause malaria in humans. However, P.falciparum alone accounts for more than 60% of worldwide malaria cases. Laboratory can help in diagnosis of Malaria by microscopically demonstrating malaria parasite or detecting antigens derived from malaria parasite or detecting nucleic acid of parasite by PCR or detecting antibodies produced against the parasite in patient blood.

NANO MALARIA TEST

Principle

Nano Malaria P.falciparum and P.vivax antigen detection test is a single use utilized immunochromatographic test which employ antibodies against Pf HRP-II (Plasmodium falciparum Histidine Rich Protein-2) and pLDH enzyme specific for P.vivax. One set of antibodies is conjugated to colloidal gold and the other set is immobilized on the nitrocellulose membrane. Nano Malaria kit detects antigens specific to P.falciparum/P.vivax in whold blood. Positive results are supportive evidence of exposure to these species of Malarial parasites. Negative results however should not be considered to exclude malaria.

Sensitivity

Nano Malaria kit for diagnosis of P.falciparum achieves sensitivity of >90% at densities above 40 parasites per micro liter of blood. Sensitivity of >95% can be achieved at >500 parasites per micro liter of blood. Nano Malaria for diagnosis of P.vivax achieves sensitivity of >90% at 100 parasites per micro liter of blood.

Sensitivity at low levels of parasitemia and in no immune individuals may be low.

Cross Reaction

Auto antibodies (Rheumatoid Factor antibodies) cross react giving false positive results with Pf HRP-II up to 6% and pLDH up to 3.3% if IgM capture antibody is used. Cross-reaction is more frequent if IgG capture antibody is employed.

Test Procedure

  • Place the Malaria test unit on flat surface.
  • Add 5 uL (or) one loop full (provided in the kit) of whole blood into the sample well (A).
  • Add 2-3 drops of Running Buffer into the sample well (S).
  • Read results within 20 minutes.

Interpretation of Results

Positive: If three pink/purple colored lines at T1, T2 and C (Control) zone appears, this indicates that sample is positive for both P.falciparum and P.vivax.
If one colored line appears at T1, this indicates that sample is positive for P.falciparum only.
If one colored line appears at T2, this indicates that sample if positive for P.vivax only.

Negative: One pink/purple colored line in the CONTROL (C) zone, with no colored line in the T1 and T2 zone indicates a negative result. A negative result after 20 minutes indicates that there is no detectable P.falciparum and P.vivax in the patient's sample, but this result does not exclude P.falciparum and P.vivax infection.

Invalid: A colored line should always appear in the CONTROL (C) zone, no matter if the TEST LINE (T1 and T2) appears or not. It there in no distinct pink/purple band visible in the CONTROL window, the test is inconclusive. Test as Invalid should be repeated.

COMPARISON WITH PERIPHERAL BLOOD SMEAR (PBF) EXAMINATION

Comparison with PBF examination
  Peripheral Blood Smear Nano Malaria
Equipment Glass Slides, Microscope, Stain Test Kit
Training Well-Trained Microscopist Any one with little training
Time 20-60 minutes or more 5-20 minutes
Test Results Direct visualizations of Parasites Color change on Test Line
Detection Sensitivity 5-10 parasites/micro liter of Blood 40-100 parasites/micro litre of blood for P.falciparum & higher for non falciparum species.
Capability Directly visualize & characterizes parasites Detects plasmodium antigen PfHRP-II & pLDH

 

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