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RAPID TESTS: PALUTOP+4

>TEST >REF.
S D M
Packaging CE mark Sensitivity Specificity Total running time
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PALUTOP+4 5481
10 tests / kit CE mark 98,7 % for Pf. 100 % 15 min.
  • FORMAT: S: stick; D: device; M: midstream,

Parasitology

PALUTOP+4

Immunochromatographic rapid test to detect 4 species of Plasmodium antigen (P. falciparum, P. vivax, P. malariae, P. ovale) in whole blood.

- RELIABLE:
- Quality system certified ISO 9001 and ISO 13485.
- Detects the presence of P. falciparum specific HRP-2, P. vivax specific pLDH and common specific pLDH in whole blood specimen. Palutop+4 is a sensitive and specific test for the detection of all malaria species, differentiation for P. falciparum and P. vivax, monitoring successfully antimalarial therapy.
- Sensitivity: 98,7% for P. falciparum.
- Specificity: 100%.
- PRACTICAL:
- Long shelf life: 18 months.
- Packaging presentation: 10 tests/kit.
- EFFICIENT:
- SIMPLE: One step test.
- FAST: Result within 15 minutes.
- Storage between 4 - 30OC.

PALUTOP+4 ® is a rapid self-performing, qualitative, two sites sandwich immunoassay using whole blood for the detection of P. falciparum specific histidine rich protein-2 (Pf HRP-2), P. vivax specific pLDH and pan malaria specific pLDH. The test can be used for the specific detection of P.falciparum and P.vivax infection, differentiation of other malarial species and for the follow up of antimalarial therapy.
In PALUTOP+4 ® the detection system for P. falciparum malaria is based on the detection of P. falciparum specific histidine rich protein –2 (Pf HRP-2) which is a water soluble protein that is released from parasitised erythrocytes of infected individuals. The detection system of P. vivax is based on the presence of P. vivax specific pLDH. Further the detection of other malarial infections such as P. ovale and P. malariae is achieved through the pan malaria specific pLDH.
Since pLDH is a product of viable parasities, the pan band may also be used to monitor the course of effective antimalarial therapy.

As with all diagnostic tests, the test result must always be correlated with clinical findings. The results of test are to be interpreted within the epidemiological, clinical and therapeutic context. When it seems indicated, the parasitological techniques of reference should be considered (microscopic examination of the thick smear and thin blood films).
In case of infection due to P.vivax or P.falciparum, or due to mixed infection by these species, the pan malaria band will also be positive. Hence differentiation of infection due to P.ovale or P.malariae cannot be done.
While monitoring therapy, if the reaction of the test remains positive with the same intensity after 5-10 days, post treatment, the possibility of a resistant strain of malaria has to be considered.
Usually, the Pv and pan bands turn negative after successful anti malarial therapy. However, since treatment duration and medication used affect the clearance of parasites, the test should be repeated after 5-10 days after the start of the treatment.
In P. falciparum malaria infection, HRP-2 is not secreted in gametogony stage. Hence, in “Carriers”, the HRP-2 band may be absent.
HRP-2 levels, post treatment persist upto 15 days, the pan band can be used to monitor the success of therapy, in P. falciparum malaria cases.
In a few cases, where the HRP-2 band is positive and the pan malaria band is negative, it may indicate a case of post treatment malaria. However, such a reaction pattern may also be obtained in a few cases of untreated malaria. In such cases, retesting after 2 days is advised.



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