OptiMAL® is a rapid malaria test, for diagnosis and therapy control of an infection by Plasmodium species (Malaria)

In 20 minutes OptiMAL® indicates:

• Presence or absence of Plasmodium species
• Differential diagnosis of Plasmodium species:
   - P. falciparum
   - P. vivax, P. malariae or P. ovale

 

Malaria - The Global Disease
About 2 billion people (about 40% of the world's population in more than 90 countries), are at risk of contracting malaria every year.
The disease causes:
   - 500 million acute clinical cases every year
   - 3 million deaths every year, mainly children and pregnant women.
Malaria Diagnosis Today
The Microscopic malaria diagnosis has been standard for over 100 years (Laveran, 1880) Up to now, microscopy is still the "gold standard" for the diagnosis of Malaria infection. Highly sensitive, specific ... but only in expert hands!

Limits of microscopy:

To find "positive"
with a blood smear with the following parasitaemia
2%
0.2%
0.02%
0.002%
Number of rbc's
which need to be observed to find a parasite
50
500
5000
50000
Number of fields
which need to be observed with a 100x objective
1
2.5
25
250
Time of observation
(If 5 seconds for one field)

5"
12.5"
2'5"
20'50"
 
The Innovation - DiaMed OptiMAL® Rapid Malaria Test
A high specific, fast and easy test system: The DiaMed OptiMAL
®
detects the presence of Plasmodium lactate dehydrogenase (pLDH), an enzyme produced by all forms of the parasite.
The presence of pLDH is revealed using monoclonal antibodies directed against isoforms of the enzyme.
There is no cross-reaction with human LDH.


 

Sensitivity
DiaMed OptiMAL
® Rapid Malaria Test indicates: presence or absence of Plasmodium species and also differentiates between:
• P.falciparum (responsible agent of fatal cases of Malaria)
• P.vivax, P.malariae of P.ovale

The test will detect parasitaemia levels of 100-200 parasites per ul of blood (corresponding to a parasitemia of 0.002%). The sensitivity of DiaMed OptiMAL® Rapid Malaria Test can be compared with microscopic observation of a thin blood smear using a 100x immersion objective for a period of approximately 30 minutes by a trained technician.
 

View OptiMAL® Malaria Test Procedure View OptiMAL® IT Procedure

Monitoring of Malaria Treatment
The test is positive only if the parasites are present in the blood. It becomes negative usually within 4-5 days following successful therapeutic treatment.
Consequently, this test is useful to determine strains of Plasmodium species which are resistant to certain prescribed treatments and may be used as part of a post-therapeutic control.
It is advised to perform this control every 48 hours: the initial positive signal (test before treatment) will decrease by the 2nd control, and will become negative in the 3rd control where therapy has been successful.

 

Performance
Specificity: 99.9%
Rheumatoid factor and human LDH samples: no false positive reactions

Diagnostic Predictive Values

Positive Predictive Value: 98% Negative Predictive Value: 99%

Clinical Acceptance

J Clin. Microbiol 1998; 36(1):203-6
Evaluation of the OptiMAL test for rapid diagnosis of Plasmodium vivax and Plasmodium falciparum malaria.
Palmer CJ, Lindo JF, Klaskala WI, Quesada JA, Kaminsky R, Baum MK, Ager AL; Center for Disease Prevention, University of Miami School of Medicine, Florida 33136, USA
"...an excellent correlation with traditional blood films in the identification of both P.Vivax malaria and P.Falciparum malaria. We conclude that the OptiMAL test is an effective tool for the rapid diagnosis of malaria."

Am J Trop Med Hug 1999 Feb;60(2):173-6
Comparison of parasite lactate dehydrogenase-based immunochromatographic antigen detection assay (OptiMAL) with microscopy for the detection of malaria parasites in human blood samples.
Cooke AH, Chiodini PL, Doherty T, Moody AH, Ries J, Pinder M; Department of Clinical Parasitology, The Hospital for Tropical Diseases, London, United Kingdom.
"...This assay can be used for the diagnosis of malaria in areas where microscopy is not available and for urgent malaria diagnosis at night and an weekends, when routine laboratories are closed and when a relatively inexperienced microscopist may be on duty."

 

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