| Limit of Detection | 1 copy in the reaction is detected within 38 cycles |
| Sensitivity | 100%† |
| Specificity | 100%† |
| Sample Type | Whole Blood (EDTA or Sodium Citrate) |
| Malaria Genotype Detection | Designed to detect all genotypes, validated on P. falciparum, P. vivax, P. knowlesi, P. fragile, P.simium, P. brasilianum, P. cynomolgi bastianellii, P. cynomolgi. |
| Time to Detection | 30 – 50 minutes, depending on the machine used |
| Thermocycler Compatibility | Spartan Dx-12, AB StepOne, AB 7000, AB 7500, BioRad CFx96, LightCycler 2.0 and most other machines with a FAM channel |
† Malaria was validated for sensitivity and specificity on a panel of 96 clinical samples. 12 high concentration and 12 low concentration samples containing Plasmodium sp. genetic material were spiked randomly into 96 nucleic acid samples extracted from Plasmodium sp. negative blood. The Malaria test had 100% sensitivity and 100% specificity in this blinded study. Thus the sensitivity of Malaria is estimated at 100% when circulating virus is present in the sample and the specificity is estimated at 100%.
Malaria Linearity
Order of magnitude dilutions of Plasmodium sp. genetic material were made from 600,000 copies to 60 copies and the cycle thresholds were recorded for each. The results were plotted to show linearity and the cycle at which 1 copy can be detected.
Malaria Sensitivity and Specificity
Malaria was validated for sensitivity and specificity on two different panels of 48 clinical samples (96 total). 12 high concentration and 12 low concentration samples containing Plasmodium sp. genetic material were spiked randomly into the 96 nucleic acid samples extracted from Plasmodium sp. negative blood. The Malaria test had 100% sensitivity and 100% specificity in this blinded study.
Malaria Genotype Detection
Using a world-wide panel of Plasmodium species provided by MR4/American Type Culture Collection, Malaria was able to detect 100% of the strains, including P. falciparum, P. vivax, P. knowlesi, P. fragile, P.simium, P. brasilianum, P. cynomolgi bastianellii, P. cynomolgi.
Design
The Malaria test incorporates the fifth and most advanced iteration of real-time PCR probe technologies, Rapid Probes, which have been shown to be faster than Tentacle Probes and Molecular Beacons. All assays are designed with proprietary bioinformatics algorithms against variants of pathogen from all over the world, insuring the assays will detect not only those strains that exist today, but also those strains that will appear in the future.
