Reliable Malaria Diagnostics

While often considered a tropical disease, Malaria remains a persistent global health threat with increasing relevance in the United States and Europe predominantly due to travel and regions with climate that supports growing mosquito populations. Recent cases of locally acquired malaria in the US (Florida, Texas, Maryland and Arkansas) and Europe highlight the urgent need for rapid and accurate diagnostics.^1,2,3 For efficient identification of P. falciparum, P. vivax and screening of 28* additional Plasmodium species, BioGX offers the Plasmodium spp., P. falciparum, P. vivax Multiplex Sample-Ready™ lyophilized reagents (BioGX REF 450-032-Series) compatible with ABI QuantiStudio™ Series, Bio-Rad CFX Series and BD MAX™ system.

A brief overview of clinical manifestations and testing approaches are defined below to highlight the importance of rapid real-time PCR diagnostics for suspected cases of travel-associated and locally acquired malaria. Speed of diagnosis allows for the immediate differentiation of the predominant species (i.e, P. falciparum and P. vivax) to improve patient outcomes.⁴

Diagnostic Strategies

Plasmodium falciparum is the most dangerous malaria species, responsible for the vast majority of malaria deaths globally. While historically concentrated in sub-Saharan Africa, it accounts for a significant portion of imported cases in Europe and the US.^5,6. In 2023, the US reported its first locally acquired malaria cases in two decades, underscoring the risk. Clinical manifestations can rapidly progress to severe anemia, cerebral malaria, and multi-organ failure. Rapid molecular testing is critical to improve patient outcomes.⁷

Plasmodium vivax is the dominant malaria parasite in most of Asia and the Americas.^8,9 Unlike P. falciparum, P. vivax can form dormant liver stages (hypnozoites) that cause relapses months or years after the initial infection.¹⁰ This poses a unique diagnostic challenge, as patients may present long after travel has ended. Accurate identification is required to improve patient outcomes.

Surveillance & Introduction to Non-Endemic Regions

From the 1500-1800, malaria was introduced to the New World via slave trade and eradication efforts within the United States spanned from the 1930-1940’s.¹¹ Within Europe, paleomicrobiology traced malaria to the 1st century and eradication was completed in the 1970’s.¹² The re-introduction of malaria into the United States and Europe has been driven by travel-related cases and now requires rapid surveillance tools in addition to diagnostics . The versatility of compatible testing platforms for the BioGX Plasmodium spp., P. falciparum, P. vivax Multiplex assay supports applications for clinical testing and environmental surveillance.

Current diagnostic tests for Plasmodium species:

• Microscopy
• Antigen Tests
• PCR

Recent Advances in Diagnostic Sensitivity

A recent publication from Lima et al. 2026¹³ at UCLA Health using the the BioGX Sample-Ready™ Plasmodium spp., P. falciparum, P.vivax Open System Reagent for the BD MAX™ System demonstrated superior diagnostic when compared to the gold standard, blood smear microscopic analysis. Specificity and sensitivity achieved a limit of detection (LoD) of 0.0001% parasitemia for Plasmodium falciparum, P. malariae, P. ovale, and P. vivax, making the assay 100 times more sensitive than microscopic blood smear examination. Additionally, the study demonstrates the semi-quantitative malaria assay improves patient outcomes by extending treatment monitoring for 8 days after parasitemia becomes undetectable via blood smear microscopy.

*Plasmodium spp. in-silico inclusivity

References

1. Naji, H. S. (2024). Locally acquired malaria in the United States. European Journal of Medical and Health Sciences, 6(1), 97-106.
2. Centers for Disease Control and Prevention (CDC). (2023). Locally Acquired Malaria Cases Identified in the United States. Health Alert Network (HAN) Advisory CDCHAN-00494.
3. Delamare, H., Tarantola, A., Thellier, M., Calba, C., Gaget, O., Consigny, P. H., Simard, F., Manguin, S., Brottet, E., Paty, M. C., Houze, S., De Valk, H., & Noël, H. (2024). Locally acquired malaria: a retrospective analysis of long-term surveillance data, European France, 1995 to 2022. Euro surveillance : bulletin Européen sur les maladies transmissibles = European communicable disease bulletin, 29(41), 2400133.
4. Abba, K., Deeks, J. J.(2011). Rapid diagnostic tests for diagnosing uncomplicated P. falciparum malaria in endemic countries. The Cochrane database of systematic reviews, 2011(7), CD008122.
5. Muentener, P., Schlagenhauf, P., & Steffen, R. (1999). Imported malaria (1985-95): trends and perspectives. Bulletin of the World Health Organization, 77(7), 560.
6. Alenou, L. D., & Etang, J. (2021). Airport Malaria in Non-Endemic Areas: New Insights into Mosquito Vectors, Case Management and Major Challenges. Microorganisms, 9(10), 2160.
7. Centers for Disease Control and Prevention (CDC). (2023). Guidelines for Treatment of Malaria in the United States. Clinicians Guide.
8. World Health Organization. (2022). World malaria report 2022. World Health Organization.
9. Howes, R. E., Battle, K. E., Mendis, K. N., Smith, D. L., Cibulskis, R. E., Baird, J. K., & Hay, S. I. (2016). Global epidemiology of Plasmodium vivax. The American journal of tropical medicine and hygiene, 95(6 Suppl), 15.
10. Flannery, E. L., Kangwanrangsan, N., Chuenchob, V., Roobsoong, W., Fishbaugher, M., Zhou, K., Billman, Z. P., Martinson, T., Olsen, T. M., Schäfer, C., Campo, B., Murphy, S. C., Mikolajczak, S. A., Kappe, S. H. I., & Sattabongkot, J. (2022). Plasmodium vivax latent liver infection is characterized by persistent hypnozoites, hypnozoite-derived schizonts, and time-dependent efficacy of primaquine. Molecular therapy. Methods & clinical development, 26, 427–440.
11. American Society of Microbiology (ASM). (2023). The History of Malaria in the United States.
12. Boualam, M. A., Pradines, B., Drancourt, M., & Barbieri, R. (2021). Malaria in Europe: A Historical Perspective. Frontiers in medicine, 8, 691095.
13. Lima, A., Gonzalez-Ferrer, S., Kwon, S., Garner, O. B., & Yang, S. (2026). Validation of a Semi-Quantitative Real-Time PCR Assay for Malaria Diagnosis and Treatment Monitoring. The Journal of Molecular Diagnostics.

Disclaimer: Information in this blog is provided for educational and informational purposes only. It is not intended to provide diagnostic or treatment recommendations. Readers are encouraged to consult appropriate scientific and public health sources.