6 June 2019

In BMC Medicine Annelies Post, Berenger Kaboré, Isaie Reuling and colleagues described a new method of malaria detection using whole blood; the XN-30 is a new automated hematology analyzer which simultaneously provides a complete blood count and quantification of parasitemia, allowing rapid treatment of malaria and malaria associated anemia. It can also reliably be used for follow-up of treatment response.

Background
Accurate and timely diagnosis of malaria is essential for disease management and surveillance. Thin and thick blood smear microscopy and malaria rapid diagnostic tests (RDTs) are standard malaria diagnostics, but both methods have limitations. The novel automated hematology analyzer XN-30 provides standard complete blood counts (CBC) as well as quantification of malaria parasitemia at the price of a CBC. This study assessed the accuracy of XN-30 for malaria detection in a controlled human malaria infection (CHMI) study and a phase 3 diagnostic accuracy study in Burkina Faso.

Methods
Sixteen healthy, malaria-naive CHMI participants were challenged with five Plasmodium falciparum-infected mosquitoes. Blood was sampled daily for XN-30, blood smear microscopy, and malaria qPCR. The accuracy study included patients aged > 3 months presenting with acute febrile illness. XN-30, microscopy, and rapid diagnostic tests (HRP-2/pLDH) were performed on site; qPCR was done in retrospect. The malaria reference standard was microscopy, and results were corrected for sub-microscopic cases.

Results
All CHMI participants became parasitemic by qPCR and XN-30 with a strong correlation for parasite density (R2 = 0.91; p < .0001). The XN-30 accurately monitored treatment and allowed detection of recrudescence. Out of 908 patients in the accuracy study, 241 had microscopic malaria (density 24-491,802 parasites/μL). The sensitivity and specificity of XN-30 compared to microscopy were 98.7% and 99.4% (PPV = 98.7%, NPV = 99.4%). Results were corrected for qPCR-confirmed sub-microscopic cases. Three microscopy-confirmed cases were not detected by XN-30. However, XN-30 detected 19/134 (14.2%) qPCR-confirmed cases missed by microscopy. Among qPCR-confirmed cases, XN-30 had a higher sensitivity (70.9% versus 66.4%; p = .0009) and similar specificity (99.6% versus 100%; p = .5) as microscopy. The accuracy of XN-30 for microscopic malaria was equal to or higher than HRP-2 and pLDH RDTs, respectively.

Conclusions
The XN-30 is a novel, automated hematology analyzer that combines standard hemocytometry with rapid, objective, and robust malaria detection and quantification, ensuring prompt treatment of malaria and malaria anemia and follow-up of treatment response.

Trial registration
Both trials were registered on clinicaltrials.gov with respective identifiers NCT02836002 (CHMI trial) and NCT02669823 (diagnostic accuracy study).

Publication
The XN-30 hematology analyzer for rapid sensitive detection of malaria: a diagnostic accuracy study.
Post A, Kaboré B, Reuling IJ, Bognini J, van der Heijden W, Diallo S, Lompo P, Kam B, Herssens N, Lanke K, Bousema T, Sauerwein RW, Tinto H, Jacobs J, de Mast Q, van der Ven AJ.

Annelies Post and Isaie Reuling are members of theme Infectious diseases and global health.

Related news items


Bart van de Warrenburg appointed visiting professor at the UKM Medical Centre in Kuala Lumpur

11 November 2019

Neurologist and Principal Investigator at the Donders Institute Bart van de Warrenburg has been appointed visiting professor at the UKM Medical Centre in Kuala Lumpur.

read more

KNAW Van Leersum beurs for Mohammad Alsady

7 November 2019

Mohammad Alsady, theme Disorders of movement, received the “KNAW Van Leersum beurs”.

read more

3D breast ultrasound elastography to improve breast cancer detection

5 November 2019

One out of seven women will be diagnosed with breast cancer during their life. Early detection of breast cancer is important to increase the survival rate. Gijs Hendriks graduated recently on a new technique, 3D elastography, to detect breast cancer better.

read more

Self-management rehabilitation program improves participation in patients with neuromuscular disease

4 November 2019

Yvonne Veenhuizen, Alexander Geurts theme Neurorehabilitation, Baziel van Engelen, theme Disorders of movement, and colleagues, showed that Energetic improves participation in patients with neuromuscular disease. They have published their results in Neurology.

read more

New NFU eBROK® course open for registration

1 November 2019

This platform is not only for researchers who want to obtain their BROK® certificate, but also for researchers who already have a BROK® certificate and want to keep their certification (re-certification).

read more

Emily Klooster wins the NVZF incentive prize

31 October 2019

For the second year in a row, a PhD candidate from the Allied Health Sciences group of IQ Healthcare (RIHS), has won the "Dutch Association for Physiotherapists in the Hospital" incentive prize.

read more