Tag Archive for Point of Care

Two Different Point-of-Care Test Devices for Malaria

Two Different Point-of-Care Test Devices for Malaria Show Why Emerging Technologies Can Be Disruptive to Clinical Pathology Laboratories

wo new handheld, point-of-care test (POC) devices for malaria  could save millions of lives in third-world countries. At the same time, these POC devices may lead to inexpensive alternatives for diagnosing common diseases in developed nations as well.

Clinical laboratory test developers see a big opportunity in developing assays to detect Malaria. That is because an estimated 200 million cases of malaria are diagnosed annually, resulting in the death of about 100 million people each year.

Recently, two organizations released news about the specific testing devices they have developed to detect malaria. One group is at the University of Washington in Seattle, Washington. The other group is NanoMal, a biotechnology company located in the United Kingdom.

UW-device
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Emerging Nucleic Acid-Based Tests for Point-of-Care Detection in low-resource setting.

The Am. J. Trop. Med. Hyg. published a Review entitled: Emerging Nucleic Acid-Based Tests for Point-of-Care Detection of Malaria.
According to the review, Point-of-Care (POC) amplification techniques such as NASBA and, in particular LAMP, will have important benefits for their potential utility in low-resource settings. Real-time PCR based techniques, however, have some major drawbacks to be used at POC: it requires sophisticated temperature and fluorescence detection systems.

Recently I had a conversation with a ‘biohacker’. Together with two others they build at home a PCR device (Amplino) including LED and detector, costing around €50,-. Their vision is to deliver affordable, easy to use malaria diagnostic POC test to the developing world.

Such closed tube PCR devices could work out for malaria, but perhaps also for leishmaniasis, sleeping sickness or even viral hemorrhagic fevers. Even more, by making use of the sensitive detection levels, it might be sufficient to collect specimens by non-invasive methods. For example, instead of performing lumbal punctures or drawing blood, the diagnosis might also be performed on bodily secretions.

How would a POC PCR-device be used in practice? The device will need a power source and an interface to validate the collected data. Most of the power is used for temperature control. Rechargeable batteries are not recommended because they are expensive and they might be depleted before the analysis is complete. A more sustainable power source would be from car-batteries. Either the POC-PCR device is directly connected to the battery under the hood or to a separate battery that can be recharged for example by using a solar panel.

Point of Care PCR

anaconda_v2An interface interprets the raw data (the detected excited light from a probe) and presents all the necessary information to the user. For validating the results, the interface needs to present sample identification, a graphical view of the amplification data, a Cycle treshold value and overview of the controls. The interface can be installed as a software package on a laptop. The laptop is directly connected to the PCR-device. A disadvantage is that all the patient- and analysis data is stored on the laptop, which is prone to theft and defective hard disks. An alternative is to send the raw data directly from the PCR-device by the mobile or satellite network to an internet-server. Using a web-based application, the data can be accessed via a web-browser on your mobile phone or tablet. The data is securely stored and accessible by multiple users.

Slowly the advances in molecular diagnostics are moving towards the rapid developments in information technology. Launching a PCR device that can be used in the middle of nowhere, that would be an invention that would leave all other POC tests miles behind. It would be not only a profit for medical diagnostics. The POC PCR devices can be applied for example phytopathology, water-treatment and veterinary outbreak-control.

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